ZYPREXA 10 mg powder for solution for injection

ZYPREXA belongs to a group of medicines called antipsychotics.

ZYPREXA Injection is used to treat quickly symptoms of agitation and distressing behaviour that may occur in diseases 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- hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. - feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

ZYPREXA Injection is given when treatment with ZYPREXA tablets is not appropriate. Your doctor will change your treatment to ZYPREXA tablets, as soon as appropriate.

You should not be given 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 Powder for Solution for Injection

- Tell the doctor or nurse if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. The doctor may also want to measure your blood pressure and pulse. - Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given ZYPREXA, talk to 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. No more injections will be given to you.
- 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 If you have had a recent heart attack, or have heart disease, including sick sinus syndrome, unstable angina or suffer from low blood pressure. Diabetes 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.

ZYPREXA is not for patients who are under 18 years.

As a routine precaution, if you are over 65 years your doctor may monitor your blood pressure.

Taking other medicines

A combination of ZYPREXA with the following medicines might make you feel drowsy: medicines taken for anxiety or to help you sleep (tranquillisers, including benzodiazpines),and antidepressants. Only take other medicines while you are on ZYPREXA if your doctor tells you that you can.

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 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.

Information on reconstitution and administration is provided in a detachable section at the end of this leaflet.

Your doctor will decide how much ZYPREXA you need and how long you need it for. The dose is usually 10 mg in for the first injection, but it may be less than this. Up to 20 mg in 24 hours may be given. The dose for patients aged over 65 years is 2.5 or 5 mg.

ZYPREXA comes as a powder. Your doctor or nurse will make it up into a solution. ZYPREXA Injection is for intramuscular use. The correct amount of solution will be injected into your muscle.

If you are given more ZYPREXA than you think you should be

Patients who have been given 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. Tell your doctor or nurse of your concern.

Only a few doses ofZYPREXA Injection are needed. Your doctor will decide when you need a dose of ZYPREXA Injection.

If you have any further questions on the use of this product, ask your doctor.

Like all medicines, ZYPREXA Injection can cause side effects, although not everybody gets them.

Common side effects with ZYPREXA Injection: affect 1 to 10 users in 100
- Slower or faster heart rate.
- Sleepiness.
- Low blood pressure.
- Discomfort at the site of injection.
- Some people may feel dizzy or faint (with a slow heart rate) after injection, 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 or a nurse as soon as possible.

Uncommon side effects: affect 1 to 10 users in 1,000
- Breathing more slowly.
- Abnormal rhythms of the heart, which can be serious.

In addition, the following side effects have been seen after patients have taken ZYPREXA orally.

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 as soon as possible. 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 Injection after the expiry date, which is stated on the carton.

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

After ZYPREXA Injection is made into a solution, use within one hour. Do not freeze after reconstitution.

Discard any unused contents.

What ZYPREXA Injection contains

- The active substance is olanzapine. Each vial contains 10 mg of the active substance. - The other ingredients are lactose monohydrate, tartaric acid, hydrochloric acid and sodium hydroxide.

What ZYPREXA Injection looks like and contents of the pack

ZYPREXA comes as a yellow powder in a vial. A vial of ZYPREXA can provide you with 10 mg of olanzapine. Your doctor or nurse will make it up into a solution that will be given as an injection.

ZYPREXA Injection is available in a pack containing 1 or 10 vial(s). 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 Pharma Fertigung und Distribution GmbH & Co. KG, Teichweg 3, D-35396 Giessen, Germany.

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 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. LuxembourgLuxemburg Eli Lilly Benelux S.A.N.V. TélTel 32 02 548 84 84 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100 Malta Charles de Giorgio Ltd. Tel 356 25600 500 Nederland Eli Lilly Nederland B.V. Tel 31 030 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.

Sími 354 540 8000 Tel 421 220 663 111

Italia Eli Lilly Italia S.p.A. Tel 39- 055 42571 Phadisco Ltd 357 22 715000 Latvija 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

This leaflet was last approved in {MM/YYYY}

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INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS

Reconstitution and administration of ZYPREXA

Reconstitute ZYPREXA Powder for Solution for Injection only with water for injections.

ZYPREXA Powder for Solution for Injection must not be combined in the syringe with any commercially available medicinal products because of incompatibilities. See examples below.

Olanzapine for injection should not be combined in a syringe with haloperidol injection because the resulting low pH has been shown to degrade olanzapine over time.

Olanzapine for injection may not be combined in a syringe nor should it be used concomitantly with benzodiazepines.

Powder for Solution for Injection

Reconstitute ZYPREXA Powder for Solution for Injection using standard aseptic techniques for reconstitution of parenteral products.

1. Withdraw 2.1 ml of water for injections into a sterile syringe. Inject into a vial of ZYPREXA Powder for Solution for Injection.

2. Rotate the vial until the contents have completely dissolved, giving a yellow coloured solution. The vial contains 11.0 mg olanzapine as a solution of 5 mg/ml. If 2.0 ml solution is withdrawn, 1 mg olanzapine is retained in the vial and syringe, thus allowing delivery of 10mg olanzapine.

3. The following table provides injection volumes for delivering various doses of olanzapine:

Dose mg Volume of injection ml 10 2.0 7.5 1.5 5 1.0 2.5 0.5

4. Administer the solution intramuscularly. Do not administer intravenously or subcutaneously.

5. Discard the syringe and any unused solution in accordance with appropriate clinical procedures.

6. Use the solution immediately within 1 hour of reconstitution. Do not store above 25º C. Do not freeze.

Parenteral medicines should be inspected visually for particulate matter prior to administration.