ZOLAFREN 5 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Zolafren, 5 mg, hard capsules
   1. Zolafren, 10 mg, hard capsules
   2. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. What is Zolafren and what is it used for
4. Important information before taking Zolafren
   1. When not to take Zolafren
   2. Warnings and precautions
   3. Children and adolescents
   4. Zolafren and other medicines
   5. Zolafren with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and operating machines
   8. Sodium
   9. Lactose monohydrate
   10. Quinoline yellow (E104)
5. How to take Zolafren
   1. Taking a higher dose of Zolafren than recommended
   2. Missing a dose of Zolafren
   3. Stopping Zolafren
6. Possible side effects
   1. Reporting side effects
7. How to store Zolafren
8. Package contents and other information
   1. What Zolafren contains
   2. What Zolafren looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Zolafren, 5 mg, hard capsules

Zolafren, 7.5 mg, hard capsules

Zolafren, 10 mg, hard capsules

Olanzapine

You should carefully 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 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 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 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, the doctor should be informed;
• If the patient has eye disorders, 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 over 65 years of age with a diagnosis of 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, the doctor should be informed.
• 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, the doctor should be contacted immediately.
• In patients taking Zolafren, weight gain has been observed. The patient's weight should be checked regularly. If necessary, consideration should be given to 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.
• The doctor should be told if the patient or their family has a history of blood clots, as similar medicines have been associated with the formation of blood clots.

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

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

If the patient has dementia and has had a stroke or "mini" stroke, they (or their caregiver) should tell their 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.
The doctor should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, the doctor should be told about:

• 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

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 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.

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 the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will decide how many capsules and how long to take Zolafren. The daily dose of Zolafren is 5 mg to 20 mg. If the 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 capsules should be taken once a day as directed by the doctor. The patient should try to take the medicine at the same time every day. It does not matter whether the capsules are taken with or without food. Zolafren capsules are taken orally. The capsule should be swallowed whole, with 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 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. The doctor should be contacted immediately if any of these symptoms occur. The doctor should be shown the packaging with the capsules.

Missing a dose of Zolafren

As soon as the patient remembers, they should take a capsule. A double dose should not be taken to make up for a missed dose.

Stopping Zolafren

In case of improvement, the patient should not stop taking the capsules. It is important to take Zolafren for as long as the doctor recommends.
If Zolafren is stopped abruptly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. The doctor may recommend gradually reducing the dose of Zolafren before stopping treatment.
In case of any further doubts about taking the medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Zolafren can cause side effects, although not everybody gets them.
The doctor should be told 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 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, 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, blood lipid levels, and transient increased liver enzyme activity at the start of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase levels in the blood, increased alkaline phosphatase activity, high gamma-glutamyltransferase activity, increased appetite, dizziness, anxiety, tremors, movement disorders (dyskinesias), constipation, dry mouth, rash, weakness, extreme fatigue, water retention 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 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 periods, changes in the breasts of 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 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 is 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 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 side effects not listed in the leaflet, the doctor or pharmacist should be told. 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
Jerozolimskie Avenue 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Zolafren

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Zolafren should be stored at a temperature below 25°C, protected from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents 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 with 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 what the package contains

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: