BICALUTAMIDE CINFA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

bicalutamide cinfa 50 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

1. What is bicalutamide cinfa and what is it used for
2. What you need to know before you take bicalutamide cinfa
3. How to take bicalutamide cinfa
4. Possible side effects
5. Storage of bicalutamide cinfa
6. Contents of the pack and other information

1. What is bicalutamide cinfa and what is it used for

bicalutamide cinfa belongs to a group of medicines called anti-androgens, which means that it interferes with some of the actions of male sex hormones (androgens) in the body.

This medicine is used in the treatment of advanced prostate cancer (daily dose of 50 mg) in combination with a medicine called luteinizing hormone-releasing hormone (LHRH) analogue - an additional hormonal treatment - or in conjunction with surgical removal of the testicles.

It is also used in the treatment of prostate cancer without metastasis, in cases where there is a high risk of progression of the disease (daily dose of 150 mg). It can be used alone or in combination with other therapeutic methods such as surgical removal of the prostate gland or radiotherapy.

2. What you need to know before you take bicalutamide cinfa

Do not takebicalutamide cinfa

• If you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman.
• If you are taking terfenadine or astemizole, which are used to treat allergies, or cisapride, which is used to treat heartburn and acid reflux.

Bicalutamide should not be given to children and adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bicalutamide cinfa:

• If you have any liver disease or liver problems. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor should regularly perform liver function tests on you. Deaths (severe liver changes and liver failure) have been reported.
• If you have a lung disease called interstitial lung disease. Symptoms of this may include severe difficulty breathing with cough or fever. Deaths have been reported.
• If you are taking any other medicine, including those obtained without a prescription. In particular, if you are taking medicines that thin the blood or medicines to prevent blood clots.
• If you have diabetes. The combined treatment of bicalutamide with LHRH analogues may alter your blood sugar levels. Your doctor should adjust your insulin dose and/or anti-diabetic medicines.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in these cases.
• If you are taking a daily dose of 150 mg of bicalutamide and have heart disease. Your doctor may choose to check your heart function periodically.

Tell your doctor if you have any heart or blood vessel disease or are being treated for it, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using bicalutamide.

If any of the above situations apply to you, inform your doctor, he will take it into account during your treatment with bicalutamide.

If you are admitted to hospital, inform the medical staff that you are taking bicalutamide.

If you are taking bicalutamide, you and/or your partner should 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.

Children and adolescents

Bicalutamide should not be given to children and adolescents under 18 years of age.

Other medicines and bicalutamide cinfa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines.

Do not take bicalutamide with the following medicines:

• Terfenadine or astemizole (for hay fever or allergy).
• Cisapride (for stomach problems).

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

• In particular, tell your doctor if you are taking blood-thinning medicines such as warfarin.
• Ciclosporin (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures or as an anaesthetic before and during surgery).
• Calcium channel blockers (e.g. diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart diseases).
• Cimetidine (for stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

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 for pain relief and for detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

Please note that these warnings may also apply to medicines that you have used some time ago.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Bicalutamide should not be taken by women, including pregnant or breast-feeding women.

Bicalutamide may have an effect on male fertility, which may be reversible.

Driving and using machines

Bicalutamide may make you feel drowsy, so you should be careful when driving or using machines.

bicalutamide cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

bicalutamide cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take bicalutamide cinfa

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

• In adults, the recommended dose is 1 tablet per day (equivalent to 50 mg of bicalutamide) or 3 tablets per day (equivalent to 150 mg of bicalutamide).
• Swallow the tablet(s) whole with the help of water.
• Try to take the tablet(s) at the same time each day.

In patients with prostate cancer without metastasis who have a high risk of disease progression, the recommended dose is 3 tablets per day (equivalent to 150 mg of bicalutamide).

If you take morebicalutamide cinfathan you should

If you ingest a dose higher than normal, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takebicalutamide cinfa

Do not take a double dose to make up for forgotten doses, simply continue with your usual treatment.

If you stop taking bicalutamide cinfa

Do not stop taking this medicine even if you feel better, unless your doctor tells you to.

If you have any further questions on 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 symptoms,tell your doctor immediately or go to the emergency department of the nearest hospital. These side effects are very serious.

• Skin rash, severe itching of the skin (with lumps), hives, skin peeling or blistering.
• Swelling of the face or neck, lips, tongue and/or throat, which may cause difficulty breathing or swallowing.
• Difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine.
• Abdominal pain.
• Yellowing of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine are:

Very common (may affect more than 1 in 10 people):

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Hot flushes.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Enlargement of the breasts and breast tenderness. Breast enlargement may not resolve spontaneously after stopping therapy, particularly after prolonged treatment.

Common (may affect up to 1 in 10 people):

• Weight gain.
• Drowsiness.
• Heart attack (deaths have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes).
• Erectile dysfunction.
• Decreased sex drive.
• Depression.

Uncommon (may affect up to 1 in 100 people):

• Interstitial lung disease (a lung disease). Deaths have been reported.
• Allergic reactions (hypersensitivity), skin swelling, hives.

Rare (may affect up to 1 in 1,000 people):

• Liver failure. Deaths have been reported.
• Increased sensitivity to sunlight.

Frequency not known (cannot be estimated from the available data):

• Changes in the electrocardiogram (ECG) (prolongation of the QT interval).

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) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of bicalutamide cinfa

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 after EXP. The expiry date refers to the last day of the month shown.

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 ofbicalutamide cinfa

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other ingredients are:

Core of the tablet:lactose monohydrate, povidone, crospovidone, sodium lauryl sulfate, magnesium stearate and purified water.

Coating of the tablet:lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000 and purified water.

Appearance and packaging

bicalutamide cinfa is presented in the form of film-coated tablets, white, cylindrical and biconvex. One side is engraved with “BCM 50”.

Each pack contains 30 or 100 (clinical pack) tablets, packaged in PVC/PE/PVDC/Aluminum blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

SYNTHON BV Microweg,

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

Synthon Hispania S.L.

Castelló, 1 Polígono Las Salinas 08830 Sant Boi de Llobregat Spain

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:May 2021

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68818/P_68818.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68818/P_68818.html