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Ebilfumin (oseltamivir) – Package leaflet - J05AH02

Updated on site: 06-Oct-2017

Medication nameEbilfumin
ATC CodeJ05AH02
Substanceoseltamivir
ManufacturerActavis Group PTC ehf

Package Leaflet: Information for the user

Ebilfumin 30 mg hard capsules oseltamivir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Ebilfumin is and what it is used for

2.What you need to know before you take Ebilfumin

3.How to take Ebilfumin

4.Possible side effects

5.How to store Ebilfumin

6.Contents of the pack and other information

1.What Ebilfumin is and what it is used for

Ebilfumin is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.

Ebilfumin can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.

Ebilfumin may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.

Ebilfumin contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection.

Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.

2. What you need to know before you take Ebilfumin

Do not take Ebilfumin:

if you are allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor if this applies to you. Do not take Ebilfumin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebilfumin.

Before you take Ebilfumin, make sure the prescribing doctor knows

if you are allergic to other medicines

if you have problems with your kidneys. If so, your dose may need adjustment

if you have a severe medical condition, which may require immediate hospitalisation

if your immune system is not working

if you have chronic heart disease or respiratory disease.

During treatment with Ebilfumin, tell a doctor immediately:

if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.

Ebilfumin is not a flu vaccine

Ebilfumin is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Ebilfumin will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.

Other medicines and Ebilfumin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. The following medicines are particularly important:

chlorpropamide (used to treat diabetes)

methotrexate (used to treat e.g. rheumatoid arthritis)

phenylbutazone (used to treat pain and inflammation)

probenecid (used to treat gout)

Pregnancy and breast-feeding

You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Ebilfumin is right for you.

The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Ebilfumin is right for you.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ebilfumin has no effect on your ability to drive or use machines.

3.How to take Ebilfumin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take Ebilfumin as soon as possible, ideally within two days of the flu symptoms starting.

The recommended doses

For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5-day course, even if you start to feel better quickly.

For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It is best to take this in the mornings with breakfast.

In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.

The recommended dose is based on the patient’s body weight. You must use the amount of oral capsules or suspension prescribed by the doctor.

Adults and adolescents 13 years and over

Body weight

Treating flu:

Preventing flu:

 

dose for 5 days

dose for 10 days

40 kg or more

75 mg twice daily

75 mg once daily

75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

 

Children 1 to 12 years

 

 

Body weight

Treating flu:

Preventing flu:

 

dose for 5 days

dose for 10 days

10 to 15 kg

30 mg twice daily

30 mg once daily

More than 15 kg and up to 23 kg

45 mg twice daily

45 mg once daily

More than 23 kg and up to 40 kg

60 mg twice daily

60 mg once daily

More than 40 kg

75 mg twice daily

75 mg once daily

75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

Infants less than 1 year (0 to 12 months)

Giving Ebilfumin to infants less than 1 year old for preventing flu during a flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.

Body weight

Treating flu:

Preventing flu:

 

dose

dose

 

for 5 days

for 10 days

3 kg to 10+ kg

3 mg per kg body

3 mg per kg,

 

weight, twice daily

once daily

mg per kg = mg for each kilogram of the infant’s body weight. For example: If a 6-month-old weighs 8 kg, the dose is

8 kg x 3mg per kg = 24 mg

Method of administration

Swallow the capsules whole with water. Do not break or chew the capsules.

Ebilfumin can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).

People who find it hard to take capsules can use a liquid form of this medicine (oral suspension). If you need an oral suspension but it’s not available from your pharmacy, you can make a liquid form of Ebilfumin from these capsules. See Making Liquid Ebilfumin at home for instructions.

If you take more Ebilfumin than you should

Stop taking Ebilfumin and contact a doctor or pharmacist immediately.

In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4.

Overdose has been reported to have occurred more frequently when oseltamivir was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Ebilfumin for children and when administering Ebilfumin capsules or liquid Ebilfumin to children.

If you forget to take Ebilfumin

Do not take a double dose to make up for a forgotten capsule.

If you stop taking Ebilfumin

There are no side effects when you stop Ebilfumin. But if Ebilfumin is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza.

The following serious side effects have been rarely reported since oseltamivir has been marketed:

Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties

Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour

Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing

Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life- threatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure

Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood

Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, get medical help immediately.

The most frequently (very common and common) reported side effects of Ebilfumin are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food.

Rare but serious effects: get medical help at once

(These may affect up to 1 in 1,000 people)

During oseltamivir treatment, rare events have been reported that include

Convulsions and delirium, including altered level of consciousness

Confusion, abnormal behaviour

Delusions, hallucinations, agitation, anxiety, nightmares

These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking oseltamivir.

Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.

If you notice any of these symptoms, especially in younger people, get medical help immediately.

Adults and adolescents 13 and over

Very common side effects

(may affect more than 1 in 10 people)

Headache

Nausea.

Common side effects

(may affect up to 1 in 10 people)

Bronchitis

Cold sore virus

Cough

Dizziness

Fever

Pain

Pain in limb

Runny nose

Sleeping difficulties

Sore throat

Stomach ache

Tiredness

Upper abdominal fullness

Upper respiratory tract infections (inflammation of the nose, throat and sinuses)

Upset stomach

Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

Allergic reactions

Altered level of consciousness

Convulsion

Heart rhythm abnormalities

Mild to severe liver function disorders

Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).

Rare side effects

(may affect up to 1 in 1,000 people)

Thrombocytopenia (low platelet count)

Visual disturbances.

Children 1 to 12 years

Very common side effects

(may affect more than 1 in 10 people)

Cough

Nasal congestion

Vomiting.

Common side effects

(may affect up to 1 in 10 people)

Conjunctivitis (red eyes and discharge or pain in the eye)

Ear inflammation and other ear disorders

Headache

Nausea

Runny nose

Stomach ache

Upper abdominal fullness

Upset stomach.

