PATIENT INFORMATION LEAFLET

OlanzapineVir20 mg buccal tablets EFG

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What OlanzapineViris and what it is used for

2. What you need to know before you start taking OlanzapineVir

3. How to take OlanzapineVir

4. Possible side effects

5. Storage of OlanzapineVir

6. Contents of the pack and additional information

Olanzapina Vir contains the active ingredient olanzapina. Olanzapina Vir belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases:

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a disease whose symptoms are hearing, seeing, or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn.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

Olanzapina Vir has demonstrated the ability to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take OlanzapinaVir

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

(increased eye pressure)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Vir

• Olanzapina Vir is not recommended for use in elderly patients with dementia as it may have serious adverse effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina 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 drowsiness or somnolence. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Vir. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or refer you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Vir. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina Vir and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medicines 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 transient ischemic attack (symptoms of a 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 a loss of salts due to prolonged diarrhea and vomiting or the use of diuretic medications (water pills).

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

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 old should not take Olanzapina Vir.

Other medicines and Olanzapina Vir

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

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

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). You may need to change your Olanzapina Vir dose.

Use of OlanzapinaVir with alcohol

You should not drink alcohol while taking Olanzapina Vir as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine. Do 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 of mothers who have been treated with Olanzapina 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 operating machinery

There is a risk of drowsiness when taking Olanzapina Vir. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

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

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

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

Olanzapina 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. Olanzapina Vir buccal tablets are for oral administration.

Olanzapina 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 around the perforations that surround it.
2. Remove the backing from the cell gently.
3. Extract the tablet carefully.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

You can also place the tablet in a cup or glass with water, orange juice, apple juice, milk, or coffee, so that it dissolves. With some drinks, the mixture may change color and possibly become opaque. You should drink it immediately.

If you take more Olanzapina Vir than you should

Patients who have taken more Olanzapina Vir than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you experience any of the symptoms specified above. Show the packaging with the tablets to the doctor.

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 used.

If you forget to take Olanzapina Vir

Take your tablet as soon as you remember. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Olanzapina Vir

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

If you stop taking Olanzapina Vir suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, or vomiting. Your doctor may suggest reducing the dose gradually before stopping treatment.

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

Like all medicines, Olanzapina Vir may cause side effects, although not everyone will experience them.

Immediately contact your doctor 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, seek immediate medical attention.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data).

Frequent side effects (which can 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 getting up from lying down or sitting. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Frequent side effects (which can affect up to 1 in 10 people) include changes in the

levels of some blood cells, circulating lipids, and at the beginning of treatment temporary increases in liver enzymes; increased levels of blood sugar and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; tremor; strange movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention causing inflammation 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.

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 the blood and urine) or coma; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; slow pulse; sensitivity to sunlight; nasal bleeding; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods; and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (which can affect up to 1 in 1000 people) include a decrease in

normal body temperature; abnormal heart rhythm; sudden death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain and prolonged and/or painful erection.

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

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

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

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 prospectus. You can also report them directly through the Spanish System of 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 out of sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Olanzapine CompositionVir

- The active ingredient is olanzapine. Each buccal dispersible tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of active ingredient.

- The other components are: crospovidone (type A), lactose monohydrate, anhydrous colloidal silicon dioxide, hydroxypropyl cellulose, peppermint flavor (consisting of: peppermint oil, peppermint oil without terpenes, eucalyptus, menthone, isomenthone, menthyl acetate, menthol), talc, magnesium stearate.

Appearance of the product and content of the packaging

OlanzapineVir5 mg, 10 mg, 15 mg, and 20 mg are yellow-colored buccal dispersible tablets. Buccal dispersible is the technical term used for those tablets that dissolve directly in the mouth, facilitating swallowing.

Olanzapine Vir 5 mg, 10 mg, 15 mg, and 20 mg is available in packaging containing 28 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

C/Industria Quimica Y Farmaceutica Vir,S.A

Laguna, 66-68-70. Industrial Park UrtinsaII

28923- Alcorcón(Madrid) Spain

Responsible 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 with the following names:

Portugal: Olanzapine Eurogenus

Spain: Olanzapine Vir buccal dispersible tablets EFG

This leaflet was approved in April 2020

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/