PATIENT INFORMATION LEAFLET

Olanzapine Combix 2.5 mg Film-Coated Tablets

Olanzapine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

Olanzapina Combix belongs to a group of medications known as antipsychotics.

Olanzapina Combix is indicated for treating a condition characterized by symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, and becoming withdrawn. People suffering from these conditions may also experience depression, anxiety, or tension.

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

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).

Warnings and precautions

• 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 serious adverse effects.

If you have any of the following conditions, 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 stroke or transient 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.

Olanzapina Combix interactions with 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 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, even those purchased without a prescription. Inform your doctor especially if you are using medication for Parkinson's disease.

Olanzapina Combix with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not take this medication while breastfeeding as small amounts of Olanzapina Combix may pass into breast milk.

Driving and operating machinery

Olanzapina Combix may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. These effects, as well as the underlying condition, 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.

Olanzapina Combix contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him 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 tablets of Olanzapina Combix 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.

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. 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 heart rate, 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 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 medications, 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 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 mammary gland, stop menstruating, or have irregular periods. If this 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 not listed 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.

No special storage conditions are required.

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

Composition of Olanzapina Combix

The active ingredient is olanzapine. Each Olanzapina Combix tablet contains 2.5 mg of olanzapine.

The other components 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 content of the container

Olanzapina Combix 2.5 mg tablets arefilm-coated tablets of white or almost white color, round, biconvex, with the mark “ZF28” on one face and smooth on the other.

Olanzapina Combix 2.5 mg is presented in containers containing 28 film-coated tablets.

Olanzapina Combix is also available in tablets of 5, 7.5 mg, and 10 mg in containers containing28 and 56 film-coated tablets.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

Zac Les Hautes Pâtures

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