Olanzin

Leaflet attached to the packaging: patient information

Olanzin, 5 mg, coated tablets

Olanzin, 10 mg, coated tablets

Olanzapine

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 specifically for you. 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Olanzin is and what it is 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 Olanzin is and what it is 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 are agitation 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 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 pressure in the eye).

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 told 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 lost salt 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. As a precaution, in patients over 65 years of age, blood pressure should be monitored.

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 told 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 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 told about:

• Medicines used to treat Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - the dose of Olanzin may need to be changed.

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 is planning to become pregnant, the doctor should be consulted 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 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 machinery and should inform their doctor.

Olanzin contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take Olanzin

This medicine should always be taken as directed by the doctor. If in doubt, the doctor or pharmacist should be consulted. The doctor will decide how many tablets and how long to take Olanzin. The daily dose is 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 coated tablets are 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, 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 disturbances. 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 packaging of 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 a 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 told 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 blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms are observed, the doctor should be consulted 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, anxiety, trembling, movement disorders (dyskinesia), constipation, dry mouth, weakness, extreme fatigue, 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: hypersensitivity (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 previously had seizures (epilepsy), 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 menstruation, 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 disturbances, 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, enlarged lymph nodes, increased liver enzyme activity, and increased eosinophil count. When taking Olanzin, elderly patients with dementia may experience: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and difficulty walking. In this group of patients, 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 or pharmacist should be told. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected 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 carton. The expiry date refers to the last day of the month stated. The medicine should not be stored above 25°C. The medicine should be stored in its original packaging to protect it from light. 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 used. 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 Olanzin coated tablet 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 (tablet 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 coated tablets: white, biconvex, round, coated tablets with a diameter of about 6 mm, with the marking "OL 5" on one side and smooth on the other. 10 mg coated tablets: white, biconvex, round, coated tablets with a diameter of about 8 mm, with the marking "OL 10" on one side and smooth on the other. Pack sizes: blisters: 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 the 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, phone: (22) 345 93 00.

Date of last revision of the leaflet: November 2024