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Aerivio Spiromax (salmeterol xinafoate / fluticasone propionate) – Package leaflet - R03AK06

Updated on site: 11-Jul-2017

Medication nameAerivio Spiromax
ATC CodeR03AK06
Substancesalmeterol xinafoate / fluticasone propionate
ManufacturerTeva B.V.

Package leaflet: Information for the patient

Aerivio Spiromax 50 microgram/500 microgram inhalation powder salmeterol/fluticasone propionate

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

-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 pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Aerivio Spiromax is and what it is used for

2.What you need to know before you use Aerivio Spiromax

3.How to use Aerivio Spiromax

4.Possible side effects

5.How to store Aerivio Spiromax

6.Contents of the pack and other information

1.What Aerivio Spiromax is and what it is used for

Aerivio Spiromax contains two medicines, salmeterol and fluticasone propionate:

Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours.

Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine for the treatment of either

Severe asthma, to help prevent attacks of breathlessness and wheeziness,

or

Chronic obstructive pulmonary disease (COPD), to reduce the number of flare ups of symptoms.

You must use Aerivio Spiromax every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD.

Aerivio Spiromax helps to stop breathlessness and wheeziness coming on. However, Aerivio Spiromax should not be used to relieve an attack of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should always have your fast-acting 'rescue' inhaler with you.

Aerivio Spiromax should only be used to treat severe asthma in adults aged 18 years and older and adults with COPD.

2. What you need to know before you use Aerivio Spiromax

Do not use Aerivio Spiromax:

-if you are allergic (hypersensitive) to salmeterol, fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Aerivio Spiromax if you have:

Heart disease, including an irregular or fast heart beat

Overactive thyroid gland

High blood pressure

Diabetes mellitus (Aerivio Spiromax may increase your blood sugar)

Low potassium in your blood

Tuberculosis (TB) now or have had in the past, or have other lung infections

Children and adolescents

This medicine should not be used in children or adolescents under the age of 18 years.

Other medicines and Aerivio Spiromax

Tell your doctor or pharmacist if you are taking or, have recently taken or might use any other medicines. This includes other medicines for asthma or any medicines obtained without a prescription. Aerivio Spiromax may not be suitable to be taken with some other medicines.

Tell your doctor if you are taking the following medicines, before starting to use Aerivio Spiromax:

Beta blockers (such as atenolol, propranolol and sotalol). Beta blockers are mostly used for high blood pressure or heart conditions such as angina.

Medicines to treat infections (such as ritonavir, ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the amount of salmeterol or fluticasone propionate in your body. This can increase your risk of side effects with Aerivio Spiromax, including irregular heartbeats, or may make side effects worse.

Corticosteroids (by mouth or by injection). Recent use of these medicines might increase the risk of Aerivio Spiromax affecting your adrenal glands.

Diuretics, also known as ‘water tablets’ used to treat high blood pressure.

Other bronchodilators (such as salbutamol).

Xanthine medicines such as aminophylline and theophylline. These are often used to treat asthma.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known whether this medicine can pass into breast milk. If you are breastfeeding, check with your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Aerivio Spiromax is not likely to affect your ability to drive or use machines.

Aerivio Spiromax contains lactose

Lactose is a type of sugar found in milk. Lactose contains small amounts of milk protein which may cause allergic reactions. If you have been told by your doctor that you have an intolerance or allergy to lactose, other sugars, or milk, contact your doctor before taking this medicinal product.

3.How to use Aerivio Spiromax

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

Use your Aerivio Spiromax every day until your doctor advises you to stop. Do not take more than the recommended dose. Check with your doctor or pharmacist if you are not sure.

Do not stop taking Aerivio Spiromax or reduce the dose of Aerivio Spiromax without talking to your doctor first.

Aerivio Spiromax should be inhaled through the mouth into the lungs.

The recommended dose is:

Severe asthma in adults 18 years of age and older

One inhalation twice a day

Chronic Obstructive Pulmonary Disease (COPD)

One inhalation twice a day

If you are using Aerivio Spiromax for asthma, your doctor will want to check your symptoms regularly.

Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma. If your doctor feels that you need a lower dose than is available from your Aerivio Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your Aerivio Spiromax but with a lower dose of the corticosteroid. However, do not change the number of inhalations your doctor has prescribed without talking to your doctor first.

If your asthma or breathing gets worse tell your doctor straight away. If you feel more wheezy, your chest feels tight more often or you need to use more of your fast-acting ‘reliever’ medicine, your chest condition may be getting worse and you could become seriously ill. You should continue to take Aerivio Spiromax but do not increase the number of puffs you take. See your doctor at once as you may need additional treatment.

Instructions for use

Training

Your doctor, nurse or pharmacist should provide you with training on how to use your inhaler, including how to take a dose effectively. This training is important to ensure you receive the dose you require. If you have not received this training please ask your doctor, nurse or pharmacist to show you how to use your inhaler properly before you use it for the first time.

Your doctor, nurse or pharmacist should also check how you use your Spiromax device from time to time to ensure that you are using the device properly and as prescribed. If you are not using Aerivio Spiromax properly and/or you are not breathing in forcefully enough, this may mean that you are not getting enough of the medicine into your lungs. If you are not getting enough medicine into your lungs, it will not help your asthma or COPD as it should

Preparing your Aerivio Spiromax

Before using your Aerivio Spiromax for the first time, you need to prepare it for use as follows:

Check the dose indicator to see that there are 60 inhalations in the inhaler.

Write the date you opened the foil pouch on the label on the inhaler.

You do not need to shake your inhaler before you use it.

How to take an inhalation

1.Hold your inhaler with the semi-transparent yellow mouthpiece cover at the bottom. You do not need to shake your inhaler.

2.Open the mouthpiece cover by folding it down until you hear one loud click. Your inhaler is now ready for use.

3.Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler.

4.Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Take care not to block the air vents.

Breathe in through your mouth as deeply and as forcefully as you can. Note that it is important that you breathe in forcefully.

5.Hold your breath for 10 seconds or as long as you comfortably can.

6.Remove your inhaler from your mouth. You may notice a taste when you take your inhalation.

7. Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover.

Afterwards, rinse your mouth with water and spit it out and/or brush your teeth. This may help to stop you getting thrush in your mouth and/or becoming hoarse.

Do not try to take your inhaler apart, remove or twist the mouthpiece cover. The mouthpiece cover is fixed to your inhaler and must not be taken off. Do not use your inhaler if it is damaged or if the mouthpiece has come apart from your inhaler. Do not open and close the mouthpiece cover unless you are about to use your inhaler.

If you open and close the mouthpiece without taking an inhalation the dose will be securely held inside the inhaler ready for the next inhalation. It is impossible to accidentally take extra medicine or a double dose in one inhalation.

Keep the mouthpiece closed all the times unless you are about to use your inhaler.

Cleaning your Inhaler

Keep your inhaler dry and clean.

If necessary you may wipe the mouthpiece of your inhaler after use with a dry cloth or tissue.

When to start using a new Aerivio Spiromax

The dose indicator on the rear of the device tells you how many doses (inhalations) are left in your inhaler, starting with 60 inhalations when it is full.

The dose indicator shows the number of inhalations remaining in even numbers only.

For inhalations remaining from 20 downwards to ‘8’, ‘6’, ‘4’, ‘2’ the numbers are displayed in red on a white background. When the numbers become red in the window, you should see your doctor and get a new inhaler.

Note:

The mouthpiece will still ‘click’ even when your inhaler is empty. If you open and close the mouthpiece without taking an inhalation the dose indicator will still register it as a count.

If you use more Aerivio Spiromax than you should

It is important to use the inhaler as instructed. If you accidentally take more doses than is recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky. You may also have dizziness, a headache, muscle weakness and aching joints.

If you have used too many doses of Aerivio Spiromax for a long time, you should talk to your doctor or pharmacist for advice. This is because using too much Aerivio Spiromax may reduce the amount of steroid hormones produced by your adrenal glands.

If you forget to use Aerivio Spiromax

Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

If you stop using Aerivio Spiromax

It is very important that you take your Aerivio Spiromax every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Aerivio Spiromax. This could make your breathing worse.

In addition, if you suddenly stop taking Aerivio Spiromax or reduce your dose of Aerivio Spiromax this may (very rarely) cause you to have problems with your adrenal glands (adrenal insufficiency) which sometimes causes side effects.

These side effects may include any of the following:

Stomach pain

Tiredness and loss of appetite, feeling sick

Sickness and diarrhoea

Weight loss

Headache or drowsiness

Low levels of sugar in your blood

Low blood pressure and seizures (fits)

When your body is under stress such as from fever, trauma (such as an accident or injury), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above.

If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).

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

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the chance of side effects your doctor will prescribe the lowest dose of this combination of drugs to control your asthma or COPD.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Aerivio Spiromax. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash

(hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If

you get any of these effects or if they happen suddenly after using Aerivio Spiromax, stop using Aerivio Spiromax and tell your doctor straight away. Allergic reactions to Aerivio Spiromax are uncommon (they may affect up to 1 in 100 people).

Other side effects are listed below:

Very common (may affect more than 1 in 10 people)

Headache - this usually gets better as treatment continues.

Increased number of colds have been reported in patients with chronic obstructive pulmonary disease (COPD).

Common (may affect up to 1 in 10 people)

Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue and hoarse voice and throat irritation. Rinsing your mouth out with water and spitting it out immediately and/or brushing your teeth after taking each dose of your medicine may help. Your doctor may prescribe an anti-fungal medicine to treat the thrush.

Aching, swollen joints and muscle pain.

Muscle cramps.

