Zolaxa Rapid

Package Leaflet: Information for the Patient

Zolaxa Rapid, 5 mg, Oral Disintegrating Tablets

Zolaxa Rapid, 10 mg, Oral Disintegrating Tablets

Zolaxa Rapid, 15 mg, Oral Disintegrating Tablets

Zolaxa Rapid, 20 mg, Oral Disintegrating Tablets

Olanzapine

Read the Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your 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 pack 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 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 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 you are 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, inform your doctor;
• If you have eye disorders, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting treatment with Zolaxa Rapid, discuss it with your doctor or pharmacist.

• Zolaxa Rapid is not recommended for use in elderly patients with 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 you experience such a symptom after taking Zolaxa Rapid, inform your doctor.
• Rarely, these types of medications can 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, contact your doctor immediately.
• In patients taking Zolaxa Rapid, weight gain has been observed. Regularly check your weight. If necessary, consider 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 treatment, your doctor should perform blood tests to determine blood sugar and lipid levels.
• Tell your doctor if you or your family have a history of blood clots, as similar medications have been associated with the formation of blood clots.

If you have any of the following conditions, inform your doctor immediately:

• Stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• Prostate disorders;
• Bowel obstruction (paralytic ileus);
• Liver or kidney disease;
• Blood disorders;
• Lung diseases;
• Heart disease;
• Diabetes;
• Seizures;
• If you know you may have lost salt due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics.

Routinely, as a precaution, in people over 65 years of age, the doctor may monitor blood pressure.
Smokers may need to adjust their dose. Inform your doctor about smoking.

Children and adolescents

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

Zolaxa Rapid and other medications

People taking Zolaxa Rapid should only take other medications with the consent of their doctor.
Taking Zolaxa Rapid in combination with antidepressants, sedatives, or sleep aids may cause drowsiness.
Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take. In particular, inform your doctor about:

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

If you need to take activated charcoal, it should be administered at least 2 hours before taking Zolaxa Rapid or 2 hours after taking this medication.

Taking Zolaxa Rapid with alcohol

Do not drink alcohol after taking Zolaxa Rapid, as this medication in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medication.
Women who are breastfeeding should not take Zolaxa Rapid, as small amounts of the medication 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, difficulty breathing, and feeding difficulties. If you observe such symptoms in your child, contact your doctor.

Driving and operating machinery

Zolaxa Rapid may cause drowsiness and dizziness. If such symptoms occur, do not drive or operate machinery. Inform your doctor.

Zolaxa Rapid contains aspartame (E 951)

The medication contains 0.35 mg of aspartame in each 5 mg Zolaxa Rapid tablet.
The medication contains 0.70 mg of aspartame in each 10 mg Zolaxa Rapid tablet.
The medication contains 1.05 mg of aspartame in each 15 mg Zolaxa Rapid tablet.
The medication 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

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will decide how many tablets and how long you should take Zolaxa Rapid. The daily dose of Zolaxa Rapid is from 5 mg to 20 mg. If symptoms of the disease recur, inform your doctor. However, do not stop taking Zolaxa Rapid unless your doctor decides to.
Take Zolaxa Rapid tablets once a day as directed by your doctor. Try to take the medication at the same time every day. It does not matter whether you take the tablets with or without food.
Take the tablets orally. The oral disintegrating tablets are fragile, so handle them carefully. Take them directly after opening the blister pack. Do not handle the tablets with wet hands, as they may disintegrate.
Place the tablet in your mouth, where it will dissolve quickly, making it easier to swallow.
You can also place the tablet in a full glass of water, orange juice, apple juice, milk, or coffee, and then stir. Some beverages may change color or become cloudy when the tablet is added and stirred. Drink the resulting liquid immediately.

Taking a higher dose of the medication 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. Contact your doctor immediately or go to the hospital if you experience any of these symptoms. Show your doctor the medication packaging.

Missing a dose of the medication

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

Stopping treatment with the medication

Even if you feel better, do not stop taking the tablets. It is important to take Zolaxa Rapid for as long as your doctor recommends.
If you suddenly stop taking Zolaxa Rapid, you may experience the following symptoms: sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible side effects

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

Inform your doctor immediately if you experience:

• 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 you observe any of these symptoms, seek medical attention 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). In DRESS, initial symptoms are flu-like, 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, inform your doctor.

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 beginning 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,
• Decreased 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,
• Absence of menstruation,
• 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.

In elderly patients with dementia treated with olanzapine, the following symptoms may occur: stroke, pneumonia, urinary incontinence, falls, lethargy (lack of response to stimuli), visual hallucinations, elevated body temperature, skin redness, and walking difficulties.
In patients with Parkinson's disease, Zolaxa Rapid may worsen the symptoms of the disease.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides)
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 this medication.

5. How to store Zolaxa Rapid

Keep out of sight and reach of children.
There are no special precautions for storing the medication.
Do not use this medication after the expiration date stated on the blister pack and carton.
The expiration date stated is the last day of the specified month.
The inscription on the packaging after the abbreviation EXP indicates the expiration date, and after the abbreviation Lot/LOT, it indicates the batch number.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Zolaxa Rapid contains

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

What Zolaxa Rapid looks like and contents of the pack

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

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: