ZOLAFREN

Package leaflet: Information for the patient

Zolafren, 5 mg, hard capsules
Zolafren, 7.5 mg, hard capsules
Zolafren, 10 mg, hard capsules
Olanzapine
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Zolafren is and what it is 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 Zolafren is and what it is used for

Zolafren contains the active substance olanzapine. Zolafren belongs to a group of medicines called antipsychotics and is used to treat:

• schizophrenia – an illness characterized by hearing, seeing, or sensing things that do not exist in reality, having beliefs that are not based on reality, being excessively suspicious and withdrawing from contact with others. The patient may also experience depression, anxiety, or tension.
• moderate to severe manic episodes – medical conditions characterized by excitement or euphoria.

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

2. Important information before using Zolafren

When not to use 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 rash, itching, facial swelling, swollen lips or difficulty breathing. If such symptoms occur, inform the doctor immediately;
• if the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Zolafren, discuss this with your doctor or pharmacist.

• Zolafren is not recommended for elderly patients diagnosed with dementia, as it may cause very serious adverse effects.
• Medicines in this class may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Zolafren, inform your doctor.
• Very rarely, medicines of this type may cause a syndrome including fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy. If these symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients treated with Zolafren. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
• Elevated blood sugar levels and elevated lipid levels (triglycerides and cholesterol) have been observed in patients taking Zolafren. Before starting and during treatment with Zolafren, your doctor should perform blood tests to monitor blood sugar and certain lipid levels.
• Inform your doctor if the patient or a family member has a history of blood clots, as similar medicines have been associated with blood clot formation.

If the patient has any of the following conditions, inform the treating doctor immediately:

• stroke or "mini" stroke (transient ischemic attack);
• Parkinson's disease;
• prostate gland disorders;
• intestinal obstruction (paralytic ileus);
• liver or kidney disease;
• blood disorders;
• heart disease;
• diabetes;
• seizures;
• if the patient knows they may have lost body salts due to prolonged, severe diarrhoea and vomiting (nausea with vomiting) or use of diuretics (water tablets).

If the patient has dementia and has ever had a stroke or "mini" stroke, this should be reported (by the patient or caregiver) to the doctor.
As a routine precaution, doctors may monitor blood pressure in patients aged 65 years and older.
Children and adolescents
Zolafren is not intended for use in patients under 18 years of age.
Zolafren and other medicines
Patients taking Zolafren should use other medicines only under medical supervision. Concomitant use of Zolafren with antidepressants, sedatives or hypnotics may cause drowsiness.
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking:

• medicines used to treat Parkinson's disease;
• carbamazepine (an anticonvulsant and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – a dose adjustment of Zolafren may be necessary.

Zolafren and alcohol
Do not drink alcohol after taking Zolafren, as this medicine combined with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Breastfeeding women should not take Zolafren, as small amounts of the medicine may pass into human milk.
Newborns whose mothers took Zolafren during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in your child, contact your doctor immediately.
Driving and operating machinery
Zolafren may cause drowsiness. If drowsiness occurs, do not drive or operate any machines or equipment. Inform your doctor.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".
Lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this 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 exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
The doctor will decide how many capsules to take and for how long. The daily dose of Zolafren ranges from 5 mg to 20 mg. If symptoms recur, inform your doctor. However, do not stop taking Zolafren unless instructed by your doctor.
Zolafren capsules should be taken once daily as directed by the doctor. Try to take the medicine at the same time each day. It does not matter whether the capsules are taken with or without food. Zolafren capsules are for oral use. Swallow the capsule whole with water.

Taking more Zolafren than recommended
In patients who have taken more than the recommended dose of Zolafren, the following symptoms have been reported: rapid heartbeat, agitation or aggressive behaviour, speech difficulties, involuntary movements (especially of the facial and tongue muscles), and reduced consciousness. Other symptoms include acute confusion (disorientation), seizures (epilepsy), coma, concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, decreased respiratory rate, choking, high or low blood pressure, and heart rhythm disturbances. Seek immediate medical attention or go to hospital if any of these symptoms occur. Show the doctor the medicine packaging.

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

Stopping Zolafren treatment
Do not stop taking the capsules even if you feel better. It is important to continue taking Zolafren for as long as your doctor recommends.
If Zolafren is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea or vomiting. Your doctor may advise gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following occur:

• abnormal movements, especially of the face or tongue (a frequently reported adverse reaction which may affect up to 1 in 10 patients);
• blood clots in the veins (an uncommonly reported adverse reaction which may affect up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain, redness of the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms are observed, medical advice should be sought immediately.
• concomitant occurrence of fever, rapid breathing, sweating, muscle stiffness, and lethargy or drowsiness (the frequency of this adverse reaction cannot be determined from available data).
• hypersensitivity (e.g. swelling of the mouth and throat, itching, rash) (an uncommonly reported adverse reaction which may affect up to 1 in 100 patients).
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms are influenza-like with facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity in blood tests, and increased number of a type of white blood cells (eosinophilia) (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (which may affect more than 1 in 10 patients) include
weight gain, drowsiness, and increased blood prolactin levels. In the early stages of
treatment, dizziness or fainting (with slowed heart function) may occur, particularly
when rising from a lying or sitting position. These symptoms usually resolve spontaneously, but if they persist, you should inform your doctor.
Common adverse reactions (which may affect up to 1 in 10 patients) include changes in the number
of certain blood cells, blood lipid levels, and transient increases in liver enzyme activity at the beginning of treatment, increased blood and urine glucose levels,
increased blood uric acid levels and creatine kinase activity,
increased alkaline phosphatase activity, elevated gamma-glutamyl transferase activity,
increased appetite, dizziness, anxiety, tremor, movement disorders (dyskinesias), constipation,
dry mouth, rash, weakness, extreme fatigue, fluid 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 adverse reactions (which may affect up to 1 in 100 patients) include
diabetes or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of
ketone bodies in blood and urine) or coma, seizures, usually in patients with a previous history of seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slowed heart rate,
irregular heartbeat (changes in the electrical activity of the heart – changes in
electrocardiogram), photosensitivity, nosebleeds, abdominal distension,
excessive salivation (sialorrhea), memory loss or amnesia, urinary incontinence,
difficulty urinating, sensation of bladder pressure, hair loss, absence or reduction
of menstrual periods, breast changes in men and women, such as lactation outside the breastfeeding period or unusual breast enlargement, increased total bilirubin concentration.
Rarely reported adverse reactions (which may affect up to 1 in 1000 patients):
thrombocytopenia, decreased body temperature, neuroleptic malignant syndrome (NMS), withdrawal symptoms, cardiac arrhythmias, sudden unexplained death, pancreatitis causing severe abdominal pain, fever and nausea, liver disease manifesting as yellowing of the skin and whites of the eyes, muscle disease manifesting as unexplained muscle aches and pain, prolonged and/or painful erection.
Adverse reactions with unknown frequency include withdrawal syndrome in newborns.
During olanzapine treatment in elderly patients diagnosed 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, the medicine Zolafren may exacerbate adverse reaction symptoms.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Zolafren

Keep this 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 stated month.
Zolafren should be stored at a temperature below 25°C and protected from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Zolafren contains

• The active substance is olanzapine. Each capsule contains 5 mg, 7.5 mg or 10 mg of active substance. The specific dose is indicated on the packaging of Zolafren capsules.
• The other ingredients are: Contents of the capsule:
• 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 and white.
Zolafren 10 mg capsules are orange.
Zolafren is available in cardboard boxes containing 30 capsules.
Marketing Authorisation 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