Uncommon side effects

(may affect up to 1 in 100 people)

Inflammation of the skin

Tympanic membrane (eardrum) disorder.

Infants less than 1 year

The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and nappy rash have been reported.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. However,

if you or your child are repeatedly sick, or

if the influenza symptoms get worse or the fever continues tell your doctor as soon as possible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Ebilfumin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store below 25 C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ebilfumin contains

-Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.

-The other ingredients are:

capsule contents: pregelatinized starch (derived from maize starch), talc, povidone (K-29/32), croscarmellose sodium, sodium stearyl fumarate

capsule shell: gelatin, yellow iron oxide (E172) and titanium dioxide (E171)

printing ink: shellac glaze-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide 28% (E527)

What Ebilfumin looks like and contents of the pack

The hard capsule consists of a rich yellow body and cap bearing the black imprint “OS 30”. Capsule size: 4.

Ebilfumin 30 mg hard capsules are available in blister packs or tablet containers of 10.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78,

220 Hafnarfjörður

Iceland

Manufacturer

Actavis ehf.

Reykjavíkurvegur 78,

IS-220 Hafnarfjörður

Iceland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Actavis Group PTC ehf.

UAB "Sicor Biotech"

IJsland / Islande / Island

Tel: +370 5 266 0203

България

Luxembourg/Luxemburg

Актавис ЕАД

Actavis Group PTC ehf.

Teл.: +359 2 489 95 85

Islande / Island

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel.: +36 1 288 6400

Danmark

Malta

Teva Denmark A/S

Actavis Ltd.

Tlf: +45 44 98 55 11

Tel: +35621693533

Deutschland

Nederland

Actavis Group PTC ehf.

Actavis Group PTC ehf.

Island

IJsland

Eesti

Norge

UAB "Sicor Biotech" Eesti filiaal

Teva Norway AS

Tel: +372 661 0801

Tlf: +47 66 77 55 90

Ελλάδα

Österreich

Specifar ΑΒΕΕ

Actavis GmbH

Τηλ: +30 210 5401500

Tel: +43 (0)662 435 235 00

España

Polska

Actavis Group PTC ehf.

Actavis Export Int. Ltd., Malta.

Islandia

Kontakt w Polsce:

 

Tel.: (+48 22) 512 29 00

France

Portugal

TEVA SANTE

Actavis Group PTC ehf.

Tél: +33 1 55 91 78 00

Islândia

Hrvatska

România

Pliva Hrvatska d.o.o.

Teva Pharmaceuticals S.R.L

Tel: +385 1 37 20 000

Tel: +4021 230 65 24

Ireland

Slovenija

Actavis Ireland Limited

Pliva Ljubljana d.o.o.

Tel: + 353 (0)21 4619040

Tel: +386 1 58 90 390

Ísland

Slovenská republika

Actavis Group PTC ehf.

TEVA Pharmaceuticals Slovakia s.r.o

Sími: +354 550 3300

Tel: +421 2 57 26 79 11

Italia

Suomi/Finland

Actavis Group PTC ehf.

ratiopharm Oy

Islanda

Puh/Tel: +358 (0)20 180 5900

Κύπρος

Sverige

Specifar ABEE

Teva Sweden AB

Τηλ: +30 210 5401500

+46 42 12 11 00

Ελλάδα

 

Latvija

United Kingdom

UAB "Sicor Biotech" filiāle Latvijā

Actavis UK Limited

Tel.: +371 673 23 666

Tel: +44 1271 385257

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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Information for the user

For people who find it hard to take capsules, including very young children, a liquid medicine may be available.

If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy from Ebilfumin capsules (see Information for healthcare professionals). This pharmacy preparation is the preferred option.

If the pharmacy preparation is not available either, you can make Ebilfumin suspension from these capsules at home.

The dose is the same for treating or preventing flu. The difference is how often it is given.

Making Liquid Ebilfumin at home

If you have the right capsule for the dose needed (a 30 mg or a 60 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. This is usually suitable for children over 1 year. See the upper set of instructions.

If you need smaller doses, making Ebilfumin suspension from capsules involves extra steps. This is suitable for younger children and babies: they usually need an Ebilfumin dose of less than 30 mg. See the lower set of instructions.

Children 1 to 12 years

To make a 30 mg or a 60 mg dose, you need:

One or two 30 mg Ebilfumin capsule(s)

Sharp scissors

One small bowl

Teaspoon (5 ml spoon)

Water

Sweet food to hide the bitter taste of the powder.

Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check the dose is correct

To find the correct amount to use, find the patient’s weight on the left of the table.

Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.

You should use only 30 mg capsules for 30 mg and 60 mg doses. Do not try to make a 45 mg or 75 mg dose by using the contents of 30 mg capsules. Use the appropriate size capsule instead.

Weight

Dose of Ebilfumin

Number of capsules

Up to 15 kg

30 mg

1 capsule

15 kg up to 23 kg

45 mg

Do not use 30 mg capsules

23 kg up to 40 kg

60 mg

2 capsules

Step 2: Pour all the powder into a bowl

Hold a 30 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors. Pour all of the powder into the bowl.

Open a second capsule for a 60 mg dose. Pour all of the powder into the bowl. Be careful with the powder, because it may irritate your skin and eyes.

Step 3: Sweeten the powder and give the dose

Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl. This is to hide the bitter taste of the Ebilfumin powder.

Stir the mixture well.

Give the whole contents of the bowl to the patient straight away.

If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.

Repeat this procedure every time you need to give the medicine.

Infants less than 1 year

To make a smaller single dose, you need:

One 30 mg Ebilfumin capsule

Sharp scissors

Two small bowls (use separate pairs of bowls for each child)

One large oral dose dispenser to measure out water – a 5 or 10 ml dispenser

One small oral dose dispenser showing measurements of 0.1 ml, to give the dose

Teaspoon (5 ml spoon)

Water

Sweet food to hide the bitter taste of the Ebilfumin.

Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce.

Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a bowl

Hold a 30 mg capsule upright over one of the bowls and carefully snip off the rounded tip with scissors. Be careful with the powder: it may irritate your skin and eyes.

Pour all of the powder into the bowl, whatever the dose you are making. The amount is the same whether you are treating or preventing flu.

Step 2: Add water to dilute the medicine

Use the larger dispenser to draw up 5 ml water.

Add the water to the powder in the bowl.

Stir the mixture with the teaspoon for about 2 minutes.

Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive ingredients.

Step 3: Choose the correct amount for your child’s weight

Look up the child’s weight on the left side of the table.

The column on the right of the table shows how much of the liquid mixture you will need to draw up.

Infants less than 1 year (including full-term newborn babies)

Child’s weight

How much mixture

(nearest)

to draw up

3 kg

1.5 ml

3.5 kg

1.8 ml

4 kg

2.0 ml

4.5 kg

2.3 ml

5 kg

2.5 ml

5.5 kg

2.8 ml

6 kg

3.0 ml

6.5 kg

3.3 ml

7 kg

3.5 ml

7.5 kg

3.8 ml

8 kg

4.0 ml

8.5 kg

4.3 ml

 

9 kg

4.5 ml

9.5 kg

4.8 ml

10 kg or more

5.0 ml

Step 4: Draw up the liquid mixture

Make sure you have the right size dispenser.

Draw up the correct amount of liquid mixture from the first bowl.

Draw it up carefully so as not to include air bubbles.

Gently squirt the correct dose into the second bowl.

Step 5: Sweeten and give to the child

Add a small amount – no more than one teaspoonful – of a sweet food to the second bowl. This is to hide the bitter taste of the Ebilfumin.

Mix the sweet food and Ebilfumin suspension well.

Give the whole contents of the second bowl (Ebilfumin suspension with sweet food added) to the child straight away.

If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid.

Give the child something to drink.

Throw away any unused liquid left in the first bowl.

Repeat this procedure every time you need to give the medicine.

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Information for healthcare professionals only

Patients who are unable to swallow capsules:

Commercially manufactured oseltamivir powder for oral suspension (6 mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed. In the event that oseltamivir powder for oral suspension is not available, the pharmacist may compound a suspension (6 mg/ml) from Ebilfumin capsules. If the pharmacy compounded suspension is also not available, patients may prepare the suspension from capsules at home.

Oral dose dispensers (oral syringes) of appropriate volume and grading should be provided for administering the pharmacy compounded suspension, and for the procedures involved in the home preparation. In both cases, the correct volumes should preferably be marked on the dispensers. For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Ebilfumin-water mixture. For measuring 5.0 ml of water, dispensers of 5 ml or 10 ml should be used.

The appropriate dispenser sizes for taking the correct volume of Ebilfumin suspension (6 mg/ml) are shown below.

Infants less than 1 year (including full-term newborn babies):

 

Amount of Ebilfumin

Dispenser size to use

Dose of Ebilfumin

suspension

(grading 0.1 ml)

9 mg

1.5 ml

2.0 ml (or 3.0 ml)

10 mg

1.7 ml

2.0 ml (or 3.0 ml)

11.25 mg

1.9 ml

2.0 ml (or 3.0 ml)

12.5 mg

2.1 ml

3.0 ml

13.75 mg

2.3 ml

3.0 ml

15 mg

2.5 ml

3.0 ml

16.25 mg

2.7 ml

3.0 ml

18 mg

3.0 ml

3.0 ml (or 5.0 ml)

19.5 mg

3.3 ml

5.0 ml

21 mg

3.5 ml

5.0 ml

22.5 mg

3.8 ml

5.0 ml

24 mg

4.0 ml

5.0 ml

25.5 mg

4.3 ml

5.0 ml

27 mg

4.5 ml

5.0 ml

28.5 mg

4.8 ml

5.0 ml

30 mg

5.0 ml

5.0 ml

Package Leaflet: Information for the user

Ebilfumin 45 mg hard capsules oseltamivir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Ebilfumin is and what it is used for

2.What you need to know before you take Ebilfumin

3.How to take Ebilfumin

4.Possible side effects

5.How to store Ebilfumin

6.Contents of the pack and other information

1. What Ebilfumin is and what it is used for

Ebilfumin is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.

Ebilfumin can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.

Ebilfumin may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.

Ebilfumin contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection.

Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.

2. What you need to know before you take Ebilfumin

Do not take Ebilfumin:

if you are allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor if this applies to you. Do not take Ebilfumin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebilfumin.

Before you take Ebilfumin, make sure the prescribing doctor knows

if you are allergic to other medicines

if you have problems with your kidneys. If so, your dose may need adjustment

if you have a severe medical condition, which may require immediate hospitalisation

if your immune system is not working

if you have chronic heart disease or respiratory disease.

During treatment with Ebilfumin, tell a doctor immediately:

if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.

Ebilfumin is not a flu vaccine

Ebilfumin is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Ebilfumin will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.

Other medicines and Ebilfumin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. The following medicines are particularly important:

chlorpropamide (used to treat diabetes)

methotrexate (used to treat e.g. rheumatoid arthritis)

phenylbutazone (used to treat pain and inflammation)

probenecid (used to treat gout)

Pregnancy and breast-feeding

You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Ebilfumin is right for you.

The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Ebilfumin is right for you.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ebilfumin has no effect on your ability to drive or use machines.

3. How to take Ebilfumin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take Ebilfumin as soon as possible, ideally within two days of the flu symptoms starting.

The recommended doses

For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5-day course, even if you start to feel better quickly.

For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It is best to take this in the mornings with breakfast.

In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.

The recommended dose is based on the patient’s body weight. You must use the amount of oral capsules or suspension prescribed by the doctor.

Adults and adolescents 13 years and over

Body weight

Treating flu:

Preventing flu:

 

dose for 5 days

dose for 10 days

40 kg or more

75 mg twice daily

75 mg once daily

75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

 

Children 1 to 12 years

 

 

Body weight

Treating flu:

Preventing flu:

 

dose for 5 days

dose for 10 days

10 to 15 kg

30 mg twice daily

30 mg once daily

More than 15 kg and up to 23 kg

45 mg twice daily

45 mg once daily

More than 23 kg and up to 40 kg

60 mg twice daily

60 mg once daily

More than 40 kg

75 mg twice daily

75 mg once daily

75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

Infants less than 1 year (0 to 12 months)

Giving Ebilfumin to infants less than 1 year old for preventing flu during a flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.

Body weight

Treating flu:

Preventing flu:

 

dose

dose

 

for 5 days

for 10 days

3 kg to 10+ kg

3 mg per kg body

3 mg per kg,

 

weight, twice daily

once daily

mg per kg = mg for each kilogram of the infant’s body weight. For example: If a 6-month-old weighs 8 kg, the dose is

8 kg x 3mg per kg = 24 mg

Method of administration

Swallow the capsules whole with water. Do not break or chew the capsules.

Ebilfumin can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).

People who find it hard to take capsules can use a liquid form of this medicine (oral suspension). If you need an oral suspension but it’s not available from your pharmacy, you can make a liquid form of Ebilfumin from these capsules. See Making Liquid Ebilfumin at home for instructions.

If you take more Ebilfumin than you should

Stop taking Ebilfumin and contact a doctor or pharmacist immediately.

In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4.

Overdose has been reported to have occurred more frequently when oseltamivir was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Ebilfumin for children and when administering Ebilfumin capsules or liquid Ebilfumin to children.

If you forget to take Ebilfumin

Do not take a double dose to make up for a forgotten capsule.

If you stop taking Ebilfumin

There are no side effects when you stop Ebilfumin. But if Ebilfumin is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza.

The following serious side effects have been rarely reported since oseltamivir has been marketed:

Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties

Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour

Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing

Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life- threatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure

Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood

Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, get medical help immediately.

The most frequently (very common and common) reported side effects of Ebilfumin are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food.

Rare but serious effects: get medical help at once

(These may affect up to 1 in 1,000 people)

During oseltamivir treatment, rare events have been reported that include

Convulsions and delirium, including altered level of consciousness

Confusion, abnormal behaviour

Delusions, hallucinations, agitation, anxiety, nightmares

These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking oseltamivir.

Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.

If you notice any of these symptoms, especially in younger people, get medical help immediately.

Adults and adolescents 13 and over

Very common side effects

(may affect more than 1 in 10 people)

Headache

Nausea.

Common side effects

(may affect up to 1 in 10 people)

Bronchitis

Cold sore virus

Cough

Dizziness

Fever

Pain

Pain in limb

Runny nose

Sleeping difficulties

Sore throat

Stomach ache

Tiredness

Upper abdominal fullness

Upper respiratory tract infections (inflammation of the nose, throat and sinuses)

Upset stomach

Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

Allergic reactions

Altered level of consciousness

Convulsion

Heart rhythm abnormalities

Mild to severe liver function disorders

Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).

Rare side effects

(may affect up to 1 in 1,000 people)

Thrombocytopenia (low platelet count)

Visual disturbances.

Children 1 to 12 years

Very common side effects

(may affect more than 1 in 10 people)

Cough

Nasal congestion

Vomiting.

Common side effects

(may affect up to 1 in 10 people)

Conjunctivitis (red eyes and discharge or pain in the eye)

Ear inflammation and other ear disorders

Headache

Nausea

Runny nose

Stomach ache

Upper abdominal fullness

Upset stomach.

Uncommon side effects

(may affect up to 1 in 100 people)

Inflammation of the skin

Tympanic membrane (eardrum) disorder.

Infants less than 1 year

The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and nappy rash have been reported.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. However,

if you or your child are repeatedly sick, or

if the influenza symptoms get worse or the fever continues tell your doctor as soon as possible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ebilfumin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store below 25 C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ebilfumin contains

-Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.

-The other ingredients are:

capsule contents: pregelatinized starch (derived from maize starch), talc, povidone (K-29/32), croscarmellose sodium, sodium stearyl fumarate

capsule shell: gelatin, titanium dioxide (E171)

printing ink: shellac glaze-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide 28% (E527)

What Ebilfumin looks like and contents of the pack

The hard capsule consists of a white opaque body and cap bearing the black imprint “OS 45”. Capsule size: 4.

Ebilfumin 45 mg hard capsules are available in blister packs or tablet containers of 10.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður Iceland

Manufacturer

Actavis ehf.

Reykjavíkurvegur 78,

IS-220 Hafnarfjörður

Iceland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Actavis Group PTC ehf.

UAB "Sicor Biotech"

IJsland / Islande / Island

Tel: +370 5 266 0203

България

Luxembourg/Luxemburg

Актавис ЕАД

Actavis Group PTC ehf.

Teл.: +359 2 489 95 85

Islande / Island

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel.: +36 1 288 6400

Danmark

Malta

Teva Denmark A/S

Actavis Ltd.

Tlf: +45 44 98 55 11

Tel: +35621693533

Deutschland

Nederland

Actavis Group PTC ehf.

Actavis Group PTC ehf.

Island

IJsland

Eesti

Norge

UAB "Sicor Biotech" Eesti filiaal

Teva Norway AS

Tel: +372 661 0801

Tlf: +47 66 77 55 90

Ελλάδα

Österreich

Specifar ΑΒΕΕ

Actavis GmbH

Τηλ: +30 210 5401500

Tel: +43 (0)662 435 235 00

España

Polska

Actavis Group PTC ehf.

Actavis Export Int. Ltd., Malta.

Islandia

Kontakt w Polsce:

 

Tel.: (+48 22) 512 29 00

France

Portugal

TEVA SANTE

Actavis Group PTC ehf.

Tél: +33 1 55 91 78 00

Islândia

Hrvatska

România

Pliva Hrvatska d.o.o.

Teva Pharmaceuticals S.R.L

Tel: +385 1 37 20 000

Tel: +4021 230 65 24

Ireland

Slovenija

Actavis Ireland Limited

Pliva Ljubljana d.o.o.

Tel: + 353 (0)21 4619040

Tel: +386 1 58 90 390

Ísland

Slovenská republika

Actavis Group PTC ehf.

TEVA Pharmaceuticals Slovakia s.r.o

Sími: +354 550 3300

Tel: +421 2 57 26 79 11

Italia

Suomi/Finland

Actavis Group PTC ehf.

ratiopharm Oy

Islanda

Puh/Tel: +358 (0) 20 180 5900

Κύπρος

Sverige

Specifar ABEE

Teva Sweden AB

Τηλ: +30 210 5401500

+46 42 12 11 00

Ελλάδα

 

Latvija

United Kingdom

UAB "Sicor Biotech" filiāle Latvijā

Actavis UK Limited

Tel.: +371 673 23 666

Tel: +44 1271 385257

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

---------------------------------------------------------------------------------------

Information for the user

For people who find it hard to take capsules, including very young children, a liquid medicine may be available.

If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy from Ebilfumin capsules (see Information for healthcare professionals). This pharmacy preparation is the preferred option.

If the pharmacy preparation is not available either, you can make Ebilfumin suspension from these capsules at home.

The dose is the same for treating or preventing flu. The difference is how often it is given.

Making Liquid Ebilfumin at home

If you have the right capsule for the dose needed (a 45 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. This is usually suitable for children over 1 year. See the upper set of instructions.

If you need smaller doses, making Ebilfumin suspension from capsules involves extra steps. This is suitable for younger, lighter children and babies: they usually need an Ebilfumin dose of less than 45 mg. See the lower set of instructions.

Children 1 to 12 years

To make a 45 mg dose, you need:

One 45 mg Ebilfumin capsule

Sharp scissors

One small bowl

Teaspoon (5 ml spoon)

Water

Sweet food to hide the bitter taste of the powder.

Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check the dose is correct

To find the correct amount to use, find the patient’s weight on the left of the table.

Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.

You should use only 45 mg capsules for 45 mg doses. Do not try to make a 30 mg, 60 mg or 75 mg dose by using the contents of 45 mg capsules. Use the appropriate size capsule instead.

Weight

Dose of Ebilfumin

Number of capsules

Up to 15 kg

30 mg

Do not use 45 mg capsules

15 kg up to 23 kg

45 mg

1 capsule

23 kg up to 40 kg

60 mg

Do not use 45 mg capsules

Step 2: Pour all the powder into a bowl

Hold a 45 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors. Pour all of the powder into the bowl.

Be careful with the powder, because it may irritate your skin and eyes.

Step 3: Sweeten the powder and give the dose

Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl. This is to hide the bitter taste of the Ebilfumin powder.

Stir the mixture well.

Give the whole contents of the bowl to the patient straight away.

If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.

Repeat this procedure every time you need to give the medicine.

Infants less than 1 year

To make a smaller single dose, you need:

One 45 mg Ebilfumin capsule

Sharp scissors

Two small bowls (use separate pairs of bowls for each child)

One large oral dose dispenser to measure out water – a 5 ml dispenser or 10 ml dispenser

One small oral dose dispenser showing measurements of 0.1 ml, to give the dose

Teaspoon (5 ml spoon)

Water

Sweet food to hide the bitter taste of the Ebilfumin.

Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce.

Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a bowl

Hold a 45 mg capsule upright over one of the bowls and carefully snip off the rounded tip with scissors. Be careful with the powder: it may irritate your skin and eyes.

Pour all of the powder into the bowl, whatever the dose you are making. The amount is the same whether you are treating or preventing flu.

Step 2: Add water to dilute the medicine

Use the larger dispenser to draw up

7.5 ml water.

Add the water to the powder in the bowl.

Stir the mixture with the teaspoon for about 2 minutes.

Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive ingredients.

Step 3: Choose the correct amount for your child’s weight

Look up the child’s weight on the left side of the table.

The column on the right of the table shows how much of the liquid mixture you will need to draw up.

Infants less than 1 year (including full-term newborn babies)

Child’s weight

How much mixture

(nearest)

to draw up

3 kg

1.5 ml

3.5 kg

1.8 ml

4 kg

2.0 ml

4.5 kg

2.3 ml

5 kg

2.5 ml

5.5 kg

2.8 ml

6 kg

3.0 ml

6.5 kg

3.3 ml

7 kg

3.5 ml

7.5 kg

3.8 ml

8 kg

4.0 ml

8.5 kg

4.3 ml

 

9 kg

4.5 ml

9.5 kg

4.8 ml

10 kg or more

5.0 ml

Step 4: Draw up the liquid mixture

Make sure you have the right size dispenser.

Draw up the correct amount of liquid mixture from the first bowl.

Draw it up carefully so as not to include air bubbles.

Gently squirt the correct dose into the second bowl.

Step 5: Sweeten and give to the child

Add a small amount – no more than one teaspoonful – of a sweet food to the second bowl. This is to hide the bitter taste of the Ebilfumin.

Mix the sweet food and Ebilfumin suspension well.

Give the whole contents of the second bowl (Ebilfumin suspension with sweet food added) to the child straight away.

If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid.

Give the child something to drink.

Throw away any unused liquid left in the first bowl.

Repeat this procedure every time you need to give the medicine.

---------------------------------------------------------------------------------------

Information for healthcare professionals only

Patients who are unable to swallow capsules:

Commercially manufactured oseltamivir powder for oral suspension (6 mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed. In the event that oseltamivir powder for oral suspension is not available, the pharmacist may compound a suspension (6 mg/ml) from Ebilfumin capsules. If the pharmacy compounded suspension is also not available, patients may prepare the suspension from capsules at home.

