Zolaxa

Package leaflet: Information for the patient

Zolaxa, 15 mg, coated tablets
Zolaxa, 20 mg, coated tablets
Olanzapine
Please read the entire leaflet carefully before using the 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

• schizophrenia – a disorder characterized by patients hearing, seeing, or sensing things that do not exist in reality, having beliefs contrary to 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 Zolaxa 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 Zolaxa

When not to use Zolaxa

• if the patient is 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 soya (see also the section "Zolaxa 20 mg tablets additionally contain sunset yellow and lecithin"). 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 Zolaxa, discuss this with the doctor or pharmacist.

• Zolaxa is not recommended for elderly patients diagnosed with dementia, as in this group of patients the medicine 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 Zolaxa, inform the doctor immediately.
• Rarely, medicines of this type may cause a group of symptoms including fever, rapid or irregular breathing, rapid or irregular heartbeat, sweating, muscle stiffness, changes in mental status (e.g. confusion with psychomotor agitation), drowsiness or sedation. If such symptoms occur, contact the doctor immediately.
• Weight gain has been observed in patients treated with Zolaxa. The 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 elevated lipid levels (triglycerides and cholesterol) have been observed in patients taking Zolaxa. Before starting and during treatment with Zolaxa, the doctor should perform blood tests to monitor blood glucose and certain lipid levels.
• Inform the doctor if the patient or their family 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 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;
• lung diseases;
• 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.

As a routine precaution, the doctor may monitor blood pressure in patients over 65 years of age.
Smoking tobacco may require an adjustment of the dose. Inform the doctor if the patient smokes.

Children and adolescents
Zolaxa is not intended for use in patients under 18 years of age.

Zolaxa with other medicines
Patients taking Zolaxa should use other medicines only under the doctor's supervision. Concomitant use of Zolaxa with antidepressants, sedatives or hypnotics may cause drowsiness.
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take. In particular, inform the doctor about the use of:

• medicines used in the treatment of Parkinson's disease;
• medicines that may affect heart function (causing changes in ECG), e.g. antiarrhythmics, certain antibiotics;
• carbamazepine (an anticonvulsant and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – dose adjustment of Zolaxa may be necessary.

If activated charcoal is required, it should be administered at least 2 hours before or 2 hours after taking Zolaxa.

Alcohol and Zolaxa
Do not drink alcohol while taking Zolaxa, as this medicine in combination 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 the doctor before using this medicine.
Breastfeeding women should not take Zolaxa, as small amounts of the medicine may pass into breast milk.
Newborns whose mothers took Zolaxa during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact the doctor immediately.

Driving and operating machinery
Zolaxa may cause drowsiness and dizziness. If these symptoms occur, do not drive or operate machinery. Inform the doctor about this.

Zolaxa contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

Zolaxa 20 mg tablets additionally contain sunset yellow and lecithin
The 20 mg tablets also contain sunset yellow (E 110), which may cause allergic reactions.
The 20 mg tablets also contain soya-derived lecithin. Do not use if hypersensitivity to peanuts or soya has been diagnosed.

3. How to use Zolaxa

This medicine should always be taken according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
Your doctor will decide how many tablets and for how long you should take Zolaxa. The daily dose of
Zolaxa ranges from 5 mg to 20 mg. If symptoms recur, inform your doctor.
However, do not stop taking Zolaxa unless your doctor advises you to do so.
Take Zolaxa tablets once daily 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 coated tablets are taken orally. Swallow the tablet whole with water.

Taking more medicine than recommended
In patients who have taken an overdose of Zolaxa, the following symptoms have been reported:
rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements
(particularly of the facial muscles and tongue), and reduced consciousness. Other symptoms include:
acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid
breathing, sweating, muscle stiffness and lethargy or drowsiness, 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
Take the missed tablet as soon as you remember. Do not take a double dose to make up for a missed dose.

Stopping the medicine
Do not stop taking the tablets just because you feel better. It is important to continue taking Zolaxa for
as long as your doctor recommends.
If Zolaxa is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety,
nausea or vomiting. Your 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 adverse reactions

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

• abnormal movements, especially of the face or tongue (an uncommon adverse reaction, which may affect up to 1 in 100 patients);
• blood clots in the veins (an uncommon 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 blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms are observed, medical advice should be sought immediately.
• concurrent occurrence of fever, rapid breathing, irregular or rapid heartbeat, sweating, muscle stiffness, changes in mental state, and drowsiness or lethargy (a rare adverse reaction, which may affect up to 1 in 1000 patients);
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, flu-like symptoms initially appear with a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and elevated levels of a specific type of white blood cell (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,
• increased blood prolactin levels,
• dizziness or fainting (with slowed heart function), particularly when rising from a lying or sitting position, especially at the beginning of treatment. 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 count of certain blood cells and blood lipid levels,
• transient increase in liver enzyme activity at the beginning of treatment,
• increased blood and urine glucose levels,
• increased blood uric acid levels and increased activity of creatine kinase and alkaline phosphatase in blood,
• increased appetite,
• dizziness,
• motor restlessness,
• tremor,
• movement disorders (dyskinesias),
• constipation,
• dryness of the oral mucosa,
• rash,
• weakness,
• extreme fatigue,
• fluid retention 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 adverse reactions (which may affect up to 1 in 100 patients) include:

• hypersensitivity (e.g. swelling of the mouth and throat, itching, rash),
• diabetes or worsening of existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma,
• seizures, usually in patients who previously experienced seizures (epilepsy),
• muscle stiffness or cramps (including eye movements),
• restless legs syndrome,
• speech disorders,
• slowed heart function, changes in ECG recording,
• photosensitivity,
• nosebleeds,
• abdominal distension, excessive salivation,
• memory loss or amnesia,
• urinary incontinence,
• difficulty urinating,
• hair loss,
• absence of menstruation,
• breast changes, such as unusual breast enlargement (in both women and men) and milk secretion outside the breastfeeding period (in women),
• increased blood bilirubin levels.

Rare adverse reactions (which may affect up to 1 in 1000 patients) include:

• decreased body temperature,
• reduced platelet count,
• withdrawal symptoms (such as sweating, insomnia, tremor, anxiety, nausea, or vomiting),
• heart rhythm disorders,
• sudden death (cardiac arrest),
• 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 pain,
• prolonged and/or painful erection.

During treatment with olanzapine in elderly patients diagnosed with dementia, the following may occur:
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 symptoms of the disease.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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 marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zolaxa

Keep the medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and the marking following "Lot" or "LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Zolaxa contains

• The active substance is olanzapine. Each coated tablet of Zolaxa contains 15 mg or 20 mg of olanzapine.
• Other ingredients are:
  Tablet core: Lactose monohydrate, povidone 30, crospovidone, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.
  Coating:
  15 mg coated tablets: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol (type 3350), quinoline yellow lake (E 104), yellow iron oxide (E 172).
  20 mg 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
15 mg coated tablets are yellow, oblong.
20 mg coated tablets are orange, oblong.
Pack contains 30 or 90 tablets.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01