Zolafren

Package Leaflet: Information for the Patient

Zolafren, 5 mg, Film-Coated Tablets

Zolafren, 10 mg, Film-Coated Tablets

Olanzapine

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their 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. Package Contents 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 medications 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 contradict 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 include 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 the patient is allergic to olanzapine or any of the other ingredients of this medication (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, the doctor should be informed;
• If the patient has eye diseases, such as certain types of glaucoma (increased eye pressure).

Warnings and Precautions

Before starting Zolafren, the patient should discuss it with their doctor or pharmacist.

• Zolafren is not recommended for patients with dementia-related psychosis, as it may cause serious side effects.
• Medications in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Zolafren, the doctor should be informed.
• Very rarely, medications of this type cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• Patients taking Zolafren have been observed to have weight gain. The patient's weight should be checked regularly. If necessary, consider consulting a dietitian or seeking help in establishing a diet.
• Patients taking Zolafren have been observed to have high blood sugar levels and high lipid levels (triglycerides and cholesterol). Before taking Zolafren and during its use, the doctor should perform blood tests to determine blood sugar levels and certain lipid levels.
• The doctor should be informed if the patient or their family has a history of blood clots, as similar medications have been associated with blood clot formation.

If the patient has any of the following conditions, they should immediately inform their doctor:

• Diabetes;
• Heart disease;
• Liver or kidney disease;
• Parkinson's disease;
• Seizures;
• Prostate disorders;
• Intestinal obstruction (paralytic ileus);
• Blood disorders;
• Stroke or "mini" stroke (transient stroke symptoms).
• If the patient knows they may have lost salt due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or the use of diuretics (urine-inducing medications).

If the patient has dementia and has had a stroke or "mini" stroke, they (or their caregiver) should inform the doctor.
As a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and Adolescents

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

Zolafren and Other Medications

Patients taking Zolafren may only take other medications with their doctor's consent. Taking Zolafren with antidepressant, sedative, or sleep-inducing medications may cause drowsiness.
The doctor should be informed about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
In particular, the doctor should be informed about the use of:

• Medications 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 and Alcohol

Alcohol should not be consumed after taking Zolafren, as this medication in combination with alcohol may cause drowsiness.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or is planning to have a child, they should consult their doctor before taking this medication.
Zolafren should not be taken by breastfeeding women, as small amounts of the medication 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, agitation, difficulty breathing, and feeding difficulties. If such symptoms are observed in the patient's child, the doctor should be contacted.

Driving and Operating Machines

Zolafren may cause drowsiness. If drowsiness occurs, the patient should not drive vehicles or operate any machines and devices. The doctor should be informed.

Zolafren Contains Lactose Monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medication.

Zolafren Contains Orange Yellow S (E 110)

The medication may cause allergic reactions.

Zolafren Contains Sodium

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

3. How to Take Zolafren

This medication should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will decide the dose and duration of Zolafren treatment. The daily dose of Zolafren is 5 mg to 20 mg. If symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Zolafren unless the doctor decides to do so.
Zolafren tablets should be taken once a day as directed by the doctor. The patient should try to take the medication at the same time every day. It does not matter whether the tablets are taken with or without food. Zolafren film-coated tablets are taken orally. The tablet should be swallowed whole with water.

Taking a Higher Than Recommended Dose of Zolafren

In patients who have taken a higher than recommended dose of Zolafren, the following symptoms have occurred: rapid heartbeat, agitation 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 disturbances. The doctor should be contacted immediately if any of these symptoms occur. The doctor should be shown the packaging with the tablets.

Missing a Dose of Zolafren

As soon as remembered, the tablet should be taken. A double dose should not be taken to make up for the missed dose.

Stopping Zolafren Treatment

In case of improvement, the patient should not stop taking the tablets. It is essential to take Zolafren for as long as the doctor recommends.
If Zolafren treatment is stopped abruptly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. The doctor may recommend a gradual reduction in the dose of Zolafren before stopping treatment.
In case of any further doubts about the use of this medication, the doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medications, Zolafren can cause side effects, although not everyone will experience them.
The doctor should be informed immediately if the following occur:

• 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 any of these symptoms are observed, the doctor should be consulted 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). 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 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 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, the doctor should be informed.
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, anxiety, trembling, movement disorders (dyskinesias), constipation, dry mouth, 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 previously had seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slow heart rate, irregular heart rhythm (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 menstruation, breast changes 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, neuroleptic malignant syndrome (NMS), withdrawal symptoms, heart rhythm disturbances, 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 is withdrawal syndrome in newborns.
In elderly patients with dementia-related psychosis treated with olanzapine, the following have been reported: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. 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 any side effects occur, including any not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 gather more information on the safety of the medication.

5. How to Store Zolafren

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the packaging.
Store at a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Medications should not be disposed of in wastewater or household waste. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Zolafren Contains

• The active substance of the medication is olanzapine. Each film-coated tablet contains 5 mg or 10 mg of the active substance. The specific dose is stated on the packaging with the 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).

Appearance and Package Contents of Zolafren

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