OLANZAPINE COMBIX 2.5 mg FILM-COATED TABLETS

2. What you need to know before you take Olanzapine Combix

Do not take Olanzapine Combix

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

Warnings and precautions

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Combix, 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.

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

If you suffer from any of the following diseases, inform 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 transient cerebral ischemia (temporary stroke symptoms).

If you suffer from dementia, you or your caregiver or relative must inform your doctor if you have ever had a stroke or cerebral ischemia.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Patients under 18 years old should not take Olanzapine Combix.

Interaction of Olanzapine Combix with other medicines

Only use other medicines at the same time as Olanzapine Combix if your doctor authorizes it. You may feel a certain sensation of drowsiness if you combine Olanzapine Combix with antidepressants or medicines for anxiety or that help you sleep (tranquilizers).

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

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription. Inform your doctor especially if you are using medication for Parkinson's disease.

Olanzapine Combix with food, drink, and alcohol

You should not drink alcohol if you have been administered Olanzapine Combix because the combination of Olanzapine Combix and alcohol may cause drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You should not take this medicine while breastfeeding, as small amounts of Olanzapine Combix may pass into breast milk.

Driving and using machines

Olanzapine Combix may cause symptoms such as drowsiness, dizziness, or changes in vision, and decrease your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

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

3. How to take Olanzapine Combix

Follow exactly the administration instructions of Olanzapine Combix indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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

You should take your Olanzapine Combix tablets 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. The Olanzapine Combix tablets are for oral administration. You should swallow the Olanzapine Combix tablets whole with water.

If you take more Olanzapine Combix than you should

Patient who have taken more Olanzapine Combix 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 be: acute confusion, convulsions (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go immediately to the hospital. Show the doctor the package with the tablets.

If you forget to take Olanzapine Combix

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 Combix

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

If you stop taking Olanzapine Combix 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 Combix 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 the blood.

Common side effects: affecting 1 to 10 in 100 patients

• Changes in the 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 sensation usually disappears spontaneously, 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 normal 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.
• Spasms in the eye muscles causing circular movements of the eyes.
• 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.
• Difficulty urinating.
• Prolonged and/or painful erection.
• 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 immediately to your doctor.

During treatment with olanzapine, elderly patients with dementia may suffer from 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 Combix may worsen symptoms in patients with Parkinson's disease

In rare cases, women who have been taking this type of medication for a long time may secrete milk from the mammary gland, stop having menstrual periods, or have them irregularly. If this situation persists, consult your doctor. In very rare cases, babies of mothers who have taken Olanzapine Combix in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

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).

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 them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Olanzapine Combix

Keep out of the reach and sight of children.

Do not use Olanzapine Combix 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 packages and medicines you no longer need in the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Combix

The active substance is olanzapine. Each Olanzapine Combix tablet contains 2.5 mg of olanzapine.

The other ingredients are: ? Tablet core: lactose monohydrate, crospovidone, hypromellose (E-464), magnesium stearate. ? Coating agent: polyvinyl alcohol, titanium dioxide (E-171), talc, soy lecithin (E-322), xanthan gum (E-415).

Appearance of the product and contents of the pack

The Olanzapine Combix 2.5 mg tablets are film-coated tablets of white or almost white color, round, biconvex, with the mark "ZF28" on one face and smooth on the other.

Olanzapine Combix 2.5 mg is available in packages containing 28 film-coated tablets.

Olanzapine Combix is also available in 5, 7.5, and 10 mg tablets in packages containing 28 and 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

Zac Les Hautes Pâturages

Parc d’Activités des Pleupliers

25 rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

This leaflet was revised in February 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/