OLANZAPINE TARBIS FARMA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Tarbis Farma 10 mg film-coated tablets EFG

Contents of the pack

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

1. What Olanzapine Tarbis Farma is and what it is used for

Olanzapine Tarbis Farma 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disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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, characterized by symptoms such as excitement or euphoria.

Olanzapine Tarbis Farma 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. What you need to know before you take Olanzapine Tarbis Farma

Do not take Olanzapine Tarbis Farma

• if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in 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 Tarbis Farma.

• Olanzapine Tarbis Farma 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 Tarbis Farma, 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 Tarbis Farma. You and your doctor should check your weight regularly.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapine Tarbis Farma. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine Tarbis Farma 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, tell your doctor as soon as possible:

• Stroke or transient lack of blood flow to the brain (transient stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a 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 Tarbis Farma

Use of Olanzapine Tarbis Farma with other medicines

Only use other medicines at the same time as Olanzapine Tarbis Farma if your doctor authorizes it. You may feel a certain sensation of drowsiness if you combine Olanzapine Tarbis Farma with antidepressants or medicines for anxiety or that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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 Tarbis Farma may need to be changed.

Use of Olanzapine Tarbis Farma with alcohol

You should not drink alcohol if you have been given Olanzapine Tarbis Farma because it can cause drowsiness.

Pregnancy, breastfeeding, and fertility

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 when you are breastfeeding, as small amounts of Olanzapine Tarbis Farma may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Olanzapine Tarbis Farma in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems, and difficulty eating. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

Olanzapine Tarbis Farma may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Olanzapine Tarbis Farma 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 Tarbis Farma

Follow the instructions for administration of this medicine indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist again.

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

You should take your Olanzapine Tarbis Farma tablets 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 Tarbis Farma tablets are for oral administration. You should swallow the Olanzapine Tarbis Farma tablets whole with water.

If you take more Olanzapine Tarbis Farma than you should

Patient who have taken more Olanzapine Tarbis Farma 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.

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 ingested.

If you forget to take Olanzapine Tarbis Farma

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 Tarbis Farma

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

If you stop taking Olanzapine Tarbis Farma suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce 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, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you have:

• unusual movements (a frequent side effect that may affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people), especially in the legs (symptoms include sweating, 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, see a 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 may affect more than 1 in 10 people) include weight gain, drowsiness, and increased prolactin levels in the blood.

Common side effects (which may affect up to 1 in 10 people) include changes in the levels of some blood cells and circulating lipids, increased blood sugar and urine levels, increased appetite, dizziness, agitation, tremors, muscle stiffness or spasms (including eye movements), speech disorders, constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention that causes swelling of the hands, ankles, or feet, and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men. In the early stages of treatment, some people experience dizziness or fainting (with slower heartbeats), especially when getting up from a lying or sitting position. This sensation usually disappears spontaneously, but if it does not, inform your doctor.

Uncommon side effects (which may affect up to 1 in 100 people) include slow heartbeat, sensitivity to sunlight, urinary incontinence, inability to urinate, hair loss, excessive salivation, absence or decrease of menstrual periods, changes in the breast in men and women such as abnormal milk production or abnormal growth, and restless legs syndrome.

Other side effects whose frequency cannot be estimated from the available data (not known) include allergic reaction (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, drop in normal body temperature, seizures, in most cases related to a history of seizures (epilepsy), muscle spasms in the eye muscles causing circular movements of the eyes, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and malaise, 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. Serious allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia).

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

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

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a side effect 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 Tarbis Farma

Keep this medicine out of the 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.

Olanzapine Tarbis Farma does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the empty cartons and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the cartons and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Tarbis Farma 10 mg

• The active ingredient is olanzapine. Each film-coated tablet contains 10 mg of active ingredient.
• The other ingredients are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose E-460, low-substitution hydroxypropyl cellulose E-463, crospovidone, anhydrous colloidal silica, and magnesium stearate E-470.

Coating of the tablet:polyvinyl alcohol, titanium dioxide E-171, talc, lecithin E-322, and xanthan gum E-415.

Appearance of the product and contents of the pack

Olanzapine Tarbis Farma 10 mg film-coated tablets are round, white, and have the inscription “10” on one side.

Olanzapine Tarbis Farma is available in packs of 28 or 56 tablets. Some pack sizes may only be marketed.

Other presentations:

Olanzapine Tarbis Farma 2.5 mg film-coated tablets EFG

Olanzapine Tarbis Farma 5 mg film-coated tablets EFG

Olanzapine Tarbis Farma 7.5 mg film-coated tablets EFG

Marketing authorization holder and manufacturer

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of last revision of this leaflet: June 2020

Other sources of information

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/.