Leaflet: information for the useruser

Arenbil 7.5 mg film-coated 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you and should not be given to others even if they have similar symptoms to yours, 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 ARENBIL is and for what it is used

2.What you need to know before starting to take ARENBIL

3.How to take ARENBIL

4.Possible side effects

5.Storage of ARENBIL

6.Contents of the pack and additional information

ARENBIL belongs to a group of medications called antipsychotics and is indicated for the treatment of the following diseases:

•Schizophrenia, a disease characterized by symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also experience depression, anxiety, or tension.

•Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

ARENBIL 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 ARENBIL

•If you are allergic to olanzapine 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).

• This medication contains soy oil. It should not be used in case of an allergy to peanuts or soy.

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 adverse effects.

•Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking ARENBIL, tell your doctor.

•In rare cases, medications of this type may 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 ARENBIL. You and your doctor should check your weight regularly.

•Elevated 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 monitor your blood sugar and fat levels before starting ARENBIL 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 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

Use of ARENBIL with other medications

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

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 ARENBIL dosage.

Use of ARENBIL with alcohol

You should not drink alcohol if you have been given ARENBIL as it may cause drowsiness.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

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

ARENBIL contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have doubts.

Your doctor will tell you how many ARENBIL tablets to take and for how long. The daily dose of ARENBIL ranges from 5 to 20 mg. Consult your doctor if you experience 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 coated ARENBIL 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/aggressiveness, 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 rigidity, drowsiness or lethargy, slowing of respiratory frequency, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the packaging with the tablets to the doctor.

If you forget to take ARENBIL

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

If you interrupt treatment with ARENBIL

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

If you stop taking ARENBIL 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.

•Clots in the veins (a rare 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, see your doctor 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 (can affect more than 1 in 10 people) include weight gain, drowsiness, and increased levels of prolactin in the blood.

Common side effects (can affect up to 1 in 10 people) include changes in levels of some blood cells and circulating lipids, increased levels of sugar in the blood and urine, increased appetite, dizziness, agitation, tremors, muscle stiffness or spasms (including eye movements), language alterations, constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention causing inflammation 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 lying down or sitting. This sensation usually disappears spontaneously, but if it does not, inform your doctor.

Rare side effects (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 leg syndrome; speech problems; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; loss of memory 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 and excessive salivation.

Other side effects in which the frequency cannot be estimated from available data (unknown), decreased normal body temperature, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellow discoloration of the skin and white areas of the eye, muscular disorder presenting as unexplained pain, and prolonged and/or painful erection.

During treatment with olanzapine, elderly patients with dementia may experience strokes, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. 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 initially manifests with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

If you experience side effects, consult your doctor or pharmacist, including if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, http://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 Arenbil 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.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.In case of doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of ARENBIL

•The active ingredient is olanzapine. Each tablet contains 7.5 mg of active ingredient.

•The other components areCore: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), soy lecithin (E-322), and xanthan gum (E-415).

Appearance of the product and contents of the packaging

Arenbil 7.5 mg is presented in the form of coated tablets. The tablets areround, white, and have the inscription “7.5”on one side.

They are presented in packs of 56 tablets.

Other presentations:

Arenbil 2.5 mg coated tablets EFG

Arenbil 5 mg coated tablets EFG

Arenbil 10 mg coated tablets EFG

Holder of the marketing authorization andresponsible 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

Last review date of this leaflet:August 2021.

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