Olanzapine Glenmark Europe 15 mg orodispersible tablets

• 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.

1. What Olanzapine Glenmark Europe is and what it is used for
2. What you need to know before you take Olanzapine Glenmark Europe
3. How to take Olanzapine Glenmark Europe
4. Possible side effects
5. How to store Olanzapine Glenmark Europe
6. Contents of the pack and other information

• 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).

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.

Olanzapine Glenmark Europe is not for patients who are under 18 years.

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.

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

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.

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 a source of phenylalanine. This may be harmful for people with phenylketonuria.

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.

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

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 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is olanzapine
• Each Olanzapine Glenmark Europe orodispersible tablet contains, 5 mg, 10 mg, 15 mg, or 20 mg olanzapine
• The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone, magnesium stearate

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.

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