OLANZAPINE FLAS CINFA 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

olanzapine flas cinfa 5 mg orodispersible tabletsEFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is olanzapina flas cinfa and what is it used for
2. What you need to know before taking olanzapina flas cinfa
3. How to take olanzapina flas cinfa
4. Possible side effects
5. Storage of olanzapina flas cinfa
6. Package contents and additional information

1. What is olanzapina flas cinfa and what is it used for

Olanzapina flas cinfa contains the active substance olanzapine. Olanzapina flas cinfa belongs to the therapeutic group of antipsychotics.

Olanzapina flas cinfa is indicated for the treatment of 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disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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, a disease whose symptoms are excitement or euphoria.

Olanzapine 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 taking olanzapina flas cinfa

Do not take olanzapina flas cinfa

• If you are allergic to olanzapine or any of the other components of this medication (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 olanzapina flas cinfa.

• The use of olanzapina flas is not recommended in elderly patients with dementia, as it may have serious side effects.
• Medications of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapina flas, tell your doctor.
• In very rare cases, medications of this type can 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 olanzapina flas. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) have been observed in the blood of patients taking olanzapina flas. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking olanzapina flas and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medications of this type have been associated with the formation of blood clots.

If you suffer from any of the following diseases, inform your doctor as soon as possible:

• Stroke or transient lack of blood flow to the brain (transient symptoms of 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 salt loss due to prolonged and intense diarrhea and vomiting or the use of diuretic medications (urination tablets).

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 is advisable for your doctor to check your blood pressure.

Children and Adolescents

Patient under 18 years old should not take olanzapina flas.

Taking olanzapina flas cinfa with other medications

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

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

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 olanzapina flas may need to be changed.

Taking olanzapina flas cinfa with alcohol

You should not drink alcohol while taking olanzapina flas, as the combination of olanzapina flas and alcohol can cause drowsiness.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

You should not take this medication while breastfeeding, as small amounts of olanzapina flas can pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with olanzapina flas 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 Using Machines

Olanzapine can cause symptoms such as drowsiness, dizziness, or changes in vision, and reduce your reaction ability. These effects, as well as the disease itself, can 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 medication.

olanzapina flas cinfa contains lactose.

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

olanzapina flas cinfa contains aspartame.

This medication contains 0.53 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine, which can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take olanzapina flas cinfa

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

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

The olanzapina flas 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.

The olanzapina flas cinfa orodispersible tablets are for oral administration.

The olanzapina flas cinfa orodispersible tablets dissolve easily, so they should be handled carefully. Do not handle the tablets with wet hands, as they may dissolve.

Take the orodispersible tablet as follows:

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press the blister (Figure 1).

1. Separate a blister

Each blister pack contains seven blisters, which are separated by perforations. Separate a blister by following the perforated lines (Figure 2).

1. Remove the foil

Remove the foil carefully, starting from the corner where it says "peel off aluminum" (Figures 3 and 4).

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on your tongue (Figure 5). It will dissolve directly in your mouth, making it easy to swallow.

You can also put the tablet in a cup or glass of water, orange juice, apple juice, milk, or coffee, stirring it. With some beverages, the mixture may change color and appear cloudy. It should be taken immediately.

If you take more olanzapina flas cinfa than you should

Patient who have taken more olanzapina flas than they should have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, 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.

Contact your doctor or go to the hospital immediately if you experience any of the above symptoms. Show your doctor the package with the tablets.

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 medication and the amount ingested.

If you forget to take olanzapina flas cinfa

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

If you interrupt treatment with olanzapina flas cinfa

Do not interrupt treatment just because you feel better. It is very important that you continue taking olanzapina flas while your doctor tells you to.

If you stop taking olanzapina flas suddenly, you may experience symptoms such as sweating, insomnia, tremors, anxiety, or 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 medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Contact your doctor immediately 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, go to the doctor immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency not knownthe frequency cannot be estimated from the available data).

Very Common Side Effects(can affect more than 1 in 10 people) include weight gain; drowsiness; and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common Side Effects(can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes 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 Side Effects(can affect up to 1 in 100 people) include excessive salivation, hypersensitivity (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; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; loss of urination ability; hair loss; absence or decrease of menstrual periods; and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth.

Rare Side Effects(can affect up to 1 in 1,000 people) include a drop in body temperature; abnormal heart rhythm; sudden unexplained death; pancreatitis, which causes severe stomach pain, fever, and discomfort; 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.

Very Rare Side Effects(can affect up to 1 in 10,000 people) include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later with an extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell in the blood (eosinophilia).

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

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package 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 contribute to providing more information on the safety of this medication.

5. Storage of olanzapina flas cinfa

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Olanzapine Flas Cinfa

• The active ingredient is olanzapine. Each buccal dispersible tablet of olanzapine flas cinfa contains 5 mg of active ingredient.
• The other components are: lactose monohydrate, calcium silicate, low-substitution hydroxypropyl cellulose, crospovidone, aspartame, orange flavor, banana flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Packaging Content

Olanzapine flas cinfa 5 mg buccal dispersible tablets are round and yellow.

Olanzapine flas cinfa 5 mg buccal dispersible tablets are available in packs of 28 tablets.

Other Presentations:

Olanzapine flas cinfa 10 mg buccal dispersible tablets: packs of 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

Sant Joan Despi (Barcelona)

Spain

Date of the Last Revision of this Leaflet:April 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73686/P_73686.html

QR code to: https://cima.aemps.es/cima/dochtml/p/73686/P_73686.html