Zolaxa

Package Leaflet: Information for the Patient

Zolaxa, 15 mg, Film-Coated Tablets

Zolaxa, 20 mg, Film-Coated Tablets

Olanzapine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Zolaxa and what is it used for
• 2. Important information before taking Zolaxa
• 3. How to take Zolaxa
• 4. Possible side effects
• 5. How to store Zolaxa
• 6. Contents of the pack and other information

1. What is Zolaxa and what is it used for

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

• Schizophrenia - a disease characterized by 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 - disease states whose symptoms include excitement or euphoria.

It has been shown that Zolaxa 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 Zolaxa

When not to take Zolaxa

• If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6), or, in the case of 20 mg tablets, allergic to peanuts or soy (see also the section "Zolaxa 20 mg also contains orange yellow and lecithin"). An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling, or shortness of breath. If such symptoms occur, tell your doctor;
• If you have eye disorders, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting treatment with Zolaxa, discuss it with your doctor or pharmacist.

• Zolaxa is not recommended for use in elderly patients with dementia, as it may cause serious side effects in this patient group.
• Medicines in this class may cause abnormal movements, especially in the face or tongue. If you experience such a symptom after taking Zolaxa, tell your doctor.
• Rarely, these types of medications cause a syndrome of symptoms including fever, rapid breathing, irregular or rapid heartbeat, sweating, muscle stiffness, and changes in mental state (e.g., altered consciousness with psychomotor agitation), drowsiness, or sleepiness. If such symptoms occur, contact your doctor immediately.
• In patients taking Zolaxa, weight gain has been observed. The patient's weight should be checked regularly. If necessary, consider consulting a dietitian or seeking help in establishing a diet.
• In patients taking Zolaxa, high blood sugar and high lipid levels have been observed. Before taking Zolaxa and during treatment, your doctor should perform blood tests to determine blood sugar and lipid levels.
• Tell your doctor if you or a family member have had blood clots in the past, as similar medications have been associated with the formation of blood clots.

If you have any of the following diseases, tell your doctor immediately:

• Stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• Prostate disorders;
• Bowel obstruction (paralytic);
• Liver or kidney disease; blood diseases;
• Lung disease;
• Heart disease;
• Diabetes;
• Seizures;
• If you know that you may have lost salt due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics.

Routinely, as a precaution, in people over 65 years of age, the doctor may check blood pressure.
Smokers may need to change their dose of the medicine. Tell your doctor if you smoke.
Children and adolescents
Zolaxa is not intended for use in patients under 18 years of age.

Zolaxa and other medicines

People taking Zolaxa may only take other medicines with the consent of their doctor. Taking Zolaxa in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
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, tell your doctor about:

• Medicines used to treat Parkinson's disease;
• Medicines that may affect heart function (cause changes in the ECG), such as anti-arrhythmic medications, certain antibiotics;
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose change may be necessary.

If you need to take activated charcoal, it should be given at least 2 hours before taking Zolaxa or 2 hours after taking this medicine.

Taking Zolaxa with alcohol

Do not drink alcohol after taking Zolaxa, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Zolaxa should not be taken by breastfeeding women, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Zolaxa in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice such symptoms in your child, contact your doctor.

Driving and using machines

Zolaxa may cause drowsiness and dizziness. If such symptoms occur, do not drive or operate machinery. Tell your doctor.

Zolaxa contains lactose and sodium

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Zolaxa 20 mg also contains orange yellow and lecithin

The 20 mg tablets also contain orange yellow (E 110). The medicine may cause allergic reactions.
The 20 mg tablets also contain soybean-derived lecithin. Do not take if you are hypersensitive to peanuts or soy.

3. How to take Zolaxa

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will decide how many tablets and how long you should take Zolaxa. The daily dose of Zolaxa is from 5 mg to 20 mg. If the symptoms of the disease recur, tell your doctor. However, do not stop taking Zolaxa unless your doctor tells you to.
Take Zolaxa tablets once a day as directed by your doctor. Try to take the medicine at the same time every day. It does not matter whether you take the tablets with or without food. Zolaxa film-coated tablets are taken orally. Swallow the tablet whole with water.

