ZOLAFREN FLAS 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolafren Flas 20 mg Oral Disintegrating 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:

1. What is Zolafren Flas and what is it used for
2. What you need to know before you take Zolafren Flas
3. How to take Zolafren Flas
4. Possible side effects
5. Storing Zolafren Flas
6. Contents of the pack and other information

1. What is Zolafren Flas and what is it used for

Zolafren Flas belongs to a group of medicines called antipsychotics and is 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disease whose symptoms are hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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.

Zolafren Flas 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 Zolafren Flas

Do not take Zolafren Flas:

• if you are allergic to olanzapine or any of the other ingredients 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 Zolafren Flas.

• Zolafren Flas 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 Zolafren Flas, 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 Zolafren Flas. 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) have been observed in the blood of patients taking Zolafren Flas. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Zolafren Flas, 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 the formation of blood clots.

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

• Stroke or transient lack of blood flow to the brain (transient stroke 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 salt loss 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 Zolafren Flas.

Other medicines and Zolafren Flas

Only use other medicines at the same time as Zolafren Flas if your doctor authorizes it. You may feel a certain feeling of drowsiness if you combine Zolafren Flas 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 medication.

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). Your dose of Zolafren Flas may need to be changed.

Use of Zolafren Flas with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take this medicine when you are breastfeeding as small amounts of Zolafren Flas may pass into breast milk.

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

Driving and using machines

Zolafren Flas can cause symptoms such as drowsiness, dizziness or changes in vision, and reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Zolafren Flas contains aspartame and mannitol

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Patients who cannot take mannitol should be aware that Zolafren Flas contains mannitol.

3. How to take Zolafren Flas

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

Your doctor will tell you how many Zolafren Flas tablets you should take and for how long. The daily dose of Zolafren Flas ranges from 5 mg to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Zolafren Flas unless your doctor tells you to.

Zolafren Flas 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. Zolafren Flas oral disintegrating tablets are for oral administration.

Zolafren Flas tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands because they can dissolve.

Place the tablet in your mouth. It will dissolve directly in your mouth, making it easy to swallow.

You can also put the tablet in a cup or glass filled with water, orange juice, apple juice, milk or coffee, stirring. With some beverages, the mixture may change color and appear cloudy. It should be drunk immediately.

If you take more Zolafren Flas than you should

Patients who have taken more Zolafren Flas 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, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased blood pressure or decreased blood pressure, 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 have taken more Zolafren Flas than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Zolafren Flas

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

If you stop taking Zolafren Flas

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

If you stop taking Zolafren Flas 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 (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, see a 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).

Other side effects:

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, at the beginning of treatment, increases in liver enzymes, 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, slow pulse, sensitivity to sunlight, nosebleeds, abdominal distension, excessive salivation, 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 1000 people) include a drop in 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 pains 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 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, extreme fatigue, visual hallucinations, a rise in body temperature, redness of the skin and walking problems. Some deaths have been reported in this particular group of patients.

Zolafren Flas may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Zolafren Flas

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

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

Zolafren Flas should be stored in the original package to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolafren Flas

• The active substance is olanzapine. Each oral disintegrating tablet contains 20 mg of the active substance.
• The other ingredients are: mannitol (E421), crospovidone type B, aspartame (E951), orange flavor (flavoring preparations, flavoring substances identical to natural substances, corn maltodextrin, alpha-tocopherol (E307)), colloidal anhydrous silica and sodium stearyl fumarate.

Appearance of the product and contents of the pack

Zolafren Flas are oral disintegrating tablets. Oral disintegrating tablet is the technical name for a tablet that dissolves directly in the mouth, so it can be easily swallowed.

Zolafren Flas 20 mg oral disintegrating tablets are yellow, round, smooth and beveled, 10 mm in diameter and engraved on one side with a "20".

They are presented in OPA-Al-PVC/Al blisters.

Package size: 28 oral disintegrating tablets.

20 mg tablets: 4 blisters of 7 tablets per box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 – 2ª planta

28023 Aravaca – Madrid, España

Phone: +34 91 357 11 25

Fax: +34 91 307 09 70

e-mail: [email protected]

Manufacturer

Adamed Pharma, S.A.

Ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice, Polonia

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

{Spain} Zolafren Flas 5 mg, 10 mg, 15 mg, 20 mg oral disintegrating tablets EFG

Date of last revision of this leaflet:November 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/