Zilena

Package Leaflet: Information for the Patient

Zylena, 5 mg, orally disintegrating tablets

Zylena, 10 mg, orally disintegrating tablets

Zylena, 15 mg, orally disintegrating tablets

Zylena, 20 mg, orally disintegrating tablets

Olanzapine

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

• 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 only. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Zylena and what is it used for

Zylena contains the active substance olanzapine. Zylena 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 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.

Zylena 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 Zylena

When not to take Zylena:

• 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, tell your doctor;
• If you have eye disorders such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before taking Zylena, discuss it with your doctor or pharmacist.

• Zylena is not recommended for use in elderly patients with dementia, as it may cause very serious side effects.
• Medicines in this class may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Zylena, tell your doctor.
• Very rarely, these types of medicines cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, contact your doctor immediately.
• In patients taking Zylena, weight gain has been observed. The patient's weight should be checked regularly. If necessary, consider consulting a dietitian or seeking help in establishing a diet.
• In patients taking Zylena, high blood sugar and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Zylena and during its use, the doctor should perform blood tests to determine blood sugar levels and certain lipid levels.
• Tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

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

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

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should tell your doctor.
Routinely, as a precaution, in people over 65 years of age, the doctor may check blood pressure.
Children and adolescents
This medicine is not intended for use in patients under 18 years of age.

Zylena and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, tell your doctor about taking:

• Medicines used to treat Parkinson's disease;
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose adjustment of Zylena may be necessary.

People taking Zylena may only use other medicines with the consent of their doctor. Taking Zylena in combination with antidepressants, sedatives, or sleeping pills may cause drowsiness.

Zylena with food, drink, or alcohol

The medicine can be taken with or without food, as food does not affect its absorption.
Do not drink alcohol after taking Zylena, as the medicine 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 or pharmacist before taking this medicine.
Zylena should not be taken by breastfeeding women, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took olanzapine in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, excitement, breathing difficulties, and feeding difficulties. If you notice such symptoms in your child, contact your doctor.

Driving and using machines

Zylena may cause drowsiness. If drowsiness occurs, do not drive vehicles or operate any machines and devices. Tell your doctor.

Zylena contains aspartame (E951)

Zylena, 5 mg contains 0.375 mg of aspartame in each tablet.
Zylena, 10 mg contains 0.750 mg of aspartame in each tablet.
Zylena, 15 mg contains 1.125 mg of aspartame in each tablet.
Zylena, 20 mg contains 1.500 mg of aspartame in each 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 Zylena

Always take this medicine 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 Zylena. The daily dose of Zylena is 5 mg to 20 mg. If symptoms of the disease recur, tell your doctor. However, do not stop taking Zylena unless your doctor tells you to.
The medicine is taken orally. The tablets should be taken once a day 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.
The tablet should be carefully removed from the blister pack and then placed in the mouth. The tablet will dissolve directly in the mouth, 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 and possibly become cloudy when the tablet is added and stirred. The resulting liquid should be taken immediately.

Taking a higher dose of Zylena than recommended

In patients who have taken a higher dose of olanzapine than recommended, the following symptoms have occurred: rapid heartbeat, excitement or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and reduced consciousness. Other symptoms include:
severe confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or excessive sleepiness, decreased breathing rate, choking, high or low blood pressure, heart rhythm disturbances. Contact your doctor immediately or go to the hospital if any of these symptoms occur. Show your doctor the package with the tablets.

Missing a dose of Zylena

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

Stopping treatment with Zylena

Do not stop taking the tablets if you feel better. It is important to take Zylena for as long as your doctor recommends.
If you stop taking the medicine suddenly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of the medicine before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell 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 10 people);
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people), 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 notice any of these symptoms, seek medical attention immediately;
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (which may affect up to 1 in 10 people) include weight gain, drowsiness, and 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 go away on their own, but if they persist, tell your doctor.
Common side effects (which may affect up to 1 in 10 people) include changes in the number of certain blood cells, blood lipid levels, and transient increases in liver enzyme activity at the start of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, anxiety, trembling, movement disorders (dyskinesia), constipation, dry mouth, weakness, extreme fatigue, water retention in the body causing swelling of the hands, feet, or ankles, fever, joint pain, and 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 people) 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, stuttering, slow heart rate, sensitivity to sunlight, nosebleeds, abdominal bloating, salivation, memory loss or lack of memory, urinary incontinence, difficulty urinating, hair loss, absence or decrease of menstrual periods, changes in the breasts in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.
Rare side effects (which may affect up to 1 in 1,000 people): decreased body temperature, heart rhythm disturbances, sudden death from an unknown cause, 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 muscle pain and weakness, prolonged and (or) painful erections.
Side effects with an unknown frequency include serious allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), which initially manifests as flu-like symptoms with a rash on the face, and then with widespread rash, high fever, lymph node enlargement, elevated liver enzyme levels in blood tests, and an increase in one type of white blood cell (eosinophilia).
During treatment with olanzapine in elderly patients with dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. Several fatal cases have been reported in these patient groups.
In patients with Parkinson's disease, taking Zylena may worsen the symptoms of the disease.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 to gather more information on the safety of this medicine.

5. How to store Zylena

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine at a certain temperature.
Store in the original package to protect from moisture.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zylena contains

• The active substance of the medicine is olanzapine. One orally disintegrating tablet of Zylena contains 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine - the exact information about the active substance content is on the package.
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone (Type A), aspartame (E951), magnesium stearate, orange flavor (contains, among others, grapefruit oil and orange oil).

What Zylena looks like and contents of the pack

Zylena, 5 mg, 10 mg, 15 mg, or 20 mg is a tablet that disintegrates in the mouth, making it easy to swallow.
Zylena, 5 mg: light yellow, round, biconvex tablets with beveled edges, with "B" embossed on one side, 6 mm in diameter.
Zylena, 10 mg: light yellow, round, biconvex tablets with beveled edges, with "C" embossed on one side, 7 mm in diameter.
Zylena, 15 mg: light yellow, round, biconvex tablets with beveled edges, with "D" embossed on one side, 8 mm in diameter.
Zylena, 20 mg: light yellow, round, biconvex tablets with beveled edges, with "E" embossed on one side, 9 mm in diameter.
One pack of the medicine contains 28, 30, 56, 60, 84, 90, 112, or 120 tablets in OPA/Aluminum/PVC/Aluminum blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
Żmigrodzka Street 242 E, 51-131 Wrocław

Medicine information

phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: