Olanzapine Glenmark Europe - Patient leaflet, side effects, dosage

1. What Olanzapine Glenmark Europe is and what it is used for

Olanzapine Glenmark Europe contains the active substance olanzapine. Olanzapine Glenmark Europe belongs to a group of medicines called antipsychotics.

Olanzapine Glenmark Europe 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 Glenmark Europe 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 Glenmark Europe

Do not take Olanzapine Glenmark Europe

• - 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 Olanzapine Glenmark Europe

• – The use of Olanzapine Glenmark Europe in elderly patients with dememtia 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 Glenmark Europe, 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 Glenmark Europe. 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 Glenmark Europe. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Glenmark Europe and regularly during treatment.

• – Tell your 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 Glenmark Europe is not for patients who are under 18 years.

Other medicines and Olanzapine Glenmark Europe

Only take other medicines while you are on Olanzapine Glenmark Europe if your doctor tells you that you can. You might feel drowsy if Olanzapine Glenmark Europe 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 antidepresant) or ciprofloxacin (an antibiotic) – it may be necessary to change your Olanzapine Glenmark Europe dose.

Olanzapine Glenmark Europe with alcohol

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

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

Olanzapine Glenmark Europe contains aspartame

Olanzapine Glenmark Europe contains a source of phenylalanine. This may be harmful for people with phenylketonuria.

3. How to take Olanzapine Glenmark Europe

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

You should take your Olanzapine Glenmark Europe orodispersible 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 Glenmark Europe orodispersible tablets are for oral use. Put the tablet in your mouth. It will dissolve directly in your mouth, so that it can be easily swallowed. You can also place the tablet in a full glass or cup of water or other suitable beverage (orange juice, apple juice, milk or coffee) and stir. Drink it straightaway.

If you take more Olanzapine Glenmark Europe than you should

Patients who have taken more Olanzapine Glenmark Europe 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 Glenmark Europe

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

If you stop taking Olanzapine Glenmark Europe

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

If you suddenly stop taking Olanzapine Glenmark Europe, 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
• Increases in the 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
• 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
• stuttering,
• Slow heart rate.
• Sensitivity to sunlight.
• Bleeding from the nose.
• Abdominal distension
• Drooling
• Memory loss or forgetfulness
• Urinary incontinence, lack of ability to urinate.
• Hair loss.
• Absence or decrease in menstrual periods.
• 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.
• Prolonged and/or painful erection.

Very rare side effects (may affect up to 1 in 10,000) 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 Glenmark Europe may worsen the symptoms

Reporting side effects

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

5. How to store Olanzapine Glenmark Europe

Keep this medicine out of sight and reach and of children

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

Store below 30° C.

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

6. Contents of the pack and other information

What Olanzapine Glenmark Europe contains

• – The active substance is olanzapine

• – Each Olanzapine Glenmark Europe orodispersible tablet contains, 5 mg, 10 mg, 15 mg, or

What Olanzapine Glenmark Europe looks like and contents of the pack

Olanzapine Glenmark Europe 5mg:

yellow coloured circular flat bevelled edge orodispersible tablets with ‘B’ debossed on one side.

Olanzapine Glenmark Europe 10 mg:

yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘D’ debossed on other side.

Olanzapine Glenmark Europe 15 mg:

yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘E’ debossed on other side.

Olanzapine Glenmark Europe 20 mg:

yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘F’ debossed on other side.

Olanzapine Glenmark Europe 5 mg, 10 mg, 15 mg and 20 mg are available in aluminium foil blisters of 28, 56, and 70 orodispersible tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Glenmark Arzneimittel GmbH

Industriestr. 31, D – 82194

Gröbenzell, Germany

Manufacturer

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvezdova 1716/2b, 140 78 Praha 4

Czech Republic

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park,

Croxley Green,

Hertfordshire, WD18 8YA,

United Kingdom

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

Authorisation Holder:

Detailed information on this medicine is available on the European Medicines Agency website:

85

Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4,4), _________

Investigations

Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16

Following short term treatment (median duration 22 days), weight gain > 7 % of baseline body weight (kg) was very common (40.6 %), > 15 % of baseline body weight was common (7.1 %) and > 25 % was common (2.5 %). With long-term exposure (at least 24 weeks), 89.4 % gained > 7 %, 55.3 % gained > 15 % and 29.1 % gained > 25% of their baseline body weight.

Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high

(> 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (> 1.016 mmol/l –

Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4,4), _________

Investigations

Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16

Following short term treatment (median duration 22 days), weight gain > 7 % of baseline body weight (kg) was very common (40.6 %), > 15 % of baseline body weight was common (7.1 %) and > 25 % was common (2.5 %). With long-term exposure (at least 24 weeks), 89.4 % gained > 7 %, 55.3 % gained > 15 % and 29.1 % gained > 25% of their baseline body weight.

Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high

(> 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (> 1.016 mmol/l – < 1.467 mmol/l) to high (> 1.467 mmol/l).

Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (> 5.17 mmol/l) were observed commonly. Changes in total fasting cholesterol levels from borderline at baseline (> 4.39 – < 5.17 mmol/l) to high (> 5.17 mmol/l) were very common.

Clinically significant weight gain was observed across all baseline Body Mass Index (BMI)

categories. Following short term treatment (median duration 47 days), weight gain > 7 % of baseline

Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4,4), _________

Investigations

Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16

Following short term treatment (median duration 22 days), weight gain > 7 % of baseline body weight (kg) was very common (40.6 %), > 15 % of baseline body weight was common (7.1 %) and > 25 % was common (2.5 %). With long-term exposure (at least 24 weeks), 89.4 % gained > 7 %, 55.3 % gained > 15 % and 29.1 % gained > 25% of their baseline body weight.

Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (> 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (> 1.016 mmol/l -< 1.467 mmol/l) to high (> 1.467 mmol/l).

Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (> 5.17

Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4,4), _________

Investigations

Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16

Following short term treatment (median duration 22 days), weight gain > 7 % of baseline body weight (kg) was very common (40.6 %), > 15 % of baseline body weight was common (7.1 %) and > 25 % was common (2.5 %). With long-term exposure (at least 24 weeks), 89.4 % gained > 7 %, 55.3 % gained > 15 % and 29.1 % gained > 25% of their baseline body weight.

Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (> 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (> 1.016 mmol/l – < 1.467 mmol/l) to high (> 1.467 mmol/l).

Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (> 5.17