OLANZAPINE COMBIX 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Olanzapina Combix 5 mg orodispersible tablets EFG

Olanzapine

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Contents of the leaflet

1. What Olanzapina Combix is and what it is used for
2. What you need to know before taking Olanzapina Combix
3. How to take Olanzapina Combix
4. Possible side effects
5. Storage of Olanzapina Combix
6. Package contents and additional information

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

Olanzapina Combix belongs to a group of medications called antipsychotics.

Olanzapina Combix is used to treat:

• A disease with symptoms such as hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and a tendency to withdraw. People suffering from this disease may also be depressed, anxious, or tense.

• A disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, talking very quickly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer, preventing the appearance of extreme mood variations (euphoria and depression) associated with this condition.

2. What you need to know before taking Olanzapina Combix

Do not take Olanzapina Combix:

• if you are allergic(hypersensitive) to the active ingredient olanzapine or to any of the other components of Olanzapina Combix (listed in section 6). An allergic reaction can occur in the form of a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you after taking Olanzapina Combix, inform your doctor.
• if you have previously been diagnosed with narrow-angle glaucoma(a disease in which the pressure inside the eye increases).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Combix.

If you or a family member has a history of blood clots, these medications may be associated with the formation of clots.

Medications of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapina Combix, inform your doctor.

Very rarely, medications of this type can produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of drowsiness or somnolence. If this happens to you, stop treatment and inform your doctor immediately.

Inform your doctor if you suffer from any of the following diseases:

• Diabetes
• Heart diseases
• Liver diseases
• Kidney diseases
• Parkinson's disease
• Epilepsy (seizures)
• Prostate problems
• Paralytic ileus (intestinal blockage)
• Blood disorders
• Stroke or transient cerebral ischemia

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

Children and adolescents under 18 years

Patients under 18 years should not take Olanzapina Combix.

Elderly patients

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

If you are over 65 years old, it is advisable, as a precaution, that your doctor monitors your blood pressure.

Interaction of Olanzapina Combix with other medications

Inform your doctor or pharmacist if you are using or have recently used or may need to take any other medication.

Do not take other medications at the same time as Olanzapina Combix, unless your doctor authorizes it.

Inform your doctor if you are taking medication for Parkinson's disease, as Olanzapina Combix may worsen symptoms.

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

You may feel drowsy if you take Olanzapina Combix with antidepressants or tranquilizers.

Olanzapina Combix with food, drinks, and alcohol

Olanzapina Combix can be taken with or without food.

Do not drink alcoholic beverages during treatment with Olanzapina Combix, as the combination of both can cause drowsiness.

Pregnancy and breastfeeding

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 medication.

Do not take Olanzapina Combix during pregnancy, unless your doctor recommends it.

Newborns of mothers who have used Olanzapina Combix in the last trimester of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn presents with any of these symptoms, contact your doctor.

Do not take Olanzapina Combix during breastfeeding, as small amounts of olanzapine may pass into breast milk.

Driving and using machines

Olanzapina may cause symptoms such as drowsiness, dizziness, or changes in vision, and reduce reaction capacity. These effects, as well as the disease itself, may impair your ability 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 medication.

Important information about some of the components of Olanzapina Combix

Olanzapina Combix contains aspartame. This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Olanzapina Combix

Follow your doctor's instructions for taking Olanzapina Combix exactly. If in doubt, consult your doctor or pharmacist again.

The recommended daily dose ranges from 5 to 20 mg. Inform your doctor if you experience symptoms again, but do not stop taking Olanzapina Combix unless your doctor has indicated it.

Take the tablets once a day (with or without food). Try to take them at the same time every day.

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

The orodispersible tablets of Olanzapina Combix are very delicate, so they should be handled with care. Do not handle the tablets with wet handsbecause they may dissolve.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently along the perforations that surround it.

1. Gently remove the back of the cell.

1. Carefully remove the tablet.

1. Place the tablet in your mouth. It will dissolve directly in your mouth, making it easy to swallow.

If you prefer, you can put the tablet in a cup or glass of water, orange juice, apple juice, milk, or coffee, stirring it. Some beverages may change color and appear cloudy. It should be drunk immediately.

If you take more Olanzapina Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

The symptoms of poisoning can be: rapid heartbeats, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and a reduced level of consciousness. Other symptoms can be: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy, slowing of respiratory frequency, aspiration, increased or decreased blood pressure, and abnormal heart rhythms.

If you forget to take Olanzapina Combix

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, continue treatment with the normal dose.

If you interrupt treatment with Olanzapina Combix

Do not interrupt treatment without consulting your doctor first, even if you feel better. Treatment interruption should be done gradually and always following your doctor's instructions.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Olanzapina Combix can cause side effects, although not everyone experiences them.

In this leaflet, when a side effect is defined as "rare", it means that it has been reported in more than 1 in 10,000 patients, but in less than 1 in 1,000.

When a side effect is defined as "very rare", it means that it has been reported in less than 1 in 10,000 patients.

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.

The side effects of olanzapine can be drowsiness or excessive fatigue, weight gain, dizziness, increased appetite, fluid retention, constipation, dry mouth, agitation, unusual movements (especially of the face or tongue), tremors, muscle stiffness or spasms, restless legs syndrome, language alterations, and changes in the levels of some blood cells and circulating fats. In some patients, pancreatitis has developed very rarely, causing severe stomach pain, fever, and malaise.

Some people experience dizziness or fainting (with slower heartbeats) in the early stages of treatment, especially when getting up from a lying or sitting position. This sensation usually disappears spontaneously, but if it does not, inform your doctor.

Very rare cases of patients with abnormal heart rhythms have been reported, which can be serious.

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

Olanzapine may worsen symptoms in patients with Parkinson's disease.

Rarely, olanzapine can cause an allergic reaction (e.g., inflammation of the mouth and throat, itching, rash), slow heart rate, or sensitivity to sunlight. Liver disease has also been reported rarely. Very rare cases of prolonged and/or painful erections or difficulty urinating, decreased body temperature, blood clots (e.g., deep vein thrombosis of the legs), or muscle disorders (presenting as unexplained pain) have been reported. Some patients have experienced high blood sugar levels or initial symptoms of diabetes worsening, with ketoacidosis (acetone in blood and urine) or coma.

Rarely, women taking medications of this type for a long time may experience milk secretion from the mammary gland, stop having their menstrual period, or have it irregularly. If this situation persists, consult your doctor.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to those of the flu, with a rash on the face that 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).

Very rarely, babies of mothers who have taken olanzapine in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

Seizures can occur rarely. In most cases, there were pre-existing seizure disorders (epilepsy).

Uncommon side effect: excessive salivation.

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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Olanzapina Combix

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging, after the EXP date. The expiration date is the last day of the month indicated.

Do not dispose of medications through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist where to dispose of unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Olanzapina Combix 5 mg orodispersible tablets

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

The other components (excipients) are: heavy magnesium carbonate, microcrystalline cellulose, crospovidone, microcrystalline cellulose and guar gum, aspartame E951, low-substitution hydroxypropyl cellulose, orange flavor, anhydrous colloidal silica, magnesium stearate, and L-methionine.

Appearance of the product and package contents

Olanzapina Combix 5 mg is presented in the form of yellow, round, biconvex orodispersible tablets, marked with an "O" on one face.

Olanzapina Combix 5 mg orodispersible tablets are presented in:

• Unit-dose aluminum blisters with a foldable sheet of 28 tablets.
• Aluminum blisters of 28 tablets.

Other presentations

Olanzapina Combix 10 mg orodispersible tablets EFG

Olanzapina Combix 15 mg orodispersible tablets EFG

Marketing authorization holder and manufacturer

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Actavis Limited.

BLB016 Bulebel Industrial Estate

Zejtun ZTN08

Malta

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 Health Products (AEMPS) http://www.aemps.gob.es/