Zilena

Leaflet accompanying the packaging: patient information

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 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 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 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 whose symptoms include 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 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 treatment with Zylena, the patient should discuss it with their doctor or pharmacist.

• Zylena is not recommended for patients over 65 years of age with a diagnosis of dementia, as it may cause very serious side effects.
• Medicines in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Zylena, the doctor should be informed.
• 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, the doctor should be contacted immediately.
• In patients taking Zylena, 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 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.
• 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 conditions, 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;
• 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 (urinary medicines).

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

Zylena and other medicines

The doctor or pharmacist 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;
• 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 take other medicines with their doctor's consent. Taking Zylena in combination with antidepressant, sedative, or sleeping medicines 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.
Alcohol should not be consumed after taking Zylena, as the 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 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 such symptoms are observed in the patient's child, the doctor should be contacted.

Driving and using machines

Zylena may cause drowsiness. If drowsiness occurs, the patient should not drive or operate any machines or mechanical devices. The doctor should be informed.

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

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 Zylena. The daily dose of Zylena is 5 mg to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Zylena unless the doctor decides to do so.
The medicine is taken orally. The 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 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 drunk 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 decreased 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 disorders. The doctor should be contacted immediately if any of these symptoms occur. The doctor should be shown the packaging of the tablets.

Missing a dose of Zylena

A missed dose should be taken as soon as possible. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Zylena

In case of improvement, the patient should not stop taking the tablets. It is important to take Zylena for as long as the doctor recommends.
If treatment with Zylena is stopped suddenly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. The doctor may recommend gradually reducing the dose of Zylena 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, Zylena can cause side effects, although not everybody gets them.
The doctor should be told immediately if the following occur:

• Abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 patients);
• Blood clots in the veins (an uncommon 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 blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms are observed, medical advice should be sought immediately;
• Simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be determined from the available data).

Very common side effects (which may affect up to 1 in 10 patients) include weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with a slow 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, 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, 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, restlessness, tremors, movement disorders (dyskinesias), 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 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, stuttering, slow heart rate, sensitivity to sunlight, nosebleeds, abdominal bloating, drooling, memory loss or lack of memory, urinary incontinence, difficulty urinating, hair loss, absence or decrease of menstrual periods, changes in the breasts of men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.
Rare side effects (which may affect up to 1 in 1000 patients): decreased body temperature, heart rhythm disorders, 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 increased number of 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 any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be told. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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 gather more information on the safety of the medicine.

5. How to store Zylena

The medicine should be stored out of sight and reach of children.
There are no special recommendations for the storage temperature of the medicine.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. 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 packaging.
• 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 what the pack contains

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: informacjaoleku@hasco-lek.pl

Date of last update of the leaflet: