Olanzin

Package Leaflet: Information for the Patient

Olanzin, 5 mg, Film-Coated Tablets

Olanzin, 10 mg, Film-Coated Tablets

Olanzapine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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. Contents of the pack 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, a disease characterized by 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. Patients with this disease may also experience depression, anxiety, or tension;
• Moderate to severe manic episodes, a disease characterized by 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 you are allergic to olanzapine 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 tongue, or difficulty breathing. You should immediately contact your doctor if you experience these symptoms;
• If you have been diagnosed with eye diseases, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Before starting to take Olanzin, you should consult your doctor or pharmacist.

• 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, you should immediately inform your doctor.
• 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, you should immediately contact your doctor.
• In patients taking Olanzin, weight gain has been observed. The patient and 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, your doctor should perform blood tests to determine blood glucose and lipid levels.
• You should tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

You should immediately inform your doctor if you have any of the following diseases:

• Stroke or "mini" stroke (transient stroke symptoms)
• Parkinson's disease
• Prostate problems
• Bowel obstruction (paralytic)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Seizures
• If you know that you may have lost salt due to prolonged, severe diarrhea and vomiting (nausea and vomiting) or the use of diuretics (urinary medicines).

If you have dementia, you or your caregiver or relative should inform your doctor if you have ever had a stroke or "mini" stroke.
Routinely, as a precaution, patients over 65 years of age 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

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Patients 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, you should tell your doctor 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 Olanzin may be necessary.

Olanzin and alcohol

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

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if you think you may be pregnant, or are planning to become pregnant, you should consult your doctor before taking this medicine. Women who are breastfeeding should not take Olanzin, 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, agitation, breathing difficulties, and feeding problems. If you notice any of these symptoms in your newborn, you should contact your doctor.

Driving and using machines

While taking Olanzin, there is a risk of drowsiness. If drowsiness occurs, you should not drive or operate machinery and inform your doctor.

Olanzin contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Olanzin

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Your doctor will decide how many tablets and how long you should take Olanzin. The daily dose is 5 mg to 20 mg of olanzapine. If symptoms of the disease recur, you should consult your doctor, but do not stop taking Olanzin unless your doctor decides to do so.
Tablets should be taken once a day as directed by your doctor. Try to take the medicine at the same time every day.
It does not matter whether you take the medicine with or without food.
Olanzin film-coated tablets are taken orally.
Swallow the tablets 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, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and reduced 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. You should immediately contact your doctor or go to the hospital if you experience any of these symptoms.
Show your doctor the package with the tablets.

Missing a dose of Olanzin

Take the tablets as soon as you remember. Do not take a double dose to make up for the missed dose.

Stopping treatment with Olanzin

Do not stop taking the medicine, even if you feel better. It is important to take Olanzin for as long as your doctor recommends.
If you suddenly stop taking Olanzin, you may experience the following symptoms:
sweating, insomnia, trembling, anxiety, or nausea and vomiting. Your doctor may recommend gradually reducing the dose of Olanzin before stopping treatment.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzin can cause side effects, although not everybody gets them.
You should immediately inform your doctor if you experience:

• 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 you notice any of these symptoms, you should immediately seek medical attention;
• 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, you should inform your doctor.
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 levels in the blood, increased appetite, dizziness, restlessness, trembling, movement disorders (dyskinesias), constipation, dry mouth, rash, fatigue, extreme tiredness, water retention in the body 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, 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, 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 are flu-like with a rash on the face, followed by a widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity, and increased eosinophil counts.
During treatment with Olanzin, elderly patients with dementia may experience: stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, elevated body temperature, redness of the skin, and difficulty walking. 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Olanzin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olanzin contains

• The active substance of Olanzin is olanzapine. Each film-coated tablet of Olanzin contains 5 mg or 10 mg of olanzapine.
• The other ingredients are: (tablet core) lactose monohydrate, hydroxypropyl cellulose, crospovidone Type A, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, and (film coating) titanium dioxide (E 171), polydextrose, hypromellose 3cP, hypromellose 6cP, hypromellose 50cP, triacetin, and macrogol 8000.

What Olanzin looks like and contents of the pack

5 mg film-coated tablets: white, biconvex, round, film-coated tablets with a diameter of about 6 mm, with the marking "OL 5" on one side and smooth on the other side.
10 mg film-coated tablets: white, biconvex, round, film-coated tablets with a diameter of about 8 mm, with the marking "OL 10" on one side and smooth on the other side.
Pack sizes:
blister packs: 14, 28, 30, and 56 tablets.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
H-4042 Debrecen
Hungary

For more information about this medicine and its names in the Member States of the European Economic Area, please contact

the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

Date of last revision of the leaflet: November 2024