Package Leaflet: Information for the User

Olanzapine Flas Cinfa 20 mg Buccodispersible Tablets EFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

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

Olanzapina flas cinfa contains the active ingredient olanzapina. Olanzapina flas cinfa belongs to the therapeutic group of antipsychotics.

Olanzapina flas cinfa is indicated for the treatment of the following diseases:

Olanzapina has demonstrated the ability to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

You should not take olanzapina flas cinfa

Warnings and precautions

Consult your doctor or pharmacist before starting to take olanzapina flas cinfa.

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

• Stroke or transient ischemic attack (temporary lack of blood flow to the brain).
• 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 a loss of salts due to prolonged diarrhea and vomiting or the use of diuretic medications (water pills).

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

As a routine precaution, if you are over 65 years old, it would be a good idea for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take olanzapina flas cinfa.

Taking olanzapina flas cinfa with other medications

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

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

Specifically, 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).You may need to adjust your dose of olanzapina flas cinfa.

Taking olanzapina flas cinfa with alcohol

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

Pregnancy and breastfeeding

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

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

The following symptoms may occur in newborn babies whose mothers were treated with olanzapina flas cinfa in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

Driving and operating machinery

Olanzapina may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you 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 cinfa contains lactose.

If your doctor has told you that you have a lactose intolerance, 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 that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, 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 the 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 buccodispersible tablets are for oral administration.

Olanzapina flas cinfa buccodispersible tablets disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate.

Take the buccodispersible tablet as follows:

1. Do not crush the buccodispersible tablet

To prevent the buccodispersible tablet from being crushed, do not press the blister (Figure 1).

1. Separate a blister

Each blister 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 is indicated to "remove aluminum" (Figures 3 and 4).

1. Remove the buccodispersible tablet

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

You can also pour the tablet into a glass or a cup filled with water, orange juice, apple juice, milk, or coffee, stirring it. With some drinks, the mixture may change color and become cloudy. You should drink it immediately.

If you take more olanzapina flas cinfa than you should

Patients 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 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 rate, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms.

Get in touch with your doctor or go to the hospital immediately if you experience any of the symptoms mentioned above.Show the doctor the packaging with the tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 the missed doses.

If you interrupt treatment with olanzapina flas cinfa

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

If you stop taking olanzapina flas 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Get in touch with your doctor immediately if you have:

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

Frequent side effects(can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes; increased levels of sugar in the blood and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; tremor; strange movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention causing inflammation 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.

Rare 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 the 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; loss of memory or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods; and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Very rare side effects(can affect up to 1 in 1,000 people) include a decrease in normal body temperature; abnormal heart rhythm; sudden death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain and prolonged and/or painful erection.

Extremely 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 for short in English). 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 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, a rise in body temperature, skin redness, and difficulty walking. 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging 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 drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Olanzapine flas cinfa composition

Product appearance and packaging contents

Olanzapine flas cinfa 20 mg buccal dispersible tablets are round, yellow tablets with an approximate diameter of 9 mm.

Olanzapine flas cinfa 20 mg tablets are available in packs of 28 tablets.

Other presentations:

Olanzapine flas cinfa 15 mg buccal dispersible tablets: packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

or

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Last review date of this leaflet:April 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/.

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/75237/P_75237.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/75237/P_75237.html