Olanzapine Flas Tarbis 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapine FLAS Tarbis 5 mg orodispersible tablets EFG

Olanzapine

Package leaflet contents:

1. What Olanzapina FLAS Tarbis is and what it is used for
2. Before taking Olanzapina FLAS Tarbis
3. How to take Olanzapina FLAS Tarbis
4. Possible side effects
5. How to store Olanzapina FLAS Tarbis
6. Further information

1. What Olanzapina FLAS Tarbis is and what it is used for

Olanzapina FLAS Tarbis belongs to the therapeutic group of antipsychotics.

Olanzapina FLAS Tarbis is indicated for the treatment of a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. Individuals suffering from this disorder may also experience depression, tension, or anxiety.

Olanzapina FLAS Tarbis is used to treat a condition characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking rapidly with racing thoughts, and sometimes marked irritability. It is also a mood stabilizer that helps prevent extreme mood swings.

2. What you need to know before starting to take Olanzapina FLAS Tarbis

Do not take Olanzapina FLAS Tarbis

• if you are allergic (hypersensitive) to olanzapine or to any of the other components of Olanzapina FLAS Tarbis. 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).

Take special care with Olanzapina FLAS Tarbis

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina FLAS Tarbis, inform your doctor.
• Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately.
• The use of Olanzapina FLAS Tarbis in elderly patients with dementia is not recommended, as it may cause serious adverse effects.

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

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epilepsy
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Blood disorders
• Stroke or reduced blood flow to the brain (transient ischemic attack symptoms).

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.

If you or a family member has a history of blood clots, these medicines may be associated with clot formation. As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Patients under 18 years of age must not take Olanzapina FLAS Tarbis.

Use of other medicines

Only take other medicines together with Olanzapina FLAS Tarbis if authorized by your doctor. You may experience drowsiness if Olanzapina FLAS Tarbis is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

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

Please inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription. Especially inform your doctor if you are taking medicines for Parkinson's disease.

Taking Olanzapina FLAS Tarbis with food and drinks

You must not drink alcohol while taking Olanzapina FLAS Tarbis, as the combination of Olanzapina FLAS Tarbis and alcohol may cause drowsiness.

Pregnancy and breastfeeding

Inform your doctor as soon as possible if you are pregnant or think you may be pregnant. You should not take this medicine during pregnancy unless your doctor recommends it. You should not take this medicine while breastfeeding, as small amounts of Olanzapina FLAS Tarbis may pass into breast milk.

Newborns of mothers who have used Olanzapine during the last 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.

Driving and using machines

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

Important information about some of the components of Olanzapina FLAS Tarbis

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

This medicine may be harmful to people with phenylketonuria because it contains aspartame, a source of phenylalanine.

3. How to take OLANZAPINA FLAS TARBIS

Follow exactly the administration instructions for Olanzapina FLAS Tarbis provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many Olanzapina FLAS Tarbis tablets you should take and for how long. The daily dose of Olanzapina FLAS Tarbis ranges between 5 and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapina FLAS Tarbis unless instructed by your doctor.

Olanzapina FLAS Tarbis tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. Olanzapina FLAS Tarbis tablets are for oral administration.

Olanzapina FLAS Tarbis orodispersible tablets crumble easily and therefore must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

Peel back the upper aluminum foil from a blister and carefully remove the Olanzapina FLAS Tarbis orodispersible tablet.

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

If you take more Olanzapina FLAS Tarbis than you should

Patients who have taken more Olanzapina FLAS Tarbis than recommended 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 immediately or go to the hospital. Show the doctor the package and tablets.

If you forget to take Olanzapina FLAS Tarbis

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

If you stop taking Olanzapina FLAS Tarbis

Do not stop treatment just because you feel better. It is very important to continue taking Olanzapina FLAS Tarbis for as long as your doctor instructs.

If you stop taking Olanzapina FLAS Tarbis suddenly, symptoms such as sweating, difficulty sleeping, tremor, anxiety, nausea, and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.

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

4. Possible adverse effects

Like all medicines, Olanzapine FLAS Tarbis may cause adverse effects, although not everybody gets them.

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

• Weight gain.
• Drowsiness.
• Increased levels of prolactin in the blood.

Common adverse effects: may affect between 1 and 10 in every 100 people

• Changes in levels of certain blood cells and circulating lipids.
• Increased levels of sugar in blood and urine.
• Increased appetite.
• Dizziness.
• Agitation.
• Tremor.
• Muscle rigidity or spasms (including eye movements).
• Speech disorders.
• Unusual movements (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Excessive fatigue.
• Fluid retention causing swelling of the hands, ankles, or feet.
• In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeat), especially when getting up from a lying or sitting position. This sensation usually disappears spontaneously, but if it does not, inform your doctor.
• Sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Uncommon adverse effects: may affect between 1 and 10 in every 1,000 people

• Slow pulse.
• Sensitivity to sunlight.
• Urinary incontinence.
• Hair loss.
• Absence or reduced menstrual periods.
• Changes in the breast gland in men and women such as abnormal production of breast milk or abnormal growth.
• Restless legs syndrome.
• Excessive salivation.

Other possible adverse effects: frequency cannot be estimated from available data

• Allergic reaction (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.
• Decrease in normal body temperature.
• Seizures; in most cases related to a history of seizures (epilepsy).
• Combination of fever, rapid breathing, sweating, muscle stiffness, and a state of mental confusion or drowsiness.
• Spasms in the eye muscles causing circular eye movements.
• Abnormal heart rhythm.
• Sudden unexplained death.
• Blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the leg); these clots may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention. Inflammation of the pancreas, causing severe stomach pain, fever, and malaise.
• Liver disease, with yellowing of the skin and whites of the eyes.
• Muscle disorder presenting as unexplained muscle pains.
• Difficulty urinating.
• Prolonged and/or painful erection.

Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, skin rash on the face spreading to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (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 group of patients.

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

Rarely, women who take this type of medicine for a long time may secrete milk from the breast, stop having regular menstrual periods, or have irregular periods. If this persists, consult your doctor. Very rarely, babies born to mothers who took Olanzapine FLAS Tarbis during the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Olanzapine FLAS Tarbes Storage

Keep out of the reach and sight of children.

Do not use Olanzapine FLAS Tarbes after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Olanzapine FLAS Tarbis 5 mg

The active substance is olanzapine. Each orodispersible tablet of Olanzapine FLAS Tarbis contains 5 mg of the active substance.

The other components are monohydrate lactose, calcium silicate, low-substituted hydroxypropyl cellulose, crospovidone, aspartame, orange flavour, banana flavour, colloidal anhydrous silica, and magnesium stearate.

Appearance of Olanzapine FLAS Tarbis 5 mg and contents of the container

Olanzapine FLAS Tarbis 5 mg orodispersible tablets are yellow.

Olanzapine FLAS Tarbis 5 mg orodispersible tablets are available in packs of 28 tablets.

Other presentations:

Olanzapine FLAS Tarbis 10 mg orodispersible tablets: packs of 28 and 56 tablets.

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. de Barcelona, 69

Sant Joan Despi (Barcelona) 08970 Spain

This leaflet was reviewed in June 2020

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