Olanzapine Mylan 15 mg film-coated tablets

Olanzapine belongs to a group of medicines called antipsychotics.

Olanzapine is used to treat 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.

Olanzapine is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.

Do not take Olanzapine Mylan

• if you are allergic (hypersensitive) to olanzapine, peanut or soya or any of the other ingredients of Olanzapine Mylan 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) .

Take special care with Olanzapine Mylan

• Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given Olanzapine Mylan 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.
• The use of olanzapine in elderly patients with dementia is not recommended as it may have serious side effects.

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

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson?s disease
• Epilepsy
• Prostate problems
• A blocked intestine (Paralytic ileus)
• Blood disorders
• Stroke or ?mini? stroke (temporary symptoms of stroke)

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 Mylan is not for patients who are under 18 years.

Taking other medicines

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

You should tell your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as it may be necessary to change your Olanzapine Mylan dose.

Please 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.

Taking Olanzapine Mylan with food and drink

Do not drink any alcohol if you have been given Olanzapine Mylan as olanzapine and alcohol together may make you feel drowsy.

Pregnancy and breast-feeding

Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. You should not take this medicine when pregnant, unless you have discussed this with your doctor. You should not be given this medicine when breast-feeding, as small amounts of olanzapine can pass into breast milk.

Driving and using machines

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

Important information about some of the ingredients of Olanzapine Mylan

Olanzapine Mylan 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. The tablet film-coating contains soya lecithin. If you are allergic to peanut or soya do not take these tablets.

Always take Olanzapine Mylan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

You should take your Olanzapine Mylan 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 Mylan tablets are for oral use. You should swallow the Olanzapine Mylan tablets whole with water.

If you take more Olanzapine Mylan than you should

Patients who have taken more olanzapine 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. Show the doctor your pack of tablets.

If you forget to take Olanzapine Mylan

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

If you stop taking Olanzapine Mylan

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

If you suddenly stop taking Olanzapine Mylan, 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 product, ask your doctor or pharmacist.

Like all medicines, Olanzapine Mylan can cause side effects, although not everybody gets them.

Very common side effects: affect 1 user in 10

• Weight gain.
• Sleepiness.
• Increases in the levels of prolactin in the blood.

Common side effects: affect 1 to 10 users in 100

• Changes in the levels of some blood cells and circulating fats.
• Increases in the level of sugars in the blood and urine.
• Feeling more hungry.
• Dizziness.
• Restlessness.
• Tremor.
• Muscle stiffness or spasm (including eye movements).
• Problems with speech.
• Unusual movement (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Rash.
• Loss of strength.
• Extreme tiredness.
• Water retention leading to swelling of the hands, ankles or feet.
• 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.
• Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.

Uncommon side effects: affect 1 to 10 users in 1,000

• Slow heart rate.
• Make you sensitive to sunlight.
• Urinary incontinence.
• Hair loss.
• Absence or decrease in menstrual periods.
• Changes in breasts in males and females such as an abnormal production of breast milk orabnormal growth.

Other possible side effects: frequency cannot be estimated from the available data.

• Allergic reaction (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.
• Lowering of normal body temperature.
• Seizures, usually associated with a history of seizures (epilepsy).
• Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
• Spasms of the muscle of the eye causing rolling movement of the eye.
• Abnormal rhythms of the heart.
• Sudden unexplained death.
• Blood clots such as deep venous thrombosis of the leg or blood clot on the lung.
• 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.
• Difficulty in passing urine.
• Prolonged and/or painful erection.

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 Mylan may worsen the symptoms.

Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods. If this persists tell your doctor. Very rarely babies born to

rd trimester may have tremors, be mothers who have taken olanzapine in the last stage of pregnancy 3sleepy or drowsy.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Do not use Olanzapine Mylan after the expiry date, which is stated on the carton .

Do not store above 25 °C.

Please return left over medicine to your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Olanzapine Mylan contains

• The active substance is olanzapine. Each Olanzapine Mylan 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 Olanzapine Mylan tablet pack.
• The other ingredients are (tablet core) lactose monohydrate, maize starch, pregelatinised maize starch, crospovidone type A, magnesium stearate and (tablet coating) polyvinyl alcohol, titanium dioxide (E171), talc (E553b), lecithin (soya) (E322), xanthan gum (E415).

What Olanzapine Mylan looks like and contents of the pack

Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg and 10 mg are round, white, film-coated tablets. Olanzapine Mylan 15 mg and 20 mg are elliptical, white, film-coated tablets.

Blisters:
Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg are available in packs of 28, 35, 56 and 70 film-coated tablets.
Olanzapine Mylan 10 mg are available in packs of 7, 28, 35, 56 and 70 film-coated tablets.

Tablet containers:
Olanzapine Mylan 2.5 mg and 5.0 mg are available in packs of 250 and 500 film-coated tablets. OlanzapineMylan 7.5 mg, 15 mg and 20 mg are available in packs of 100 film-coated tablets. Olanzapine Mylan 10 mg are available in packs of 100 and 500 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer: McDermott Laboratories Ltd. t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

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

Authorisation Holder:

BelgiëBelgiqueBelgien Mylan bvbasprl TélTel 0032 02 686 07 11 LuxembourgLuxemburg Generics UK Ltd TélTel 44 1707 853000 United Kingdom

Generics UK Ltd Te. 44 1707 853000 United Kingdom Magyarország Generics UK Ltd Tel 44 1707 853000 United Kingdom

Ceská republika Mylan Pharmaceuticals.s.r.o. Tel 420 274 770 201 Malta George Borg Barthet Ltd Tel 356 21244205

Danmark Mylan ApS Tlf 45 3694 4568 Nederland Mylan B.V Tel 31 033 2997080

Deutschland Mylan dura GmbH Tel 49-0 6151 9512 0 Norge Mylan AB Tlf 46 8-555 227 50 Sverige

Österreich Arcana Arzneimittel GmbH Tel 43 1 979 37 95 - 113 Eesti Generics UK Ltd Tel 44 1707 853000 United Kingdom

Generics Pharma Hellas 30 210 9936410 Polska Mylan Sp. z o.o. Tel 48 22 644 22 41

España Mylan Pharmaceuticals, S.L tel 34 94 565 55 00 Portugal Laquifa Laboratórios S.A Tel 351 21 3613 500 .

France Mylan SAS Tel 33 4 37532761 România Generics UKLimited Tel 44 1707 853000 United Kingdom

Ireland Mc Dermott Laboratories Ltd Tel 1800 272 272 Slovenija Generics UK Ltd Tél 44 1707 853000 United Kingdom

Ísland Mylan AB Sími 46 8-555 227 50 Slovenská republika Mylan s r. o Tel 421 2 32 604 901

SuomiFinland Mylan OY Italia Mylan S.p.A Tel 3902-61246921 PuhTel 358 9-46 60 03

Pharmaceutical Trading Co Ltd 35 7 24656165 Sverige Mylan AB Tel 46 8-555 227 50

United Kingdom Generics UK Ltd Tel 44 1707 853000 Latvija Generics UK Ltd Tel 44 1707 853000 United Kingdom

Lietuva

Generics [UK] Ltd
Tel: +44 1707 853000
(United Kingdom)

This leaflet was last approved in {MM/YYYY}.