ZALASTA 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zalasta 5 mg orodispersible tablets EFG

Zalasta 7.5 mg orodispersible tablets EFG

Zalasta 10 mg orodispersible tablets EFG

Zalasta 15 mg orodispersible tablets EFG

Zalasta 20 mg orodispersible 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 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.

Contents of the pack and other information:

1. What is Zalasta and what is it used for

1. What you need to know before you take Zalasta

1. How to take Zalasta
2. Possible side effects

1. Storage of Zalasta

1. Contents of the pack and other information

1. What is Zalasta and what is it used for

Zalasta contains the active substance olanzapine. Zalasta belongs to a group of medicines called antipsychotics, used to treat the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be 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 you take Zalasta

Do not take Zalasta

• If you are allergic to olanzapine or any of the other components of this medicine (listed in section 6). The allergic reaction may manifest as a 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

Consult your doctor or pharmacist before starting to take Zalasta

• Zalasta is not recommended for use in elderly patients with dementia, as it may have serious side effects.

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

• Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking Zalasta. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Zalasta. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking Zalasta and regularly during treatment.

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

If you suffer from any of the following diseases, inform your doctor as soon as possible:

• Stroke or transient lack of blood flow to the brain (temporary stroke symptoms).

• Parkinson's disease

• Prostate problems

• Intestinal blockage (paralytic ileus)
• Liver or kidney disease

• Blood disorders

• Heart diseases

• Diabetes
• Seizures

• If you think you may have loss of salts due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination tablets)

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years of age should not take Zalasta.

Use of Zalasta with other medicines

Only use other medicines at the same time as Zalasta if your doctor authorizes it. You may feel drowsy if you combine Zalasta with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

• In particular, 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). They may need to change your dose of Zalasta.

Use of Zalasta with alcohol

You should not drink alcohol if you have been given Zalasta because it can cause drowsiness.

Pregnancy and breastfeeding

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

The following symptoms may occur in newborns of mothers who have used Zalasta in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and difficulty eating. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Zalasta. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Zalasta contains aspartame

This medicine contains 0.50 mg of aspartame in each 5 mg orodispersible tablet.

This medicine contains 0.75 mg of aspartame in each 7.5 mg orodispersible tablet.

This medicine contains 1.00 mg of aspartame in each 10 mg orodispersible tablet.

This medicine contains 1.50 mg of aspartame in each 15 mg orodispersible tablet.

This medicine contains 2.00 mg of aspartame in each 20 mg orodispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

3. How to take Zalasta

Follow exactly the administration instructions of this medicine indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

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

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

Zalasta tablets should be taken once a day, following your doctor's instructions.

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

How to take Zalasta

Zalasta tablets crumble easily, so they should be handled with care. Do not handle the tablets with wet hands because they can crumble. Remove the tablet from the packaging as follows:

1. Hold the blister by the sides and separate an individual packaging from the rest of the blister along the perforations.
2. Pull the aluminum edge and remove it completely.
3. Let the tablet fall into your hand.
4. Place the tablet on your tongue immediately.

Within a few seconds, the tablet begins to disintegrate and can be swallowed with or without water. The mouth should be empty before placing the tablet on the tongue.

You can also put the tablet in a cup or glass of water. It should be drunk immediately.

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/aggression, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the 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 forgotten dose.

If you stop taking Zalasta

Do not stop treatment just because you feel better. It is very important that you continue taking Zalasta while your doctor tells you to.

If you stop taking Zalasta suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

4. Possible side effects

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

Contact your doctor immediately if you have:

• unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to the doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency cannot be estimated from the available data)

Very common side effects (which can affect more than 1 in 10 people) include weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, agitation, tremors, unusual movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention that causes swelling of the hands, ankles, or feet, fever, joint pain, and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects (which can affect up to 1 in 100 people) include hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash), diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma, seizures, in most cases 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, loss of ability to urinate, hair loss, absence or decrease of menstrual periods, and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rare side effects (which can affect up to 1 in 1,000 people) include a drop in normal body temperature, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellowing of the skin and the white areas of the eyes, muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially manifests with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, excessive fatigue, visual hallucinations, a rise in body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

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

Reporting of side effects

If you experience any side effect, consult your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side 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 expiration date that appears on the carton. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and additional information

What Zalasta contains

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

See section 2 "Zalasta contains aspartame".

Appearance of Zalasta and pack size

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

Zalasta 5 mg orodispersible tablets are available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.

Zalasta 7.5 mg orodispersible tablets are available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.

Zalasta 10 mg orodispersible tablets are available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.

Zalasta 15 mg orodispersible tablets are available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.

Zalasta 20 mg orodispersible tablets are available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.

Marketing authorisation 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder.

Date of last revision of this prospectus:

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