Package leaflet: Information for the user

Olanzapine Adamed 2.5 mg hard capsules Olanzapine Adamed 5 mg hard capsules Olanzapine Adamed 7.5 mg hard capsules Olanzapine Adamed 10 mg hard capsules Olanzapine Adamed 15 mg hard capsules Olanzapine Adamed 20 mg hard capsules Olanzapine

Read all this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Olanzapine Adamed is and what it is used for

2.    What you need to know before you take Olanzapine Adamed

3.    How to take Olanzapine Adamed

4.    Possible side effects

5.    How to store Olanzapine Adamed

6.    Contents of the pack and other information

1. What Olanzapine Adamed is and what it is used for

Olanzapine Adamed belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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

•    Moderate to serve manic episodes, a condition with symptoms of excitement or euphoria.

Olanzapine Adamed has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.

2. What you need to know before you take Olanzapine Adamed Do not take Olanzapine Adamed

•    If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking Olanzapine Adamed.

•    The use of Olanzapine Adamed in elderly patients with dementia is not recommended as it may have serious side effects.

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

•    Weight gain has been seen in patients taking Olanzapine Adamed. You and your doctor should check your weight regularly.

•    High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Adamed. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Adamed and regularly during treatment.

•    Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.

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

•    Stroke or “mini” stroke (temporary symptoms of stroke)

•    Parkinson’s disease

•    Prostate problems

•    A blocked intestine (Paralytic ileus)

•    Liver or kidney disease

•    Blood disorders

•    Heart disease

•    Diabetes

•    Seizures

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.

Children and adolescents

Olanzapine Adamed is not for patients who are under 18 years.

Other medicines and Olanzapine Adamed

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

Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking:

•    medicines for Parkinson’s disease.

•    carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Adamed dose.

Olanzapine Adamed with alcohol

Do not drink any alcohol if you have been given Olanzapine Adamed as together with alcohol it may make you feel drowsy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Adamed can pass into breast milk.

The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Adamed in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

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

Olanzapine Adamed 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.

3. How to take Olanzapine Adamed

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

You should take your Olanzapine Adamed capsules once a day following the advice of your doctor. Try to take your capsules at the same time each day. It does not matter whether you take them with or without food. Olanzapine Adamed capsules are for oral use. You should swallow the Olanzapine Adamed capsules whole with water.

If you take more Olanzapine Adamed than you should

Patients who have taken more Olanzapine Adamed 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 if you experience any of the above symptoms. Show the doctor your pack of capsules.

If you forget to take Olanzapine Adamed

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

If you stop taking Olanzapine Adamed

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

If you suddenly stop taking Olanzapine Adamed, 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 medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if you have:

•    unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;

•    blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately;

•    a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood. 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.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.

Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (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; seizures, usually associated with a history of seizures (epilepsy); musle stiffness or spasms (including eye movements); problems with speech; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death; 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; and 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 Adamed may worsen the symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Olanzapine Adamed

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton.

This medicinal product does not require any special temperature storage conditions.

Olanzapine Adamed should be stored in original package in order to protect from light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Olanzapine Adamed contains

The active substance is olanzapine. Each Olanzapine Adamed hard capsule contains 2.5 mg or 5 mg or 7.5 mg or 10 mg or 15 mg or 20 mg of the active substance.

The other ingredients are:

-    microcrystalline cellulose (type 112), lactose monohydrate and magnesium stearate, gelatin, and titanium dioxide (E171).

The Olanzapine Adamed 2.5 mg, 15 mg and 20 mg also contain:

-    black iron oxide (E172)

The Olanzapine Adamed 7.5 mg, 10 mg and 15 mg also contain:

-    erythrosin-FD&C Red 3 (E127), quinoline yellow (E104).

What Olanzapine Adamed looks like and contents of the pack

Olanzapine Adamed 2.5 mg capsules are hard gelatin capsules of size 3, containing with a white body and grey cap.

Olanzapine Adamed 5 mg capsules are hard gelatin capsules of size 3, containing 5 with a white body and cap.

Olanzapine Adamed 7.5 mg capsules are hard gelatin capsules of size 3, containing with a white body and orange cap.

Olanzapine Adamed 10 mg capsules are hard gelatin capsules of size 3, containing 10 mg olanzapine with an orange body and cap.

Olanzapine Adamed 15 mg capsules are hard gelatin capsules of size 1, containing 15 mg olanzapine with an orange body and grey cap.

Olanzapine Adamed 20 mg capsules are hard gelatin capsules of size 1, containing 20 mg olanzapine with a grey body and cap.

Olanzapine Adamed 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg capsules are available in packs containing 28 and 56 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Marketing Authorization Holder:

Laboratorios Adamed Sp. z o. o.

Dembinskiego 13 street,

01-644 Warsaw Poland

Manufacturer:

Adamed Sp. z o.o.

Pienkow 149, 05-152 Czosnow Poland

Pabianickie Zaklady Farmaceutyczne Polfa S.A.

Marszalka Jozefa Pilsudskiego 5 street,

95-200 Pabianice Poland

This medicinal product is authorized in the Member States of the EEA under the following names:

Country	Trade name
United Kingdom	Olanzapine Adamed 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg, hard capsules
Spain	Zolafren 2,5 mg, 5 mg, 7,5 mg, 10 mg, 15 mg and 20 mg capsulas duras
This leaflet was last approved in 08/2013

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