Zolaxa

Package leaflet: Information for the patient

Zolaxa, 5 mg, coated tablets
Zolaxa, 10 mg, coated tablets
Olanzapinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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.

Leaflet contents

1. What Zolaxa is and what it is used for
2. What you should know 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 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.

Zolaxa has been shown to prevent 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). Allergic reactions may include rash, itching, facial swelling, lip swelling or shortness of breath. 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 your doctor or pharmacist.

• Use of Zolaxa is not recommended in elderly patients with dementia, as this medicine may cause very serious adverse effects in this patient group.
• Medicines of this class may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Zolaxa, inform your doctor.
• Rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, irregular or rapid heartbeat, sweating, muscle stiffness, changes in mental status (e.g. confusion with psychomotor agitation), drowsiness or sedation. If such symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients taking Zolaxa. 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 Zolaxa. Before starting and during treatment with Zolaxa, your doctor should perform blood tests to monitor blood glucose and certain lipid levels.
• Inform your doctor if the patient has ever had blood clots in the past, or if there is a family 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;
• lung diseases;
• heart disease;
• diabetes;
• seizures;
• if the patient suspects they may have lost body salts due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or use of diuretics.

As a routine precaution, doctors may monitor blood pressure in patients over 65 years of age.
Patients who smoke tobacco may require a dose adjustment of the medicine. Inform your doctor if you smoke.

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 with the approval of a doctor. Taking Zolaxa together with antidepressants, sedatives or hypnotics may cause drowsiness.
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Specifically, inform your doctor if the patient is taking:

• medicines used to treat 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 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 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 three 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 baby, contact your doctor immediately.

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

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

3. How to use Zolaxa

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Your doctor will decide how many tablets you should take and for how long to continue treatment with 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 otherwise instructed by your doctor.
Zolaxa tablets should be taken once daily as directed by your doctor. Try to take the medicine at the same time each day. It does not matter whether the tablets are taken during or independent of meals. Zolaxa coated tablets are for oral use.
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 (especially of the facial and tongue muscles), and reduced consciousness. Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, 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 dose as soon as you remember. Do not take a double dose to make up for the missed one.

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 has prescribed.
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 completely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
You should immediately inform your doctor if 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 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 lethargy or drowsiness (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 with a rash on the face appear initially, 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 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,
• increased blood prolactin levels,
• dizziness or fainting (with slowed heart rate) at the beginning of treatment, especially 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 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 levels of uric acid, creatine phosphokinase and alkaline phosphatase,
• increased appetite,
• dizziness,
• motor restlessness,
• tremor,
• movement disorders (dyskinesias),
• constipation,
• dryness of the oral mucosa,
• rash,
• loss of strength,
• extreme fatigue,
• fluid retention causing swelling of 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 compounds in blood and urine) or coma,
• seizures, usually in patients who previously experienced seizures (epilepsy),
• muscle stiffness or spasms (including eye movements),
• restless legs syndrome,
• speech disorders,
• slowed heart rate, changes in ECG recording,
• photosensitivity,
• nosebleeds,
• abdominal bloating, 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 normal body temperature,
• reduced platelet count,
• withdrawal symptoms (such as sweating, insomnia, tremor, anxiety, nausea or vomiting),
• heart rhythm disturbances,
• 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 disease symptoms.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zolaxa

Keep this 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 label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must 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 package and other information

What Zolaxa contains

• The active substance is olanzapine. Each coated tablet contains 5 mg or 10 mg of olanzapine.
• The other ingredients are:
  Tablet core: monohydrate lactose, povidone 30, crospovidone, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate;
  Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol (type 3350), talc.

What Zolaxa looks like and contents of the pack
The coated tablets are white or almost white, round, and biconvex.
The pack contains 30 or 90 tablets.

Marketing Authorisation Holder and Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański, Poland
Tel. + 48 22 364 61 01