Zolaxa Rapid

Leaflet attached to the packaging: patient information

Zolaxa Rapid, 5 mg, orally disintegrating tablets

Zolaxa Rapid, 10 mg, orally disintegrating tablets

Zolaxa Rapid, 15 mg, orally disintegrating tablets

Zolaxa Rapid, 20 mg, orally disintegrating tablets

Olanzapine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Zolaxa Rapid and what is it 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 - a disease characterized by the patient 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 - conditions characterized by excitement or euphoria.

It has been shown that Zolaxa Rapid 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 Rapid

When not to take 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 a rash, itching, swelling of the face, lip swelling, or difficulty breathing. If such symptoms occur, the doctor should be informed;
• If the patient has eye disorders, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

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

• Zolaxa Rapid is not recommended for patients over 65 years of age with a diagnosis of dementia, 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 Rapid, 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 state (e.g., altered consciousness with psychomotor agitation), drowsiness, or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• In patients taking Zolaxa Rapid, weight gain has been observed. 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.
• In patients taking Zolaxa Rapid, high blood sugar and high lipid levels have been observed. Before taking Zolaxa Rapid and during its use, the doctor should perform blood tests to determine blood sugar and lipid levels.
• The doctor should be told 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);
• Liver or kidney disease;
• Blood diseases;
• Lung diseases;
• Heart disease;
• Diabetes;
• Seizures;
• If the patient knows they may have lost salt due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or the use of diuretics.

As a precaution, in people over 65 years of age, the doctor may monitor blood pressure.
Smokers may need to adjust their dose. The doctor should be informed about smoking.

Children and adolescents

Zolaxa Rapid is not intended for use in patients under 18 years of age.

Zolaxa Rapid and other medicines

People taking Zolaxa Rapid may only take other medicines with their doctor's consent.
Taking Zolaxa Rapid in combination with antidepressants, sedatives, or sleeping pills may cause drowsiness.
The doctor should be told 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 told about:

• Medicines used to treat Parkinson's disease;
• Medicines that may affect heart function (cause changes in the ECG), such as anti-arrhythmic drugs, some 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 given at least 2 hours before taking Zolaxa Rapid or 2 hours after taking this medicine.

Taking Zolaxa Rapid with alcohol

Alcohol should not be consumed after taking Zolaxa Rapid, 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 Rapid should not be taken by breastfeeding women, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Zolaxa Rapid 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 Rapid may cause drowsiness and dizziness. If such symptoms occur, the patient should not drive or operate machinery. The doctor should be informed.

Zolaxa Rapid contains aspartame (E 951)

The medicine contains 0.35 mg of aspartame in each 5 mg Zolaxa Rapid tablet.
The medicine contains 0.70 mg of aspartame in each 10 mg Zolaxa Rapid tablet.
The medicine contains 1.05 mg of aspartame in each 15 mg Zolaxa Rapid tablet.
The medicine contains 1.40 mg of aspartame in each 20 mg Zolaxa Rapid tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Zolaxa Rapid

This medicine should always be taken as directed by the doctor. If there are any doubts, the doctor or pharmacist should be consulted.
The doctor will decide how many tablets and how long to take Zolaxa Rapid. The daily dose of Zolaxa Rapid is from 5 mg to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, Zolaxa Rapid should not be discontinued unless the doctor decides to do so.
Zolaxa Rapid 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.
The tablets are taken orally. The orally disintegrating tablets are easily crushed, so they should be handled carefully. They should be taken immediately after opening the blister pack. The tablets should not be taken with wet hands, as they may disintegrate.
The tablet should be placed in the mouth, where it will quickly dissolve, making it easier to swallow.
The tablet can also be placed in a full glass of water, orange juice, apple juice, milk, or coffee, and then stirred. Some drinks may change color or become cloudy when the tablet is added and stirred. The resulting liquid should be taken immediately.

Taking a higher dose of the medicine than recommended

In patients who have taken a higher dose of Zolaxa Rapid 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:
severe 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. The doctor should be contacted immediately or the patient should go to the hospital if any of these symptoms occur. The doctor should be shown the packaging of the medicine.

Missing a dose of the medicine

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 the medicine

Even if the patient feels better, they should not stop taking the tablets. It is important to take Zolaxa Rapid for as long as the doctor recommends.
If Zolaxa Rapid is stopped abruptly, 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 there are any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Zolaxa Rapid 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 (a common side effect that may affect up to 1 in 100 patients);
• Blood clots in the veins (a common 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 bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms are observed, the doctor should be contacted 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 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 increases in liver enzyme activity at the start of treatment,
• Increased glucose levels in the blood and urine,
• Increased levels of uric acid and creatine kinase 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 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 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,
• Amenorrhea,
• 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 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.

During olanzapine treatment in elderly patients 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 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, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Zolaxa Rapid

Store in a place out of sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiration date stated on the blister pack and carton.
The expiration date is the last day of the specified month.
The entry on the packaging after the abbreviation EXP means the expiration 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 used. This will help protect the environment.

6. Contents of the packaging and other information

What Zolaxa Rapid contains

• The active substance of the medicine is olanzapine. Each orally disintegrating tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
• The other ingredients of the medicine are: microcrystalline cellulose, crospovidone, aspartame (E 951), peppermint flavor, magnesium stearate.

What Zolaxa Rapid looks like and what the packaging contains

The orally disintegrating tablets are yellow, slightly rough to the touch, round, and biconvex.
The packaging contains 28, 30, or 56 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of the last update of the leaflet: