Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Olanzin (Olanzapină Teva 5 mg comprimate filmate)
5 mg, film-coated tablets
Olanzapinum
Olanzin and Olanzapină Teva 5 mg comprimate filmate are different brand names for the same
medicinal product.
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are similar.
If the patient experiences any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Olanzin is and what it is used for

The active substance in Olanzin is olanzapine. Olanzin belongs to a group of medicines called antipsychotics and is used to treat:

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

Olanzin has been shown to prevent recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment during a manic episode.

2. Important information before using Olanzin

When not to use Olanzin:

if the patient is allergic to olanzapine, peanuts, or soya, or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may present with the following symptoms: rash, itching, facial swelling, swelling of the lips, or difficulty breathing. If any of these symptoms occur, contact a doctor immediately;
if the patient has previously been diagnosed with eye disorders such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Olanzin, consult a doctor or pharmacist.

Use of Olanzin is not recommended in elderly patients with dementia, as it may cause very serious adverse effects.
Medicines of this type may cause unusual movements, particularly of the face or tongue. If such symptoms occur after taking Olanzin, inform the doctor immediately.
Very rarely, medicines of this type may cause a group of symptoms such as: fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, contact a doctor immediately.
Weight gain has been observed in patients treated with Olanzin. The patient and doctor should regularly monitor the patient's body weight. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
In patients treated with olanzapine, high blood sugar levels and elevated lipid levels (triglycerides and cholesterol) have been observed. Before starting and during treatment with Olanzin, the doctor should perform blood tests to monitor blood glucose 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.

Inform the doctor immediately if the patient has any of the following conditions:

stroke or "mini" stroke (transient ischemic attack);
Parkinson's disease;
prostate problems;
intestinal obstruction (paralytic ileus);
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 tablets).

If the patient has dementia, the patient or caregiver or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
As a routine precaution, blood pressure should be monitored in patients over 65 years of age.

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

Olanzin with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patients taking Olanzin should use other medicines only with the approval of a doctor. Concomitant use of Olanzin with antidepressants, sedatives, or hypnotics may cause drowsiness.
In particular, inform the 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 Olanzin may be necessary.

Olanzin and alcohol
Do not drink any alcohol while taking Olanzin, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, if pregnancy is suspected, or if the woman is planning a pregnancy, consult a doctor before using this medicine. Women who are breastfeeding should not take Olanzin, as small amounts of olanzapine may pass into breast milk.

Newborns whose mothers took olanzapine during the third trimester of pregnancy (last three months) may experience the following adverse effects: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms are observed in the newborn, contact a doctor.

Driving and operating machinery
While taking Olanzin, there is a risk of drowsiness. If drowsiness occurs, do not drive or operate machinery, and inform the doctor.

Olanzin contains lactose and soya lecithin
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Do not use this medicine if the patient is allergic to peanuts or soya.

3. How to use Olanzin

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
Olanzin is available in the following doses: 5 mg and 10 mg.
Your doctor will decide how many tablets and for how long you should take Olanzin. The daily dose ranges from
5 mg to 20 mg of olanzapine. If symptoms of the illness recur, contact your doctor, but do not stop taking Olanzin
unless your doctor advises otherwise.
Tablets should be taken once daily, as directed by the doctor. Try to take the medicine at the same time each day.
It does not matter whether the medicine is taken during a meal or not.
Olanzin coated tablets are taken orally. The tablets should be swallowed whole with water.
Taking more Olanzin than prescribed
In patients who have taken more tablets than recommended, the following symptoms have occurred:
rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the facial muscles and tongue), and reduced consciousness. Other symptoms include: acute confusion, seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or excessive sleepiness, decreased respiratory rate, choking, high or low blood pressure, and heart rhythm disturbances. Seek immediate medical attention or go to the hospital if any of the above symptoms occur.
Show the tablet packaging to the doctor.
Missed dose of Olanzin
Take the tablet as soon as you remember. Do not take a double dose to make up for the missed dose.
Stopping Olanzin treatment
Do not stop taking the medicine, even if you feel better. It is important to continue taking Olanzin for as long as your doctor recommends.
If Olanzin treatment is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, or nausea and vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment.
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 immediately inform your doctor if any of the following occur:

abnormal movements, especially of the face or tongue (a commonly reported adverse reaction, which may affect up to 1 in 10 people);
blood clots in the veins (an uncommonly reported adverse reaction, which may affect up to 1 in 100 people), 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 occur, seek medical advice immediately;
occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sedation (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (may affect more than 1 in 10 people) include:
weight gain, drowsiness, and increased blood prolactin levels. In the early stages of
treatment, dizziness or fainting (with slowed heart function) 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 (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 beginning of treatment, increased blood and urine glucose levels,
increased blood uric acid and creatine kinase activity,
increased appetite, dizziness, anxiety, tremor, movement disorders (dyskinesias), constipation,
dryness of the oral mucosa, rash, weakness, extreme fatigue, fluid retention leading to
swelling of the hands, ankles or feet, fever, joint pain, and sexual disorders,
such as decreased libido in men and women or erectile dysfunction in men.
Uncommon adverse reactions (may affect up to 1 in 100 people)
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 who previously
experienced seizures (epilepsy), muscle stiffness or spasms (including eye movements),
restless legs syndrome, speech disorders, stuttering, slowed heart function,
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 milk discharge outside
lactation or unusual breast enlargement.
Rare adverse reactions (may affect up to 1 in 1000 people) include:
lowering of normal body temperature, heart rhythm disturbances, sudden death of
unknown cause, 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 pain, prolonged and (or) painful erection.
Very rare adverse reactions include severe allergic reactions, such as drug reaction with
eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms are
influenza-like with a rash on the face, followed by widespread rash, high fever, enlarged lymph nodes,
increased liver enzyme activity in blood tests, and increased levels of a specific type of white blood cells
(eosinophilia).
During treatment with Olanzin, in elderly patients diagnosed with dementia, the following may occur:
stroke, pneumonia, urinary incontinopenia, falls, extreme fatigue, visual hallucinations,
elevated body temperature, skin redness, and difficulty walking. In this patient group,
a number of fatal cases have been reported.
In patients with Parkinson's disease, Olanzin may worsen symptoms of adverse reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell 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
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Olanzin

Keep this medicine out of sight and reach of children.
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.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Olanzin contains

The active substance is olanzapine. Each coated tablet of Olanzin contains 5 mg of olanzapine.
Other ingredients are: (tablet core) lactose, microcrystalline cellulose, crospovidone, magnesium stearate; and (coating Opadry AMB White OY-B-28920 of the coated tablet) polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.

What Olanzin looks like and contents of the pack
Round, biconvex, white coated tablets, 8 mm in diameter, marked with "O1" on one side.
Pack sizes:
Blister packs: 30 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer:
Actavis Ltd.
BLB 016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjörður
Iceland
Balkanpharma-Dupnitsa AD
3 Samakovsko Shosse Str.
Dupnitsa, 2600
Bulgaria
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Romania, country of export: 8205/2015/04
Parallel import authorisation number: 112/18