ARENBIL FLAS 15 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Arenbil Flas 15 mg Orodispersible Tablets efg

olanzapine

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 Arenbil Flas and what is it 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. Package Contents and Additional Information

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

Arenbil Flas contains the active ingredient olanzapine. 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disease whose symptoms are hearing, seeing, or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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.

This medication 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 Arenbil Flas

Do not take Arenbil Flas

• 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 Arenbil Flas

• The use of this medication 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 Arenbil 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 this medication. 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 Arenbil Flas. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking this medication 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 stroke symptoms)
• 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 would be advisable for your doctor to check your blood pressure.

Children and Adolescents

Patients under 18 years of age should not take Arenbil Flas.

Other Medications and Arenbil Flas

Only use other medications at the same time as this medication if your doctor authorizes it. You may feel drowsy if you combine it 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 Arenbil Flas may need to be changed.

Using Arenbil Flas with Alcohol

You should not drink alcohol while taking this medication, as the combination with 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 Arenbil Flas can pass into breast milk.

The following symptoms may occur in newborn babies of mothers who have been treated with this medication 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, you should contact your doctor.

Driving and Using Machines

There is a risk of drowsiness when taking Arenbil Flas. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

Arenbil Flas contains Lactose, Aspartame, and Sodium.

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

This medication contains 1.59 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that 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.

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

3. How to Take Arenbil Flas

Follow your doctor's instructions for taking this medication exactly. If you are in 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. The orodispersible tablets of Arenbil Flas are for oral administration.

The tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands, as they may break.

1. Hold the blister pack by the ends and separate one of the cells, breaking it gently along the perforations that surround it.
2. Gently remove the back of the cell.
3. Carefully remove the tablet.
4. Place the tablet in your mouth. It will dissolve directly in your mouth, making it easy to swallow.

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

If you take more Arenbil Flas than you should

Patients who have taken more Arenbil 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, slowing of respiratory rate, 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 above symptoms. Show the doctor the package with the tablets.

In case of overdose or accidental ingestion, you can also contact 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 Arenbil Flas

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

If you stop taking Arenbil Flas

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

If you stop taking this medication 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 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 (the frequency cannot be estimated from the available data)

Very common side effects (which 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 (which 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.

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 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; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of urination ability; 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 (which can affect up to 1 in 1000 people) include a drop in normal 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 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, redness of the skin, and walking problems. Some deaths have been reported in this particular group of patients.

This medication may worsen symptoms in patients with Parkinson's disease.

Reporting Side Effects

If you experience any side effects, consult your doctor or nurse, 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: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Arenbil Flas

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.

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. 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 Arenbil Flas

The active ingredient is olanzapine. Each orodispersible tablet of Arenbil Flas contains 15 mg of active ingredient.

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

Appearance of Arenbil Flas 15 mg and Package Contents

Arenbil Flas 15 mg orodispersible tablets are yellow.

Arenbil Flas 15 mg orodispersible tablets are available in packages of 28 tablets.

Other Presentations:

Arenbil Flas 5 mg orodispersible tablets: packages of 28 tablets.

Arenbil Flas 10 mg orodispersible tablets: packages of 28 and 56 tablets.

Arenbil Flas 20 mg orodispersible tablets: packages of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Date of the Last Revision of this Package Leaflet:January 2024

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