OLANZAPINE COMBIX 5 mg FILM-COATED TABLETS

2. Before taking Olanzapina Combix

Do not take Olanzapina Combix

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

Be careful with Olanzapina Combix

• If you or a family member have a history of blood clots, these medications may be associated with the formation of clots.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapina Combix, tell your doctor.
• In very rare cases, 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 Olanzapina Combix in elderly patients with dementia is not recommended, as it may have serious side effects.

If you suffer from 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 transient cerebral ischemia (temporary 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 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 Olanzapina Combix.

Use of other medicines

Only use other medicines at the same time as Olanzapina Combix if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Combix with antidepressants or medications 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 Olanzapina Combix.

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

Taking Olanzapina Combix with food and drinks

You should not drink alcohol if you have been given Olanzapina Combix, as the combination of Olanzapina Combix 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 Olanzapina Combix may pass into breast milk.

Newborns of mothers who have used Olanzapina Combix 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

Olanzapina Combix may cause symptoms such as drowsiness, dizziness, or changes in vision, and may 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.

Important information about some of the ingredients of Olanzapina Combix

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.

3. How to take Olanzapina Combix

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

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

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

If you take more Olanzapina Combix than you should

Patient who have taken more Olanzapina Combix 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, drowsiness or lethargy, slowing of respiratory rate, aspiration, increased blood pressure or decreased blood pressure, 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 Olanzapina 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 Olanzapina Combix

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

If you stop taking Olanzapina 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, Olanzapina Combix can cause side effects, although not everyone 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 feeling usually disappears on its own, but if it does not, inform your doctor.

• Sexual dysfunction 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.
• Muscle 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 malaise.
• 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 to your doctor immediately.

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

Olanzapina Combix may worsen symptoms in patients with Parkinson's disease

In rare cases, women who have been taking these types of medications for a long time may secrete milk from the mammary gland, stop having menstrual periods, or have irregular periods. If this situation persists, consult your doctor. In very rare cases, babies of mothers who have taken Olanzapina 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 a possible side effect 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 help provide more information on the safety of this medicine.

5. Storage of Olanzapina Combix

Keep out of the reach and sight of children.

Do not use Olanzapina Combix after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

Store in the original package.

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 at 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. Further information

Composition of Olanzapina Combix

The active ingredient is olanzapine. Each Olanzapina Combix tablet contains 5 mg of olanzapine.

The other ingredients are 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 package contents

Olanzapina Combix 5 mg film-coated tablets are white or almost white, round, biconvex, with the mark "ZF29" on one side and smooth on the other.

Olanzapina Combix 5 mg is available in packages containing 28 film-coated tablets.

Olanzapina Combix is also available in 7.5 mg tablets in packages containing 56 film-coated tablets and in 10 mg tablets in packages containing 28 or 56 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid), Spain

Manufacturer

Zydus France

25, parc d’activités 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 inFebruary 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/