OLANZAPINE TEVA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Teva 2.5 mg film-coated tablets EFG

Olanzapine Teva 5 mg film-coated tablets EFG

Olanzapine Teva 7.5 mg film-coated tablets EFG

Olanzapine Teva 10 mg film-coated tablets EFG

Olanzapine Teva 15 mg film-coated tablets EFG

Olanzapine Teva 20 mg film-coated tablets EFG

olanzapine

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Olanzapine Teva and what is it used for
2. What you need to know before taking Olanzapine Teva
3. How to take Olanzapine Teva
4. Possible side effects
5. Storage of Olanzapine Teva
6. Package contents and additional information

1. What is Olanzapine Teva and what is it used for

Olanzapine Teva contains the active substance olanzapine. Olanzapine Teva belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases.

• Schizophrenia, a disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed with anxiety or tension.

• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapine Teva has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before taking Olanzapine Teva

Do not take Olanzapine Teva

• if you are allergic to olanzapine or any of the other components of this medication (listed in section 6). The allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
• if you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapine Teva.

• The use of olanzapine Teva is not recommended in elderly patients with dementia, as it may have serious side effects.

• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Teva, tell your doctor.

• Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.

• A weight gain has been observed in patients taking Olanzapine Teva. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.

• High levels of sugar and fat (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapine Teva. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking Olanzapine Teva and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

If you have any of the following diseases, tell your doctor as soon as possible:

• Stroke or "mini" stroke (transient stroke symptoms).
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you think you may have loss of salts due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination tablets)

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years of age should not take Olanzapine Teva.

Other medicines and Olanzapine Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Only use other medicines at the same time as Olanzapine Teva if your doctor authorizes it. You may feel a certain sensation of sleepiness if you combine Olanzapine Teva with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

In particular, tell your doctor if you are taking:

• medication for Parkinson's disease
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Olanzapine Teva may need to be changed.

Use of Olanzapine Teva with alcohol

You should not drink alcohol if you have been given Olanzapine Teva, as it can cause drowsiness when combined with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

You should not take this medication while breastfeeding, as small amounts of Olanzapine Teva may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Olanzapine Teva in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness when taking Olanzapine Teva. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine Teva contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Olanzapine Teva

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapine Teva tablets to take and for how long. The daily dose of Olanzapine Teva ranges from 5 mg to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapine Teva unless your doctor tells you to.

You should take your Olanzapine Teva tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Olanzapine Teva tablets are for oral administration. You should swallow the Olanzapine Teva tablets whole with water.

If you take more Olanzapine Teva than you should

Patient who have taken more Olanzapine Teva than they should have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the tablets.

If you forget to take Olanzapine Teva

Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapine Teva

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Teva while your doctor tells you to.

If you stop taking Olanzapine Teva suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medication can cause side effects, although not everyone gets them.

Contact your doctor immediately if you have:

• unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain, and redness in the leg), which can travel through the blood to the lungs,
• causing chest pain and difficulty breathing. If you experience any of these symptoms, go to the doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency cannot be estimated from the available data).

Very common side effects (which can affect more than 1 in 10 people) include weight gain, drowsiness, and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This sensation usually disappears on its own, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment, increased blood sugar and urine levels; increased levels of uric acid and creatine phosphokinase in the blood: increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue, fluid retention that causes swelling of the hands, ankles, or feet: fever; joint pain; and sexual dysfunction such as decreased libido in men.

Uncommon side effects (which can affect up to 1 in 100 people) include hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods; and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rare side effects (which can affect up to 1 in 1,000 people) include a drop in normal body temperature; abnormal heart rhythm, sudden unexplained death; blood clots such as deep vein thrombosis of the legs and blood clots in the lungs; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and the white areas of the eyes; muscle disorder that presents as unexplained pain; and prolonged and/or painful erections.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia).

In elderly patients with dementia, treatment with olanzapine has been associated with stroke, pneumonia, urinary incontinence, falls, excessive fatigue, visual hallucinations, elevated body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapine Teva may worsen symptoms in patients with Parkinson's disease.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olanzapine Teva

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton after "EXP". The expiration date is the last day of the month indicated.

Store below 25°C. Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Olanzapine Teva Composition

• The active ingredient is olanzapine.

Each Olanzapine Teva 2.5 mg film-coated tablet contains 2.5 mg of active ingredient.

Each Olanzapine Teva 5 mg film-coated tablet contains 5 mg of active ingredient.

Each Olanzapine Teva 7.5 mg film-coated tablet contains 7.5 mg of active ingredient.

Each Olanzapine Teva 10 mg film-coated tablet contains 10 mg of active ingredient.

Each Olanzapine Teva 15 mg film-coated tablet contains 15 mg of active ingredient.

Each Olanzapine Teva 20 mg film-coated tablet contains 20 mg of active ingredient.

• The other ingredients are:

Tablet core:lactose monohydrate, hydroxypropylcellulose, crospovidone (type A), colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.

Tablet coating:hypromellose, polydextrose, glycerol triacetate, macrogol 8000, titanium dioxide (E171). The 15 mg dose also contains carmine indigo (E132) and the 20 mg dose contains red iron oxide (E172).

Product Appearance and Package Contents

Olanzapine Teva 2.5 mg film-coated tablets are white, biconvex, round, and engraved with "OL 2.5" on one side and smooth on the other.

Olanzapine Teva 5 mg film-coated tablets are white, biconvex, round, and engraved with "OL 5" on one side and smooth on the other.

Olanzapine Teva 7.5 mg film-coated tablets are white, biconvex, round, and engraved with "OL 7.5" on one side and smooth on the other.

Olanzapine Teva 10 mg film-coated tablets are white, biconvex, round, and engraved with "OL 10" on one side and smooth on the other.

Olanzapine Teva 15 mg film-coated tablets are light blue, biconvex, oval, and engraved with "OL 15" on one side and smooth on the other.

Olanzapine Teva 20 mg film-coated tablets are pink, biconvex, oval, and engraved with "OL 20" on one side and smooth on the other.

Olanzapine Teva 2.5 mg film-coated tablets are available in cardboard boxes of 28, 30, 35, 56, 70, or 98 film-coated tablets.

Olanzapine Teva 5 mg film-coated tablets are available in packages of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98, or 98 x 1 film-coated tablets.

Olanzapine Teva 7.5 mg film-coated tablets are available in packages of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98, or 98 x 1 film-coated tablets.

Olanzapine Teva 10 mg film-coated tablets are available in packages of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98, or 98 x 1 film-coated tablets.

Olanzapine Teva 15 mg film-coated tablets are available in packages of 28, 30, 35, 50, 56, 70, or 98 film-coated tablets.

Olanzapine Teva 20 mg film-coated tablets are available in packages of 28, 30, 35, 56, 70, or 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5 2

031GA Haarlem

Netherlands

Manufacturer

Teva Pharmaceutical Works Co. Ltd

Pallagi út 13

4042 Debrecen

Hungary

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of the last revision of this leaflet: <{MM/AAAA}><{month AAAA}>.

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/.