Zalasta 2.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zalasta 2.5 mg tablets EFG

Zalasta 5 mg tablets EFG

Zalasta 7.5 mg tablets EFG

Zalasta 10 mg tablets EFG

Zalasta 15 mg tablets EFG

Zalasta 20 mg tablets EFG

Olanzapine

Read all of 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 other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Zalasta is and what it is used for

2. What you need to know before taking Zalasta

3. How to take Zalasta

4. Possible side effects

5. How to store Zalasta

6. Contents of the pack and other information

1. What Zalasta is and what it is used for

Zalasta contains the active substance olanzapine. Zalasta belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also feel depressed, anxious, or tense.

• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Zalasta has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before taking Zalasta

Do not take Zalasta

• If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.

• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Zalasta

• The use of Zalasta is not recommended in elderly patients with dementia, as it may cause serious adverse effects.

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Zalasta, tell your doctor.

• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately.

• Weight gain has been observed in patients taking Zalasta. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.

• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Zalasta. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Zalasta and regularly during treatment.

• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or transient ischemic attack (temporary stroke-like symptoms)

• Parkinson's disease

• Prostate problems

• Intestinal blockage (paralytic ileus)

• Liver or kidney disease

• Blood disorders

• Heart disease

• Diabetes

• Seizures

• If you think you may have loss of body salts due to prolonged and severe diarrhea or vomiting, or due to taking diuretic medicines (water tablets)

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

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

Children and adolescents

Patients under 18 years of age must not take Zalasta.

Taking Zalasta with other medicines

Only use other medicines together with Zalasta if your doctor authorizes it. You may experience drowsiness if Zalasta is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

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

• Specifically, tell your doctor if you are taking: medication for Parkinson's disease

• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Zalasta may need to be adjusted.

Drinking alcohol while taking Zalasta

You must not drink alcohol while taking Zalasta, as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You must not take this medicine while breastfeeding, as small amounts of Zalasta may pass into breast milk.

The following symptoms may occur in newborns of mothers who have taken Zalasta during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness while taking Zalasta. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Zalasta contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Zalasta

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Zalasta tablets to take and for how long. The daily dose of Zalasta ranges between 5 mg and 20 mg.

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

Zalasta tablets should be taken once daily, as directed by your doctor.

Try to take the tablets at the same time every day. You may take them with or without food.

The tablets must be swallowed whole with water.

If you take more Zalasta than you should

Patients who have taken more Zalasta than they should have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the pack of tablets.

If you forget to take Zalasta

Take your tablets as soon as you remember. Do not take a double dose to make up for the missed dose.

If you stop taking Zalasta

Do not stop treatment simply because you feel better. It is very important that you continue taking Zalasta for as long as your doctor tells you to.

If you stop taking Zalasta suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you have:

• unusual movements (a common adverse effect which may affect up to 1 in 10 people), especially of the face or tongue.

• blood clots in the veins (an uncommon adverse effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include sweating, pain, and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of mental confusion or drowsiness (frequency cannot be estimated from the available data).

Very common adverse effects (may affect more than 1 in 10 people) include weight gain, drowsiness, and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells, circulating lipids, and temporary increases at the beginning of treatment in liver enzymes, increased levels of blood sugar and sugar in urine, increased levels of uric acid and creatine phosphokinase in blood, increased appetite, dizziness, restlessness, tremor, unusual movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive tiredness, fluid retention causing swelling of the hands, ankles, or feet, fever, joint pain, and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash), diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma, seizures—most cases are related to a history of seizures (epilepsy)—muscle stiffness or spasms (including eye movements), restless legs syndrome, speech problems, stuttering; slow pulse, sensitivity to sunlight, nosebleeds, abdominal distension, memory loss or forgetfulness, urinary incontinence, inability to urinate, hair loss, absence or reduction of menstrual periods, and changes in the mammary gland in both men and women such as abnormal production of breast milk or abnormal growth.

Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature, abnormal heart rhythm, sudden unexplained death, inflammation of the pancreas causing severe stomach pain, fever, and malaise, liver disease with yellowing of the skin and whites of the eyes (jaundice), muscle disorder presenting as unexplained muscle pains, and prolonged and/or painful erection (priapism).

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, a skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular patient group.

Zalasta may worsen symptoms in patients with Parkinson's disease.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system detailed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zalasta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture. This medicine does not require any special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Zalasta contains

• The active substance is olanzapine. Each Zalasta tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
• The other components are: lactose monohydrate, microcrystalline cellulose powder, pregelatinized starch, maize starch, colloidal anhydrous silica, magnesium stearate.

See section 2 “Zalasta contains lactose”.

What Zalasta looks like and contents of the pack

Zalasta 2.5 mg tablets are: round, slightly biconvex, light yellow with possible yellow specks.

Zalasta 5 mg tablets are: round, slightly biconvex, light yellow with possible yellow specks, marked with “5” on one side.

Zalasta 7.5 mg tablets are: round, slightly biconvex, light yellow with possible yellow specks, marked with “7.5” on one side.

Zalasta 10 mg tablets are: round, slightly biconvex, light yellow with possible yellow specks, marked with “10” on one side.

Zalasta 15 mg tablets are: round, slightly biconvex, light yellow with possible yellow specks, marked with “15” on one side.

Zalasta 20 mg tablets are: round, slightly biconvex, light yellow with possible yellow specks, marked with “20” on one side.

Zalasta 2.5 mg tablets are available in packs of 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 5 mg tablets are available in packs of 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 7.5 mg tablets are available in packs of 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 10 mg tablets are available in packs of 7, 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 15 mg tablets are available in packs of 14, 28, 35, 56 and 70 tablets in blisters.
Zalasta 20 mg tablets are available in packs of 14, 28, 35, 56 and 70 tablets in blisters.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warszawa, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.