ARENBIL 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Arenbil 10 mg film-coated 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 and what is it used for
2. What you need to know before you take ARENBIL
3. How to take ARENBIL
4. Possible side effects
5. Storage of ARENBIL
6. Contents of the pack and other information

1. What is ARENBIL and what is it used for

ARENBIL belongs to a group of medicines called 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disease whose symptoms are hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn.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, characterized by symptoms such as excitement or euphoria.

ARENBIL 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

Do not take ARENBIL

• If you are allergic to olanzapine or any of the other components 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).
• This medicine contains soybean oil. It should not be used in case of allergy to peanuts or soybeans.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ARENBIL

• ARENBIL is not recommended for use 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, tell your doctor.
• Very rarely, 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 ARENBIL. You and your doctor should check your weight regularly.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking ARENBIL. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking ARENBIL and regularly during treatment.
• If you or a family member have 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, inform your doctor as soon as possible:

• Stroke or transient cerebral ischemia (temporary stroke symptoms).
• Parkinson's disease
• Prostate problems
• Paralytic ileus (intestinal blockage)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or cerebral ischemia.

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

Use of ARENBIL with other medicines

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

Tell your doctor or pharmacist if you are using, have recently used, or may need to use 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 may need to be changed.

Use of ARENBIL with alcohol

You should not drink alcohol if you have been given ARENBIL because it 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 may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used ARENBIL in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

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

ARENBIL contains lactose

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

3. How to take ARENBIL

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have any doubts.

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

You should take your ARENBIL tablets 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. The ARENBIL film-coated tablets are for oral administration. You should swallow the ARENBIL tablets whole with water.

If you take more ARENBIL than you should

Patients who have taken more ARENBIL 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, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the tablets.

If you forget to take ARENBIL

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

If you stop taking ARENBIL

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

If you stop taking ARENBIL suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. 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 (an uncommon side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include sweating, 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.

Common side effects (which can affect up to 1 in 10 people) include changes in the levels of some blood cells and lipids, increased blood sugar and urine levels, increased appetite, dizziness, agitation, tremors, muscle stiffness or spasms (including eye movements), language disorders, constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention that causes swelling of the hands, ankles, or feet, and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men. In the early stages of treatment, some people experience dizziness or fainting (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, inform your doctor.

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; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; loss of urination ability; 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 and excessive salivation.

Other side effects whose frequency cannot be estimated from the available data (not known) 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 parts of the eyes, muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

During treatment with olanzapine, elderly patients with dementia may suffer from 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.

ARENBIL may worsen symptoms in patients with Parkinson's disease.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS is initially manifested with symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, fever, swelling of the lymph nodes, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia).

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, http://www.notificaRAM.es/.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ARENBIL

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

Do not use ARENBIL after the expiration date stated on the package after CAD. The expiration 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 packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ARENBIL

• The active ingredient is olanzapine. Each tablet contains 10 mg of active ingredient.
• The other ingredients are

Core:lactose monohydrate, microcrystalline cellulose (E-460), low-substituted hydroxypropyl cellulose (E-463a), crospovidone, anhydrous colloidal silica (E-551), and magnesium stearate (E-470b). Coating:polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soybean lecithin (E-322), and xanthan gum (E-415).

Appearance of the product and contents of the pack

Arenbil 10 mg is presented in the form of film-coated tablets. The tablets are round, white, and have the inscription “10” on one side.

They are available in packages of 28 or 56 tablets.

Other presentations:

Arenbil 2.5 mg film-coated tablets EFG

Arenbil 5 mg film-coated tablets EFG

Arenbil 7.5 mg film-coated tablets EFG

Marketing authorization holder andmanufacturer

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 leaflet:August 2021.

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