Olanzin

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Olanzin (Olanzapine Teva 5 mg film-coated tablets)

5 mg, film-coated tablets

Olanzapine
Olanzin and Olanzapine Teva 5 mg film-coated tablets are different trade names for the same medicine.

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 to you specifically. 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, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Olanzin and what is it used for
• 2. Important information before taking Olanzin
• 3. How to take Olanzin
• 4. Possible side effects
• 5. How to store Olanzin
• 6. Package contents and other information

1. What is Olanzin and what is it used for

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

• Schizophrenia, i.e., a disease characterized by the patient hearing, seeing, or feeling things that do not exist in reality, having beliefs that contradict reality, being overly suspicious, and withdrawing from contact with others. Patients with this disease may also experience depression, anxiety, or tension;
• Moderate to severe manic episodes, i.e., a disease state whose symptoms include excitement or euphoria.

It has been shown that Olanzin 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 Olanzin

When not to take Olanzin:

• If the patient is allergic to olanzapine, peanuts, or soy, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can be recognized by the following symptoms: rash, itching, swelling of the face, swelling of the lips, or difficulty breathing. The doctor should be contacted immediately if these symptoms occur;
• If the patient has been previously diagnosed with eye diseases, such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Before starting to take Olanzin, the patient should consult their doctor or pharmacist.

• Taking Olanzin is not recommended for elderly patients with dementia, as it may cause very serious side effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If such symptoms occur after taking Olanzin, the doctor should be informed immediately.
• Very rarely, medicines of this type cause a syndrome of symptoms such as fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• In patients taking Olanzin, weight gain has been observed. The patient and their doctor should regularly check the patient's weight. If necessary, consider consulting a dietitian or seeking help in establishing a diet.
• In patients taking olanzapine, high blood sugar and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Olanzin and during its use, the doctor should perform blood tests to determine blood glucose and lipid levels.
• The doctor should be informed if the patient or their family has a history of blood clots, as similar medicines have been associated with the formation of blood clots.

The doctor should be informed immediately if the patient has any of the following diseases:

• stroke or "mini" stroke (transient stroke symptoms);
• Parkinson's disease;
• prostate problems;
• intestinal obstruction (paralytic);
• liver or kidney disease;
• blood diseases;
• heart disease;
• diabetes;
• seizures;
• if the patient knows they may have experienced salt loss due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or the use of diuretics (urinary medicines).

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.
Routinely, as a precaution, patients over 65 years old should have their blood pressure checked.

Children and adolescents

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

Olanzin and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patient taking Olanzin may only take other medicines with the doctor's consent. Taking Olanzin in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
In particular, the doctor should be informed about the use of:

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

Olanzin with alcohol

No alcohol should be consumed while taking Olanzin, as this medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected, or if the patient plans to become pregnant, the doctor should be consulted before taking this medicine. Olanzin should not be taken by breastfeeding women, as small amounts of olanzapine may pass into breast milk.
In newborns whose mothers took olanzapine in the third trimester of pregnancy (the last three months of pregnancy), the following side effects may occur: trembling, muscle stiffness, and (or) weakness, drowsiness, excitement, breathing difficulties, and feeding problems. If these symptoms are observed in the newborn, the doctor should be contacted.

Driving and using machines

While taking Olanzin, there is a risk of drowsiness. If drowsiness occurs, the patient should not drive or operate machines and should inform their doctor.

Olanzin contains lactose and soy lecithin

If the patient has been previously diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
If the patient is allergic to peanuts or soy, they should not take this medicine.

3. How to take Olanzin

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Olanzin is available in the following doses: 5 mg and 10 mg.
The doctor will decide how many tablets and how long to take Olanzin. The daily dose is from 5 mg to 20 mg of olanzapine. If the symptoms of the disease recur, the doctor should be consulted, but the patient should not stop taking Olanzin unless the doctor decides to do so.
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 medicine is taken with or without food.
Olanzin film-coated tablets should be taken orally. The tablets should be swallowed whole with water.

Taking a higher dose of Olanzin than recommended

In patients who have taken more tablets than they should, 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, seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased breathing rate, choking, high or low blood pressure, and heart rhythm disorders. The doctor should be contacted immediately or the patient should go to the hospital if any of these symptoms occur.
The doctor should be shown the package with the tablets.

Missing a dose of Olanzin

The tablets should be taken as soon as the patient remembers. A double dose should not be taken to make up for the missed dose.

Stopping Olanzin treatment

The patient should not stop taking the medicine, even if they feel better. It is important to take Olanzin for as long as the doctor recommends.
If Olanzin treatment is stopped suddenly, the following symptoms may occur:
sweating, insomnia, trembling, anxiety, or nausea and vomiting. The doctor may recommend gradually reducing the dose of Olanzin before stopping treatment.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzin can cause side effects, although not everybody gets them.
The doctor should be informed 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 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 any of these symptoms are observed, the doctor should be informed 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 (may affect more than 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, the doctor should be informed.
Common side effects (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 glucose and urine levels, increased uric acid and creatine phosphokinase activity in the blood, increased appetite, dizziness, restlessness, tremors, movement disorders (dyskinesias), constipation, dry mouth, weakness, extreme fatigue, water retention causing 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 side effects (may affect up to 1 in 100 people) include:
allergic reactions (e.g., swelling in the mouth and throat, itching, rash), diabetes or worsening of its course, rarely 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 (may affect up to 1 in 1000 people) include:
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 eye color to yellow, muscle disease characterized by unexplained muscle pain and weakness, prolonged and (or) painful erections.
Very rare side effects include severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms include flu-like symptoms with a rash on the face, followed by a widespread rash, high fever, enlarged lymph nodes, increased liver enzyme activity, and increased eosinophil counts.
During Olanzin treatment, elderly patients with dementia may experience: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. In this patient group, several fatal cases have been reported.
In patients with Parkinson's disease, Olanzin may worsen side effects.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Olanzin

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the package. The expiry date refers to the last day of the month stated.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Olanzin contains

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

What Olanzin looks like and what the package contains

Round, biconvex, white film-coated tablets with a diameter of 8 mm, marked with "O1" on one side.
Package sizes:
blister packs: 30 film-coated tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Romania, the country of export:

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer:

Actavis Ltd.
BLB 016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjor ð ur
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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Romanian marketing authorization number: 8205/2015/04

Parallel import authorization number: 112/18 Date of leaflet approval: 09.03.2023

[Information about the trademark]