ZYPREXA 20 mg coated tablets

ZYPREXA belongs to a group of medicines called antipsychotics.

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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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

ZYPREXA 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 ZYPREXA

- if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of ZYPREXA.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 ZYPREXA

- Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given ZYPREXA 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 ZYPREXA 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 Parkinsons 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.

ZYPREXA is not for patients who are under 18 years.

Taking other medicines

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

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

Driving and using machines

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

Important information about some of the ingredients of ZYPREXA

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

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

If you take more ZYPREXA than you should

Patients who have taken more ZYPREXA 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 ZYPREXA

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

If you stop taking ZYPREXA

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

If you suddenly stop taking ZYPREXA, 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, ZYPREXA 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 ZYPREXA 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 ZYPREXA 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 ZYPREXA after the expiry date, which is stated on the carton .

ZYPREXA should be stored in its original pack in order to protect from light and moisture.

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 ZYPREXA contains

- The active substance is olanzapine. Each ZYPREXA 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 ZYPREXA tablet pack.
- The other ingredients are
- (tablet core) lactose monohydrate, hyprolose, crospovidone, microcrystalline cellulose, magnesium stearate and
- (tablet coating) hypromellose, titanium dioxide (E171), carnauba wax.
- In addition the different ZYPREXA tablet strengths also contain the following ingredients:

TABLET STRENGTH OTHER INGREDIENTS

ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg tablets tablet coating shellac, macrogol, propylene glycol, polysorbate 80 and indigo carmine colour E132

ZYPREXA 15 mg tablets tablet coating triacetin and indigo carmine colour E132

ZYPREXA 20 mg tablets tablet coating macrogol and synthetic red iron oxide E172

What ZYPREXA looks like and contents of the pack
ZYPREXA 2.5 mg, 5 mg, 7.5 mg and 10 mg coated tablets are white.
ZYPREXA 15 mg coated tablets are light blue.
ZYPREXA 20 mg coated tablets are pink.

ZYPREXA tablets are available in 28, 35, 56, 70 or 98 tablet packs. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Eli Lilly Nederland BV, Grootslag 1 ? 5, NL-3991 RA, Houten, The Netherlands.
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

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

BelgiëBelgiqueBelgien Eli Lilly Benelux S.A.N.V. TélTel 32 02 548 84 84 .. - 359 2 491 41 40 LuxembourgLuxemburg Eli Lilly Benelux S.A.N.V. TélTel 32 02 548 84 84 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100

eská republika Eli Lilly R, s.r.o. Tel 420 234 664 111 Danmark Eli Lilly Danmark AS Tlf. 45 45 26 60 00 Deutschland Lilly Deutschland GmbH Tel 49 0 6172 273 2222 Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 372 6817 280 a - .... 30 210 629 4600 España Lilly S.A. Tel 34 91 663 50 00 France Lilly France SAS Tél 33 0 1 55 49 34 34 Ireland Eli Lilly and Company Ireland Limited Tel 353 0 1 661 4377 Ísland Icepharma hf. Sími 354 540 8000 Italia Eli Lilly Italia S.p.A. Tel 39 055 42571 Phadisco Ltd 357 22 715000 Latvija Malta Charles de Giorgio Ltd. Tel 356 25600 500 Nederland Eli Lilly Nederland B.V. Tel 31030 6025800 Norge Eli Lilly Norge A.S Tlf 47 22 88 18 00 Österreich Eli Lilly Ges. m.b.H. Tel 43 0 1 711 780 Polska Eli Lilly Polska Sp. z o.o. Tel 48 0 22 440 33 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel 351 21 412 66 00 România Eli Lilly România S.R.L. Tel 40 21 4023000 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358 09 8545 250 Sverige Eli Lilly Sweden AB Tel 46 08 7378800 United Kingdom Eli Lilly Holdings Limited, prstvniecba Latvij Eli Lilly and Company Limited Tel 371 67364000 Tel 44 0 1256 315000 Lietuva Eli Lilly Holdings Limited atstovyb Tel 370 5 2649600

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