Oral dose dispensers (oral syringes) of appropriate volume and grading should be provided for administering the pharmacy compounded suspension, and for the procedures involved in the home preparation. In both cases, the correct volumes should preferably be marked on the dispensers. For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Ebilfumin-water mixture. For measuring 5.0 ml of water, dispensers of 5 ml or 10 ml should be used.

The appropriate dispenser sizes for taking the correct volume of Ebilfumin suspension (6 mg/ml) are shown below.

Infants less than 1 year (including full-term newborn babies):

 

Amount of Ebilfumin

Dispenser size to use

Dose of Ebilfumin

suspension

(grading 0.1 ml)

9 mg

1.5 ml

2.0 ml (or 3.0 ml)

10 mg

1.7 ml

2.0 ml (or 3.0 ml)

11.25 mg

1.9 ml

2.0 ml (or 3.0 ml)

12.5 mg

2.1 ml

3.0 ml

13.75 mg

2.3 ml

3.0 ml

15 mg

2.5 ml

3.0 ml

16.25 mg

2.7 ml

3.0 ml

18 mg

3.0 ml

3.0 ml (or 5.0 ml)

19.5 mg

3.3 ml

5.0 ml

21 mg

3.5 ml

5.0 ml

22.5 mg

3.8 ml

5.0 ml

24 mg

4.0 ml

5.0 ml

25.5 mg

4.3 ml

5.0 ml

27 mg

4.5 ml

5.0 ml

28.5 mg

4.8 ml

5.0 ml

30 mg

5.0 ml

5.0 ml

Package Leaflet: Information for the user

Ebilfumin 75 mg hard capsules oseltamivir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Ebilfumin is and what it is used for

2.What you need to know before you take Ebilfumin

3.How to take Ebilfumin

4.Possible side effects

5.How to store Ebilfumin

6.Contents of the pack and other information

1. What Ebilfumin is and what it is used for

Ebilfumin is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.

Ebilfumin can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu.

Ebilfumin may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.

Ebilfumin contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection.

Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.

2. What you need to know before you take Ebilfumin

Do not take Ebilfumin:

if you are allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor if this applies to you. Do not take Ebilfumin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ebilfumin.

Before you take Ebilfumin, make sure the prescribing doctor knows

if you are allergic to other medicines

if you have problems with your kidneys. If so, your dose may need adjustment

if you have a severe medical condition, which may require immediate hospitalisation

if your immune system is not working

if you have chronic heart disease or respiratory disease.

During treatment with Ebilfumin, tell a doctor immediately:

if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects.

Ebilfumin is not a flu vaccine

Ebilfumin is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Ebilfumin will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.

Other medicines and Ebilfumin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. The following medicines are particularly important:

chlorpropamide (used to treat diabetes)

methotrexate (used to treat e.g. rheumatoid arthritis)

phenylbutazone (used to treat pain and inflammation)

probenecid (used to treat gout)

Pregnancy and breast-feeding

You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Ebilfumin is right for you.

The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Ebilfumin is right for you.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ebilfumin has no effect on your ability to drive or use machines.

3. How to take Ebilfumin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take Ebilfumin as soon as possible, ideally within two days of the flu symptoms starting.

The recommended doses

For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5-day course, even if you start to feel better quickly.

For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It is best to take this in the mornings with breakfast.

In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.

The recommended dose is based on the patient’s body weight. You must use the amount of oral capsules or suspension prescribed by the doctor.

Adults and adolescents 13 years and over

Body weight

Treating flu:

Preventing flu:

 

dose for 5 days

dose for 10 days

40 kg or more

75 mg twice daily

75 mg once daily

75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

 

Children 1 to 12 years

 

 

Body weight

Treating flu:

Preventing flu:

 

dose for 5 days

dose for 10 days

10 to 15 kg

30 mg twice daily

30 mg once daily

More than 15 kg and up to 23 kg

45 mg twice daily

45 mg once daily

More than 23 kg and up to 40 kg

60 mg twice daily

60 mg once daily

More than 40 kg

75 mg twice daily

75 mg once daily

75 mg can be made up of a 30 mg capsule plus a 45 mg capsule

Infants less than 1 year (0 to 12 months)

Giving Ebilfumin to infants less than 1 year old for preventing flu during a flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.

Body weight

Treating flu:

Preventing flu:

 

dose

dose

 

for 5 days

for 10 days

3 kg to 10+ kg

3 mg per kg body

3 mg per kg,

 

weight, twice daily

once daily

mg per kg = mg for each kilogram of the infant’s body weight. For example: If a 6-month-old weighs 8 kg, the dose is

8 kg x 3mg per kg = 24 mg

Method of administration

Swallow the capsules whole with water. Do not break or chew the capsules.

Ebilfumin can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting).

People who find it hard to take capsules can use a liquid form of this medicine (oral suspension). If you need an oral suspension but it’s not available from your pharmacy, you can make a liquid form of Ebilfumin from these capsules. See Making Liquid Ebilfumin at home for instructions.

If you take more Ebilfumin than you should

Stop taking Ebilfumin and contact a doctor or pharmacist immediately.

In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4.

Overdose has been reported to have occurred more frequently when oseltamivir was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Ebilfumin for children and when administering Ebilfumin capsules or liquid Ebilfumin to children.

If you forget to take Ebilfumin

Do not take a double dose to make up for a forgotten capsule.

If you stop taking Ebilfumin

There are no side effects when you stop Ebilfumin. But if Ebilfumin is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza.

The following serious side effects have been rarely reported since oseltamivir has been marketed:

Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties

Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour

Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing

Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life- threatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure

Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood

Neuropsychiatric disorders, as described below.

If you notice any of these symptoms, get medical help immediately.

The most frequently (very common and common) reported side effects of Ebilfumin are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food.

