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Zyprexa (olanzapine) – Package leaflet - N05AH03

Updated on site: 11-Oct-2017

Medication nameZyprexa
ATC CodeN05AH03
Substanceolanzapine
ManufacturerEli Lilly Nederland B.V.

Package leaflet: Information for the user

ZYPREXA 2.5 mg coated tablets

ZYPREXA 5 mg coated tablets

ZYPREXA 7.5 mg coated tablets

ZYPREXA 10 mg coated tablets

ZYPREXA 15 mg coated tablets

ZYPREXA 20 mg coated tablets

Olanzapine

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 ZYPREXA is and what it is used for

2.What you need to know before you take ZYPREXA

3.How to take ZYPREXA

4.Possible side effects

5.How to store ZYPREXA

6.Contents of the pack and other information

1.What ZYPREXA is and what it is used for

ZYPREXA contains the active substance olanzapine. ZYPREXA belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.

Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.

ZYPREXA has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.

2. What you need to know before you take ZYPREXA

Do not take ZYPREXA

If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.

If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before you take ZYPREXA.

The use of ZYPREXA in elderly patients with dementia is not recommended as it may have serious side effects.

Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given ZYPREXA tell your doctor.

Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once.

Weight gain has been seen in patients taking ZYPREXA. You and your doctor should check your weight regularly. Consider referral to a dietician or help with a diet plan if necessary.

High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPREXA. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking ZYPREXA and regularly during treatment.

Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.

If you suffer from any of the following illnesses tell your doctor as soon as possible:

Stroke or “mini” stroke (temporary symptoms of stroke)

Parkinson’s disease

Prostate problems

A blocked intestine (Paralytic ileus)

Liver or kidney disease

Blood disorders

Heart disease

Diabetes

Seizures

If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)

If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.

As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.

Children and adolescents

ZYPREXA is not for patients who are under 18 years.

Other medicines and ZYPREXA

Only take other medicines while you are on ZYPREXA if your doctor tells you that you can. You might feel drowsy if ZYPREXA is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).

Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking:

medicines for Parkinson’s disease.

carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your ZYPREXA dose.

ZYPREXA with alcohol

Do not drink any alcohol if you have been given ZYPREXA as together with alcohol it may make you feel drowsy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA can pass into breast milk.

The following symptoms may occur in newborn babies, of mothers that have used ZYPREXA in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

There is a risk of feeling drowsy when you are given ZYPREXA. If this happens do not drive or operate any tools or machines. Tell your doctor.

ZYPREXA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.How to take ZYPREXA

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

Your doctor will tell you how many ZYPREXA tablets to take and how long you should continue to take them. The daily dose of ZYPREXA is between 5 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking ZYPREXA unless your doctor tells you to.

You should take your ZYPREXA tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. ZYPREXA coated tablets are for oral use. You should swallow the ZYPREXA tablets whole with water.

If you take more ZYPREXA than you should

Patients who have taken more ZYPREXA than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital straight away if you experience any of the above symptoms. Show the doctor your pack of tablets.

If you forget to take ZYPREXA

Take your tablets as soon as you remember. Do not take two doses in one day.

If you stop taking ZYPREXA

Do not stop taking your tablets just because you feel better. It is important that you carry on taking ZYPREXA for as long as your doctor tells you.

If you suddenly stop taking ZYPREXA, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.

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.

Tell your doctor immediately if you have:

unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;

blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately;

a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.

Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.

Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia).

While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.

In patients with Parkinson's disease ZYPREXA may worsen the symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor 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 ZYPREXA

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton.

ZYPREXA should be stored in its original pack in order to protect from light and moisture.

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 to protect the environment.

6. Contents of the pack and other information

What ZYPREXA contains

The active substance is olanzapine. Each ZYPREXA tablet contains either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of the active substance. The exact amount is shown on your ZYPREXA tablet pack.

The other ingredients are

-(tablet core) lactose monohydrate, hyprolose, crospovidone, microcrystalline cellulose, magnesium stearate and

-(tablet coating) hypromellose, titanium dioxide (E171), carnauba wax.

In addition the different ZYPREXA tablet strengths also contain the following ingredients:

TABLET STRENGTH

ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets

ZYPREXA 15 mg tablets

ZYPREXA 20 mg tablets

OTHER INGREDIENTS

(tablet coating) shellac, macrogol, propylene glycol, polysorbate 80 and indigo carmine colour (E132), ethanol anhydrous, isopropyl alcohol, butyl alcohol, ammonium hydroxide

(tablet coating) triacetin and indigo carmine colour (E132)

(tablet coating) macrogol and synthetic red iron oxide (E172)

What ZYPREXA looks like and contents of the pack

ZYPREXA 2.5 mg coated tablets are white imprinted with “LILLY” and a numeric identicode “4112”. ZYPREXA 5 mg coated tablets are white imprinted with “LILLY” and a numeric identicode “4115”. ZYPREXA 7.5 mg coated tablets are white imprinted with “LILLY” and a numeric identicode “4116”. ZYPREXA 10 mg coated tablets are white imprinted with “LILLY” and a numeric identicode “4117”. ZYPREXA 15 mg coated tablets are blue.

ZYPREXA 20 mg coated tablets are pink.

ZYPREXA is available in packs containing 28, 35, 56, 70 or 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

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

België/Belgique/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32 (0)2 548 84 84

България

ТП "Ели Лили Недерланд" Б.В. - България Тел: + 359 2 491 41 40

Česká republika

Eli Lilly ČR, s.r.o. Tel: + 420 234 664 111

Danmark

Eli Lilly Danmark A/S

Tlf.: + 45 45 26 60 00

Deutschland

Lilly Deutschland GmbH

Tel: + 49 (0) 6172 273 2222

Eesti

Eli Lilly Holdings Limited Eesti filiaal Tel: + 372 6817 280

Ελλάδa

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: + 30 210 629 4600

España

Lilly S.A.

Tel: + 34 91 663 50 00

France

Lilly France SAS

Tél: + 33 (0) 1 55 49 34 34

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353 (0) 1 661 4377

Ísland

Icepharma hf.

Sími: + 354 540 8000

Italia

Eli Lilly Italia S.p.A.

Tel: + 39 055 42571

Κύπρος

Phadisco Ltd

Τηλ: + 357 22 715000

Latvija

Eli Lilly Holdings Limited, pārstāvniecība Latvijā

Tel: + 371 67364000

This leaflet was last revised in {month XXXX}

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel: + 370 (5) 2649600

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32 (0)2 548 84 84

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Nederland

Eli Lilly Nederland B.V.

Tel: + 31(0)30 6025800

Norge

Eli Lilly Norge A.S

Tlf: + 47 22 88 18 00

Österreich

Eli Lilly Ges. m.b.H. Tel: + 43 (0) 1 711 780

Polska

Eli Lilly Polska Sp. z o.o.

Tel: + 48 (0) 22 440 33 00

Portugal

Lilly Portugal Produtos Farmacêuticos, Lda

Tel: + 351 21 412 66 00

România

Eli Lilly România S.R.L.

Tel: + 40 21 4023000

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: + 386 (0)1 580 00 10

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358 (0)9 8545 250

Sverige

Eli Lilly Sweden AB

Tel: + 46 (0)8 7378800

United Kingdom

Eli Lilly and Company Limited

Tel: + 44 (0) 1256 315000

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

Package leaflet: Information for the user

ZYPREXA 10 mg powder for solution for injection

Olanzapine

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.

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

What is in this leaflet:

1.What ZYPREXA is and what it is used for

2.What you need to know before you are given ZYPREXA

3.How ZYPREXA is given

4.Possible side effects

5.How to store ZYPREXA

6.Contents of the pack and other information

1. What ZYPREXA is and what it is used for

ZYPREXA contains the active substance olanzapine. ZYPREXA Injection belongs to a group of medicines called antipsychotics and is used to treat symptoms of agitation and distressing behaviour that may occur in the following conditions:

Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.

Mania, a condition with symptoms of excitement or euphoria.

ZYPREXA Injection is given when rapid control of agitation and distressing behaviour is needed and treatment with ZYPREXA tablets is not appropriate. Your doctor will change your treatment to ZYPREXA tablets, as soon as appropriate.

2. What you need to know before you are given ZYPREXA

You should not be given ZYPREXA

If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.

If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor or nurse before you are given ZYPREXA Injection

Tell the doctor or nurse if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. The doctor or nurse may also want to measure your blood pressure and pulse.

The use of ZYPREXA in elderly patients with dementia (confusion and memory loss) is not recommended as it may have serious side effects.

Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given ZYPREXA, talk to your doctor.

Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once. No more injections will be given to you.

Weight gain has been seen in patients taking ZYPREXA. You and your doctor should check your weight regularly. Consider referral to a dietician or help with a diet plan if necessary.

High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPREXA. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking ZYPREXA and regularly during treatment.

Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.

If you suffer from any of the following illnesses tell your doctor as soon as possible:

Stroke or “mini” stroke (temporary symptoms of stroke)

Parkinson’s disease

Prostate problems

A blocked intestine (Paralytic ileus)

Liver or kidney disease

Blood disorders

If you have had a recent heart attack, or have heart disease, including sick sinus syndrome, unstable angina or suffer from low blood pressure.

Diabetes

Seizures

If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)

If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.

As a routine precaution, if you are over 65 years your doctor may monitor your blood pressure.

Children and adolescents

ZYPREXA is not for patients who are under 18 years.

Other medicines and ZYPREXA

A combination of ZYPREXA with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep (tranquillisers, including benzodiazepines), and antidepressants. Only take other medicines while you are on ZYPREXA if your doctor tells you that you can.

If you receive ZYPREXA injection, a benzodiazepine injection is not recommended at the same time as this may result in excessive sleepiness, may have serious effects on your heart rate or your breathing, and, in very rare cases, may result in death. If your doctor has to give a benzodiazepine injection to treat your condition, there should be at least a one hour time period after the ZYPREXA injection and you are to be monitored closely after the benzodiazepine injection is given.

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially tell your doctor if you are taking medicines for Parkinson’s disease.

ZYPREXA with alcohol

Do not drink any alcohol if you have been given ZYPREXA as together with alcohol it may make you feel drowsy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. You should not be given this medicine when breast-feeding, as small amounts of ZYPREXA can pass into breast milk.

The following symptoms may occur in newborn babies, of mothers that have used ZYPREXA in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

There is a risk of feeling drowsy when you are given ZYPREXA. If this happens do not drive or operate any tools or machines. Tell your doctor.

3.How ZYPREXA is given

Information on reconstitution and administration is provided in a detachable section at the end of this leaflet.

Your doctor will decide how much ZYPREXA you need and how long you need it for. The dose is usually 10 mg for the first injection, but it may be less than this. Up to 20 mg in 24 hours may be given. The dose for patients aged over 65 years is 2.5 mg or 5 mg.

ZYPREXA comes as a powder. Your doctor or nurse will make it up into a solution. ZYPREXA Injection is for intramuscular use. The correct amount of solution will be injected into your muscle.

If you are given more ZYPREXA than you think you should be

Patients who have been given more ZYPREXA than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high or low blood pressure, abnormal rhythms of the heart. Tell your doctor or nurse of your concern.

Only a few doses of ZYPREXA Injection are needed. Your doctor will decide when you need a dose of ZYPREXA Injection.

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

4. Possible side effects

Like all medicines, ZYPREXA injection can cause side effects, although not everybody gets them.

Tell your doctor immediately if you have:

unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;

blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately;

a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Common side effects (may affect up to 1 in 10 people) with ZYPREXA Injection include slower or faster heart rate; sleepiness; low blood pressure; discomfort at the site of injection.

Some people may feel dizzy or faint (with a slow heart rate) after injection, especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor or a nurse as soon as possible.

Uncommon side effects (may affect up to 1 in 100 people) include breathing more slowly; and abnormal rhythms of the heart, which can be serious.

In addition, the following side effects have been seen after patients have taken ZYPREXA orally.

Other very common side effects (may affect more than 1 in 10 people) include weight gain; and increases in levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor.

Other common side effects(may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.

Other uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash): diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; slow heart rate; sensitivity to sunlight; bleeding from nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains; and prolonged and/or painful erection.

Very rare side effects include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen on blood tests and an increase in a type of white blood cells (eosinophilia).

While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.

In patients with Parkinson's disease ZYPREXA may worsen the symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor 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 ZYPREXA

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.

Do not store above 25°C. Store in original package in order to protect from light.

After ZYPREXA Injection is made into a solution, use within one hour. Do not freeze after reconstitution.

Discard any unused contents.

6. FURTHER INFORMATION

What ZYPREXA Injection contains

The active substance is olanzapine. Each vial contains 10 mg of the active substance.

The other ingredients are lactose monohydrate, tartaric acid, hydrochloric acid and sodium hydroxide.

What ZYPREXA Injection looks like and contents of the pack

ZYPREXA comes as a yellow powder in a vial. A vial of ZYPREXA can provide you with 10 mg of olanzapine. Your doctor or nurse will make it up into a solution that will be given as an injection.

ZYPREXA Injection is available in a pack containing 1 or 10 vial(s). Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

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

België/Belgique/Belgien

 

Lietuva

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Eli Lilly Benelux S.A./N.V.

 

Eli Lilly

Holdings Limited atstovybė

Tél/Tel: + 32 (0)2 548 84 84

 

Tel: + 370 (5) 2649600

 

 

 

 

 

 

 

България

 

 

 

 

 

 

 

 

 

 

 

 

 

Luxembourg/Luxemburg

 

 

 

 

 

 

 

ТП "Ели

Лили Недерланд" Б.В. - България

 

Eli Lilly Benelux S.A./N.V.

 

 

 

Тел ; + 359 2 491 41 40

 

 

 

 

 

Tél/Tel: + 32 (0)2 548 84 84

 

 

Česká republika

 

 

 

 

 

 

 

 

 

 

 

Magyarország

 

 

 

 

 

 

 

 

 

 

Eli Lilly ČR, s.r.o.

 

 

 

 

 

 

 

 

 

 

Lilly Hungária

Kft.

 

 

 

 

 

 

 

 

Tel: + 420 234 664

 

 

 

 

 

Tel: + 36 1 328 5100

 

 

 

 

 

 

Danmark

 

 

 

 

 

 

 

 

 

 

Malta

 

 

 

 

 

 

 

 

 

Eli Lilly

Danmark A/S

 

 

 

 

 

Charles

de Giorgio Ltd.

 

 

 

Tlf: + 45 45 26 60 00

 

 

 

 

 

 

Tel: + 356 25600 500

 

 

 

 

Deutschland

 

 

 

 

 

 

 

Nederland

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Eli Lilly

 

 

 

 

 

Lilly Deutschland GmbH

 

 

 

 

Nederland B.V.

Tel: + 49 (0) 6172 273 2222

 

 

 

Tel: + 31 (0)30 6025800

 

 

Eesti

 

 

 

 

 

 

Norge

 

 

 

 

 

Eli Lilly Holdings Limited Eesti filiaal

 

 

Eli Lilly Norge A.S

 

 

Tel: + 372 6817 280

 

 

 

Tlf: + 47 22 88 18 00

 

Ελλάδa

 

 

 

Österreich

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

 

 

 

Eli Lilly Ges. m.b.H.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Τηλ: + 30 210 629 4600

 

 

 

 

 

 

 

Tel: + 43 (0) 1 711 780

 

 

 

 

 

 

 

 

 

 

 

 

España

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Polska

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Spaly

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bioquímica S.A.

Eli Lilly Polska Sp. z o.o.

 

 

 

 

 

 

 

Tel: + 34 91 663 50 00

 

 

 

 

 

 

Tel: + 48 (0) 22 440 33 00

 

 

 

 

 

 

France

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Portugal

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Lilly France SAS

 

 

 

 

 

 

 

 

 

 

 

Lilly Portugal Produtos Farmacêuticos, Lda

 

 

Tél: + 33 (0) 1 55

49 34 34

 

 

 

Tel: + 351 21 412 66 00

 

 

 

 

 

 

 

Hrvatska

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

România

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Eli Lilly

Hrvatska d.o.o.

 

 

 

 

 

 

Eli Lilly

România S.R.L.

 

 

 

 

 

Tel: +385 1 2350 999

 

 

 

 

 

 

 

 

 

 

Tel: + 40 21 4023000

 

 

 

 

 

 

 

 

 

 

Ireland

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Slovenija

 

 

 

 

 

 

 

 

 

 

 

 

 

Eli Lilly

 

and Company (Ireland) Limited

 

 

Eli Lilly

farmacevtska družba, d.o.o.

 

 

Tel: + 353 (0) 1 661 4377

 

 

 

Tel: + 386 (0)1 580 00 10

 

 

 

 

 

Ísland

 

 

 

 

 

 

 

 

 

 

 

 

Slovenská republika

 

 

 

 

 

 

 

 

Icepharma hf.

 

 

 

 

 

 

 

Eli Lilly Slovakia, s.r.o.

 

 

 

 

 

Sími: + 354 540 8000

 

 

 

Tel: + 421 220 663 111

 

 

 

 

 

 

Italia

 

 

 

 

 

 

 

 

 

 

Suomi/Finland

 

 

 

 

 

 

 

 

Eli Lilly Italia S.p.A.

 

 

 

Oy Eli Lilly Finland Ab

 

 

 

 

Tel: + 39 055 42571

 

 

 

 

 

Puh/Tel: + 358 (0)9 8545 250

 

 

 

Κύπρος

 

 

 

 

 

 

Sverige

 

 

 

 

 

 

Phadisco

 

 

 

 

 

Eli Lilly

 

 

 

 

 

Ltd

Sweden AB

 

Τηλ: + 357 22 715000

 

 

Tel: + 46 (0)8 7378800

 

 

 

 

Latvija

 

 

 

 

United Kingdom

 

 

 

 

Eli Lilly

 

 

 

 

 

 

 

Holdings Limited, pārstāvniecība Latvijā

Eli Lilly and Company Limited

 

 

Tel: + 371 67364000

 

 

Tel: + 44 (0) 1256 315000

 

 

This leaflet was last revised in {month XXXX}

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

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

(Perforation to allow health care provider information to be detached)

INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS

Reconstitution and administration of ZYPREXA

Reconstitute ZYPREXA Powder for Solution for Injection only with water for injections.

ZYPREXA Powder for Solution for Injection must not be combined in the syringe with any commercially available medicinal products because of incompatibilities. See examples below.

Olanzapine for injection should not be combined in a syringe with haloperidol injection because the resulting low pH has been shown to degrade olanzapine over time.

Olanzapine for injection may not be combined in a syringe nor should it be used concomitantly with benzodiazepines.

Powder for Solution for Injection

Reconstitute ZYPREXA Powder for Solution for Injection using standard aseptic techniques for reconstitution of parenteral products.

1.

Withdraw 2.1 ml of water for injections into a sterile syringe. Inject into a vial of ZYPREXA

 

Powder for Solution for Injection.

 

 

2.

Rotate the vial until the contents have completely dissolved, giving a yellow coloured solution.

 

The vial contains 11.0 mg olanzapine as a solution of 5 mg/ml. If 2.0 ml solution is withdrawn,

 

1 mg olanzapine is retained in the vial and syringe, thus allowing delivery of 10mg olanzapine.

3.

The following table provides injection volumes for delivering various doses of olanzapine:

 

 

 

 

 

 

 

Dose (mg)

Volume of injection (ml)

 

 

2.0

 

 

 

7.5

1.5

 

 

 

1.0

 

 

 

2.5

0.5

 

4.

Administer the solution intramuscularly. Do not administer intravenously or subcutaneously.

5.

Discard the syringe and any unused solution in accordance with appropriate clinical procedures.

6.

Use the solution immediately within 1 hour of reconstitution. Do not store above 25º C. Do not

 

freeze.

 

 

Parenteral medicines should be inspected visually for particulate matter prior to administration.

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