ARENBIL FLAS 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Arenbil Flas 10 mg Orodispersible Tablets EFG

olanzapine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Arenbil Flas and what is it used for
2. What you need to know before you take Arenbil Flas
3. How to take Arenbil Flas
4. Possible side effects
5. Storing Arenbil Flas
6. Contents of the pack and other information

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

Arenbil Flas contains the active substance olanzapine. It belongs to a group of medicines called antipsychotics and is used to treat 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a disease whose symptoms are hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion and becoming withdrawn.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 medicine 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 you take Arenbil Flas

Do not take Arenbil Flas

• If you are allergic to olanzapine or any of the other ingredients of this medicine (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 medicine is not recommended in elderly patients with dementia as it may have serious side effects.
• Medicines 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, medicines 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 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 check your blood sugar and fat levels before you start taking this medicine and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

If you suffer from any of the following diseases, tell your doctor as soon as possible:

• Stroke or transient lack of blood flow to the brain (transient symptoms of stroke)
• 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 due to the use of diuretic medications (urination tablets)

If you suffer from dementia, you or your caregiver or relative 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 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 medications for anxiety or that help you sleep (tranquilizers).

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

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 medicine 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 medicine. You should not take this medicine when you are 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 medicine 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 medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains 1.06 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may 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 medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially "sodium-free".

3. How to take Arenbil Flas

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

Your doctor will tell you how many tablets you should 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 medicine unless your doctor tells you to.

The tablets should be taken once a day, following the instructions of your doctor. 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 crumble easily, so they should be handled with care. Do not handle the tablets with wet hands as they can break.

1. Hold the blister by the ends and separate one of the cells, breaking it gently at 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 drinks, the mixture may change color and appear cloudy. It should be drunk 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 be: 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 immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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 medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 lying down or sitting. This feeling usually goes away on its own, but if it doesn't, 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 dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon 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, 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 mammary 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 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 pains 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 a widespread 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.

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

Reporting of side effects

If you experience any side effect, consult your doctor or nurse, even if it is a possible side effect not listed in this 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 medicine.

5. Storing Arenbil Flas

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Arenbil Flas

The active substance is olanzapine. Each orodispersible tablet of Arenbil Flas contains 10 mg of active substance.

The other ingredients 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 10 mg and contents of the pack

Arenbil Flas 10 mg orodispersible tablets are yellow.

Arenbil Flas 10 mg orodispersible tablets are available in packs of 28 and 56 tablets.

Other presentations:

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

Arenbil Flas 15 mg orodispersible tablets: packs of 28 tablets.

Arenbil Flas 20 mg orodispersible tablets: packs 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 last revision of this leaflet:January 2024

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