Arenbil 5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Arenbil 5 mg film-coated 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 and should not be given to other people, even if they have the same symptoms as you, because it may 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 is and what it is used for
- What you need to know before taking Arenbil
- How to take Arenbil
- Possible adverse effects
- How to store Arenbil
- Contents of the pack and other information
1. What Arenbil is and what it is used for
ARENBIL belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:
- Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also feel 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 taking Arenbil
Do not take ARENBIL
- 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 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 pressure in the eye).
- This medicine contains soya oil. It should not be used if you are allergic to peanut or soya.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take ARENBIL
- The use of ARENBIL is not recommended in 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 occurs after taking ARENBIL, 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 happens, contact your doctor immediately.
- Weight gain has been observed in patients taking ARENBIL. You and your doctor should monitor your weight regularly.
- Increased levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking ARENBIL. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking ARENBIL 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 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.
Taking ARENBIL with other medicines
Only use other medicines together with ARENBIL if your doctor authorizes it. You may experience increased drowsiness if ARENBIL is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 may need to be adjusted.
Alcohol and ARENBIL
Do not drink alcohol while taking ARENBIL, as it may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You should not take this medicine while breastfeeding, as small amounts of ARENBIL may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken ARENBIL during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
There is a risk of drowsiness while taking ARENBIL. If this occurs, do not drive or operate machinery. Discuss this with your doctor.
ARENBIL contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Arenbil
Follow exactly the instructions for using this medicine as given by your doctor. If in 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 to take and for how long. The daily dose of ARENBIL ranges between 5 and 20 mg. Consult your doctor if your symptoms return, but do not stop taking ARENBIL unless your doctor tells you to do so.
You should take your ARENBIL tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. ARENBIL coated tablets are for oral administration. 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 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 blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to hospital if you experience any of the symptoms listed above. Show the doctor the medicine package.
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 for as long as your doctor tells you to.
If you stop taking ARENBIL 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 experiences 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 sweating, 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 attention immediately.
- a combination of fever, rapid breathing, sweating, muscle rigidity, and mental confusion or drowsiness (frequency cannot be estimated from 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.
Common adverse effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating lipids, increased blood and urine sugar levels, increased appetite, dizziness, agitation, tremor, muscle stiffness or spasms (including eye movements), speech disturbances, constipation, dry mouth, skin rash, loss of strength, excessive tiredness, fluid retention causing 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 may experience dizziness or fainting (with slower heartbeats), especially when standing up from a lying or sitting position. This sensation usually resolves spontaneously, but if it does not, inform your doctor.
Uncommon adverse effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (acetone 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; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual periods; and changes in the mammary gland in both men and women such as abnormal production of breast milk or abnormal growth, and excessive salivation.
Other adverse effects whose frequency cannot be estimated from available data (not known) include decreased body temperature, abnormal heart rhythm, sudden unexplained death, inflammation of the pancreas causing severe stomach pain, fever and malaise, liver disease with yellowing of the skin and whites of the eyes, muscle disorder presenting as unexplained muscle pain, and prolonged and/or painful erection.
During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated 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.
Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, facial skin rash that later spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaRAM.es/.
By reporting adverse 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 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. Return unused or expired containers and medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of ARENBIL
- The active substance is olanzapine. Each tablet contains 5 mg of active substance.
- The other components are Core: monohydrate lactose, 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), soya lecithin (E-322) and xanthan gum (E-415).
Appearance of the product and contents of the pack
Arenbil 5 mg is presented as film-coated tablets. The tablets are round, white, and marked with the inscription “5” on one side.
Packaged in packs of 28 tablets.
Other presentations:
Arenbil 2.5 mg film-coated tablets EFG
Arenbil 7.5 mg film-coated tablets EFG
Arenbil 10 mg film-coated tablets EFG
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 latest revision of this leaflet: August 2021.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.