Leaflet: information for the user

Zalasta 5 mg buccal dispersible tablets EFG

Zalasta 7.5 mg buccal dispersible tablets EFG

Zalasta 10 mg buccal dispersible tablets EFG

Zalasta 15 mg buccal dispersible tablets EFG

Zalasta 20 mg buccal dispersible tablets EFG

Olanzapine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you start taking Zalasta

1. How to take Zalasta
2. Possible side effects

1. Storage of Zalasta

1. Contents of the pack and additional information

Zalasta contains the active ingredient olanzapina. Zalasta belongs to a group of medicines called antipsychotics for treating the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing, or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer 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 shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take Zalasta

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

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

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 adverse effects.

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

• Very rarely, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens, contact your doctor immediately.
• Weight gain has been observed in patients taking Zalasta. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or refer 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 monitor your blood sugar and fat levels before starting Zalasta and regularly during treatment.

• If you or a family member has a history of blood clots, consult your doctor, as medications 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 lack of blood flow to the brain).

• Parkinson's disease

• Prostate problems

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

• Blood disorders

• Heart disease

• Diabetes
• Seizures

• If you think you may be losing electrolytes due to prolonged diarrhea and vomiting or the use of diuretic medications (water pills).

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, it would be a good idea for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Zalasta.

Use of Zalasta with other medications

Only use other medications 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 sleep (tranquilizers).

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

• Specifically, tell your doctor if you are taking: Parkinson's disease medication
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). You may need to adjust your Zalasta dose.

Use of Zalasta with alcohol

You should not drink alcohol if you have been given Zalasta as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take thismedication while breastfeeding as small amounts of Zalasta may pass into breast milk.

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

Driving and operating machinery

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

Zalasta contains aspartame

This medication contains 0.50 mg of aspartame in each 5 mg buccal dispersible tablet.

This medication contains 0.75 mg of aspartame in each 7.5 mg buccal dispersible tablet.

This medication contains 1.00 mg of aspartame in each 10 mg buccal dispersible tablet.

This medication contains 1.50 mg of aspartame in each 15 mg buccal dispersible tablet.

This medication contains 2.00 mg of aspartame in each 20 mg buccal dispersible tablet.

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

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

In case of 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 from 5 mg to 20 mg.

Consult your doctor if you experience 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 are prone to breaking easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may break apart. Remove the tablet from the blister pack as follows:

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

In a few seconds, the tablet will begin to disintegrate and can be swallowed with or without water. Your mouth should be empty before depositing the tablet on your tongue.

You can also drop the tablet into a glass or cup filled with water. It should be swallowed 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/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowed respiratory rate, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the packaging with the tablets to your doctor.

If you forget to take Zalasta

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

If you interrupt treatment with Zalasta

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

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

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Immediately contact your doctor 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 (a rare 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, seek immediate medical attention.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Frequent side effects (which can 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 down or sitting. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in levels of some blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes, increased levels of blood sugar and urine, increased levels of uric acid and creatine phosphokinase in the blood, increased appetite, dizziness, agitation, tremors, strange movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention causing inflammation 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.

Rare 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 the blood and urine) or coma, seizures, in most cases related to a history of seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless leg syndrome, speech problems, stuttering; slow pulse, sensitivity to sunlight, nasal bleeding, 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 breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (which can affect up to 1 in 1000 people) include a decrease in normal body temperature, abnormal heart rhythm, sudden death without apparent explanation, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellowing of the skin and white areas of the eye, muscle disorder that presents as unexplained pain, and prolonged and/or painful erection.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased levels of 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 walking difficulties. Some deaths have been reported in this particular group of patients.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAnexo V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of in wastewater or trash. Ask your pharmacist how to dispose of medications that you no longer need. This will help protect the environment.

What Zalasta contains

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

See section 2 “Zalasta contains aspartame”.

Appearance of Zalasta and packaging size

Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg buccal dispersible tablets are: yellow speckled, round, slightly biconvex, with possible spots.

Zalasta 5 mg buccal dispersible tablets are available in packs of 14, 28, 35, 56, and 70 tablets in blisters.

Zalasta 7.5 mg buccal dispersible tablets are available in packs of 14, 28, 35, 56, and 70 tablets in blisters.

Zalasta 10 mg buccal dispersible tablets are available in packs of 14, 28, 35, 56, and 70 tablets in blisters.

Zalasta 15 mg buccal dispersible tablets are available in packs of 14, 28, 35, 56, and 70 tablets in blisters.

Zalasta 20 mg buccal dispersible 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 medicinal product, please contact the local representative of the marketing authorization holder.

Last update of this leaflet:

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