Rare but serious effects: get medical help at once

(These may affect up to 1 in 1,000 people)

During oseltamivir treatment, rare events have been reported that include

Convulsions and delirium, including altered level of consciousness

Confusion, abnormal behaviour

Delusions, hallucinations, agitation, anxiety, nightmares

These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking oseltamivir.

Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.

If you notice any of these symptoms, especially in younger people, get medical help immediately.

Adults and adolescents 13 and over

Very common side effects

(may affect more than 1 in 10 people)

Headache

Nausea.

Common side effects

(may affect up to 1 in 10 people)

Bronchitis

Cold sore virus

Cough

Dizziness

Fever

Pain

Pain in limb

Runny nose

Sleeping difficulties

Sore throat

Stomach ache

Tiredness

Upper abdominal fullness

Upper respiratory tract infections (inflammation of the nose, throat and sinuses)

Upset stomach

Vomiting.

Uncommon side effects

(may affect up to 1 in 100 people)

Allergic reactions

Altered level of consciousness

Convulsion

Heart rhythm abnormalities

Mild to severe liver function disorders

Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).

Rare side effects

(may affect up to 1 in 1,000 people)

Thrombocytopenia (low platelet count)

Visual disturbances.

Children 1 to 12 years

Very common side effects

(may affect more than 1 in 10 people)

Cough

Nasal congestion

Vomiting.

Common side effects

(may affect up to 1 in 10 people)

Conjunctivitis (red eyes and discharge or pain in the eye)

Ear inflammation and other ear disorders

Headache

Nausea

Runny nose

Stomach ache

Upper abdominal fullness

Upset stomach.

Uncommon side effects

(may affect up to 1 in 100 people)

Inflammation of the skin

Tympanic membrane (eardrum) disorder.

Infants less than 1 year

The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and nappy rash have been reported.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. However,

if you or your child are repeatedly sick, or

if the influenza symptoms get worse or the fever continues tell your doctor as soon as possible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ebilfumin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store below 25 C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ebilfumin contains

-Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.

-The other ingredients are:

capsule contents: pregelatinized starch (derived from maize starch), talc, povidone (K-29/32), croscarmellose sodium, sodium stearyl fumarate

capsule shell: cap: gelatin, yellow iron oxide (E172) and titanium dioxide (E171), body: gelatin, titanium dioxide (E171)

printing ink: shellac glaze-45% (20% esterified), black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide 28% (E527)

What Ebilfumin looks like and contents of the pack

The hard capsule consists of a white opaque body and a rich yellow cap bearing the black imprint “OS 75”. Capsule size: 2.

Ebilfumin 75 mg hard capsules are available in blister packs or tablet containers of 10.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður

Iceland

Manufacturer

Actavis ehf.

Reykjavíkurvegur 78,

IS-220 Hafnarfjörður

Iceland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Lietuva

Actavis Group PTC ehf.

UAB "Sicor Biotech"

IJsland / Islande / Island

Tel: +370 5 266 0203

България

Luxembourg/Luxemburg

Актавис ЕАД

Actavis Group PTC ehf.

Teл.: +359 2 489 95 85

Islande / Island

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel.: +36 1 288 6400

Danmark

Malta

Teva Denmark A/S

Actavis Ltd.

Tlf: +45 44 98 55 11

Tel: +35621693533

Deutschland

Nederland

Actavis Group PTC ehf.

Actavis Group PTC ehf.

Island

IJsland

Eesti

Norge

UAB "Sicor Biotech" Eesti filiaal

Teva Norway AS

Tel: +372 661 0801

Tlf: +47 66 77 55 90

Ελλάδα

Österreich

Specifar ΑΒΕΕ

Actavis GmbH

Τηλ: +30 210 5401500

Tel: +43 (0)662 435 235 00

España

Polska

Actavis Group PTC ehf.

Actavis Export Int. Ltd., Malta.

Islandia

Kontakt w Polsce:

 

Tel.: (+48 22) 512 29 00

France

Portugal

TEVA SANTE

Actavis Group PTC ehf.

Tél: +33 1 55 91 78 00

Islândia

Hrvatska

România

Pliva Hrvatska d.o.o.

Teva Pharmaceuticals S.R.L

Tel: +385 1 37 20 000

Tel: +4021 230 65 24

Ireland

Slovenija

Actavis Ireland Limited

Pliva Ljubljana d.o.o.

Tel: + 353 (0)21 4619040

Tel: +386 1 58 90 390

 

Ísland

Slovenská republika

Actavis Group PTC ehf.

TEVA Pharmaceuticals Slovakia s.r.o

Sími: +354 550 3300

Tel: +421 2 57 26 79 11

Italia

Suomi/Finland

Actavis Group PTC ehf.

ratiopharm Oy

Islanda

Puh/Tel: +358 (0)20 180 5900

Κύπρος

Sverige

Specifar ABEE

Teva Sweden AB

Τηλ: +30 210 5401500

+46 42 12 11 00

Ελλάδα

 

Latvija

United Kingdom

UAB "Sicor Biotech" filiāle Latvijā

Actavis UK Limited

Tel.: +371 673 23 666

Tel: +44 1271 385257

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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Information for the user

For people who find it hard to take capsules, including very young children, a liquid medicine may be available.

If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy from Ebilfumin capsules (see Information for healthcare professionals). This pharmacy preparation is the preferred option.

If the pharmacy preparation is not available either, you can make Ebilfumin suspension from these capsules at home.

The dose is the same for treating or preventing flu. The difference is how often it is given.

Making Liquid Ebilfumin at home

If you have the right capsule strength for the dose needed (a 75 mg dose), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. This is usually suitable for children over 1 year. See the upper set of instructions.

If you need smaller doses, making Ebilfumin suspension from capsules involves extra steps. This is suitable for younger children and babies: they usually need an Ebilfumin dose of less than 30 mg. See the lower set of instructions.

