Zalasta 5 mg orodispersible tablets

Zalasta belongs to a group of medicines called antipsychotics.

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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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

Zalasta 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 Zalasta

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

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

Zalasta is not for patients who are under 18 years.

Taking other medicines

Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.

Tell your doctor if:

• you are taking medicines for Parkinson?s disease,
• you are taking antidepressants or medicines taken for anxiety or to help you sleep(tranquillisers). You might feel drowsy if Zalasta is taken in combination with these medicines,
• if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change your Zalasta dose.

Taking Zalasta with food and drink

Zalasta may be taken with or without food. Your mouth should be empty before placing the tablet on the tongue.

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

Pregnancy

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.

Breast-feeding

You should not be given this medicine when breast-feeding, as small amounts of Zalasta can pass into breast milk.

Driving and using machines

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

Important information about some of the ingredients of Zalasta

Zalasta contains a source of phenylalanine. May be harmful for people with phenylketonuria.

Always take Zalasta exactly as your doctor has told you. You should check with your doctor or pharmacists if you are not sure.

Your doctor will tell you how many Zalasta tablets to take and how long you should continue to take them. The daily dose of Zalasta is between 5-20 mg.

Consult your doctor if your symptoms return but do not stop taking Zalasta unless your doctor tells you to.

You should take your Zalasta 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.

How to take Zalasta

Zalasta tablets break easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may break up. To take a tablet out of the packaging:

1. Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.

2. Pull up the edge of the foil and peel foil off completely.

3. Tip the tablet out onto your hand.

4. Put the tablet on the tongue as soon as it is removed from the packaging.

The tablet begins breaking up in the mouth within seconds and can then be swallowed with or without water. Your mouth should be empty before placing the tablet on the tongue.

You can also place the tablet in a full glass or cup of water. Drink it straight away.

If you take more Zalasta than you should

Patients who have taken more Zalasta 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 Zalasta

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

If you stop taking Zalasta

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

If you suddenly stop taking Zalasta, 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, Zalasta 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 inmales.

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 Zalasta 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 Zalasta 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 or pharmacist.

Keep out of the reach and sight of children.

Do not use Zalasta after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Zalasta contains

• The active substance is olanzapine. Each orodispersible tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg olanzapine.
• The other ingredients are mannitol, microcrystalline cellulose, crospovidone, low-substituted hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate.

What Zalasta looks like and contents of the pack

Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are: round, slightly biconvex, yellow marbled tablets with possible individual spots.

Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

1. KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

2. KRKA Polska Sp. z o.o., ul. Równoleg-a 5, 02-235 Warsaw, Poland

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

BelgiëBelgiqueBelgien KRKA, d.d., Novo mesto TélTel 32 03 321 63 52 LuxembourgLuxemburg KRKA, d.d., Novo mesto TélTel 32 03 321 63 52 KRKA Te. 359 02 962 34 50 Magyarország KRKA Magyarország Kereskedelmi Kft. Tel. 361 0 355 8490 eská republika KRKA R, s.r.o. Tel 420 0 221 115 150 Malta KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66 Danmark KRKA Sverige AB Tlf 46 0 8 643 67 66 SE Nederland KRKA, d.d., Novo mesto Tel 32 3 321 63 52 BE Deutschland TAD Pharma GmbH Tel 49 0 4721 6060 Norge KRKA Sverige AB Tlf 46 0 8 643 67 66 SE Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel 372 06 597 365 Österreich KRKA Pharma GmbH, Wien Tel 43 01 66 24 300 QUALIA PHARMA S.A. 30 0210 2832941 Polska KRKA Polska Sp. z o.o. Tel. 48 022 573 7500 España KRKA, d.d., Novo mesto Tel 34 061 5089 809 Portugal KRKA Farmacêutica, Unipessoal Lda. Tel 351 021 46 43 650 France KRKA, d.d., Novo mesto Tél 32 3 321 63 52 BE România KRKA Romania S.R.L., Bucharest Tel 402 01 310 66 05 Ireland KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66 Slovenija KRKA, d.d., Novo mesto Tel 386 0 1 47 51 100 Ísland KRKA Sverige AB Sími 46 0 8 643 67 66 SE Slovenská republika KRKA Slovensko, s.r.o. Tel 421 0 2 571 04 501 Italia KRKA, d.d., Novo mesto Tel 39 069448827 SuomiFinland KRKA Sverige AB PuhTel 46 0 8 643 67 66 SE

Kipa Pharmacal Ltd. 357 24 651 882 Sverige KRKA Sverige AB Tel 46 0 8 643 67 66 SE Latvija KRKA, d.d., Novo mesto Tel 371 6 733 86 10 United Kingdom Consilient Health UK Ltd. Tel 44 02089562310 Lietuva UAB KRKA Lietuva Tel 370 52 36 27 40

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