Taking a higher dose of Zolaxa than recommended

In patients who have taken a higher dose of Zolaxa 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: acute 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. Contact your doctor immediately or go to the hospital if you experience any of these symptoms. Show your doctor the packaging of the medicine.

Missing a dose of Zolaxa

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

Stopping treatment with Zolaxa

Do not stop taking the tablets even if you feel better. It is important to take Zolaxa for as long as your doctor recommends.
If you suddenly stop taking Zolaxa, you may experience the following symptoms: sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of the medicine before stopping treatment.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zolaxa can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience:

• Abnormal movements, especially in the face or tongue (an uncommon side effect that may affect up to 1 in 100 people);
• Blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people), 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 you notice any of these symptoms, seek medical attention immediately.
• Simultaneous occurrence of fever, rapid breathing, irregular or rapid heartbeat, sweating, muscle stiffness, and changes in mental state, as well as drowsiness or sleepiness (a rare side effect that may affect up to 1 in 1,000 people);
• 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 levels of a specific type of white blood cell (eosinophilia) (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (which may affect more than 1 in 10 people) include:

• Weight gain,
• Drowsiness,
• 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, tell your doctor.

Common side effects (which may affect up to 1 in 10 people) include:

• Changes in the number of certain blood cells and lipid levels in the blood,
• Transient increase in liver enzyme activity at the start of treatment,
• Increased glucose levels in the blood and urine,
• Increased levels of uric acid and creatine phosphokinase and alkaline phosphatase in the blood,
• Increased appetite,
• Dizziness,
• Restlessness,
• Trembling,
• Movement disorders (dyskinesias),
• Constipation,
• Dry mouth,
• Rash,
• Loss of strength,
• Extreme fatigue,
• Water retention in the body causing swelling of the hands, feet, or ankles,
• Fever, joint pain,
• 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:

• Hypersensitivity (e.g., swelling in the mouth and throat, itching, rash),
• 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,
• Slow heart rate, changes in the ECG,
• Sensitivity to sunlight,
• Nosebleeds,
• Bloating, excessive salivation,
• Memory loss or lack of memory,
• Urinary incontinence,
• Difficulty urinating,
• Hair loss,
• Absence of menstruation,
• Changes in the breasts, such as unusual breast enlargement (in both women and men) and milk secretion outside of breastfeeding (in women),
• Increased bilirubin levels in the blood.

Rare side effects (which may affect up to 1 in 1,000 people) include:

• Decreased body temperature,
• Decreased platelet count,
• Withdrawal symptoms (such as sweating, insomnia, trembling, anxiety, nausea, or vomiting),
• Heart rhythm disorders,
• Sudden death (cardiac arrest),
• 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 pain,
• Prolonged and (or) painful erection.

In elderly patients with dementia treated with olanzapine, the following have been observed: stroke, pneumonia, urinary incontinence, falls, lethargy (lack of reaction to stimuli), visual hallucinations, elevated body temperature, redness of the skin, and difficulty walking.
In patients with Parkinson's disease, Zolaxa may worsen the symptoms of the disease.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zolaxa

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zolaxa contains

• The active substance of the medicine is olanzapine. Each Zolaxa film-coated tablet contains 15 mg or 20 mg of olanzapine.
• The other ingredients are: Tablet core: lactose monohydrate, povidone 30, crospovidone, sodium carboxymethyl cellulose (type A), colloidal silicon dioxide, magnesium stearate. Coating: 15 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol (type 3350), quinoline yellow lake (E 104), yellow iron oxide (E 172). 20 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol (type 3350), lecithin, orange yellow lake (E 110), quinoline yellow lake (E 104).

What Zolaxa looks like and contents of the pack

The 15 mg film-coated tablets are yellow, oval.
The 20 mg film-coated tablets are orange, oval.
The pack contains 30 or 90 tablets.

Marketing authorization holder and manufacturer

Pharmaceutical Works POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: