OLANZAPINE VIR 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

OlanzapineVir15 mg orodispersible tablets EFG

Read allof 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. See section 4.

Contents of the pack

1. What Olanzapine Vir is and what it is used for
2. What you need to know before you take Olanzapine Vir
3. How to take Olanzapine Vir
4. Possible side effects
5. Storage of Olanzapine Vir
6. Contents of the pack and other information

1. What Olanzapine Vir is and what it is used for

Olanzapine Vir contains the active substance olanzapine. Olanzapine Vir belongs to a group of medicines called antipsychotics and is used to treat the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious or tense.
• Moderate to severe manic disorder, a disease whose symptoms are excitement or euphoria.

Olanzapine Vir has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. Before taking Olanzapine Vir

Do not take OlanzapineVir

• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Olanzapine Vir (see section 6). The allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapine Vir

• Olanzapine Vir is not recommended for use in elderly patients with dementia as it may have serious side effects.
• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking Olanzapine Vir, tell your doctor.
• In very 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 to you, contact your doctor immediately.
• A weight gain has been observed in patients taking Olanzapine Vir. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapine Vir. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking Olanzapine Vir and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

If you suffer from any of the following diseases, inform your doctor as soon as possible:

• Stroke or lack of blood flow to the brain (transient symptoms of stroke).
• Parkinson's disease.
• Prostate problems.
• Intestinal blockage (paralytic ileus).
• Liver or kidney disease.
• Blood disorders.
• Heart disease.
• Diabetes.
• Seizures.
• If you think you may have salt loss due to prolonged and intense diarrhea and vomiting or due to the use of diuretic medications (urination tablets).

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or lack of blood flow to the brain.

As a routine precaution, if you are over 65 years old, it would be advisable for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years of age should not take Olanzapine Vir.

Other medicines and Olanzapine Vir

Only use other medicines at the same time as Olanzapine Vir if your doctor authorizes it. You may feel drowsy if you combine Olanzapine Vir with antidepressants or medications for anxiety or that help you sleep (tranquilizers).

Tell your doctor if you are taking, have recently taken, or may need to take any other medication.

In particular, tell your doctor if you are taking:

• Medication for Parkinson's disease.
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Olanzapine Vir may need to be changed.

Use of OlanzapineVirwith alcohol

You should not drink alcohol while taking Olanzapine Vir, as the combination with alcohol can cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not take this medicine while breastfeeding, as small amounts of Olanzapine Vir may pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with Olanzapine Vir in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness when you are taking Olanzapine Vir. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Olanzapine Vir contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Olanzapine Vir

Follow the instructions for administration of Olanzapine Vir indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many Olanzapine Vir tablets you should take and for how long. The daily dose of Olanzapine Vir ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapine Vir unless your doctor tells you to.

Olanzapine Vir tablets should be taken 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. Olanzapine Vir orodispersible tablets are for oral administration.

Olanzapine Vir tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister by the ends and separate one of the cells, breaking it gently along the perforations that surround it.
2. Gently remove the backing sheet from the cell.
3. Carefully remove the tablet.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, making it easy to swallow.

You can also put the tablet in a cup or glass with water, orange juice, apple juice, milk, or coffee, for it to dissolve. With some beverages, the mixture may change color and possibly become opaque. It should be drunk immediately.

If you take more OlanzapineVirthan you should

Patients who have taken more Olanzapine Vir than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, 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 stiffness, and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you experience any of the above symptoms. Show the doctor the package with the tablets.

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 used.

If you forget to take OlanzapineVir

Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking OlanzapineVir

Do not stop treatment because you feel better. It is very important that you continue taking Olanzapine Vir while your doctor tells you to.

If you stop taking Olanzapine VIR suddenly, symptoms such as sweating, insomnia, tremors, anxiety, nausea, or vomiting may appear. Your doctor may suggest gradually reducing the dose before stopping treatment.

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 Vir can cause side effects, although not everybody gets them.

Contact your doctor immediately if you have:

• Unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, go to the doctor immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency cannot be estimated from the available data).

Very common side effects (which can affect more than 1 in 10 people) include weight gain; drowsiness; and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of certain blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes swelling of the hands, ankles, or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (which can affect up to 1 in 100 people) include hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma; seizures, most of which are related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of urination ability; hair loss; absence or decrease of menstrual periods; and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Very rare side effects (which can affect up to 1 in 1000 people) include a drop in normal body temperature; abnormal heart rhythm; sudden unexplained death; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and the white areas of the eyes; muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later with an extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell in the blood (eosinophilia).

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 problems. Some deaths have been reported in this particular group of patients.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed 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 Vir

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of OlanzapineVir

• The active substance is olanzapine. Each orodispersible tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of active substance.

• The other ingredients are: crospovidone (type A), lactose monohydrate, colloidal anhydrous silicon dioxide, hydroxypropylcellulose, peppermint flavor (consisting of: peppermint oil, terpene-free peppermint oil, eucalyptus, menthol, isomenthol, menthyl acetate, menthol), talc, magnesium stearate.

Appearance of the product and contents of the pack

Olanzapine Vir 5 mg, 10 mg, 15 mg, and 20 mg are yellow orodispersible tablets. Orodispersible is the technical name used for tablets that dissolve directly in the mouth, making them easier to swallow.

Olanzapine Vir 5 mg, 10 mg, 15 mg, and 20 mg are available in packs containing 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

C/Industria Quimica Y Farmaceutica Vir, S.A

Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923- Alcorcón (Madrid) Spain

Manufacturer:

Pharmathen, S.A Dervenakion 6,

15351, Pallini, Attiki

Greece

Pharmathen Internacional, S.A Sapes Industrial Park

Block 5

69300 Rodopi

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Olanzapina Eurogenus

Spain: Olanzapina Vir orodispersible tablets EFG

This leaflet was approved in April 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/