Olanzapine Teva 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olanzapina Teva 2.5 mg film-coated tablets EFG

Olanzapina Teva 5 mg film-coated tablets EFG

Olanzapina Teva 7.5 mg film-coated tablets EFG

Olanzapina Teva 10 mg film-coated tablets EFG

Olanzapina Teva 15 mg film-coated tablets EFG

Olanzapina Teva 20 mg film-coated tablets EFG

olanzapine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Olanzapina Teva is and what it is used for
2. What you need to know before taking Olanzapina Teva
3. How to take Olanzapina Teva
4. Possible side effects
5. How to store Olanzapina Teva
6. Contents of the pack and other information

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

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

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing unreal things, false beliefs, unusual suspiciousness, and becoming withdrawn. People with this condition may also feel depressed, anxious, or tense.

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

Olanzapina 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 to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may present as 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

Talk to your doctor or pharmacist before taking Olanzapine Teva.

• The use of Olanzapine Teva is not recommended in elderly patients with dementia, as it may cause serious adverse effects.

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapine Teva, inform your doctor.

• Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental status changes such as confusion or extreme drowsiness. If this happens, contact your doctor immediately.

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

• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapine Teva. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting treatment with Olanzapine Teva and regularly during treatment.

• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or “mini” stroke (transient ischemic attack – temporary 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 body salts due to prolonged severe diarrhea or vomiting, or due to the use of diuretic medicines (water tablets)

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

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Children and adolescents

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

Other medicines and Olanzapine Teva

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

Only use other medicines together with Olanzapine Teva if your doctor has authorized it. You may experience increased drowsiness if Olanzapine Teva is taken with antidepressants or medicines for anxiety or sleep (tranquilizers).

Specifically, tell your doctor if you are taking:

• Medicines 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 adjusted.

Alcohol and Olanzapine Teva

Do not drink alcohol while taking Olanzapine Teva, as it may cause drowsiness when combined with alcohol.

Pregnancy and breastfeeding

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

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

The following symptoms may occur in newborns of mothers who have taken Olanzapine Teva during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing 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 while taking Olanzapine Teva. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapine Teva contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Olanzapine Teva

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, 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 between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapine Teva unless your doctor tells you to.

You should take your Olanzapine Teva tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food. Olanzapine Teva tablets are for oral administration. Swallow the tablets whole with water.

If you take more Olanzapine Teva than you should

Patients who have taken more Olanzapine Teva than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the symptoms listed above. Show the doctor the pack and 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 simply because you feel better. It is very important that you continue taking Olanzapine Teva for as long as your doctor advises.

If you stop taking Olanzapine Teva suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Contact your doctor immediately if you experience:

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

Very common adverse effects (may affect more than 1 in 10 people) include weight gain, drowsiness, and increased levels of prolactin in the blood. During the initial stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when getting up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, temporary increases in liver enzymes at the beginning of treatment, increased levels of blood and urine sugar; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; weakness; excessive tiredness; fluid retention causing swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunction such as decreased libido in men.

Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases are 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 reduction of menstrual periods; and changes in the mammary gland in both men and women such as abnormal production of breast milk or abnormal growth.

Rare adverse effects (may affect up to 1 in 1,000 people) include decreased body temperature; abnormal heart rhythm; sudden unexplained death; blood clots such as deep vein thrombosis in the legs and blood clots in the lung; inflammation of the pancreas, causing severe stomach pain, fever and malaise; liver disease, with yellowing of the skin and whites of the eyes; a muscle disorder presenting as unexplained muscle pains; and prolonged and/or painful erection.

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, skin rash starting on the face and spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular patient group.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Teva

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

Do not use this medicine after the expiry date which is stated on the cardboard package after "EXP". The expiry date refers to 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 unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Teva

• The active substance is olanzapine.

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

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

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

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

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

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

• The other components are:

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

Tablet coating: hypromellose, polydextrose, glyceryl triacetate, polyethylene glycol 8000, titanium dioxide (E171). In addition, the 15 mg strength contains indigo carmine (E132) and the 20 mg strength contains red iron oxide (E172).

Nature of the product and contents of the pack

Olanzapine Teva 2.5 mg film-coated tablets are film-coated, white, biconvex, round tablets, marked “OL 2.5” on one side and smooth on the other.

Olanzapine Teva 5 mg film-coated tablets are film-coated, white, biconvex, round tablets, marked “OL 5” on one side and smooth on the other.

Olanzapine Teva 7.5 mg film-coated tablets are film-coated, white, biconvex, round tablets, marked “OL 7.5” on one side and smooth on the other.

Olanzapine Teva 10 mg film-coated tablets are film-coated, white, biconvex, round tablets, marked “OL 10” on one side and smooth on the other.

Olanzapine Teva 15 mg film-coated tablets are film-coated, light blue, biconvex, oval tablets, marked “OL 15” on one side and smooth on the other.

Olanzapine Teva 20 mg film-coated tablets are film-coated, pink, biconvex, oval tablets, marked “OL 20” on one side and smooth on the other.

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Co. Ltd

Pallagi út 13

4042 Debrecen

Hungary

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: <{MM/YYYY}><{month YYYY}>.

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