Package leaflet: Information for the user

Zolafren, 15 mg, film-coated tablets
Zolafren, 20 mg, film-coated tablets
Olanzapinum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

What Zolafren is and what it is used for
Important information before taking Zolafren
How to take Zolafren
Possible side effects
How to store Zolafren
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 – a disease characterized by patients hearing, seeing, or sensing things that do not exist in reality, having beliefs that contradict reality, being excessively suspicious and withdrawing from contact with others. The patient may 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 of 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 group of symptoms 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. Patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing a proper diet.
Elevated blood sugar levels and increased lipid levels (triglycerides and cholesterol) have been observed in patients taking Zolafren. Before starting and during treatment with Zolafren, the doctor should perform blood tests to monitor blood glucose and certain lipid levels.
Inform the 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 stroke symptoms);
Parkinson's disease;
prostate gland disorders;
intestinal obstruction (paralytic);
liver or kidney disease;
blood disorders;
heart disease;
diabetes;
seizures;
if the patient knows they may have lost body salts due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or use of diuretics (water pills).

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 precautionary measure, doctors may monitor blood pressure in patients over 65 years of age.
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 with the doctor's approval. Concomitant use of Zolafren with antidepressants, sedatives or hypnotics may cause drowsiness.
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
In particular, inform the doctor if the patient is taking:

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

Alcohol and Zolafren
Do not drink alcohol after taking Zolafren, as this medicine combined with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor 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, restlessness, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact the doctor.
Driving and operating machinery
Zolafren may cause drowsiness. If drowsiness occurs, do not drive or operate any machinery or equipment. Inform your doctor.
Zolafren contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
Zolafren contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".
This medicine may cause allergic reactions.

3. How to use Zolafren

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
The doctor will decide how many tablets and for how long Zolafren should be taken. The daily dose of Zolafren ranges from 5 mg to 20 mg. If symptoms of the disease recur, inform the doctor. However, do not discontinue treatment with Zolafren unless instructed by the doctor.
Zolafren tablets should be taken once daily as directed by the physician. Try to take the medicine at the same time each day. It does not matter whether the tablets are taken with or without food. Zolafren coated tablets are administered orally. The tablet should be swallowed whole with water.

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

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

Stopping Zolafren treatment
Do not stop taking the tablets even if you feel better. It is important to continue taking Zolafren for as long as prescribed by the doctor.
If Zolafren is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea, or vomiting. The doctor may recommend 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 side effects

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

involuntary movements, especially of the face or tongue (a common side effect, which may affect up to 1 in 10 patients);
blood clots in the veins (an uncommon side effect, 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 occur, seek medical advice immediately;
concomitant occurrence of fever, rapid breathing, sweating, muscle stiffness and drowsiness or sedation (the frequency of this side effect cannot be determined from available data);
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash) (an uncommon side effect, which may affect up to 1 in 100 patients);
severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), which initially presents as flu-like symptoms with a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, elevated liver enzymes evident in blood tests, and increased count of one type of white blood cells (eosinophilia) (the frequency of this side effect cannot be determined from available data).

Very common side effects (which may affect more than 1 in 10 people) include
weight gain, drowsiness and increased blood prolactin levels. In the early stages of
treatment, dizziness or fainting (with slowed heart rate) may occur, particularly when
rising from a lying or sitting position. These symptoms usually resolve on their own, but if they
persist, you should inform your doctor.
Common side effects (which may affect up to 1 in 10 people) include changes in the count
of certain blood cells, blood lipid levels, transient increases in liver enzyme activity (particularly
at the beginning of treatment), increased blood and urine glucose levels, increased blood uric acid and creatine kinase activity,
increased alkaline phosphatase activity, markedly 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 side effects (which may affect up to 1 in 100 people) 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 prior 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 electrocardiogram),
photosensitivity, nosebleeds, abdominal distension, excessive salivation (hypersalivation), memory loss or amnesia,
urinary incontinence, difficulty urinating, sensation of bladder pressure, hair loss, absence or reduction of menstrual bleeding,
breast changes in men and women such as milk discharge outside of breastfeeding or unusual breast enlargement,
increased total bilirubin concentration.
Rare side effects (which may affect up to 1 in 1,000 people):
thrombocytopenia, decreased body temperature, neuroleptic malignant syndrome (NMS), withdrawal symptoms,
heart rhythm disturbances, sudden unexplained death, pancreatitis causing severe abdominal pain, fever and nausea,
liver disease manifesting as yellowing of the skin and whites of the eyes (jaundice), muscle disease presenting as unexplained muscle aches and pain, prolonged and (or) painful erection.
A side effect of unknown frequency includes withdrawal syndrome in newborns.
During treatment with olanzapine 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, Zolafren may worsen side effects.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported
directly to the Department for Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Zolafren

Keep this medicine 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 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 coated tablet contains 15 mg or 20 mg of the active substance. The specific strength is indicated on the Zolafren tablet packaging.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch, magnesium stearate, titanium dioxide (E 171), hypromellose, macrogol 400, yellow iron oxide (E 172).

What Zolafren looks like and contents of the pack
Zolafren 15 mg: yellow, film-coated, biconvex tablets, 8 mm in diameter.
Pack contains 30 or 90 film-coated tablets.
Zolafren 20 mg: yellow, film-coated, biconvex tablets with score lines on both sides, 9 mm in diameter.
Pack contains 30 or 90 film-coated tablets.
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.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice