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Olanzapine Apotex (olanzapine) – Package leaflet - N05AH03

Updated on site: 08-Oct-2017

Medication nameOlanzapine Apotex
ATC CodeN05AH03
Substanceolanzapine
ManufacturerApotex Europe B.V.  

Package leaflet: Information for the user

Olanzapine Apotex 2.5 mg film-coated tablets

Olanzapine Apotex 5 mg film-coated tablets

Olanzapine Apotex 7.5 mg film-coated tablets

Olanzapine Apotex 10 mg film-coated tablets

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 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 Olanzapine Apotex is and what it is used for

2.What you need to know before you take Olanzapine Apotex

3.How to take Olanzapine Apotex

4.Possible side effects

5.How to store Olanzapine Apotex

6.Contents of the pack and other information

1.What Olanzapine Apotex is and what it is used for

Olanzapine Apotex contains the active substance olanzapine. Olanzapine Apotex 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.

Olanzapine Apotex 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 Olanzapine Apotex

Do not take Olanzapine Apotex

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 taking Olanzapine Apotex.

The use of Olanzapine Apotex 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 Olanzapine Apotex 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 Olanzapine Apotex. 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 Olanzapine Apotex. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Apotex 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

Olanzapine Apotex is not for patients who are under 18 years.

Other medicines and Olanzapine Apotex

Only take other medicines while you are on Olanzapine Apotex if your doctor tells you that you can. You might feel drowsy if Olanzapine Apotex 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 Olanzapine Apotex dose.

Olanzapine Apotex with alcohol

Do not drink any alcohol if you have been given Olanzapine Apotex 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 Olanzapine Apotex can pass into breast milk.

The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Apotex 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 Olanzapine Apotex. If this happens do not drive or operate any tools or machines. Tell your doctor.

Olanzapine Apotex 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 Olanzapine Apotex

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

You should take your Olanzapine Apotex 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.

Olanzapine Apotex film-coated tablets are for oral use. You should swallow the Olanzapine Apotex tablets whole with water.

If you take more Olanzapine Apotex than you should

Patients who have taken more Olanzapine Apotex 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 Olanzapine Apotex

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

If you stop taking Olanzapine Apotex

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

If you suddenly stop taking Olanzapine Apotex, 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 in blood tests and an increase in a type of white blood cell (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 Olanzapine Apotex 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 Olanzapine Apotex

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 and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Olanzapine Apotex contains

The active substance is olanzapine.

Each Olanzapine Apotex 2.5 mg film-coated tablet contains 2.5 mg olanzapine.

Each Olanzapine Apotex 5 mg film-coated tablet contains 5 mg olanzapine.

Each Olanzapine Apotex 7.5 mg film-coated tablet contains 7.5 mg olanzapine.

Each Olanzapine Apotex 10 mg film-coated tablet contains 10 mg olanzapine.

The other ingredients are (tablet core) lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, (tablet coat) hypromellose, hydroxypropylcellulose, macrogol 8000, titanium dioxide (E171).

What Olanzapine Apotex looks like and contents of the pack

Olanzapine Apotex 2.5 mg are white, round, biconvex film-coated tablets engraved ‘APO’ on one side and ‘OLA’ over ‘2.5’ on the other side.

Olanzapine Apotex 5 mg are white, round biconvex film-coated tablets engraved ‘APO’ on one side and ‘OLA’ over ‘5’ on the other side.

Olanzapine Apotex 7.5 mg are white, round biconvex film-coated tablets engraved ‘APO’ on one side and ‘OLA’ over ‘7.5’ on the other side.

Olanzapine Apotex 10 mg are white, round biconvex film-coated tablets engraved ‘APO’ on one side and ‘OLA’ over ‘10’ on the other side.

Olanzapine Apotex 2.5 mg film-coated tablets are available in blisters packs of 28 tablets.

Olanzapine Apotex 7.5 mg film-coated tablets are available in blisters packs of 28 and 56 tablets.

Olanzapine Apotex 5 mg and 10 mg film- coated tablets are available in blister packs of 28, 56 and 98 tablets..

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Manufacturer

Apotex Nederland B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

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

België/Belgique/Belgien

Luxembourg/Luxemburg

NV Apotex SA

NV Apotex SA

Tél/Tel:(32) 475.35.40

Tél/Tel:(32) 475.35.40

България

Magyarország

Apotex Europe B.V.

Apotex Europe B.V.

тел. (31) 71. 565.77. 77

Tel: (31) 71. 565.77. 77

Česká republika

Malta

Apotex (ČR) s.r.o.

Apotex Europe B.V.

Tel: (420) 234.705.700

Tel: (31) 71. 565.77.77

Danmark

Nederland

Apotex Europe B.V.

Apotex Nederland B.V.

Tlf.: (31) 71. 565.77. 77

Tel: (31) 71. 52.43.100

Deutschland

Norge

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77. 77

Tlf.: (31) 71. 565.77. 77

Eesti

Österreich

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77. 77

Tel: (31) 71. 565.77. 77

Ελλάδα

Polska

Apotex Europe B.V.

Apotex Polska Sp. z o.o.

Τηλ: (31) 71. 565.77. 77

Tel: (48) 22.311.20.00

España

Portugal

Apotex ESPAÑA S.L.

Apotex Europe B.V.

Tel: (34) 91.486.15.65

Tel: (31) 71. 565.77. 77

France

 

NV Apotex SA

România

Tél: (32) 475.35.40

Apotex Europe B.V.

Hrvatska

Tel: (31) 71. 565.77. 77

Apotex Europe B.V..

 

Tel: (31) 71. 565.77.77

 

Ireland

Slovenija

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77.77

Tel: (31) 71. 565.77. 77

Ísland

Slovenská republika

Apotex Europe B.V.

Apotex Europe B.V.

Sími: (31) 71. 565.77. 77

Tel: (31) 71. 565.77. 77

Italia

Suomi/Finland

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77. 77

Puh/Tel: (31) 71. 565.77. 77

Κύπρος

Sverige

Apotex Europe B.V.

Apotex Europe B.V.

Τηλ: (31) 71. 565.77. 77

Tel: (31) 71. 565.77. 77

Latvija

United Kingdom

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77. 77

Tel: (31) 71. 565.77.77

Lietuva

 

Apotex Europe B.V.

 

Tel. (31) 71. 565.77. 77

 

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.

Package leaflet: Information for the user

Olanzapine Apotex 5 mg orodispersible tablets

Olanzapine Apotex 10 mg orodispersible tablets

Olanzapine Apotex 15 mg orodispersible tablets

Olanzapine Apotex 20 mg orodispersible tablets

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 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 Olanzapine Apotex is and what it is used for

2.What you need to know before you take Olanzapine Apotex

3.How to take Olanzapine Apotex

4.Possible side effects

5.How to store Olanzapine Apotex

6.Contents of the pack and other information

1.What Olanzapine Apotex is and what it is used for

Olanzapine Apotex contains the active substance olanzapine. Olanzapine Apotex 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.

Olanzapine Apotex 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 Olanzapine Apotex

Do not take Olanzapine Apotex

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 taking Olanzapine Apotex.

The use of Olanzapine Apotex 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 Olanzapine Apotex 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 Olanzapine Apotex. 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 Olanzapine Apotex. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Apotex 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

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

Olanzapine Apotex is not for patients who are under 18 years.

Other medicines and Olanzapine Apotex

Only take other medicines while you are on Olanzapine Apotex if your doctor tells you that you can. You might feel drowsy if Olanzapine Apotex 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 Olanzapine Apotex dose.

Olanzapine Apotex with alcohol

Do not drink any alcohol if you have been given Olanzapine Apotex 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 OlanzapineApotex can pass into breast milk

The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Apotex 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 Olanzapine Apotex. If this happens do not drive or operate any tools or machines. Tell your doctor.

3.How to take Olanzapine Apotex

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

You should take your Olanzapine Apotex 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. Olanzapine Apotex orodispersible tablets are for oral use.

Olanzapine Apotex tablets break easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may break up.

You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or or coffee and stir. With some drinks, the mixture may change colour and possibly become cloudy. Drink it straight away.

If you take more Olanzapine Apotex than you should

Patients who have taken more Olanzapine Apotex 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 Olanzapine Apotex

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

If you stop taking Olanzapine Apotex

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

If you suddenly stop taking Olanzapine Apotex, 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 in blood tests and an increase in a type of white blood cell (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 Olanzapine Apotex 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 Olanzapine Apotex

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 and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Olanzapine Apotex contains

The active substance is olanzapine.

Each Olanzapine Apotex 5 mg orodispersible tablet contains 5 mg olanzapine.

Each Olanzapine Apotex 10 mg orodispersible tablet contains 10 mg olanzapine.

Each Olanzapine Apotex 15 mg orodispersible tablet contains 15 mg olanzapine.

Each Olanzapine Apotex 20 mg orodispersible tablet contains 20 mg olanzapine.

The other ingredients are mannitol (E421), microcrystalline cellulose, carmellose calcium, sucralose, magnesium stearate and colloidal anhydrous silica.

What Olanzapine Apotex looks like and contents of the pack

Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.

Olanzapine Apotex 5 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO’ on one side and ‘OL’ over ‘5’ on the other side.

Olanzapine Apotex 10 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO’ on one side and ‘OL’ over ‘10’ on the other side.

Olanzapine Apotex 15 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO’ on one side and ‘OL’ over ‘15’ on the other side

Olanzapine Apotex 20 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO’ on one side and ‘OL’ over ‘20’ on the other side.

Olanzapine Apotex 5 mg and 10 mg orodispersible tablets are available in blisters packs of 28 , 56 and 98 tablets.

Olanzapine Apotex 20 mg orodispersible tablets are available in blister packs of 28 and 56 tablets.

Olanzapine Apotex 15 mg orodispersible tablets are available in blisters packs of 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Manufacturer

Apotex Nederland B.V.

Archimedesweg 2

2333 CN Leiden

The Netherlands

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

België/Belgique/Belgien

Luxembourg/Luxemburg

NV Apotex SA

NV Apotex SA

Tél/Tel:(32) 475.35.40

Tél/Tel:(32) 475.35.40

България

Magyarország

Apotex Europe B.V.

Apotex Europe B.V.

тел. (31) 71. 565.77. 77

Tel: (31) 71. 565.77. 77

Česká republika

Malta

Apotex (ČR) s.r.o.

Apotex Europe B.V.

Tel: (420) 234.705.700

Tel: (31) 71. 565.77.77

Danmark

Nederland

Apotex Europe B.V.

Apotex Nederland B.V.

Tlf.: (31) 71. 565.77. 77

Tel: (31) 71. 52.43.100

Deutschland

Norge

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77. 77

Tlf.: (31) 71. 565.77. 77

Eesti

Österreich

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77. 77

Tel: (31) 71. 565.77. 77

Ελλάδα

Polska

Apotex Europe B.V.

Apotex Polska Sp. z o.o.

Τηλ: (31) 71. 565.77. 77

Tel: (48) 22.311.20.00

España

Portugal

Apotex ESPAÑA S.L.

Apotex Europe B.V.

Tel: (34) 91.486.15.65

Tel: (31) 71. 565.77. 77

France

 

NV Apotex SA

România

Tél: (32) 475.35.40

Apotex Europe B.V.

Hrvatska

Tel: (31) 71. 565.77. 77

Apotex Europe B.V..

 

Tel: (31) 71. 565.77.77

 

Ireland

Slovenija

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77.77

Tel: (31) 71. 565.77. 77

Ísland

Slovenská republika

Apotex Europe B.V.

Apotex Europe B.V.

Sími: (31) 71. 565.77. 77

Tel: (31) 71. 565.77. 77

Italia

Suomi/Finland

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77. 77

Puh/Tel: (31) 71. 565.77. 77

Κύπρος

Sverige

Apotex Europe B.V.

Apotex Europe B.V.

Τηλ: (31) 71. 565.77. 77

Tel: (31) 71. 565.77. 77

Latvija

United Kingdom

Apotex Europe B.V.

Apotex Europe B.V.

Tel: (31) 71. 565.77. 77

Tel: (31) 71. 565.77.77

Lietuva

 

Apotex Europe B.V.

 

Tel. (31) 71. 565.77. 77

 

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.

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