Summary of Product Characteristics: Information for the User

Arenbil Flas 5 mg Buccodispersible Tablets EFG

olanzapine

Read this leaflet carefully before you start taking 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.

1.What is Arenbil Flas and what it is used for

2.What you need to know before taking Arenbil Flas

3.How to take Arenbil Flas

4.Possible side effects

5.Storage of Arenbil Flas

6.Contents of the pack and additional information

Arenbil Flas contains the active ingredient olanzapina. It 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a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion and becoming withdrawn.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 shown 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 Arenbil Flas

-If you are allergic to olanzapine or any of the other ingredients in this medicine (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 Arenbil Flas.

• This medicine is not recommended for use in elderly patients with dementia as it may have serious adverse effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Arenbil Flas, tell your doctor.
• In very 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.
• Weight gain has been observed in patients taking this medicine. 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) in the blood have been observed in patients taking Arenbil Flas. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting this medicine and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medicines 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 diuretics (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, your doctor should check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Arenbil Flas.

Other medicines and Arenbil Flas

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

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

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 Arenbil Flas.

Use of Arenbil Flas with alcohol

You should not drink alcohol while taking this medicine as the combination with 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 medicine. Do not take this medicine while breastfeeding as small amounts of Arenbil Flas may pass into breast milk.

The following symptoms may occur in newborn babies whose mothers were treated with this medicine in the last three months of pregnancy (last trimester): 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 Arenbil Flas. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

Arenbil Flas contains lactose, aspartame, and sodium.

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

This medicine 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.

This medicine 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 to take and for how long. The daily dose 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.

The tablets should be taken once a day, following your doctor's instructions. Try to take them at the same time every day. They can be taken with or without food. Arenbil Flas tablets are for oral administration.

The tablets disintegrate easily, so they should be handled with care. Do not handle the tablets with wet hands because they can 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. Remove the back of the cell gently.

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.It should be consumed immediately.

If you take moreArenbil Flasthan you should

Patients who have taken more Arenbil Flas 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 frequency, aspiration, increased or decreased blood pressure, or abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you experience any of the symptoms mentioned above.Bring the packaging with the tablets to show the doctor.

In case of overdose or accidental ingestion, you can also consult your pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeArenbil Flas

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

If you interrupt treatment withArenbil Flas

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

If you stop taking this medication suddenly, you may experience symptoms such as sweating, inability to sleep, 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.

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 medical attention immediately.

•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 feeling 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 the 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; nosebleeds; abdominal distension; excessive salivation; memory loss 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.

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 for its acronym in English). 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 (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.

This medicine 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 the Spanish 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 usethis medicationafter 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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Arenbil Flas

The active ingredient is olanzapine. Each buccal dispersible tablet of Arenbil Flas 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).

Appearance of Arenbil Flas 5 mg and contents of the packaging

Arenbil Flas 5 mg buccal dispersible tablets are yellow.

Arenbil Flas 5 mg buccal dispersible tablets are available in packs of 28 tablets.

Other presentations:

Arenbil Flas 10 mg buccal dispersible tablets: packs of 28 and 56 tablets.

Arenbil Flas 15 mg buccal dispersible tablets: packs of 28 tablets.

Arenbil Flas 20 mg buccal dispersible tablets: packs of 28 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Last review date of this leaflet: January 2024

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