Zolafren

Leaflet attached to the packaging: patient information

Zolafren, 15 mg, coated tablets

Zolafren, 20 mg, coated tablets

Olanzapine

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist or nurse. 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 the patient 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 - conditions whose symptoms are agitation or euphoria.

It has been shown that Zolafren prevents the recurrence of these symptoms in patients with bipolar affective disorder, in whom a good response to manic episode treatment with olanzapine has been achieved.

2. Important information before taking Zolafren

When not to take Zolafren

Warnings and precautions

Before starting treatment with Zolafren, you should 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, you should 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, you should contact your doctor immediately.
• In patients taking Zolafren, weight gain has been observed. You should have your weight checked regularly. If necessary, you should 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, your doctor should perform blood tests to determine blood sugar levels and levels of certain lipids.
• You should 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, you should immediately inform your doctor:

• stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• prostate disorders;
• intestinal obstruction (paralytic);
• liver or kidney disease;
• blood diseases;
• heart disease;
• diabetes;
• seizures;

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should tell your doctor.
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 consent of their doctor. Taking Zolafren in combination with antidepressant, sedative or sleeping medicines may cause drowsiness.
You should 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, you should 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.

Taking Zolafren with alcohol

You should 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 are planning to have a baby, you should consult your doctor before taking this medicine.
Zolafren should not be taken by women who are breastfeeding, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers have taken 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 difficulty feeding. If you notice such symptoms in your child, you should contact your doctor.

Driving and using machines

Zolafren may cause drowsiness. If drowsiness occurs, you should not drive or operate any machines or equipment. You should inform your doctor.

Zolafren contains lactose monohydrate

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

Zolafren contains sodium

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

3. How to take Zolafren

This medicine should always be taken according to your doctor's instructions. If you are unsure, you should ask your doctor or pharmacist.
Your doctor will decide how many tablets 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, you should inform your doctor. However, you should not stop taking Zolafren unless your doctor decides to do so.
Zolafren tablets should be taken once a day as directed by your doctor. You should try to take the medicine at the same time every day. It does not matter whether you take the tablets with or without food. Zolafren coated tablets are taken orally. The tablet should be swallowed whole, with a glass of water.

Taking a higher dose of Zolafren than recommended

In patients who have taken a higher dose of Zolafren than recommended, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue) and decreased 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 disturbances. You should contact your doctor immediately or go to the hospital if you experience any of these symptoms. You should show your doctor the packaging with the tablets.

Missing a dose of Zolafren

As soon as you remember, you should take a tablet. You should not take a double dose to make up for the missed dose.

Stopping treatment with Zolafren

In case of improvement, you should not stop taking the tablets. 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 this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately inform your doctor 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 difficulty breathing. If you notice any of these symptoms, you should 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 determined 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), which initially manifests as flu-like symptoms with a rash on the face, and then as a widespread rash, high fever, lymph node enlargement, elevated liver enzyme activity visible in blood tests, and an increased number of one type of white blood cell (eosinophilia) (the frequency of this side effect cannot be determined 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 slowed heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, you should inform 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 (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) in the past, muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slowed heart rate, irregular heartbeat (changes in the electrocardiogram), sensitivity to sunlight, nosebleeds, abdominal bloating, excessive salivation (hypersalivation), memory loss or lack of memory, urinary incontinence, difficulty urinating, feeling of urgency to urinate, hair loss, absence or decrease of menstrual bleeding, 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 disturbances, sudden death from an unknown cause, pancreatitis causing severe abdominal pain, fever, and nausea, liver disease manifesting as a change in skin and white eye color to yellow, muscle disease manifesting as unexplained muscle pain and weakness, prolonged and (or) painful erections.
The frequency of the following side effect cannot be determined: 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, redness of the skin, 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 any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, ul. 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zolafren

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store in the original packaging to protect from light and moisture. Store at a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should 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 coated tablet contains 15 mg or 20 mg of the active substance. The specific dose is stated on the packaging of Zolafren tablets.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl cellulose, magnesium stearate, titanium dioxide (E 171), hypromellose, macrogol 400, yellow iron oxide (E 172).

What Zolafren looks like and what the pack contains

Zolafren 15 mg: yellow, biconvex, coated tablets, 8 mm in diameter.
The packaging contains 30 or 90 coated tablets.
Zolafren 20 mg: yellow, biconvex, coated tablets with a score line on both sides, 9 mm in diameter.
The packaging contains 30 or 90 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.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: