Olanzapine Combix 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapina Combix 15 mg orodispersible tablets EFG

Olanzapine

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents

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 adverse effects
5. How to store Olanzapina Combix
6. Contents of the pack and other information

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

Olanzapina Combix belongs to a group of medicines called antipsychotics.

Olanzapina Combix is used to treat:

• A condition with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, and a tendency to withdraw socially. People with this condition may also feel depressed, anxious, or tense.

• A disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes having marked irritability. It is also a mood stabilizer, preventing extreme mood swings (mania 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 substance olanzapine or to any of the other ingredients of Olanzapina Combix (listed in section 6). An allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this occurs after taking Olanzapina Combix, inform your doctor.
• if you have previously been diagnosed with narrow-angle glaucoma (a condition in which pressure inside the eye increases).

Warnings and precautions

Talk to your doctor or pharmacist before starting Olanzapina Combix.

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

Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapina Combix, inform your doctor.

Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy. If this occurs, stop treatment and contact your doctor immediately.

Inform your doctor if 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
• Stroke or transient ischemic attack (TIA)

If you have dementia, you, your caregiver, or a family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

Children and adolescents under 18 years

Patients under 18 years of age must not take Olanzapina Combix.

Elderly patients

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

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

Interaction of Olanzapina Combix with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take other medicines at the same time as Olanzapina Combix, unless authorized by your doctor.

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

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

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

Olanzapina Combix with food, drinks, and alcohol

Olanzapina Combix may be taken with or without food.

Do not drink alcohol during treatment with Olanzapina Combix, as combining both may cause drowsiness.

Pregnancy and breastfeeding

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

You must not take Olanzapina Combix during pregnancy unless your doctor advises you to do so.

Newborns of mothers who have taken Olanzapina Combix during the third trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

You must not take Olanzapina Combix while breastfeeding, as small amounts of olanzapine may pass into breast milk.

Driving and using machines

Olanzapina may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Important information about some of the ingredients of Olanzapina Combix

Olanzapina Combix contains aspartate. This medicine may be harmful for people with phenylketonuria because it contains aspartame, a source of phenylalanine.

3. How to take Olanzapina Combix

Follow exactly the instructions for use of Olanzapina Combix as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended daily dose ranges from 5 to 20 mg. Inform your doctor if your symptoms return, but do not stop taking Olanzapina Combix unless your doctor has specifically instructed you to do so.

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

Do not stop treatment when you feel better. It is very important that you continue taking Olanzapina Combix for as long as your doctor has instructed.

Olanzapina Combix orodispersible tablets are very delicate and must therefore be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister pack at the edges and separate one blister cell by gently breaking along the perforations surrounding it.

2. Gently peel back the backing of the blister.

3. Carefully remove the tablet.

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

If preferred, you may place the tablet into a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stir. Some liquids may change color and become cloudy. The mixture should be drunk immediately.

If you take more Olanzapina Combix than you should

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

Symptoms of poisoning may include: rapid heartbeat, agitation/aggression, speech difficulties, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, and somnolence or lethargy, slowed respiratory rate, 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 miss a dose, continue with your next scheduled dose at the usual time.

If you stop taking Olanzapina Combix

Do not stop treatment without first consulting your doctor, even if you feel better. Discontinuation of treatment should be done gradually and always in accordance with your doctor's instructions.

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

4. Possible adverse effects

Like all medicines, Olanzapina Combix may cause adverse effects, although not everyone experiences them.

In this leaflet, when an adverse effect is described as "rare", it means that it has been reported in more than 1 in 10,000 patients, but in fewer than 1 in 1,000.

When an adverse effect is described as "very rare", this means it has been reported in fewer 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 may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.

Adverse effects of olanzapine may include 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, speech disturbances, and changes in levels of certain 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) during the initial stages of treatment, especially when standing up from lying down or sitting. This sensation usually resolves spontaneously, but if it does not, inform your doctor.

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

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

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

Rarely, olanzapine may cause an allergic reaction (e.g., swelling of the mouth and throat, itching, rash), slow heart rate, or sensitivity to sunlight. Rare cases of liver disease have also been reported. Very rarely, prolonged and/or painful erection or difficulty urinating, abnormally low body temperature, blood clots such as deep vein thrombosis in the legs, or unexplained muscle pain have been reported. Some patients, very rarely, have experienced high blood sugar levels or early signs of worsening diabetes, with ketoacidosis (ketones in blood and urine) or coma.

Rarely, women who take this type of medication for a prolonged period may experience milk secretion from the mammary gland, absence of menstruation, or irregular menstrual cycles. If this condition persists, consult your doctor.

Severe allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, facial rash that spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

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

Seizures may occur rarely. In most cases, there was a history of seizures (epilepsy).

Uncommon adverse effect: excessive salivation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Combix 15 mg orodispersible tablets

The active substance is olanzapine. Each orodispersible tablet contains 15 mg of olanzapine.

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

Appearance of the product and contents of the pack

Olanzapine Combix 15 mg is presented as yellow, round, biconvex orodispersible tablets marked with 'O2' on one side.

Olanzapine Combix 15 mg orodispersible tablets are available in:

• Unit-dose aluminum blisters with peelable foil containing 28 tablets.
• Aluminum blisters containing 28 tablets.

Other presentations

Olanzapine Combix 5 mg orodispersible tablets EFG

Olanzapine Combix 10 mg orodispersible tablets EFG

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS COMBIX, S.L.U

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcon (Madrid)

Spain

Manufacturer

Actavis Limited.

BLB016 Bulebel Industrial Estate

Zejtun ZTN08

Malta

This leaflet was last revised in February 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/