Package leaflet: Information for the patient

Zylena, 5 mg, orodispersible tablets
Zylena, 10 mg, orodispersible tablets
Zylena, 15 mg, orodispersible tablets
Zylena, 20 mg, orodispersible tablets
Olanzapine
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

What Zylena is and what it is used for
Important information before taking Zylena
How to take Zylena
Possible side effects
How to store Zylena
Contents of the pack and other information

1. What Zylena is and what it is used for

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

schizophrenia – a disorder characterized by patients hearing, seeing, or sensing things that do not exist in reality, having beliefs that contradict reality, being excessively suspicious, and withdrawing from social interactions. Patients may also experience depression, anxiety, or tension;
moderate to severe manic episodes – medical conditions characterized by excitement or euphoria.

Zylena prevents recurrence of these symptoms in patients with bipolar affective disorder who have previously responded well to olanzapine treatment during a manic episode.

2. Important information before using Zylena

When not to use Zylena:

if the patient is allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, facial swelling, swollen lips or shortness of breath. 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 Zylena, discuss this with your doctor or pharmacist.

Use of Zylena is not recommended in elderly patients with dementia, as it may cause very serious adverse reactions.
Medicines of this class may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Zylena, inform your doctor.
Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or sedation. If such symptoms occur, contact your doctor immediately.
Weight gain has been observed in patients taking Zylena. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
Elevated blood sugar levels and elevated lipid levels (triglycerides and cholesterol) have been observed in patients taking Zylena. Before starting and during treatment with Zylena, the doctor should perform blood tests to monitor blood sugar and certain lipid levels.
Inform the doctor if the patient or a family member has a history of blood clots, as similar medicines have been associated with blood clot formation.

If the patient has any of the following conditions, inform the doctor immediately:

stroke or "mini" stroke (transient ischemic attack);
Parkinson's disease;
prostate gland disorders;
intestinal obstruction (paralytic);
liver or kidney disease;
blood disorders;
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 (water pills).

If the patient has dementia and has ever had a stroke or "mini" stroke, this should be reported to the doctor (by the patient or caregiver).
As a routine precaution, doctors may monitor blood pressure in patients aged 65 years and older.

Children and adolescents
This medicine is not intended for use in patients under 18 years of age.

Zylena with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform your doctor if the patient is taking:

medicines used to treat Parkinson's disease;
carbamazepine (an anticonvulsant and mood-stabilizing medicine), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – a dose adjustment of Zylena may be necessary.

Patients taking Zylena should use other medicines only with the approval of a doctor. Concomitant use of Zylena with antidepressants, sedatives or hypnotics may cause drowsiness.

Zylena with food, drink or alcohol
This medicine may be taken independently of meals, as food does not affect its absorption.
Alcohol should not be consumed after taking Zylena, 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 or pharmacist before using this medicine.
Breastfeeding women should not take Zylena, as small amounts of the medicine may pass into breast milk.

Newborns whose mothers took olanzapine during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, 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
Zylena may cause drowsiness. If drowsiness occurs, the patient should not drive or operate any machines or mechanical equipment. Inform the 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 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 Zylena

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will decide how many tablets and for how long you should take Zylena. The daily dose of Zylena ranges from 5 mg to 20 mg. If symptoms recur, inform your doctor. However, do not stop taking Zylena unless your doctor instructs you to do so.
This medicine is taken orally. Take the tablets 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 tablet should be carefully removed from the blister and placed into the mouth. The tablet will dissolve directly in the oral cavity, making it easier to swallow.
Alternatively, the tablet may 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 drunk immediately.

Taking more Zylena than prescribed
In patients who have taken an overdose of olanzapine, the following symptoms have been observed: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the facial and tongue muscles), and reduced level of consciousness. Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness and drowsiness or excessive sleepiness, reduced respiratory rate, choking, high or low blood pressure, and heart rhythm disturbances. Seek immediate medical attention or go to a hospital if any of these symptoms occur. Show the doctor the medicine packaging.

Missed dose of Zylena
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for a missed dose.

Stopping treatment with Zylena
Do not discontinue taking the tablets just because you feel better. It is important to continue taking Zylena for as long as your doctor recommends.
If treatment is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea, or vomiting. Your doctor may advise gradually reducing the dose before stopping treatment completely.

If you have any further questions about the use of 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 contact your doctor immediately if any of the following occur:

abnormal movements, especially of the face or tongue (a frequently reported adverse reaction which may affect up to 1 in 10 patients);
blood clots in the veins (an uncommonly reported 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 the blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms are observed, seek medical advice immediately;
occurrence of fever, rapid breathing, sweating, muscle stiffness and drowsiness or lethargy at the same time (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (which may affect up to 1 in 10 patients) include
weight gain, drowsiness and increased blood prolactin levels. In the early stages of
treatment, dizziness or fainting (with slowed heart rate) may occur, particularly
when rising from a lying or sitting position. These symptoms usually resolve on their own, 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 number
of certain blood cells, blood lipid levels and transient increases in liver enzyme activity at the beginning of treatment, increased blood and urine glucose levels,
increased blood uric acid levels and creatine phosphokinase activity, increased appetite,
dizziness, restlessness, tremor, movement disorders (dyskinesias), constipation, dryness of the oral mucosa, rash, weakness, extreme fatigue, fluid retention
leading to 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 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 pre-existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in
blood and urine) or coma, seizures, usually in patients with a previous history of
seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slowed heart rate, photosensitivity,
nosebleeds, abdominal distension, salivation, memory loss or amnesia,
urinary incontinence, difficulty urinating, hair loss, absence or reduction of
menstruation, breast changes in men and women, such as galactorrhea (milk discharge outside of lactation) or unusual breast enlargement.
Rarely reported adverse reactions (which may affect up to 1 in 1000 patients): decreased
normal body temperature, heart rhythm disturbances, sudden unexplained death,
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 aches and pains, prolonged and (or) painful erection.
Adverse reactions with unknown frequency include serious allergic reactions, such as
drug reaction with eosinophilia and systemic symptoms (DRESS), which initially presents
as flu-like symptoms with facial rash, followed by widespread rash, high
fever, swollen lymph nodes, elevated liver enzymes evident in blood tests and increased levels of one type of white blood cell (eosinophilia).
During treatment with olanzapine in elderly patients diagnosed 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, treatment with Zylena may worsen symptoms of this
disease.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. 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 to provide more information on the
safety of the medicine.

5. How to store Zylena

Keep this medicine out of the sight and reach of children.
There are no special storage temperature requirements for this 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Zylena contains

The active substance is olanzapine. One orally disintegrating tablet of Zylena contains 5 mg, 10 mg, 15 mg or 20 mg of olanzapine – the exact content of the active substance is indicated on the packaging.
The other ingredients (excipients) are: microcrystalline cellulose, crospovidone (Type A), aspartame (E951), magnesium stearate, orange flavour (containing, 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 in the form of orally disintegrating tablets,
making them easy to swallow.
Zylena 5 mg: light yellow, round, biconvex tablets with bevelled edges,
imprinted with the letter "B" on one side, 6 mm in diameter.
Zylena 10 mg: light yellow, round, biconvex tablets with bevelled edges,
imprinted with the letter "C" on one side, 7 mm in diameter.
Zylena 15 mg: light yellow, round, biconvex tablets with bevelled edges,
imprinted with the letter "D" on one side, 8 mm in diameter.
Zylena 20 mg: light yellow, round, biconvex tablets with bevelled edges,
imprinted with the letter "E" on one side, 9 mm in diameter.
One package contains 28, 30, 56, 60, 84, 90, 112 or 120 tablets in blisters
OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław
Product information
tel.: 22 742 00 22
e-mail: [email protected]