ZOLAFREN FLAS 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Zolafren Flas 5 mg Oral Disintegrating Tablets EFG

olanzapine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Zolafren Flas and what is it used for
2. What you need to know before taking Zolafren Flas
3. How to take Zolafren Flas
4. Possible side effects
5. Storage of Zolafren Flas
6. Package Contents and Additional Information

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

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whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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

Do not take Zolafren Flas:

• if you are allergic to olanzapine or any of the other components of this medication (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.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Zolafren Flas, tell your doctor.
• In very rare cases, medications of this type can 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 control your blood sugar and fat levels before you start taking Zolafren Flas 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 the formation of blood clots.

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

• Stroke or transient cerebral ischemia (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 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 cerebral ischemia.

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

Children and Adolescents

Patient under 18 years old should not take Zolafren Flas.

Other Medications and Zolafren Flas

Only use other medications at the same time as Zolafren Flas if your doctor authorizes it. You may feel drowsy if you combine Zolafren Flas with antidepressants or medications for anxiety or sleep aids (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 administered Zolafren Flas, as it may 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 medication. You should not take this medication while 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 may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may impair your ability 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 medication.

Zolafren Flas Contains Aspartame and Mannitol

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

Patient who cannot take mannitol should note that Zolafren Flas contains mannitol.

3. How to Take Zolafren Flas

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will tell you how many Zolafren Flas tablets to 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 handle them carefully. Do not handle the tablets with wet hands, as they may 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 of water, orange juice, apple juice, milk, or coffee, and stir. With some beverages, the mixture may change color and appear cloudy. You should drink it immediately.

If You Take More Zolafren Flas Than You Should

Patient 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 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, slowed breathing 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 these symptoms. Show your 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 medication and the amount taken. It is recommended to bring the package and package leaflet of the medication 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, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• 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 (affecting 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 (affecting up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and increased 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 dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (affecting 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, mostly 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 urination ability, 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.

Very rare side effects (affecting up to 1 in 1000 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 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 flu-like symptoms, with a skin rash that spreads to other areas, fever, swelling of the 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, a rise in body temperature, skin redness, 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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Zolafren Flas

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

Do not use this medication after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Zolafren Flas should be stored in its original packaging to protect it from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Zolafren Flas

• The active ingredient is olanzapine. Each oral disintegrating tablet contains 5 mg of the active substance.
• The other components 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 Package Contents

Zolafren Flas are oral disintegrating tablets. Oral disintegrating tablet is the technical name for a tablet that dissolves directly in the mouth, making it easy to swallow.

Zolafren Flas 5 mg oral disintegrating tablets are yellow, round, smooth, and beveled, 6 mm in diameter, and engraved with a "5" on one side.

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

Package size: 28 oral disintegrating tablets.

5 mg tablets: 2 blisters of 14 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, Spain

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, Poland

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 the Last Revision of this Package Leaflet:November 2023

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