BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS
How to use BICALUTAMIDE AUROVITAS 150 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Bicalutamide Aurovitas 150 mg film-coated tablets EFG
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
- What is Bicalutamide Aurovitas and what is it used for
- What you need to know before you take Bicalutamide Aurovitas
- How to take Bicalutamide Aurovitas
- Possible side effects
- Storage of Bicalutamide Aurovitas
- Contents of the pack and other information
1. What is Bicalutamide Aurovitas and what is it used for
This medicinal product contains the active substance bicalutamide, which belongs to a group of medicines called anti-androgens.
- Bicalutamide is indicated for the treatment of prostate cancer (a gland that, in men, produces seminal fluid) and acts by reducing the amount of testosterone (a hormone) produced by your body.
- This medicine will also be prescribed to you alone or in combination with other medicines:
- after prostate removal.
- after radiotherapy treatment (a medical technique that uses radiation to treat cancer).
- This medicine will be prescribed to you as monotherapy:
- if the tumor spreads to other organs and cannot be removed or if the action of agents in the testicles is inhibited.
Talk to your doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Bicalutamide Aurovitas
Do not take Bicalutamide Aurovitas
- If you are a woman.
- If you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
- If you are already taking a medicine called cisapride or some antihistamines (terfenadine or astemizole).
Bicalutamide should not be given to children.
Do not take bicalutamide if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before taking bicalutamide.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take bicalutamide:
- If you have any liver problems. Your doctor may perform blood tests before and during your treatment with bicalutamide.
- If you have any of the following: any heart or blood vessel disease, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these diseases. The risk of heart rhythm problems may increase with bicalutamide treatment.
- If you are taking bicalutamide, you and/or your partner must use a contraceptive method while you are being treated with bicalutamide and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.
If you are hospitalized, inform the healthcare staff that you are taking bicalutamide.
Children and adolescents
Bicalutamide should not be given to children or adolescents.
Medical tests
Your doctor may perform blood tests to check if there are any changes in your blood.
Other medicines and Bicalutamide Aurovitas
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This includes medicines that are not prescribed by a doctor and medicines that are based on plants. This is because bicalutamide may affect the way other medicines work. Also, some other medicines may affect the way bicalutamide works.
Do not take bicalutamide if you are already taking any of the following medicines:
- Cisapride (used for some types of indigestion).
- Some antihistamines (terfenadine or astemizole).
Bicalutamide may interfere with some medicines used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (e.g., methadone (used to relieve pain and for part of the treatment of drug addiction), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Oral medicines to prevent blood clotting (oral anticoagulants). Anticoagulants or medicines to prevent blood clots. Your doctor may perform blood tests before and during your treatment with bicalutamide.
- Cyclosporin (used to suppress the immune system).
- Calcium channel blockers (to treat high blood pressure or some heart diseases).
- Cimetidine (to treat stomach problems).
- Ketoconazole (to treat fungal infections).
Pregnancy, breastfeeding, and fertility
Bicalutamide should not be used in women.
Bicalutamide may cause limited fertility or infertility in men for a temporary period.
Driving and using machines
Bicalutamide is unlikely to affect your ability to drive or use tools or machines. However, some people may feel drowsy occasionally while taking bicalutamide. If this happens, consult your doctor or pharmacist.
Sunlight or ultraviolet (UV) light
Avoid excessive direct sunlight or ultraviolet light while taking bicalutamide.
Bicalutamide Aurovitas contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".
Bicalutamide Aurovitas contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
3. How to take Bicalutamide Aurovitas
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.
The recommended dose is one tablet per day. Swallow the tablet whole with a glass of water. Try to take the tablet at the same time every day. Do not stop taking this medicine, even if you feel well, unless your doctor tells you to.
Use in children and adolescents
Bicalutamide should not be given to children.
If you take more Bicalutamide Aurovitas than you should
In case of overdose or accidental ingestion, consult your doctor or 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 Bicalutamide Aurovitas
If you forget to take the medicine, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed doses.
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.
If you notice any of the following side effects, contact your doctor immediately – you may need urgent medical treatment:
Allergic reactions(uncommon, may affect up to 1 in 100 people):
The symptoms may include the sudden appearance of:
- Rash, itching, or hives on the skin.
- Swelling of the face, lips, tongue, throat, or other parts of the body.
- Shortness of breath, wheezing, or difficulty breathing.
Also, inform your doctor immediately if you notice any of the following symptoms:
Common(may affect up to 1 in 10 people):
- Yellowing of the skin or the whites of the eyes (jaundice). These may be signs of liver problems or, in rare cases, liver failure (may affect up to 1 in 1,000 patients).
- Abdominal pain.
- Blood in the urine.
Uncommon(may affect up to 1 in 100 people):
- Severe difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or high fever. These may be signs of a lung disease called "interstitial lung disease".
Frequency not known(cannot be estimated from the available data):
- Changes in the electrocardiogram (prolongation of the QT interval).
Other side effects:
Very common(may affect more than 1 in 10 people):
- Skin rash.
- Increased breast size and breast tenderness.
- Weakness.
Common(may affect up to 1 in 10 people):
- Hot flushes.
- Feeling of discomfort (nausea).
- Itching.
- Dry skin.
- Difficulty achieving an erection (erectile dysfunction).
- Weight gain.
- Decreased sexual desire and reduced fertility.
- Hair loss.
- Excessive hair growth/re-growth of hair.
- Low red blood cell count (anemia). This may make you feel tired or look pale.
- Decreased appetite.
- Depression.
- Drowsiness.
- Indigestion.
- Dizziness.
- Constipation.
- Gas (flatulence).
- Chest pain.
- Swelling.
Rare(may affect up to 1 in 1,000 people):
- Increased sensitivity of the skin to sunlight.
Your doctor may perform blood tests to check if there are any changes in your blood. Do not worry about this list of side effects. You may not get any of them.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Bicalutamide Aurovitas
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 carton and blister after EXP. The expiry date is the last day of the month stated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
Composition of Bicalutamide Aurovitas
- The active substance is bicalutamide. Each film-coated tablet contains 150 mg of bicalutamide.
- The other ingredients (excipients) are:
Core of the tablet:lactose monohydrate, sodium carboxymethyl starch type A (potato), povidone, magnesium stearate.
Coating of the tablet:HPMC 2910/hypromellose, titanium dioxide (E171), macrogol.
Appearance and packaging
Film-coated tablet.
Bicalutamide Aurovitas 150 mg film-coated tablets EFG:
White, round, film-coated tablet with "B2" marked on one side and smooth on the other.
Bicalutamide Aurovitas film-coated tablets are available in blister packs of 1, 10, 28, 30, 56, 60, 90, and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Or
Generis Farmacêutica, S.A.
Rua João de Deus, nº 19, Venda Nova
2700-487 Amadora
Portugal
Or
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France
You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
This medicine is authorised in the Member States of the European Economic Area under the following names:
Germany: Bicalutamid PUREN 150 mg film-coated tablets
Belgium: Bicalutamide Eugia 150 mg film-coated tablets/comprimés pelliculés/Filmtabletten
Spain: Bicalutamida Aurovitas 150 mg film-coated tablets EFG
Italy: Bicalutamide Aurobindo Italia
Netherlands: Bicalutamide Eugia 150 mg, film-coated tablets
Portugal: Bicalutamida Generis
Date of last revision of this leaflet: July 2024
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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