OLANZAPINE COMBIX 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapine Combix 10 mg film-coated tablets EFG

Olanzapine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Olanzapine Combix is and what it is used for
2. Before you take Olanzapine Combix
3. How to take Olanzapine Combix
4. Possible side effects
5. Storing Olanzapine Combix
6. Further information

1. What Olanzapine Combix is and what it is used for

Olanzapine Combix belongs to a group of medicines called antipsychotics.

Olanzapine Combix is used to treat a disease with symptoms such as hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with these diseases may also be depressed, tense, or anxious.

Olanzapine Combix is used to treat a disorder characterized by symptoms such as feeling elated, having excessive energy, a decreased need for sleep, talking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the appearance of extreme mood swings.

2. 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).

Be careful with Olanzapine Combix

• If you or a family member have a history of blood clots, these medications can be associated with the formation of clots.
• Medicines of this type can 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 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 Olanzapine Combix.

Using other medicines

Only use other medicines at the same time as Olanzapine Combix if your doctor authorizes it. You may feel drowsy if you combine Olanzapine Combix with antidepressants or medicines for anxiety or to help you sleep (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 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 Olanzapine Combix with food and drinks

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

Newborns of mothers who have used Olanzapine 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

Olanzapine Combix can cause symptoms such as drowsiness, dizziness, or changes in vision, and reduce your reaction ability. These effects, as well as the disease itself, can 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 Olanzapine 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 Olanzapine Combix

Follow your doctor's instructions for taking Olanzapine Combix exactly. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many Olanzapine Combix tablets to take and for how long. The daily dose of Olanzapine Combix ranges from 5 to 20 mg. Consult your doctor if your symptoms return, 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. 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/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 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 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 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 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 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 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.

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 their menstrual period, or have it 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 enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).

Reporting 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. Storing 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.

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 Olanzapine Combix

The active ingredient is olanzapine. Each Olanzapine Combix tablet contains 10 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 and packaging of the product

Olanzapine Combix 10 mg film-coated tablets are white or almost white, round, biconvex, with the mark "ZF31" on one face and smooth on the other.

Olanzapine Combix 10 mg is available in packages containing 28 or 56 film-coated tablets.

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

Not all pack 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/