Bicalutamida mabo 50 mg comprimidos recubiertos con pelicula efg

Prospecto: information for the user

Bicalutamida Mabo 50 mg film-coated tablets EFG

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

- Keep this prospect as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4

1. What Bicalutamida Mabo is and for what it is used.

2. What you need to know before starting to take Bicalutamida Mabo

3. How to take Bicalutamida Mabo

4. Possible adverse effects.

5. Storage of Bicalutamida Mabo

6. Contents of the package and additional information.

Bicalutamidabelongs to a group of medications called anti-androgens, which means it interferes with some of the actions of androgens (male sex hormones) in the body.

This medicationis used in the treatment of advanced prostate cancer. It is taken along with a medication called a luteinizing hormone-releasing hormone (LHRH) analogue, additional hormone therapy, or in conjunction with surgical removal of the testicles.

Do not takeBicalutamida Mabo:

If you are allergic (hypersensitive) to bicalutamida or to any of the other components of the medication (listed in section 6).

Warnings and precautions:

Consult your doctor, pharmacist before starting to take this medication:

• If you have any liver disorder or disease that affects your liver. The medication should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor will need to perform regular liver function tests.
• If you have a severe renal function disorder. The medication should only be taken after your doctor has carefully considered the possible benefits and risks.
• Inform your doctor if you have any heart or blood vessel disorder or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when bicalutamida is used.

Other medications and Bicalutamida Mabo :

Inform your doctor or pharmacist if you are using, or have recently used, or may need to use any other medication, including those purchased without a prescription.

Bicalutamida should not be taken with the following medications:

• Terfenadina or astemizol (for hay fever or allergy).
• Cisaprida (for stomach disorders).

Bicalutamida may interact with some medications used to treat heart rhythm problems (e.g. quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications [e.g. metadona (used for pain relief and detoxification of other medications), mosifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses].

If you take bicalutamida with any of the following medications, the effect of bicalutamida and the other medications may be affected. Consult your doctor before taking any of the following medications with bicalutamida:

-Warfarina or any medication similar to prevent blood coagulation.

-Ciclosporina (used to reduce the immune system to prevent and treat organ or bone marrow transplant rejection).

-Calcium channel blockers (to treat high blood pressure or some heart diseases).

-Cimetidina (to treat stomach ulcers).

-Ketoconazol (used to treat fungal infections of the skin and nails).

Children and adolescents

This medicationshould not be administered to children or adolescents (under 18 years).

Pregnancy and breastfeeding:This is not applicable as this medication is not used in women.

Driving and operating machinery:

There is a possibility that the tablets may make you feel dizziness or drowsiness. If you are affected by these symptoms, you should not drive or operate machinery.

BicalutamidaMabo contains Lactose. This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment. Do not discontinue treatment before your doctor tells you to. In case of hospital admission, inform the healthcare staff that you are taking bicalutamida.

The usual dose is:

• For adults, the usual dose is 1 tablet per day.

• Swallow the tablet whole with water.

• You can take the tablets with or without food.

• Try to take the tablet at the same time every day.

If you take more Bicalutamida Mabo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, Telephone 91 5620420, indicating the name of the medication and the amount ingested.

If you forgot to take Bicalutamida Mabo

If you forgot to take your daily dose and remember later, do not take it and wait until it is time for your next administration. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Bicalutamida Mabo

Do not stop taking this medication even if you feel well, unless your doctor tells you otherwise.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationmay have side effects,although not everyone will experience them.

Severe side effects

Contact your doctor or pharmacist immediately if you experience any of the following:

Severe side effects that are rare(may affect up to 1 in 100 patients/people):

• Severe allergic reactions that can cause swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing, or severe skin itching with the appearance of lumps.
• Severe difficulty breathing, sudden worsening of breathing difficulty, possibly with cough or fever. Some patients taking bicalutamide develop a lung inflammation called interstitial lung disease.
• Yellow skin and eyes (jaundice). These side effects may be symptoms of liver damage.

Severe side effects that are very rare(may affect up to 1 in 1,000 patients/people):

Yellow skin discoloration and white eye discoloration due to liver problems (including liver failure).

Other side effects

Inform your doctor if you are concerned about any of the following side effects:

Very common side effects(may affect more than 1 in 10 patients/people):

• Increased sensitivity or breast enlargement.
• Decreased libido, erectile dysfunction, impotence.
• Hot flashes.

Common side effects(may affect up to 1 in 10 patients/people):

• Nausea (feeling unwell)
• Diarrhea or constipation
• Dizziness
• Difficulty sleeping
• Rash on the skin, itching, sweating, excessive body hair
• Feeling weak.
• Weight gain
• Diabetes mellitus
• Edema
• General pain, pelvic pain
• Chills
• Blood test results may be altered depending on liver function.
• Decreased red blood cells, which may cause paleness and cause weakness or difficulty breathing.

Rare side effects(may affect up to 1 in 100 patients/people):

• Loss of appetite, weight loss
• Depression
• Increased blood sugar levels
• Drowsiness
• Shortness of breath
• Dry mouth, indigestion, flatulence (gas)
• Hair loss
• Need to urinate at night, blood in the urine,
• Abdominal pain, chest pain, headache, back pain, neck pain

Very rare side effects(may affect up to 1 in 1,000 patients/people):

• Vomiting
• Dry skin

Side effects of unknown frequency (cannot be estimated from available data):Changes in the electrocardiogram ECG (prolongation of the QT interval).

*The frequency obtained from clinical trials/safety studies, if no data are available, should be unknown frequency.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

This medication does not require special conditions for conservation.

Store in the original packaging to protect it from light and moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bicalutamida Mabo

• The active principle is bicalutamide. Eachtablet contains 50 mg of bicalutamide.
• The other components are:

Core:lactose monohydrate, povidone, crospovidone, sodium lauryl sulfate, magnesium stearate,

Coating: lactose monohydrate, hydroxypropyl methylcellulose, titanium dioxide (E- 171) and polyethylene glycol.

Appearance of Bicalutamida Maboand contents of the packaging

White, round, biconvex tablets marked with BCM 50 on one face; they are presented in blister packaging.

Each package contains 30 coated tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821. Coslada. Madrid

Spain

Responsible for manufacturing

SYNTHON BV
Microweg, 22, P.O.Box 7071 (Nijmegen) - NL-6545 - Netherlands

or

SYNTHON HISPANIA, S.L.
Castello 1, Poligono Las Salinas. (Sant Boi de Llobregat (Barcelona)) - 08830 - Spain

Date of the last review of this leaflet:January 2015

The 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/