Arenbil Flas 5 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Arenbil Flas 5 mg orodispersible tablets EFG
olanzapine
Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Arenbil Flas is and what it is used for
- What you need to know before taking Arenbil Flas
- How to take Arenbil Flas
- Possible side effects
- How to store Arenbil Flas
- Contents of the pack and other information
1. What Arenbil Flas is and what it is used for
Arenbil Flas contains the active substance olanzapine. It belongs to the therapeutic group of antipsychotics and is indicated for the treatment of the following conditions:
- Schizophrenia, a disorder whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.
- Moderate to severe manic disorder, a condition whose symptoms include 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 taking Arenbil Flas
Do not take Arenbil Flas
- If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may appear as 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
Talk to your doctor or pharmacist before taking Arenbil Flas
- This medicine is not recommended for elderly patients with dementia, as it may cause serious adverse effects.
- Medicines of this type may cause unusual movements, especially of the face or tongue. If this happens after taking Arenbil Flas, inform your doctor.
- Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately.
- Weight gain has been observed in patients taking this medicine. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.
- Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking Arenbil Flas. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting treatment 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 blood clot formation.
If you have any of the following conditions, inform your doctor as soon as possible:
- Stroke or transient ischemic attack (temporary stroke-like 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 be losing salts due to prolonged severe diarrhea or vomiting, or from using diuretic medicines (water tablets)
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 monitor your blood pressure.
Children and adolescents
Patients under 18 years of age must not take Arenbil Flas.
Other medicines and Arenbil Flas
Only take other medicines at the same time as this medicine if authorized by your doctor. You may feel increased drowsiness if this medicine is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).
Tell your doctor if you are taking, have recently taken, or might 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). Your dose of Arenbil Flas may need to be adjusted.
Use of Arenbil Flas with alcohol
Do not drink alcohol while taking this medicine, as combining it with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You must 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 of mothers who have been treated with this medicine during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If your baby develops any of these symptoms, contact your doctor.
Driving and using machines
There is a risk of drowsiness while taking Arenbil Flas. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
Arenbil Flas contains lactose, aspartame, and sodium.
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
This medicine contains 0.53 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".
3. How to take Arenbil Flas
Follow exactly the instructions for using this medicine as given by your doctor. If 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 your symptoms return, but do not stop taking this medicine unless instructed by your doctor.
The tablets should be taken once daily, as directed by your doctor. Try to take them at the same time each day. They may be taken with or without food. The Arenbil Flas orodispersible tablets 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 may disintegrate.
- Hold the blister pack at the edges and separate one of the blisters, gently breaking it along the perforations surrounding it.
- Gently peel back the back of the blister.
- Carefully remove the tablet.
- Place the tablet in the mouth. It will dissolve directly in the mouth, making it very easy to swallow.
Alternatively, the tablet may be placed in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some beverages, the mixture may change color and become cloudy. It should be consumed immediately.
If you take more Arenbil Flas than you should
Patients who have taken more Arenbil Flas than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue), and 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, slowed breathing rate, aspiration, increased or decreased blood pressure, or abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the packaging with the tablets.
In case of overdose or accidental ingestion, you may also immediately contact your pharmacist or call the Toxicology Information Service at telephone number: 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 for as long as your doctor instructs.
If you stop taking this medicine suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Contact your doctor immediately if you have:
- unusual movements (a common adverse effect which may affect up to 1 in 10 people), especially of the face or tongue.
- blood clots in the veins (an uncommon adverse effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
- a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from the available data).
Very common adverse effects (may 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 standing up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, consult your doctor.
Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes; increased levels of blood and urine sugar; increased levels of uric acid and creatine phosphokinase in blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive tiredness; fluid retention causing 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.
Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. mouth and throat swelling, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, which in most cases are 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 reduction of menstrual periods; and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.
Rare adverse effects (may affect up to 1 in 1,000 people) include decreased normal body temperature; abnormal heart rhythm; sudden unexplained death; inflammation of the pancreas, causing severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and whites of the eyes; a muscle disorder presenting as unexplained muscle pains, and prolonged and/or painful erection.
Very rare adverse effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with flu-like symptoms and a rash on the face, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes observed in blood tests, and an increase in 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, increased 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 adverse effects
If you experience any adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Arenbil Flas
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of any containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Arenbil Flas
The active substance is olanzapine. Each Arenbil Flas orodispersible tablet contains 5 mg of active substance.
The other components are monohydrate lactose, calcium silicate, low-substituted hydroxypropyl cellulose (E-463), crospovidone, aspartame (E-951), orange flavour, banana flavour (contains sodium), anhydrous colloidal silica (E-551) and magnesium stearate (E-470).
Appearance of Arenbil Flas 5 mg and contents of the pack
Arenbil Flas 5 mg orodispersible tablets are yellow.
Arenbil Flas 5 mg orodispersible tablets are available in packs of 28 tablets.
Other presentations:
Arenbil Flas 10 mg orodispersible tablets: packs of 28 and 56 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 the most recent revision of this leaflet: January 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/.