The following side effects have also been reported in patients with chronic obstructive pulmonary disease (COPD):

Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of the following symptoms while taking Aerivio Spiromaxas they could be symptoms of a lung infection: fever or chills; increased mucus production, changes in mucus colour; increased cough or increased breathing difficulties.

Bruising and fractures.

Inflammation of sinuses (sinusitis, a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache).

A reduction in the amount of potassium in the blood (you may get an uneven heartbeat, muscle weakness, cramp).

Uncommon (may affect up to 1 in 100 people)

Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.

Cataract (cloudy lens in the eye).

Very fast heart beat (tachycardia).

Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually harmless and get less as treatment continues.

Chest pain.

Feeling worried (although this effect occurs mainly in children when prescribed this combination of drugs but in a lower strength).

Disturbed sleep.

Allergic skin rash.

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

Breathing difficulties or wheezing that gets worse straight after taking Aerivio Spiromax. If this happens stop using your Aerivio Spiromax inhaler. Use your fast acting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.

Aerivio Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time. The effects include:

Slowing of growth in children and adolescents

Thinning of the bones

Glaucoma

Weight gain

Rounded (moon shaped) face (Cushing’s syndrome)

Your doctor will check you regularly for any of these side effects and make sure you are taking the lowest dose of this combination of drugs to control your asthma.

Behavioural changes, such as being unusually active and irritable (although these effects occur mainly in children when prescribed this combination of drugs but in a lower strength).

Uneven or irregular heart beat or an extra heart beat (arrhythmias). Tell your doctor, but do not stop taking Aerivio Spiromax unless the doctor tells you to stop.

A fungal infection in the oesophagus (food canal), which might cause difficulties in swallowing.

Frequency not known, but may also occur:

Depression or aggression (although these effects are more likely to occur in children when prescribed this combination of drugs but in a lower strength).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Aerivio Spiromax

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 the label of your inhaler after EXP. The expiry date refers to the last day of that month.

Do not store above 25 oC. Keep the mouthpiece cover closed after removal of the foil wrapping.

Use within 3 months of removing from the foil wrapping. Use the label on the inhaler to write down the opening date of the foil pouch.

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 Aerivio Spiromax contains

-The active substances are salmeterol and fluticasone propionate. Each metered dose contains 50 micrograms salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone propionate. Each delivered dose (the dose that leaves the mouthpiece) contains 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate.

-The other ingredient is lactose monohydrate (see section 2 under ‘Aerivio Spiromax contains lactose’).

What Aerivio Spiromax looks like and contents of the pack

Aerivio Spiromax is an inhalation powder.

Each Aerivio Spiromax inhaler contains 60 inhalations and has a white body with a semi-transparent yellow mouthpiece cover.

Packs of 1 and 3 inhalers. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

Unit 27/35, IDA Industrial Park, Cork Road, Waterford, Ireland

Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

(For Poland only) Teva Operations Poland Sp. z o.o. Mogilska 80 Str. 31-546 Kraków, Poland

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

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./AG

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Tel: +370 5 266 02 03

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

Teva Pharma Belgium N.V./S.A./AG

Teл: +359 2 489 95 82

Tel/Tél: +32 3 820 73 73

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Magyarország Zrt

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

 

Teva Denmark A/S

Malta

Tlf: +45 44 98 55 11

Teva Pharmaceuticals Ireland

 

L-Irlanda

 

Tel: +353 51 321 740

Deutschland

Nederland

Teva GmbH

Teva Nederland B.V.

Tel: +49 731 402 08

Tel: +31 800 0228 400

Eesti

Norge

Teva Eesti esindus UAB Sicor Biotech Eesti

Teva Norway AS

filiaal

Tlf: +47 6677 55 90

Tel: +372 661 0801

Österreich

 

Ελλάδα

ratiopharm Arzneimittel Vertriebs GmbH

Teva Ελλάς Α.Ε.

Tel: +43 1 97007 0

Τηλ: +30 210 72 79 099

 

España

Polska

Teva Pharma S.L.U.

Teva Pharmaceuticals Polska Sp. z o.o.

Tél: +34 91 387 32 80

Tel.: +48 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos Lda

Tél: +33 1 55 91 7800

Tel: +351 21 476 75 50

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +4021 230 6524

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 51 321 740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

Vistor

Teva Pharmaceuticals Slovakia s.r.o.

Simi: +354 535 7000

Tel: +421 2 5726 7911

Italia

Suomi/Finland

Teva Italia S.r.l.

Teva FinlandPuh/Tel: +358 20 180 5900

Tel: +39 028 917 981

 

Κύπρος

Sverige

Teva Ελλάς Α.Ε.

Teva Sweden AB

Ελλάδα

Tel: +46 42 12 11 00

Τηλ: +30 210 72 79 099

 

Latvija

United Kingdom

Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67 323 666

Tel: +44 1977 628 500

This leaflet was last revised in month YYYY.

 

Other sources of information

 

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

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