PATIENT INFORMATION LEAFLET

Olanzapina FLAS Tarbis 5 mg buccal tablets EFG

Olanzapina

Olanzapina FLAS Tarbis belongs to the therapeutic group of antipsychotics.

Olanzapina FLAS Tarbis is indicated for treating a disease whose symptoms are hearing, seeing, or feeling unreal things, holding false beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious, or tense.

Olanzapina FLAS Tarbis is used to treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking rapidly with flight of ideas, and sometimes considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme mood variations.

Do not take Olanzapina FLAS Tarbis

-If you are allergic (hypersensitive) to olanzapina or any of the other components of Olanzapina FLAS Tarbis. 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).

Be especially careful 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, tell your doctor.

-In 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, contact your doctor immediately.

-The use of Olanzapina FLAS Tarbis in elderly patients with dementia is not recommended as it may have severe adverse effects.

If you have any of the following diseases, 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

-Cerebral infarction or lack of blood flow to the brain (transient symptoms of cerebral infarction).

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

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

Patients under 18 years old should not take Olanzapina FLAS Tarbis.

Use of other medications

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

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your dose of Olanzapina FLAS Tarbis.

Please inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription. Especially inform your doctor if you are using medications to treat Parkinson's disease.

Taking Olanzapina FLAS Tarbis with food and drinks

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

Pregnancy and breastfeeding

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

Newborns of mothers who have used Olanzapina in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn experiences any of these symptoms, contact your doctor.

Driving and operating machinery

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

Important information about some of the components of Olanzapina FLAS Tarbis

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

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

Follow exactly the administration instructions forOlanzapina FLAS Tarbisas indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Olanzapina FLAS Tarbis 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 FLAS Tarbis tablets are for oral administration.

Olanzapina FLAS Tarbis buccal tablets disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate.

Separate the upper aluminum foil from a blister and carefully remove the Olanzapina FLAS Tarbis buccal tablet.

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

If you take moreOlanzapina FLAS Tarbisthan you should

Patients who have taken more Olanzapina FLAS Tarbis 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 or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the packaging with the tablets.

If you forget to takeOlanzapina FLAS Tarbis

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

If you interrupt treatment with Olanzapina FLAS Tarbis

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

If you stop taking Olanzapina FLAS Tarbis suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

Like all medicines, Olanzapina FLAS Tarbis can cause side effects, although not everyone will experience them.

Very common side effects: that affect 1 in 10 patients

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

Common side effects: that affect between 1 and 10 in every 100 patients

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

Uncommon side effects: that affect between 1 and 10 in every 1,000 patients

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

Other possible side effects: their frequency cannot be estimated from the available data

• Allergic reaction (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.
• Decreased 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 confusion or drowsiness.
• Eye muscle spasms causing circular movements of the eyes.
• Abnormal heart rhythm.
• Sudden death without apparent explanation.
• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.Pancreatitis, which causes severe stomach pain, fever, and discomfort.
• Liver disease, with yellowing of the skin and white areas of the eye.
• Muscular disorder presenting as unexplained pain.
• Difficulty urinating.
• Prolonged and/or painful erection.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased eosinophils.

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

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

In rare cases, women taking this type of medication for a long period may experience milk secretion from the breast gland, stop having their period, or have irregular periods. If this persists, consult your doctor. Very rarely, babies born to mothers who took Olanzapina FLAS Tarbis in the last stage of pregnancy (third trimester) may experience tremor, drowsiness, or lethargy.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not useOlanzapina FLAS Tarbisafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Olanzapina FLAS Tarbis 5mg

The active ingredient is olanzapine. Each buccal dispersible tablet ofOlanzapina FLAS Tarbiscontains 5mg of active ingredient.

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

Appearance of Olanzapina FLAS Tarbis 5mg and content of the packaging

Olanzapina FLAS Tarbis5mg buccal dispersible tablets are yellow.

Olanzapina FLAS Tarbis5mg buccal dispersible tablets are available in packs of 28tablets.

Other presentations:

Olanzapina FLAS Tarbis 10 mg buccal dispersible tablets: packs of 28 and 56tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

Sant Joan Despi (Barcelona) 08970 Spain

This leaflet was revised in June 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.