Patient Information Leaflet

Olanzapina Flas Qualigen5 mg buccal dispersible 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 similar symptoms to 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.

1.What Olanzapina Flas Qualigen is and what it is used for

2.What you need to know before you start taking Olanzapina Flas Qualigen

3.How to take Olanzapina Flas Qualigen

4.Possible side effects

5.Storage of Olanzapina Flas Qualigen

6. Contents of the pack and additional information

Olanzapina Flas Qualigen contains the active ingredient olanzapina. This medication belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious or tense.

• Moderate to severe manic disorder, a disease whose symptoms are excitement or euphoria.

This medication 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.

Do not take Olanzapina Flas Qualigen

-If you are allergic to olanzapina or any of the other components of this medication (listed in section 6). 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina Flas Qualigen.

• Olanzapina Flas Qualigen is not recommended for elderly patients with dementia as it may have severe adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Olanzapina Flas Qualigen, tell your doctor.
• In 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 occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Flas Qualigen. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or refer you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking this medication. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Olanzapina Flas Qualigen 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 blood clot formation.

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 be losing electrolytes due to prolonged diarrhea and vomiting or the use of diuretic medications (diuretics).

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, your doctor should check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Olanzapina Flas Qualigen.

Other medications and Olanzapina Flas Qualigen

Only use other medications at the same time as this medication if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Flas Qualigen 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 Olanzapina Flas Qualigen dosage.

Use of Olanzapina Flas Qualigen with alcohol

You should not drink alcohol while taking this medication, as the combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. Do not take this medication while breastfeeding, as small amounts of this medication may pass into breast milk.

The following symptoms may occur in newborn babies whose mothers were treated with Olanzapina Flas Qualigen 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

There is a risk of drowsiness when taking this medication. If this occurs, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapina Flas Qualigen contains lactose, aspartame, and sodium.

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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 due to the body's inability to eliminate it correctly.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

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

Olanzapina Flas Qualigen 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 Qualigen buccal tablets are for oral administration.

Olanzapina Flas Qualigen tablets disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands because they may break apart.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently through the perforations that surround it.

2. Gently remove the back of the cell.

3. Carefully extract the tablet.

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

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

If you take more Olanzapina Flas Qualigen than you should

Patients who have taken more Olanzapina Flas Qualigen than they should have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, 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. Contact your doctor or go to the hospital immediately if you experience any of the symptoms specified above. Show the packaging with the tablets to your doctor.

You can also consult with your pharmacist 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 Qualigen

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 Qualigen

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

If you stop taking Olanzapina Flas Qualigen 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.

Immediately contact your doctor 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, seek immediate medical attention.

•A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Frequent side effects (which 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 down or sitting. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in levels of some blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes; increased levels of blood sugar 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 (which can affect up to 1 in 100 people) include 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; nasal bleeding; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; 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.

Rare side effects (which can affect up to 1 in 1000 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.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS by its English acronym). Initially, DRESS manifests with symptoms similar to the flu with a rash on the face and later, with extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of 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 difficulty walking. Some deaths have been reported in this particular group of patients.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on 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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Olanzapina Flas Qualigen

The active ingredient is olanzapine. Each buccal dispersible tablet of Olanzapina FLas

Qualigen contains 5 mg of active ingredient.

The other components are lactose monohydrate, calcium silicate, low-substituted hydroxypropyl cellulose(E-463), crospovidone, aspartame(E-951), orange aroma, banana aroma (contains sodium), anhydrous colloidal silica (E-551) and magnesium stearate(E-470). See section 2Olanzapina Flas Qualigen contains lactose, aspartame and sodium.

Appearance of Olanzapina Flas Qualigen 5 mg and content of the container

Olanzapina Flas Qualigen 5 mg buccal dispersible tablets are yellow.

Olanzapina Flas Qualigen 5 mg buccal dispersible tablets are available in containers of 28 tablets.

Other presentations:

Olanzapina Flas Qualigen 10 mg buccal dispersible tablets: containers of 28 and 56 tablets.

Olanzapina Flas Qualigen 15 mg buccal dispersible tablets: containers of 28 tablets.

Olanzapina Flas Qualigen 20 mg buccal dispersible tablets: containers of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Date of the last review of this leaflet: 05/2024

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