OLANZAPINE COMBIX 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapine Combix 10 mg orodispersible tablets EFG

Olanzapine

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

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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. What you need to know before you take Olanzapine Combix
3. How to take Olanzapine Combix
4. Possible side effects
5. Storage of Olanzapine Combix
6. Contents of the pack and other 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 for the treatment of:

• A disease with symptoms such as hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion and 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, a reduced need for sleep, 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 you take Olanzapine Combix

Do not take Olanzapine Combix:

• if you are allergic(hypersensitive) to the active substance olanzapine or to any of the other ingredients of Olanzapine Combix (listed in section 6). An allergic reaction may appear in the form of a rash, itching, swelling of the face or lips or difficulty breathing. If this happens to you after taking Olanzapine 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 Olanzapine 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 can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Combix, inform your doctor.

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

Tell your doctor if you have any of the following diseases:

• Diabetes
• Heart disease
• Liver disease
• Kidney disease
• 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

Patient under 18 years should not take Olanzapine Combix.

Elderly patients

Olanzapine Combix is not recommended for use 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 checks your blood pressure.

Interaction of Olanzapine Combix with other medicines

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

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

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

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

You may feel a certain sensation of drowsiness if you take Olanzapine Combix with antidepressants or tranquilizers.

Olanzapine Combix with food, drinks, and alcohol

Olanzapine Combix can be taken with or without food.

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

Pregnancy and lactation

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 medicine.

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

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

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

Driving and using machines

Olanzapine may cause symptoms such as drowsiness, dizziness, or changes in vision, and decrease 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 medicine.

Important information about some of the ingredients of Olanzapine Combix

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

3. How to take Olanzapine Combix

Follow the administration instructions of Olanzapine Combix indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended daily dose ranges from 5 to 20 mg. Inform your doctor if you suffer from symptoms again, but do not stop taking Olanzapine 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 Olanzapine Combix while your doctor tells you to.

The orodispersible tablets of Olanzapine 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 by the ends and separate one of the cells, breaking it gently through 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, so it will be very easy to swallow.

If you prefer, you can put the tablet in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, stirring. Some drinks may change color and take on a cloudy appearance. It should be drunk immediately.

If you take more Olanzapine 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 medicine and the amount ingested. It is recommended to take the package and the leaflet of the medicine 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 may be: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy, slowing of respiratory frequency, aspiration, increase or decrease in blood pressure, and abnormal heart rhythms.

If you forget to take Olanzapine 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 stop treatment with Olanzapine Combix

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

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

4. Possible side effects

Like all medicines, Olanzapine Combix can cause side effects, although not everybody gets 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 present 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 them severe stomach pain, fever, and discomfort.

Some people experience dizziness or fainting (with slower heartbeats) in the early stages of treatment, especially when getting up from lying down or sitting. 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 suffer from stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin redness, and walking problems. Some deaths have been reported in this particular group of patients.

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

Rarely, olanzapine could 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 disorder (presenting as unexplained pain) have been reported. Some patients have very rarely experienced high blood sugar levels or initial symptoms of diabetes worsening, with ketoacidosis (acetone in blood and urine) or coma.

Rarely, women taking these types of medications for a long time may secrete milk from the mammary gland, stop having their monthly 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 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).

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

Seizures can occur rarely. In most cases, there were previous histories of seizures (epilepsy).

Uncommon side effect: excessive salivation.

Reporting of 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 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 Olanzapine Combix

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the package, after EXP. The expiration date is the last day of the month indicated.

Do not throw away medicines via wastewater or household waste. Deposit the packages and medicines that you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist where to dispose of unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Combix 10 mg orodispersible tablets

The active substance is olanzapine. Each orodispersible tablet contains 10 mg of olanzapine.

The other ingredients (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 contents of the pack

Olanzapine Combix 10 mg is presented in the form of yellow, round, biconvex orodispersible tablets, marked with an 'O1' on one face.

Olanzapine Combix 10 mg orodispersible tablets are presented in:

• Unit-dose blisters of aluminum with a foldable sheet of 28 and 56 tablets.
• Aluminum blisters of 28 and 56 tablets.

Other presentations

Olanzapine Combix 5mg orodispersible tablets EFG

Olanzapine 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/