Zolafren

Package Leaflet: Information for the Patient

Zolafren, 5 mg, film-coated tablets

Zolafren, 10 mg, film-coated tablets

Olanzapine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Zolafren and what is it used for
• 2. Important information before taking Zolafren
• 3. How to take Zolafren
• 4. Possible side effects
• 5. How to store Zolafren
• 6. Contents of the pack and other 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:

• Schizophrenia - a disease characterized by hearing, seeing, or feeling things that do not exist in reality, having beliefs that are contrary to reality, being overly suspicious, and withdrawing from contact with others. The patient may experience depression, anxiety, or tension;
• Moderate to severe manic episodes - disease states whose symptoms are excitement or euphoria.

It has been shown that Zolafren prevents the recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment for a manic episode.

2. Important information before taking Zolafren

When not to take Zolafren

• If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling, or shortness of breath. If such symptoms occur, inform your doctor;
• If you have eye diseases, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Before starting treatment with Zolafren, discuss it with your doctor or pharmacist.

• Zolafren is not recommended for use in elderly patients with dementia, as it may cause very serious side effects.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Zolafren, inform your doctor.
• Very rarely, these types of medicines cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, contact your doctor immediately.
• In patients taking Zolafren, weight gain has been observed. The patient's weight should be checked regularly. If necessary, consider consulting a dietitian or seeking help in establishing a diet.
• In patients taking Zolafren, high blood sugar levels and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Zolafren and during its use, the doctor should perform blood tests to determine blood sugar levels and certain lipid levels.
• Tell your doctor if you or a family member have had blood clots, as similar medicines have been associated with the formation of blood clots.

If you have any of the following conditions, inform your doctor immediately:

• Diabetes;
• Heart disease;
• Liver or kidney disease;
• Parkinson's disease;
• Seizures;
• Prostate disorders;
• Intestinal obstruction (paralytic ileus);
• Blood diseases;
• Stroke or "mini" stroke (transient stroke symptoms).
• If you know that you may have lost salt due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or the use of diuretics (urinary medicines).

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should inform your doctor.
Routinely, as a precaution, in people over 65 years of age, the doctor may check blood pressure.

Children and adolescents

Zolafren is not intended for use in patients under 18 years of age.

Zolafren and other medicines

People taking Zolafren may use other medicines only with the consent of a doctor. Taking Zolafren in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, tell your doctor if you are taking:

• Medicines used to treat Parkinson's disease;
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose adjustment of Zolafren may be necessary.

Zolafren with alcohol

Do not drink alcohol after taking Zolafren, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Zolafren should not be taken by breastfeeding women, as small amounts of the medicine may pass into human milk.
In newborns whose mothers took Zolafren in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, excitement, difficulty breathing, and feeding difficulties. If you notice such symptoms in your child, contact your doctor.

Driving and operating machinery

Zolafren may cause drowsiness. If drowsiness occurs, do not drive vehicles or operate any machines and devices. Inform your doctor.

Zolafren contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

Zolafren contains sunset yellow FCF (E 110)

The medicine may cause allergic reactions.

Zolafren contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means the medicine is considered "sodium-free".

3. How to take Zolafren

This medicine should always be taken as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
The doctor will decide how many tablets and for how long you should take Zolafren. The daily dose of Zolafren is 5 mg to 20 mg. If the symptoms of the disease recur, inform your doctor. However, do not stop taking Zolafren unless your doctor decides to do so.
Zolafren tablets should be taken once a day as directed by your doctor. Try to take the medicine at the same time every day. It does not matter whether you take the tablets during meals or not. Zolafren film-coated tablets are taken orally. Swallow the tablet whole with water.

Taking a higher dose of Zolafren than recommended

In patients who took a higher dose of Zolafren than recommended, the following symptoms occurred: rapid heartbeat, excitement or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and reduced consciousness. Other symptoms include:
severe confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased breathing rate, choking, high or low blood pressure, heart rhythm disorders. Contact your doctor immediately or go to the hospital if any of these symptoms occur. Show your doctor the packaging with the tablets.

