Leaflet: information for the user

Olanzapina Teva 5 mg buccal dispersible tablets EFG

Olanzapina Teva 10 mg buccal dispersible tablets EFG

Olanzapina Teva 15 mg buccal dispersible tablets EFG

Olanzapina Teva 20 mg buccal dispersible tablets EFG

olanzapina

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it 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 not listed in this leaflet. See section 4.

Olanzapina Teva contains the active ingredient Olanzapina. Olanzapina 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a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed with anxiety or tension.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

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

Do not take Olanzapina Teva

• if you are allergic to olanzapina or any of the other ingredients of this medication (listed in section 6). An allergic reaction may manifest as a 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 eye pressure).

Warnings and precautions

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

• Olanzapina Teva is not recommended for elderly patients with dementia as it may have serious adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Teva, tell your doctor.
• In rare cases, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Teva. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or refer you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Teva. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina Teva and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medications 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 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 electrolyte loss due to prolonged diarrhea and vomiting or the use of diuretic medications (water pills).

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or cerebral hypoperfusion.

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 old should not take Olanzapina Teva.

Other medications and Olanzapina Teva

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

Only use other medications at the same time as Olanzapina Teva if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Teva with antidepressants or medications for anxiety or sleep (tranquilizers).

Specifically, 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). You may need to adjust your Olanzapina Teva dosage.

Use of Olanzapina Teva with alcohol

You should not drink alcohol if you have been administered Olanzapina Teva, as it may cause drowsiness when combined with alcohol.

Pregnancy and breastfeeding

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

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

The following symptoms may occur in newborns of mothers who used Olanzapina 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 experiences any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of drowsiness when taking Olanzapina Teva. If this occurs, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapina Teva contains lactose, sucrose, and aspartame

This medication contains lactose and sucrose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains 2.25 mg/4.5 mg/6.75 mg/9 mg of aspartame in each 5 mg/10 mg/15 mg/20 mg buccal dispersible tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to properly eliminate it.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 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 buccal tablets are for oral administration.

Olanzapine Teva tablets disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate. Place your tablet in your mouth. It will dissolve directly in your mouth, making it easy to chew.

You can also pour the tablet into a glass or cup filled with water, orange juice, apple juice, milk, or coffee, stirring it. With some drinks, the mixture may change color and become 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/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the packaging with the tablets to your doctor.

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 the missed dose.

If you interrupt treatment with Olanzapine Teva

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

If you stop taking Olanzapine Teva suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor 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 (a rare 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, seek immediate medical attention.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data).

Frequent side effects (which can 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 getting up from a lying or sitting position. This sensation usually disappears spontaneously, 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 at the beginning of treatment, temporary increases in liver enzymes; increased levels of blood sugar and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; tremor; strange movements (dyskinesia): constipation, dry mouth; skin rash; loss of strength; excessive fatigue, fluid retention causing inflammation 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.

Rare 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 the blood and urine) or coma, seizures, in most cases related to a history of seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless leg syndrome; speech problems, stuttering, slow pulse; sensitivity to sunlight; nasal bleeding, 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 breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (which can affect up to 1 in 1000 people) include a decrease in normal body temperature;, abnormal heart rhythm, sudden death without apparent explanation; blood clots such as deep vein thrombosis of the legs and blood clots in the lung;, pancreatitis, which causes severe stomach pain, fever, and discomfort;, liver disease, with yellowing of the skin and white areas of the eye;, muscle disorder that presents as unexplained pain; and, prolonged and/or painful erection.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) DRESS initially manifests with symptoms similar to the flu, with skin rash on the face that then spreads to other areas, fever, lymph node swelling, 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, a rise in body temperature, skin redness, and difficulty walking. 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton box after “EXP”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Olanzapina Teva

• The active ingredient is olanzapina.

Each buccal dispersible tablet of Olanzapina Teva 5 mg contains 5 mg of active ingredient.

Each buccal dispersible tablet of Olanzapina Teva 10 mg contains 10 mg of active ingredient.

Each buccal dispersible tablet of Olanzapina Teva 15 mg contains 15 mg of active ingredient.

Each buccal dispersible tablet of Olanzapina Teva 20 mg contains 20 mg of active ingredient.

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

Appearance of the product and contents of the package

Buccal dispersible tablets are the technical name for tablets that dissolve directly in the mouth to be swallowed more easily.

Olanzapina Teva 5 mg buccal dispersible tablets are yellow, round, biconvex, 8 mm in diameter.

Olanzapina Teva 10 mg buccal dispersible tablets are yellow, round, biconvex, 10 mm in diameter.

Olanzapina Teva 15 mg buccal dispersible tablets are yellow, round, biconvex, 11 mm in diameter.

Olanzapina Teva 20 mg buccal dispersible tablets are yellow, round, biconvex, 12 mm in diameter.

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

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

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:

Last review date of this leaflet:<{MM/AAAA}><{mes AAAA}>.

More detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu/.