Zolaxa rapid

Package leaflet: Information for the patient

Zolaxa Rapid, 5 mg, orodispersible tablets
Zolaxa Rapid, 10 mg, orodispersible tablets
Zolaxa Rapid, 15 mg, orodispersible tablets
Zolaxa Rapid, 20 mg, orodispersible tablets
Olanzapine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

• schizophrenia – an illness characterised by hearing, seeing or sensing things that do not exist in reality, having beliefs that are not in accordance with 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 characterised by excitement or euphoria.

Zolaxa Rapid has been shown to prevent relapse 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 Rapid

When not to use Zolaxa Rapid

• 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, swelling of the 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 Rapid, discuss this with your doctor or pharmacist.

• Zolaxa Rapid is not recommended for elderly patients with dementia, as in this group of patients the medicine may cause very serious adverse effects.
• Medicines of this class may cause abnormal movements, particularly of the face or tongue. If such a symptom occurs after taking Zolaxa Rapid, 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 any of these symptoms occur, contact your doctor immediately.
• Weight gain has been observed in patients treated with Zolaxa Rapid. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
• High blood sugar levels and elevated lipid levels (triglycerides and cholesterol) have been observed in patients taking Zolaxa Rapid. Before starting and during treatment with Zolaxa Rapid, the doctor should perform blood tests to monitor blood glucose and certain lipid levels.
• Inform the doctor if the patient has ever had blood clots, or if there is a family history of thrombosis, 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 knows they may have lost body salts due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or use of diuretics.

As a routine precautionary measure, doctors may monitor blood pressure in patients over 65 years of age.
Smoking may require a dose adjustment of the medicine. Inform the doctor about tobacco use.
Children and adolescents
Zolaxa Rapid is not intended for use in patients under 18 years of age.
Zolaxa Rapid and other medicines
Patients taking Zolaxa Rapid should use other medicines only under the guidance of a doctor.
Concomitant use of Zolaxa Rapid 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. Specifically, inform the 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-stabilizing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – dose adjustment of Zolaxa Rapid may be necessary.

If the patient needs to take activated charcoal, it should be administered at least 2 hours before or 2 hours after taking Zolaxa Rapid.
Use of Zolaxa Rapid with alcohol
Do not drink alcohol after taking Zolaxa Rapid, 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 her doctor before using this medicine.
Breastfeeding women should not take Zolaxa Rapid, as small amounts of the medicine may pass into breast milk.
Newborns whose mothers took Zolaxa Rapid during the third trimester (last 3 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 the newborn, contact the doctor immediately.
Driving and operating machinery
Zolaxa Rapid may cause drowsiness and dizziness. If these symptoms occur, the patient should not drive or operate machinery. Inform the doctor about this.
Zolaxa Rapid contains aspartame (E 951)
The medicine contains 0.35 mg of aspartame in each Zolaxa Rapid 5 mg tablet.
The medicine contains 0.70 mg of aspartame in each Zolaxa Rapid 10 mg tablet.
The medicine contains 1.05 mg of aspartame in each Zolaxa Rapid 15 mg tablet.
The medicine contains 1.40 mg of aspartame in each Zolaxa Rapid 20 mg tablet.
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

3. How to take Zolaxa Rapid

This medicine should always be taken as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Your doctor will decide how many tablets and for how long you should take Zolaxa Rapid. The daily dose of
Zolaxa Rapid ranges from 5 mg to 20 mg. If symptoms recur, inform your doctor.
However, do not stop taking Zolaxa Rapid unless instructed to do so by your doctor.
Zolaxa Rapid 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 apart from meals.
The tablets are taken orally. Orally disintegrating tablets are fragile and should be handled with care.
They should be taken immediately after opening the blister. Do not handle the tablets with wet hands, as they may disintegrate.
Place the tablet in the mouth, where it will rapidly dissolve, making it easier to swallow.
Alternatively, the tablet can be placed in a full glass of water, orange juice, apple juice, milk, or coffee, and then stirred. Some beverages may change color and possibly become cloudy after the tablet is added and mixed. The prepared liquid should be consumed immediately.

Taking more medicine than recommended
In patients who have taken more than the recommended dose of Zolaxa Rapid, 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 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 the hospital if any of
the above symptoms occur. Show the doctor the medicine packaging.

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

Stopping the medicine
Even if you feel better, do not stop taking the tablets. It is important to continue taking Zolaxa Rapid for as long as your doctor has instructed.
If Zolaxa Rapid 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 doubts about using 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 inform your doctor immediately 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 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 breathing difficulties. If any of these symptoms occur, seek medical advice immediately;
• simultaneous 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 1,000 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 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 function), especially when rising from a lying or sitting position, particularly 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 creatine kinase and alkaline phosphatase activity in blood,
• 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 bodies in blood and urine) or coma,
• seizures, usually in patients who previously had seizures (epilepsy),
• muscle stiffness or spasms (including eye movements),
• restless legs syndrome,
• speech disorders,
• slowed heart function, 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 1,000 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 Rapid may worsen disease symptoms.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, 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
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 Rapid

Keep the medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
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 the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/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. This will help protect the environment.

6. Contents of the packaging and other information

What Zolaxa Rapid contains

• The active substance is olanzapine. Each orodispersible tablet contains 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
• Other components of the medicine are: microcrystalline cellulose, crospovidone, aspartame (E 951), peppermint flavour, magnesium stearate.

What Zolaxa Rapid looks like and contents of the packaging
Orodispersible tablets are yellow in colour with a slightly rough surface,
round and biconvex.
The packaging contains 28, 30 or 56 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Tel. +48 22 364 61 01