Missing a dose of Zolafren

Take the tablet as soon as you remember. Do not take a double dose to make up for the missed dose.

Stopping treatment with Zolafren

Do not stop taking the tablets when you feel better. It is important to take Zolafren for as long as your doctor recommends.
If you suddenly stop taking Zolafren, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of Zolafren before stopping treatment.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor immediately if you experience:

• Abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 patients);
• Blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, seek medical attention immediately;
• Simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).
• Hypersensitivity (e.g., swelling in the mouth and throat, itching, rash) (an uncommon side effect that may affect up to 1 in 100 patients).
• Severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms are flu-like with a rash on the face, followed by a widespread rash, high body temperature, enlarged lymph nodes, elevated liver enzyme activity, and increased eosinophil count (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (which may affect more than 1 in 10 patients) include weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with a decrease in heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually resolve on their own, but if they persist, inform your doctor.
Common side effects (which may affect up to 1 in 10 patients) include changes in the number of certain blood cells and lipid levels in the blood, transient increases in liver enzyme activity (especially at the beginning of treatment), increased blood sugar and urine levels, increased uric acid and creatine phosphokinase activity in the blood, increased alkaline phosphatase activity, high gamma-glutamyltransferase activity, increased appetite, dizziness, restlessness, tremors, movement disorders (dyskinesias), constipation, dry mouth, rash, weakness, extreme fatigue, water retention in the body causing swelling of the hands, feet, or ankles, fever, joint pain, and sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.
Uncommon side effects (which may affect up to 1 in 100 patients) include diabetes or worsening of its course, occasionally with ketoacidosis (presence of ketone bodies in the blood and urine) or coma, seizures, usually in patients who have had seizures (epilepsy) before, muscle stiffness or cramps (including eye movements), restless legs syndrome, speech disorders, stuttering, slow heart rate, irregular heartbeat (changes in the electrocardiogram), sensitivity to sunlight, nosebleeds, abdominal bloating, excessive salivation (hypersalivation), memory loss or amnesia, urinary incontinence, difficulty urinating, feeling of urgency to urinate, hair loss, absence or decrease of menstrual periods, changes in the breasts in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement, increased total bilirubin levels.
Rarely reported side effects (which may affect up to 1 in 1000 patients):
Thrombocytopenia, decreased body temperature, malignant neuroleptic syndrome (NMS), withdrawal symptoms, heart rhythm disorders, sudden death from an unknown cause, pancreatitis causing severe abdominal pain, fever, and nausea, liver disease characterized by a change in skin and white eye color to yellow, muscle disease characterized by unexplained muscle pain and weakness, prolonged and (or) painful erections.
A side effect with an unknown frequency includes withdrawal syndrome in newborns.
During treatment with olanzapine in elderly patients with dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and difficulty walking. Several fatal cases have been reported in this patient group.
In patients with Parkinson's disease, Zolafren may exacerbate side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Zolafren

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
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 other information

What Zolafren contains

• The active substance of the medicine is olanzapine. Each film-coated tablet contains 5 mg or 10 mg of the active substance. The specific dose is indicated on the packaging of Zolafren tablets.
• Other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethylcellulose, magnesium stearate, titanium dioxide (E 171), hypromellose, macrogol 400, yellow iron oxide (E 172), orange yellow S (E 110).

What Zolafren looks like and what the pack contains

Zolafren 5 mg: film-coated tablets, beige, biconvex, with a dividing line, 7 mm in diameter. The dividing line on the tablet is not intended for breaking the tablet.
The pack contains 30, 90, or 120 film-coated tablets.
Zolafren 10 mg: film-coated tablets, beige, biconvex, 7 mm in diameter.
The pack contains 30, 90, or 120 film-coated tablets.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Importer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: