OLANZAPINE TARBIS 5 mg ORALLY DISINTEGRATING TABLETS

2. Before you start taking Olanzapine FLAS Tarbis

Do not take Olanzapine FLAS Tarbis

• if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Olanzapine FLAS Tarbis. 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).

Be careful with Olanzapine FLAS Tarbis

• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine FLAS Tarbis, tell your doctor.
• Very rarely, medicines of this type can cause 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.
• The use of Olanzapine FLAS Tarbis in elderly patients with dementia is not recommended, as it may have serious side effects.

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

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epilepsy
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Blood disorders
• Stroke or lack of blood flow to the brain (transient stroke symptoms).

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

If you or a family member have a history of blood clots, these medicines may be associated with the formation of clots. As a routine precaution, if you are over 65 years old, your doctor may check your blood pressure.

Patients under 18 years old should not take Olanzapine FLAS Tarbis.

Use of other medicines

Only use other medicines at the same time as Olanzapine FLAS Tarbis if your doctor authorizes it. You may feel drowsy if you combine Olanzapine FLAS Tarbis with antidepressants or medicines for anxiety or sleep aids (tranquilizers).

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your dose of Olanzapine FLAS Tarbis.

Please inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription. Especially inform your doctor if you are using medicines to treat Parkinson's disease.

Taking Olanzapine FLAS Tarbis with food and drinks

You should not drink alcohol while taking Olanzapine FLAS Tarbis, as the combination of Olanzapine FLAS Tarbis and alcohol may cause drowsiness.

Pregnancy and breastfeeding

Tell your doctor as soon as possible if you are pregnant or think you may be pregnant. You should not take this medicine during pregnancy unless your doctor recommends it. You should not take this medicine while breastfeeding, as small amounts of Olanzapine FLAS Tarbis may pass into breast milk.

Newborns of mothers who have used Olanzapine in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding problems. If your newborn experiences any of these symptoms, contact your doctor.

Driving and using machines

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

Important information about some of the ingredients of Olanzapine FLAS Tarbis

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

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Olanzapine FLAS Tarbis

Follow the administration instructions of Olanzapine FLAS Tarbis indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The tablets of Olanzapine FLAS Tarbis should be taken once a day, following the instructions of your doctor. Try to take the tablets at the same time every day. You can take them with or without food. The tablets of Olanzapine FLAS Tarbis are for oral administration.

The orodispersible tablets of Olanzapine FLAS Tarbis dissolve easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

Separate the aluminum foil from a blister and carefully remove the orodispersible tablet of Olanzapine FLAS Tarbis.

Place the tablet in your mouth. It will dissolve directly in your mouth, making it easy to swallow.

If you take more Olanzapine FLAS Tarbis than you should

Patient who have taken more Olanzapine FLAS Tarbis 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, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the package with the tablets.

If you forget to take Olanzapine FLAS Tarbis

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 FLAS Tarbis

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

If you stop taking Olanzapine FLAS Tarbis 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olanzapine FLAS Tarbis can cause side effects, although not everybody gets them.

Very common side effects: affecting 1 in 10 patients

• Weight gain.
• Drowsiness.
• Increased prolactin levels in blood.

Common side effects: affecting 1 to 10 in 100 patients

• Changes in levels of some blood cells and circulating lipids.
• Increased blood sugar and urine levels.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremors.
• Muscle stiffness or spasms (including eye movements).
• Language disorders.
• Unusual movements (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Excessive fatigue.
• Fluid retention that causes swelling of the hands, ankles, or feet.
• In the early stages of treatment, some people experience dizziness or fainting (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually disappears on its own, but if it does not, inform your doctor.
• Sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects: affecting 1 to 10 in 1,000 patients

• Slow pulse.
• Sensitivity to sunlight.
• Urinary incontinence.
• Hair loss.
• Absence or decrease of menstrual periods.
• Changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.
• Restless legs syndrome
• Excessive salivation

Other possible side effects: frequency cannot be estimated from available data

• Allergic reaction (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.
• Decrease in body temperature.
• Seizures, in most cases related to a history of seizures (epilepsy).
• Combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness.
• Muscle spasms in the eye muscles causing circular movements of the eyes.
• Abnormal heart rhythm.
• Sudden unexplained death.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to your doctor immediately. 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 manifests as unexplained pain.
• Difficulty urinating.
• Prolonged and/or painful erection.

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).

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 walking problems. Some deaths have been reported in this particular group of patients.

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

Rarely, women who take medicines of this type for a long time may experience milk secretion from the mammary gland, cessation of menstruation, or irregular menstruation. If this situation persists, consult your doctor. Very rarely, babies of mothers who have taken Olanzapine FLAS Tarbis in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

If you experience any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Olanzapine FLAS Tarbis

Keep out of the reach and sight of children.

Do not use Olanzapine FLAS Tarbis after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicinal products in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicinal products. By doing so, you will help protect the environment.

6. Package contents and further information

Composition of Olanzapine FLAS Tarbis 5 mg

The active ingredient is olanzapine. Each orodispersible tablet of Olanzapine FLAS Tarbis contains 5 mg of active ingredient.

The other ingredients are lactose monohydrate, calcium silicate, low-substituted hydroxypropyl cellulose, crospovidone, aspartame, orange flavor, banana flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance of Olanzapine FLAS Tarbis 5 mg and package contents

Olanzapine FLAS Tarbis 5 mg orodispersible tablets are yellow.

Olanzapine FLAS Tarbis 5 mg orodispersible tablets are available in packages of 28 tablets.

Other presentations:

Olanzapine FLAS Tarbis 10 mg orodispersible tablets: packages of 28 and 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

Sant Joan Despi (Barcelona) 08970 Spain

This leaflet was revised in June 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.