Olanzapine Teva 20 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olanzapina Teva 5mg orodispersible tablets EFG

Olanzapina Teva 10mg orodispersible tablets EFG

Olanzapina Teva 15mg orodispersible tablets EFG

Olanzapina Teva 20mg orodispersible tablets EFG

olanzapine

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

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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 things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.
• Moderate to severe manic episode, 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 starting 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 manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, 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 starting Olanzapine Teva.

• 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 confusion or drowsiness. If you experience this, 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 dietitian.

• 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 you start taking 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 use of diuretic medicines (water 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 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

Inform 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 authorizes it. You may feel drowsy if Olanzapine Teva is combined 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.

Use of Olanzapine Teva with alcohol

You must 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 might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

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

The following symptoms may occur in newborns whose mothers have used Olanzapine Teva during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor immediately.

Driving and using machines

There is a risk of drowsiness when taking Olanzapine Teva. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapine Teva contains lactose, sucrose, and aspartame

This medicine contains lactose and sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him or her 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, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Olanzapine Teva

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, 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 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.

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

Olanzapine Teva tablets crumble easily and should therefore be handled with care. Do not handle the tablets with wet hands, as they may disintegrate. Place your tablet in the mouth. It will dissolve directly in the mouth and can be chewed easily.

Alternatively, the tablet may be placed in a glass or cup containing water, orange juice, apple juice, milk, or coffee, and stirred. With some drinks, the mixture may change color and become cloudy. The mixture should be drunk immediately.

If you take more Olanzapine Teva than you should

Patients who have taken more Olanzapine than prescribed 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 rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the container 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 for as long as your doctor tells you to.

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 everyone will experience 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 attention immediately.
• a combination of fever, rapid breathing, sweating, muscle rigidity, and mental confusion or drowsiness (frequency cannot be estimated from available data).

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

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

Uncommon adverse effects (which may affect up to 1 in 100 people) include hypersensitivity (e.g. mouth and throat swelling, itching, skin rash), diabetes or worsening of existing diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, mostly in patients with a history of seizures (epilepsy); muscle rigidity 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; inability to urinate; hair loss; absence or reduced menstrual periods; and changes in the breast gland in both men and women such as abnormal milk production or abnormal breast growth.

Rare adverse effects (which may affect up to 1 in 1,000 people) include decreased normal body temperature; abnormal heart rhythm; sudden unexplained death; blood clots such as deep vein thrombosis in the legs and pulmonary embolism; inflammation of the pancreas, causing severe stomach pain, fever and malaise; liver disease, with yellowing of the skin and whites of the eyes; muscle disorder presenting as unexplained muscle pain; 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, a facial skin rash that spreads 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.

Olanzapine 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 listed 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 stated on the cardboard carton after "EXP". The expiry date refers to the last day of the month indicated.

Store 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 any packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Teva

• The active substance is olanzapine.

Each Olanzapine Teva 5 mg orodispersible tablet contains 5 mg of active substance.

Each Olanzapine Teva 10 mg orodispersible tablet contains 10 mg of active substance.

Each Olanzapine Teva 15 mg orodispersible tablet contains 15 mg of active substance.

Each Olanzapine Teva 20 mg orodispersible tablet contains 20 mg of active substance.

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

Nature of the product and pack contents

Orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth, making it easier to swallow.

Olanzapine Teva 5 mg orodispersible tablets are yellow, round, biconvex, 8 mm in diameter.

Olanzapine Teva 10 mg orodispersible tablets are yellow, round, biconvex, 10 mm in diameter.

Olanzapine Teva 15 mg orodispersible tablets are yellow, round, biconvex, 11 mm in diameter.

Olanzapine Teva 20 mg orodispersible tablets are yellow, round, biconvex, 12 mm in diameter.

Carton packs of Olanzapine Teva 5 mg, 10 mg and 15 mg orodispersible tablets contain 28, 30, 35, 50, 56, 70 or 98 tablets.

Packs of Olanzapine Teva 20 mg orodispersible tablets contain 28, 30, 35, 56, 70 or 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031GA Haarlem

The 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

The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

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