PATIENT INFORMATION LEAFLET

Olanzapina Combix 15 mg buccal tablets EFG

Olanzapina

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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Olanzapina Combixbelongs to a group of medications known as antipsychotics.

OlanzapinaCombixis used to treat:

• A condition characterized by symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, and a tendency to withdraw. People who suffer from this condition may also be depressed, anxious, or tense.

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

Do not take OlanzapinaCombix:

• If you areallergic(hypersensitive) to the active ingredient olanzapina or to any of the other components of OlanzapinaCombix(listed in section 6). An allergic reaction may occur in the form of a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens after taking OlanzapinaCombix, inform your doctor.
• If you have previously been diagnosed withnarrow-angle glaucoma(a condition in which the pressure inside the eye increases).

Warnings and precautions

Consult your doctor or pharmacist before starting to take OlanzapinaCombix.

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

Medicines of this type may cause unusual movements, especially in the face orthe tongue. Ifyou experience this after taking OlanzapinaCombix,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 somnolence. If this happens, discontinue treatment andinform your doctor immediately.

Inform your doctorif you have any of the following conditions:

• Diabetes
• Heart disease
• Liver disease
• Kidney disease
• Parkinson's disease
• Epilepsy (seizures)
• Prostate problems
• Intestinal blockage (Paralytic ileus)
• Blood disorders
• Transient cerebral ischemia or cerebral infarction

If you havedementia, you, your caregiver, or a family member mustinform your doctorif you have ever had a cerebral infarction or transient cerebral ischemia.

Children and adolescents under 18 years

Patients under 18 years should not take OlanzapinaCombix.

Older patients

OlanzapinaCombixshould not be used in elderly patients with dementia, as it may have serious adverse effects.

If you are over 65 years old, it is recommended that your doctor monitor your blood pressure.

Interaction of OlanzapinaCombixwith other medicines

Inform 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 OlanzapinaCombix,unless your doctor has authorized it.

Inform your doctorif you are takingmedication for Parkinson's disease, as OlanzapinaCombixmay worsen symptoms.

Inform your doctorif you are takingfluvoxamine(an antidepressant) orciprofloxacin(an antibiotic), as your dose of OlanzapinaCombixmay need to be adjusted.

You may feel drowsy if you take OlanzapinaCombixwith antidepressants or tranquilizers.

OlanzapinaCombixwith food, drinks, and alcohol

OlanzapinaCombixcan be taken with or without food.

Do not drink alcoholic beverages during treatment with OlanzapinaCombix, as the combination may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

You should not take OlanzapinaCombixduring pregnancy, unless your doctor recommends it.

Newborn babies of mothers who have taken OlanzapinaCombixin the last trimester of pregnancy may experience the following symptoms: tremor, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn baby experiences any of these symptoms, contact your doctor.

You should not take OlanzapinaCombixduring breastfeeding, as small amounts of olanzapina may pass into breast milk.

Driving and operating machinery

Olanzapinamay cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. 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 medicine.

Important information about some of the components of OlanzapinaCombix

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

Follow exactly the administration instructions for OlanzapinaCombixas 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 experience symptoms again, but do not stop taking OlanzapinaCombixunless your doctor has instructed you to do so.

Take the tablets once a day (with or without meals). 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 takingOlanzapinaCombixas directed by your doctor.

OlanzapinaCombixtablets are very delicate, so they must be handled with care.Do not handle the tablets with wet handsbecause they may disintegrate.

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

2. Remove the back of the cell gently.

3. Carefully extract the tablet.

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

If you prefer, you can place the tablet in a cup or a glass filled with water, orange juice, apple juice, milk, or coffee, stirring it. Some drinks may change color and become cloudy. You mustdrink immediately.

If you take more OlanzapinaCombixthan you should

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

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

If you forget to takeOlanzapinaCombix

Do not take a double dose to compensate for the missed dose. If you forget to take a dose, continue treatment with the normal dose.

If you interrupt treatment withOlanzapinaCombix

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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, OlanzapinaCombixcan cause side effects, although not everyone will experience 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 less than 1 in 1,000.

When a side effect is defined as “very rare”, this 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 olanzapina may include excessive drowsiness or 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 some blood cells and circulating fats. In some patients, pancreatitis has developed in very rare cases, causing 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 or sitting. This sensation usually disappears on its own, but if it does not, inform your doctor.

There have been rare cases of patients with abnormal heart rhythms that can be serious.

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

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

In rare cases, olanzapina could cause an allergic reaction (e.g., inflammation of the mouth and throat, itching, rash), slow heart rate, or sensitivity to sunlight. There have also been reports of liver diseases in rare cases. In very rare cases, there have been reports of prolonged and painful erections or difficulty urinating, normal body temperature drop, blood clots that present, for example, as deep vein thrombosis of the legs, or muscle disorder that presents as unexplained pain. Some patients, in very rare cases, have experienced high blood sugar levels or initial symptoms of worsening diabetes, with ketoacidosis (acetone in blood and urine) or coma.

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 situation persists, consult your doctor.

There have been reports of severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with symptoms similar to the flu, with skin rash on the face that then spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

Very rarely, babies born to mothers who took olanzapina in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

Seizures may occur in rare cases. In most cases, there were pre-existing seizure disorders (epilepsy).

Rare 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 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 medicine.

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

No special storage conditions are required.

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

Do not dispose of the medication through the drains or in the trash. Deposit the packaging and unused medication at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist where to dispose of unused medication. By doing so, you will help protect the environment.

Composition ofOlanzapinaCombix15mg buccal dispersible tablets

The active ingredient is olanzapina. Each buccal dispersible tablet contains 15 mg of olanzapina.

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 contents of the packaging

OlanzapinaCombix15 mg is presented in the form of yellow, round, biconvex, and marked with an ‘O2’ on one side.

OlanzapinaCombix15 mgbuccal dispersible tablets are presented in:

• Single-dose aluminum blisters with a deployable foil of28tablets.
• Aluminum blisters of28tablets.

Other presentations

OlanzapinaCombix5 mg buccal dispersible tablets EFG

OlanzapinaCombix10 mg buccal dispersible tablets EFG

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 Alarcon (Madrid)

Spain

Responsible for manufacturing

Actavis Limited.

BLB016 Bulebel Industrial Estate

Zejtun ZTN08

Malta

This leaflet has been reviewed in February 2020

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