ZOLAFREN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Zolafren 5 mg Tablets EFG

olanzapine

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to 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 and what is it used for
2. What you need to know before taking Zolafren
3. How to take Zolafren
4. Possible side effects
5. Storage of Zolafren
6. Contents of the pack and further information

1. What is Zolafren and what is it used for

Zolafren contains the active substance olanzapine. Zolafren 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disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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 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

Do not take Zolafren:

• 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

Talk to your doctor or pharmacist before starting to take Zolafren.

• Zolafren 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, tell your doctor.
• In very rare cases, medicines of this type can cause 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. 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 fat (triglycerides and cholesterol) in the blood have been observed in patients taking Zolafren. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Zolafren 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, tell your doctor as soon as possible:

• Stroke or temporary lack of blood flow to the brain (transient symptoms of stroke)
• 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 salts due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medicines (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.

Using Zolafren with other medicines

Only use other medicines at the same time as Zolafren if your doctor authorizes it. You may feel drowsy if you combine Zolafren with antidepressants or medicines 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). Your dose of Zolafren may need to be changed.

Using Zolafren with alcohol

You should not drink alcohol if you have been given Zolafren, 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 medicine. You should not take this medicine when you are breastfeeding, as small amounts of Zolafren may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Zolafren 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 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 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 contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Zolafren contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

3. How to take Zolafren

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

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

You should take the tablets 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. The tablets are for oral administration. Swallow the tablets whole with water.

If you take more Zolafren than you should

If you have taken more Zolafren 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 package leaflet of the medicine to the healthcare professional.

Patient who have taken more Zolafren 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 Zolafren

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

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

If you stop taking Zolafren 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 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 may affect up to 1 in 10 people), especially of the face or tongue.
• have blood clots in the veins (a rare side effect that may 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.
• have 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).
• have an allergic reaction (for example, swelling of the mouth and throat, itching, skin rash) (a rare side effect that may affect up to 1 in 100 people)
• have severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially appears as flu-like symptoms with a rash on the face and then with a widespread rash, high fever, swollen lymph nodes, elevated liver enzyme levels observed in blood tests, and elevated levels of a type of white blood cell (eosinophilia) (the frequency of this side effect cannot be estimated from the available data).

Very common side effects(may affect more than 1 in 10 people) include weight gain; drowsiness; and elevated 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(may affect up to 1 in 10 people) include changes in the levels of certain blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment; elevated blood sugar and urine levels; elevated uric acid and creatine phosphokinase levels in the blood; elevated alkaline phosphatase; elevated gamma-glutamyltransferase; 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.

Uncommon side effects(may affect up to 1 in 100 people) include diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; seizures, most of which are related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; prolonged QT interval; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of urination ability; difficulty urinating; 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(may affect up to 1 in 1,000 people) include low platelet count in the blood (thrombocytopenia); decreased 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 parts of the eyes; and muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Frequency not known(cannot be estimated from the available data) side effect includes neonatal withdrawal syndrome.

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

Zolafren 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 they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolafren

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

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

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

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE 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 further information

Composition of Zolafren

• The active substance is olanzapine. Each tablet contains 5 mg of olanzapine.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate (type A), and magnesium stearate.

Appearance of the product and pack contents

Zolafren 5 mg is presented in the form of round, biconvex, yellow tablets, scored on one side. The tablets can be divided into two equal parts.

It is presented in packs of 28 or 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Laboratorios, S.L.U.

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

28023 Madrid, España.

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicine is authorized in the Member States of the European Economic Area

under the following names:

{Poland} {Ranofren}

{Spain} {Zolafren}

Date of last revision of this package leaflet:January 2024

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