Zolafren

Package Leaflet: Information for the Patient

Zolafren, 5 mg, hard capsules

Zolafren, 7.5 mg, hard capsules

Zolafren, 10 mg, hard capsules

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.
• 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, tell 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 agitation 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, tell your doctor;
• If you have eye disorders, such as certain types of glaucoma (increased eye pressure).

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 can cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Zolafren, tell 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 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 and lipid levels.
• Tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

If you have any of the following diseases, tell your doctor immediately:

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

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should tell 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 only take other medicines with the doctor's consent. 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 about 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, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Zolafren should not be taken by breastfeeding women, as small amounts of the medicine may pass into breast 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, agitation, 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. Tell your doctor.

Sodium

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

Lactose monohydrate

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

Quinoline yellow (E104)

Zolafren 7.5 mg and Zolafren 10 mg contain quinoline yellow (E104), which may cause allergic reactions.

3. How to take Zolafren

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will decide how many capsules and how long you should take Zolafren. The daily dose of Zolafren is 5 mg to 20 mg. If the symptoms of the disease recur, tell your doctor. However, do not stop taking Zolafren unless your doctor tells you to.
Zolafren capsules 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 capsules with or without food. Zolafren capsules are taken orally. Swallow the capsule 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, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and impaired 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 if you experience any of these symptoms. Show your doctor the packaging of the capsules.

Missing a dose of Zolafren

Take the capsule 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 capsules even if you feel better. It is important to take Zolafren for as long as your doctor recommends.
If you suddenly stop taking Zolafren, you may experience the following symptoms: 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 questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zolafren can cause side effects, although not everybody gets them.
Tell 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 bloodstream 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, tell your doctor.
Common side effects (which may affect up to 1 in 10 patients) include changes in the number of certain blood cells, lipid levels in the blood, and transient increases in liver enzyme activity 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, anxiety, trembling, movement disorders (dyskinesia), 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) in the past, muscle stiffness or spasms (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.
Rare side effects (which may affect up to 1 in 1000 patients):
thrombocytopenia, decreased body temperature, neuroleptic malignant 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 worsen side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zolafren

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Zolafren should be stored below 25°C, protected 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 capsule contains 5 mg, 7.5 mg, or 10 mg of the active substance. The specific dose is stated on the packaging of the Zolafren capsules.
• Other ingredients are: Capsule contents:
• Microcrystalline cellulose
• Lactose monohydrate
• Magnesium stearate

Capsule shell
5 mg:

• Gelatin
• Titanium dioxide (E171)

7.5 mg and 10 mg:

• Gelatin
• Titanium dioxide (E171)
• Quinoline yellow (E104)
• Erythrosine (E127)

What Zolafren looks like and contents of the pack

Zolafren 5 mg capsules are white.
Zolafren 7.5 mg capsules are orange-white.
Zolafren 10 mg capsules are orange.
Zolafren is available in cardboard boxes containing 30 capsules.

Marketing authorization holder

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

Manufacturer

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

Date of last revision of the leaflet: