Olanzapine Teva 5 mg film-coated tablets

Olanzapine Teva belongs to a group of medicines called antipsychotics.

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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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

• if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Olanzapine Teva.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 Teva

• Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given Olanzapine Teva 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 Teva 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 Teva is not for patients who are under 18 years.

Taking other medicines

Only take other medicines while you are on Olanzapine Teva if your doctor tells you that you can. You might feel drowsy if Olanzapine Teva 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 Teva 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 Teva with food and drink

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

Driving and using machines

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

Important information about some of the ingredients of Olanzapine Teva

Olanzapine Teva 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.

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

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

If you take more Olanzapine Teva than you should

Patients who have taken more Olanzapine Teva 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 Teva

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

If you stop taking Olanzapine Teva

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

If you suddenly stop taking Olanzapine Teva, 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 Teva 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 or abnormal 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 Teva 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 mothers who have taken Olanzapine Teva in the last stage of pregnancy (3 rd trimester) may have tremors, be sleepy 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 Teva after the expiry date which is stated on the carton.

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

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 Teva contains

• The active substance is olanzapine. Each Olanzapine Teva 2.5 mg film-coated tablet contains 2.5 mg of the active substance. Each Olanzapine Teva 5 mg film-coated tablet contains 5 mg of the active substance. Each Olanzapine Teva 7.5 mg film-coated tablet contains 7.5 mg of the active substance. Each Olanzapine Teva 10 mg film-coated tablet contains 10 mg of the active substance. Each Olanzapine Teva 15 mg film-coated tablet contains 15 mg of the active substance. Each Olanzapine Teva 20 mg film-coated tablet contains 20 mg of the active substance.
• The other ingredients are: (tablet core) lactose monohydrate, Hydroxypropylcellulose, Crospovidone (type A), Silica colloidal anhydrous, Microcrystalline cellulose, Magnesium stearate, (tablet coating) Hypromellose, polydextrose, glycerol diacetate, macrogol 8000, titanium dioxide (E171).
• In addition, the 15 mg strength contains indigo carmine (E132) and the 20 mg strength contains iron oxide red (E172)

What Olanzapine Teva looks like and contents of the pack

Olanzapine Teva 2.5 mg film-coated tablet is a white, biconvex, round tablet, with the inscription ?OL 2.5? on one side.
Olanzapine Teva 5 mg film-coated tablet is a white, biconvex, round tablet, with the inscription ?OL 5? on one side.
Olanzapine Teva 7.5 mg film-coated tablet is a white, biconvex, round tablet, with the inscription ?OL 7.5? on one side.
Olanzapine Teva 10 mg film-coated tablet is a white, biconvex, round tablet, with the inscription ?OL 10? on one side.
Olanzapine Teva 15 mg film-coated tablet is a light blue, biconvex, oval tablet, with the inscription ?OL 15? on one side.
Olanzapine Teva 20 mg film-coated tablet is a pink, biconvex, oval tablet, with the inscription ?OL 20? on one side.

Olanzapine Teva 2.5 mg film-coated tablets are available in cartons of 28, 30, 35, 56 or 70 film-coated tablets.
Olanzapine Teva 5 mg film-coated tablets are available in cartons of 28, 30, 35, 50, 56 or 70 film-coated tablets.
Olanzapine Teva 7.5 mg film-coated tablets are available in cartons of 28, 30, 35, 56 or 70 film-coated tablets.
Olanzapine Teva 10 mg film-coated tablets are available in cartons of 7, 28, 30, 35, 50, 56 or 70 film-coated tablets.
Olanzapine Teva 15 mg film-coated tablets are available in cartons of 28, 30, 35, 50, 56or 70 film-coated tablets.
Olanzapine Teva 20 mg film-coated tablets are available in cartons of 28, 30, 35, 56 or 70 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, The Netherlands

Manufacturer:
Teva Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Hungary
Teva Pharmaceutical Works, Táncsics Mihály út 82, H-2100 Gödöllo, Hungary
Teva Kutno S.A., Sienkiewicza 25 str, 99 300 Kutno, Poland
Gry-Pharma GmbH, Kandelstr. 10, 79199 Kirchzarten, Germany
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A.AG Telephone 32 38.20.73.76 LuxembourgLuxemburg Teva Pharma Belgium N.V.S.A.AG Telephone 32 38.20.73.76

Teva Pharmaceuticals Bulgaria EOOD Telephone 359 2 943 02 51. Magyarország Teva Magyarország Zrt., Tel 36 1 288 6410

eská republika Teva Pharmaceuticals CR, s.r.o Telephone 420 606 763 892 Malta Teva UK Limited Telephone 44 1323 501 111.

Danmark Teva Sweden AB Telephone 46 42 12 11 00 Nederland Pharmachemie BV Telephone 31 235 147 147

Deutschland Teva Generics GmbH Tel 49 7661 98 45 04 Norge Teva Sweden AB Telephone 46 42 12 11 00

Eesti UAB Sicor Biotech Estonian Affiliate Telephone 372 611 2407. Österreich Teva UK Limited Telephone 44 1323 501 111.

Teva UK Limited Telephone 44 1323 501 111. Polska Teva Pharmaceuticals Polska Sp. z o.o Telephone 48 22 345 93 00

España Teva Genéricos Española, S.L. Telephone 34 91 535 91 80 34 637 72 50 63 Portugal Teva Pharma - Produtos Farmacêuticos Lda Telephone 351 214 235 910

France Teva Classics S.A. Telephone 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Telephone 4021 212 08 90.

Ireland Teva UK Limited Telephone 44 1323 501 111. Slovenija Teva UK Limited Telephone 44 1323 501 111.

Ísland Teva UK Limited Telephone 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Telephone 421 2 5726 7974

Italia Teva Italia S.r.l. Telephone 39 0289179805 SuomiFinland Teva Sweden AB Telephone 46 42 12 11 00

Teva UK Limited Telephone 44 1323 501 111. Sverige Teva Sweden AB Telephone 46 42 12 11 00

Latvija UAB Sicor Biotech Latvian Affiliate Telephone 371 6714 25 63. United Kingdom Teva UK Limited Telephone 44 1323 501 111.

Lietuva
UAB ?Sicor Biotech?
Telephone: +370 5 211 35 00.

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