Zolaxa

Leaflet attached to the packaging: patient information

Zolaxa, 5 mg, coated tablets

Zolaxa, 10 mg, coated tablets

Olanzapine

Read the leaflet carefully before taking the medicine, 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 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 inform their 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. Package contents 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 the patient hearing, seeing, or feeling things that do not exist in reality, having beliefs that are inconsistent with reality, being overly suspicious, and withdrawing from contact with others. The patient may experience depression, anxiety, or tension;
• Moderate to severe manic episodes - conditions 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

Warnings and precautions

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

• Zolaxa is not recommended for patients with dementia-related psychosis, as it may cause serious side effects in this group of patients.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Zolaxa, the doctor should be informed.
• Rarely, these types of medicines cause a syndrome of symptoms including fever, rapid breathing, irregular or rapid heartbeat, sweating, muscle stiffness, and changes in mental status (e.g., altered consciousness with psychomotor agitation), drowsiness, or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• Patients taking Zolaxa have been observed to have weight gain. 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.
• Patients taking Zolaxa have been observed to have high blood sugar and high lipid levels. Before taking Zolaxa 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 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;
• lung diseases;
• heart disease;
• diabetes;
• seizures;

As a precaution, in people over 65 years of age, the doctor may check blood pressure.
Smokers may need to have their dose adjusted. The doctor should be informed about smoking.
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 their doctor's consent. Taking Zolaxa in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
The doctor should be informed 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 informed about:

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

If the patient needs to take activated charcoal, it should be administered at least 2 hours before taking Zolaxa or 2 hours after taking this medicine.

Taking Zolaxa with alcohol

Alcohol should not be consumed after taking Zolaxa, 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 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 such symptoms are observed in the baby, the doctor should be contacted.

Driving and operating machinery

Zolaxa may cause drowsiness and dizziness. If such symptoms occur, the patient should not drive or operate machinery. The doctor should be informed.

Zolaxa contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their 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".

3. How to take Zolaxa

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 tablets and for how long to take Zolaxa. The daily dose of Zolaxa is from 5 mg to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Zolaxa unless the doctor decides to do so.
Zolaxa tablets 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 tablets are taken with or without food. Zolaxa coated tablets are taken orally.
The tablet should be swallowed whole, with a glass of 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, excitement or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and decreased consciousness. Other symptoms include:
severe confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased respiratory 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 of the medicine.

Missing a dose of Zolaxa

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

Stopping Zolaxa treatment

In case of improvement, the patient should not stop taking the tablets. It is important to take Zolaxa for as long as the doctor recommends.
If Zolaxa treatment is stopped suddenly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. The doctor may recommend gradually reducing the dose of the medicine before stopping treatment.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The doctor should be informed immediately if the following occur:

• abnormal movements, especially in the face or tongue (an uncommon side effect that may affect up to 1 in 100 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 blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms are observed, medical advice should be sought immediately;
• simultaneous occurrence of fever, rapid breathing, irregular or rapid heartbeat, sweating, muscle stiffness, and changes in mental status (e.g., altered consciousness), as well as drowsiness or sleepiness (a rare side effect that may affect up to 1 in 1,000 patients);
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms include flu-like symptoms 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 patients) include:

• weight gain,
• drowsiness,
• 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 increased 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,
• fluid 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 patients) 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 previously had seizures (epilepsy),
• muscle stiffness or spasms (including eye movements),
• restless legs syndrome,
• speech disorders,
• slow heart rate, changes in the ECG,
• sensitivity to sunlight,
• nosebleeds,
• abdominal bloating, excessive salivation,
• memory loss or lack of memory,
• urinary incontinence,
• difficulty urinating,
• hair loss,
• absence of menstruation,
• breast changes, such as unusual breast enlargement (in both men and women) 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 patients) 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-related psychosis treated with olanzapine, the following have been observed: stroke, pneumonia, urinary incontinence, falls, lethargy (lack of response to stimuli), visual hallucinations, elevated body temperature, skin redness, and difficulty walking.
In patients with Parkinson's disease, Zolaxa may worsen the symptoms of the disease.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zolaxa

The medicine should be stored out of 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 stated on the packaging means the last day of the given month.
The inscription 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. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Zolaxa contains

• The active substance of the medicine is olanzapine. Each coated tablet contains 5 mg or 10 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: polyvinyl alcohol, titanium dioxide (E 171), macrogol (type 3350), talc.

What Zolaxa looks like and what the package contains

The coated tablets are white or almost white, round, and biconvex.
The package contains 30 or 90 tablets.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of the last update of the leaflet: