OLANZAPINE FLAS CINFA 15 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking olanzapina flas cinfa

Do nottakeolanzapina 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 may 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 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 fat (triglycerides and cholesterol) have been observed in the blood of patients taking olanzapina flas. Your doctor should perform blood tests to check 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 cerebral ischemia (transient stroke symptoms).
• Parkinson's disease.
• Prostate problems.
• Intestinal obstruction (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 cerebral ischemia.

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 may 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 may pass into breast milk.

The following symptoms may occur in newborns 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 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 impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

olanzapina flas cinfacontains 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 per tablet.

Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it properly.

3. How to take olanzapina flas cinfa

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will tell you how many olanzapina flas tablets to 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.

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.

Olanzapina flas cinfa orodispersible tablets are for oral administration.

Olanzapina flas cinfa orodispersible tablets dissolve easily, so handle them carefully. Do not handle the tablets with wet hands, as they may break apart.

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, 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, and stir. With some beverages, the mixture may change color and appear cloudy. Drink it 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/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, slowed breathing 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 stop taking olanzapina flas cinfa

Do not stop 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 experiences 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 (a rare side effect that may 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, see a 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(may 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 sensation usually disappears on its own, but if it does not, consult your doctor.

Common Side Effects(may affect up to 1 in 10 people) include changes in the levels of certain 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(may 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, most often 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(may 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 parts of the eyes; and a muscular disorder that presents as unexplained pain and prolonged and/or painful erections.

Very Rare Side Effects(may 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.

Olanzapina 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 Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of olanzapina flas cinfa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated 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 you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olanzapine Flas Cinfa

• The active ingredient is olanzapine. Each buccal dispersible tablet of olanzapine flas cinfa contains 15 mg of active ingredient.
• The other components are: lactose monohydrate, calcium silicate, low-substitution hydroxypropyl cellulose (E-463), crospovidone, aspartame (E-951), orange flavor, banana flavor, anhydrous colloidal silica, and magnesium stearate (E-470).

Appearance of the Product and Package Contents

Olanzapine flas cinfa 15 mg buccal dispersible tablets are round, yellow tablets with an approximate diameter of 8 mm.

Olanzapine flas cinfa 15 mg tablets are available in packages of 28 tablets.

Other Presentations:

Olanzapine flas cinfa 20 mg buccal dispersible tablets: packages of 28 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. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Date of the Last Revision of this Prospectus:April 2020

Detailed and updated information on this medication 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 medication by scanning the QR code included in the prospectus 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/75236/P_75236.html

QR code to: https://cima.aemps.es/cima/dochtml/p/75236/P_75236.html