Adults, adolescents 13 years and over, and children weighing 40 kg and over

To make a 75 mg dose, you need:

One 75 mg Ebilfumin capsule

Sharp scissors

One small bowl

Teaspoon (5 ml spoon)

Water

Sweet food to hide the bitter taste of the powder.

Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Check the dose is correct

To find the correct amount to use, find the patient’s weight on the left of the table.

Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu.

You should use only 75 mg capsules for 75 mg doses. Do not try to make a 75 mg dose by using the contents of 30 mg or 45 mg capsules.

Weight

Dose of Ebilfumin

Number of capsules

 

 

 

40 kg and over

75 mg

1 capsule

Not for children who weigh less than 40 kg

 

 

 

You will need to prepare a dose of less than 75 mg for children who weigh less than 40 kg. See below.

Step 2: Pour all the powder into a bowl

Hold a 75 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors. Pour all of the powder into the bowl.

Be careful with the powder, because it may irritate your skin and eyes.

Step 3: Sweeten the powder and give the dose

Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl. This is to hide the bitter taste of the Ebilfumin powder.

Stir the mixture well.

Give the whole contents of the bowl to the patient straight away.

If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all.

Repeat this procedure every time you need to give the medicine.

Infants less than 1 year, and children weighing less than 40 kg

To make a smaller single dose, you need:

One 75 mg Ebilfumin capsule

Sharp scissors

Two small bowls

One large oral dose dispenser to measure out water – a 5 or 10 ml dispenser

One small oral dose dispenser showing measurements of 0.1 ml, to give the dose

Teaspoon (5 ml spoon)

Water

Sweet food to hide the bitter taste of the Ebilfumin.

Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce.

Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.

Step 1: Pour all the powder into a bowl

Hold a 75 mg capsule upright over one of the bowls and carefully snip off the rounded tip with scissors. Be careful with the powder: it may irritate your skin and eyes.

Pour all of the powder into the bowl, whatever the dose you are making. The amount is the same whether you are treating or preventing flu.

Step 2: Add water to dilute the medicine

Use the larger dispenser to draw up 12.5 ml water.

Add the water to the powder in the bowl.

Stir the mixture with the teaspoon for about 2 minutes.

Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive ingredients.

Step 3: Choose the correct amount for your child’s weight

Look up the child’s weight on the left side of the table.

The column on the right of the table shows how much of the liquid mixture you will need to draw up.

Infants less than 1 year (including full-term newborn babies)

Child’s weight

How much mixture

(nearest)

to draw up

3 kg

1.5 ml

3.5 kg

1.8 ml

4 kg

2.0 ml

4.5 kg

2.3 ml

5 kg

2.5 ml

5.5 kg

2.8 ml

6 kg

3.0 ml

6.5 kg

3.3 ml

 

7 kg

3.5 ml

7.5 kg

3.8 ml

8 kg

4.0 ml

8.5 kg

4.3 ml

9 kg

4.5 ml

9.5 kg

4.8 ml

10 kg or more

5.0 ml

Step 4: Draw up the liquid mixture

Make sure you have the right size dispenser.

Draw up the correct amount of liquid mixture from the first bowl.

Draw it up carefully so as not to include air bubbles.

Gently squirt the correct dose into the second bowl.

Step 5: Sweeten and give to the child

Add a small amount – no more than one teaspoonful – of a sweet food to the second bowl. This is to hide the bitter taste of the Ebilfumin.

Mix the sweet food and Ebilfumin suspension well.

Give the whole contents of the second bowl (Ebilfumin suspension with sweet food added) to the child straight away.

If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid.

Give the child something to drink.

Throw away any unused liquid left in the first bowl.

Repeat this procedure every time you need to give the medicine.

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Information for healthcare professionals only

Patients who are unable to swallow capsules:

Commercially manufactured oseltamivir powder for oral suspension (6 mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed. In the event that oseltamivir powder for oral suspension is not available, the pharmacist may compound a suspension (6 mg/ml) from Ebilfumin capsules. If the pharmacy compounded suspension is also not available, patients may prepare the suspension from capsules at home.

Oral dose dispensers (oral syringes) of appropriate volume and grading should be provided for administering the pharmacy compounded suspension, and for the procedures involved in the home preparation. In both cases, the correct volumes should preferably be marked on the dispensers. For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Ebilfumin-water mixture. For measuring 12.5 ml of water, a 10 ml dispenser should be used.

The appropriate dispenser sizes for taking the correct volume of Ebilfumin suspension (6 mg/ml) are shown below.

Infants less than 1 year (including full-term newborn babies):

 

Amount of Ebilfumin

Dispenser size to use

Dose of Ebilfumin

suspension

(grading 0.1 ml)

9 mg

1.5 ml

2.0 ml (or 3.0 ml)

10 mg

1.7 ml

2.0 ml (or 3.0 ml)

11.25 mg

1.9 ml

2.0 ml (or 3.0 ml)

12.5 mg

2.1 ml

3.0 ml

13.75 mg

2.3 ml

3.0 ml

15 mg

2.5 ml

3.0 ml

16.25 mg

2.7 ml

3.0 ml

18 mg

3.0 ml

3.0 ml (or 5.0 ml)

19.5 mg

3.3 ml

5.0 ml

21 mg

3.5 ml

5.0 ml

22.5 mg

3.8 ml

5.0 ml

24 mg

4.0 ml

5.0 ml

25.5 mg

4.3 ml

5.0 ml

27 mg

4.5 ml

5.0 ml

28.5 mg

4.8 ml

5.0 ml

30 mg

5.0 ml

5.0 ml

Children 1 year or older, weighing less than 40 kg:

 

 

Amount of Ebilfumin

Dispenser size to use

Dose of Ebilfumin

suspension

(grading 0.1 ml)

30 mg

5.0 ml

5.0 ml (or 10.0 ml)

45 mg

7.5 ml

10.0 ml

60 mg

10.0 ml

10.0 ml

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