PATIENT INFORMATION LEAFLET

Olanzapina Combix 7.5 mg Film-Coated Tablets

Olanzapine

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Olanzapina Combix belongs to a group of medicines called antipsychotics.

Olanzapina Combix is indicated for treating a disease whose symptoms include hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious, or tense.

Olanzapina Combix is used to treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme variations in mood.

Do not take Olanzapina Combix

• If you are allergic (hypersensitive) to olanzapine or any of the other components of Olanzapina Combix. 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).

Be especially careful with Olanzapina Combix

• If you or a family member has a history of blood clots, these medications may be associated with their formation.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Combix, tell your doctor.
• In 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, contact your doctor immediately.

The use of Olanzapina Combix in elderly patients with dementia is not recommended as it may have severe adverse effects.

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

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

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

Patients under 18 years old should not take Olanzapina Combix.

Use of other medications

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 to help sleep (tranquilizers).

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

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased 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. Do not take this medication during pregnancy unless your doctor recommends it. Do not take this medication while breastfeeding as small amounts of Olanzapina Combix may pass into breast milk.

Newborn babies 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 difficulties. If your newborn baby experiences any of these symptoms, contact your doctor.

Driving and operating machinery

Olanzapina Combix may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Important information about some of the components of Olanzapina Combix

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

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

Your doctor will tell you how many Olanzapina Combix tablets to 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.

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. Swallow the Olanzapina Combix tablets whole with water.

If you take more Olanzapina Combix than you should

Patients 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 rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the packaging 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 the missed dose.

If you interrupt treatment with Olanzapina Combix

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

If you stop taking Olanzapina Combix 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 product, ask your doctor or pharmacist.

Like all medicines, Olanzapina Combix may cause side effects, although not everyone will experience them.

Very common side effects: affecting 1 in 10 patients

Common side effects: affecting between 1 and 10 in every 100 patients

This sensation usually disappears on its own, but if it does not, inform your doctor.

Uncommon side effects: affecting between 1 and 10 in every 1,000 patients

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

During treatment with olanzapina, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and walking difficulties. 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 taking this type of medication for a long period may experience milk secretion from the breast gland, stop having their period, or have irregular periods. If this situation persists, consult your doctor. In very rare cases, babies born to mothers who have taken Olanzapina Combix in the last stage of pregnancy (third trimester) may experience tremor, drowsiness, or lethargy.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased eosinophils.

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

Keep out of reach and sight of children.

Do not use Olanzapina Combixafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of through drains or inthe trash. Disposeof the containers and medicines you no longer need at the SIGREcollection pointof the pharmacy. Incase of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Olanzapina Combix

The active ingredient is olanzapine. Each tablet of Olanzapina Combix contains 7.5 mg of olanzapine.

The other components 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 contents of the package

Olanzapina Combix 7.5 mg tablets arefilm-coated tablets of white or almost white color, round, biconvex, with the mark “ZF30” on one face and smooth on the other.

Olanzapina Combix 7.5 mg is presented in packages containing 56 film-coated tablets.

Olanzapina Combix is also available in 5 mg tablets in packages containing 28 film-coated tablets and in 10 mg tablets in packages containing 28 or 56 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the Marketing Authorization

Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid), Spain

Responsible for Manufacturing

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

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/