Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Olanzin (Olanzapină Teva 10 mg film-coated tablets)
10 mg, film-coated tablets
Olanzapinum
Olanzin and Olanzapină Teva 10 mg comprimate filmate are different brand names of the same
medicinal product.
Please read this leaflet carefully before taking this medicine because it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Olanzin is and what it is used for
What you need to know 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, a disorder characterized by hearing, seeing, or sensing things that are not real, having beliefs that are not based on reality, being excessively suspicious and withdrawn from others. 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 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 taking olanzapine, high blood sugar levels and elevated lipid levels (triglycerides and cholesterol) have been observed. Before 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 any 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 ischaemic 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 diarrhoea and vomiting (nausea with vomiting) or use of diuretics (water tablets).

If the patient has dementia, the patient or their 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
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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 combined with alcohol may cause drowsiness.

Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if pregnancy is suspected, or when 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: tremors, 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 immediately.

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.
If the patient is allergic to peanuts or soya, this medicine should not be used.

3. How to use Olanzin

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Olanzin is available in the following doses: 5 mg and 10 mg.
Your doctor will decide how many tablets to take and for how long. The daily dose ranges from
5 mg to 20 mg of olanzapine. If symptoms recur, contact your doctor, but do not stop taking Olanzin
unless instructed by your doctor.
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. Swallow the tablets 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 behaviour, difficulty speaking, involuntary movements
(particularly of the facial and tongue muscles), and reduced consciousness. Other symptoms include:
acute confusion, seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing,
sweating, muscle stiffness, and drowsiness or somnolence, decreased 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 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 a missed dose.
Stopping treatment with Olanzin
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 treatment with Olanzin 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.
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 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 sedation at the same time (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. During 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 spontaneously, but if they
persist, inform your doctor.

Common adverse reactions (may affect up to 1 in 10 people) include:
changes in the count 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 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, 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 secretion 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 facial rash, followed by widespread rash, high fever, swollen lymph nodes,
increased liver enzyme activity evident in blood tests, and elevated 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 incontinence, falls, extreme fatigue, visual hallucinations,
elevated body temperature, skin redness, and difficulty walking. In this patient group,
there have been several fatal cases 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 at 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 the medicine Olanzin

Keep the 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. Such measures 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 10 mg of olanzapine.
The 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, 10 mm in diameter, marked with "O3" on one side.
Pack sizes:
Blister packs: 30 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible entity 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
Authorization number in Romania, country of export: 8206/2015/04
Parallel import authorization number: 111/18