Olanzapine Vir 20 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

OlanzapinaVir 20 mg orodispersible tablets EFG

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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Olanzapina Vir contains the active substance olanzapine. Olanzapina Vir belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.
• Moderate to severe manic disorder, a condition whose symptoms include excitement or euphoria.

Olanzapina 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 Olanzapina Vir

Do not take Olanzapina Vir

• If you are allergic (hypersensitive) to olanzapine or to any of the other components of Olanzapina Vir (see section 6). The allergic reaction may manifest as 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 Olanzapina Vir

• The use of Olanzapina Vir is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
• Medications of this type may cause unusual movements, especially of the face or tongue. If this occurs after taking Olanzapina Vir, inform your doctor.
• Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of mental confusion or drowsiness. If you experience this, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Vir. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.
• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapina Vir. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Olanzapina Vir and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medications of this type have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or reduced blood flow to the brain (transient ischemic attack).
• 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 loss of body salts due to prolonged severe diarrhea or vomiting, or due to taking diuretic medicines (water tablets).

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

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Children and adolescents

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

Other medicines and Olanzapina Vir

Only use other medicines together with Olanzapina Vir if authorized by your doctor. You may feel drowsiness if Olanzapina Vir is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

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

Specifically, 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 Olanzapina Vir may need to be adjusted.

Use of Olanzapina Vir with alcohol

Do not drink alcohol while taking Olanzapina Vir, as combining it with alcohol may cause drowsiness.

Pregnancy and breastfeeding

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

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

Driving and use of machines

There is a risk of drowsiness when taking Olanzapina Vir. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Olanzapina Vir contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Olanzapine Vir

Follow exactly the instructions for administering Olanzapine Vir given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many Olanzapine Vir tablets to take and for how long. The daily dose of Olanzapine Vir ranges between 5 and 20 mg. Speak with your doctor if your symptoms return, but do not stop taking Olanzapine Vir unless your doctor tells you to do so.

Olanzapine Vir tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food. The orodispersible tablets of Olanzapine Vir 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 pack at the edges and separate one blister by gently tearing along the perforations surrounding it.
2. Carefully peel back the backing film from the blister.
3. Gently remove the tablet.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

Alternatively, you may place the tablet in a cup or glass containing water, orange juice, apple juice, milk, or coffee to allow it to dissolve. With some drinks, the mixture may change color and possibly become cloudy. The solution should be drunk immediately.

If you take more Olanzapine Vir than you should

Patients who have taken more Olanzapine Vir than prescribed have experienced the following symptoms: 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, drowsiness or lethargy, slowed breathing 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 symptoms listed above. Show the doctor the packaging of the medicine.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Olanzapine Vir

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

If you stop taking Olanzapine Vir

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Vir for as long as your doctor advises.

If you stop taking Olanzapine Vir suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, or vomiting may occur. Your doctor may recommend gradually reducing the dose before stopping treatment.

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

4. Possible adverse effects

Like all medicines, Olanzapine Vir may cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• Unusual movements (a common adverse effect which may affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (an uncommon adverse effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from available data).

Very common adverse effects (may affect more than 1 in 10 people) include:

weight gain; drowsiness; and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when standing up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, consult your doctor.

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

Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g., swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases 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; inability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the mammary gland in both men and women, such as abnormal production of breast milk or abnormal growth.

Rare adverse effects (may affect up to 1 in 1,000 people) include:

decrease in normal body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas, causing severe stomach pain, fever, and malaise; liver disease, with yellowing of the skin and whites of the eyes; a muscular disorder presenting as unexplained muscle pain and/or prolonged and/or painful erection.

Very rare adverse effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a type of white blood cells (eosinophilia).

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

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

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 via 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 Vir

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging 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. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of OlanzapinaVir

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

• The other components are: crospovidone (type A), lactose monohydrate, colloidal anhydrous silicon dioxide, hydroxypropylcellulose, mint flavour (containing: peppermint oil, terpene-free peppermint oil, eucalyptus, menthone, isomenthone, methyl acetate, menthol), talc, magnesium stearate.

Nature and contents of the container

Olanzapina Vir 5 mg, 10 mg, 15 mg, and 20 mg are yellow orodispersible tablets. Orodispersible is the technical term used for tablets that dissolve directly in the mouth, facilitating swallowing.

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

Marketing Authorisation Holder and Manufacturer

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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Portugal: Olanzapina Eurogenus

Spain: Olanzapina Vir orodispersible tablets EFG

This summary of product characteristics was approved in April 2020

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