OLANZAPINE TEVA 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Teva 5mg orodispersible tablets EFG

Olanzapine Teva 10mg orodispersible tablets EFG

Olanzapine Teva 15mg orodispersible tablets EFG

Olanzapine Teva 20mg orodispersible tablets EFG

olanzapine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Olanzapine Teva contains the active substance olanzapine. Olanzapine Teva belongs to a group of medicines called antipsychotics and is used to treat the following conditions.

• Schizophrenia, a disease with symptoms such as hearing, seeing or feeling things that are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with these diseases may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, 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 you take Olanzapine Teva

Do not take Olanzapine Teva

• if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). The allergic reaction can 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 been previously 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.

• Olanzapine Teva is not recommended for use 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 fats (triglycerides and cholesterol) have been observed in the blood of patients taking Olanzapine Teva. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine Teva and regularly during treatment.
• If you or a family member have a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

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

• Stroke or "mini" stroke (transient symptoms of stroke).
• 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 might take any other medicines.

Only use other medicines at the same time as Olanzapine Teva if your doctor authorizes it. You may feel drowsy 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 because, together with alcohol, it can cause drowsiness.

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 medicine.

You should not take this medicine when you are breastfeeding because small amounts of Olanzapine Teva can 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, 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 when taking Olanzapine Teva. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine Teva contains lactose, sucrose, and aspartame

This medicine contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 2.25 mg/4.5 mg/6.75 mg/9 mg of aspartame in each 5 mg/10 mg/15 mg/20 mg orodispersible tablet. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Olanzapine Teva

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapine Teva tablets you should 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.

Olanzapine Teva tablets should be taken 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 orodispersible tablets are for oral administration.

Olanzapine Teva tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands because they can crumble. Place your tablet in your mouth. It will dissolve directly in your mouth, so you can chew it easily.

You can also put the tablet in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, stirring. With some beverages, the mixture may change color and appear cloudy. You should drink it immediately.

If you take more Olanzapine Teva than you should

Patients who have taken more Olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, 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, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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, see a 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 feeling usually goes away on its own, but if it doesn't, 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 uric acid and creatine phosphokinase levels 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 dysfunctions such as decreased libido in men and women or erectile dysfunction 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 parts 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 initially manifests 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 may cause stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, redness of the skin, 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, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects 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 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 carton after "EXP". The expiry date is the last day of the month stated.

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. Package Contents and Additional Information

Olanzapina Teva Composition

• The active ingredient is olanzapine.

Each 5 mg Olanzapina Teva orodispersible tablet contains 5 mg of active ingredient.

Each 10 mg Olanzapina Teva orodispersible tablet contains 10 mg of active ingredient.

Each 15 mg Olanzapina Teva orodispersible tablet contains 15 mg of active ingredient.

Each 20 mg Olanzapina Teva orodispersible tablet contains 20 mg of active ingredient.

• The other ingredients are mannitol, aspartame (E951), magnesium stearate, crospovidone type B, lactose monohydrate, hydroxypropylcellulose, and lemon flavor [flavoring preparation(s), maltodextrin, sucrose, gum arabic (E414), glycerol triacetate (E1518), and alpha-tocopherol (E307)].

Product Appearance and Package Contents

Orodispersible tablets are the technical name for a tablet that dissolves directly in the mouth to make it easier to swallow.

The 5 mg Olanzapina Teva orodispersible tablets are yellow, round, and biconvex, with a diameter of 8 mm.

The 10 mg Olanzapina Teva orodispersible tablets are yellow, round, and biconvex, with a diameter of 10 mm.

The 15 mg Olanzapina Teva orodispersible tablets are yellow, round, and biconvex, with a diameter of 11 mm.

The 20 mg Olanzapina Teva orodispersible tablets are yellow, round, and biconvex, with a diameter of 12 mm.

The cardboard boxes of Olanzapina Teva 5 mg, 10 mg, and 15 mg orodispersible tablets contain 28, 30, 35, 50, 56, 70, or 98 tablets.

The packages of Olanzapina Teva 20 mg orodispersible tablets contain 28, 30, 35, 56, 70, or 98 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer

Teva Pharmaceutical Works Co. Ltd

Pallagi út 13

4042 Debrecen

Hungary

TEVA PHARMA S.L.U.

Poligono Industrial Malpica, c/C, no. 4

50.016 Zaragoza

Spain

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:<{MM/AAAA}><{month AAAA}>.

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