BICALUTAMIDE ACCORD 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

This medicine contains a substance called bicalutamide, which belongs to a group of medicines called: "anti-androgens".

These medicines block some of the effects of male sex hormones (androgens) in the body. One of the effects of androgens is that they stimulate tumor growth. Anti-androgens inhibit tumor growth.

This medicine is used to inhibit tumor growth in the prostate and improve the quality of life (palliative treatment).

• This medicine is used only in men with metastatic prostate cancer that cannot be operated on and who have had their testicles removed totally or partially or are taking a LHRH agonist (a type of medicine that prevents the body from forming testosterone).

2. What you need to know before you take Bicalutamida Accord

Do not take Bicalutamida Accord:

• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• if you are a woman (including pregnant or breastfeeding women).
• if you are already taking a medicine called cisapride or certain antihistamines (terfenadine or astemizole).

Do not take Bicalutamida Accord if any of the above warnings apply to your situation. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Bicalutamide should not be given to children.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take bicalutamide

• if you have: any heart or blood vessel disorder, including rhythm disorders (arrhythmia), or if you are being treated with medicines for these disorders. The risk of rhythm disorders may increase when taking bicalutamide.
• if you are taking anticoagulants or medicines to prevent blood clots.
• if you have liver disorders. Your doctor will want to check your liver function regularly.
• if you have diabetes and are already taking LHRH analogs (e.g., goserelin, buserelin, leuprorelin, and triptorelin). The active substance of this medicine (bicalutamide) may have a negative effect on your blood sugar levels. Therefore, your doctor will want to check your blood sugar levels regularly.
• if you go to the doctor, tell the medical team that you are taking Bicalutamida Accord.
• if you are taking bicalutamide, you and/or your partner should use contraceptives while taking bicalutamide and for 130 days after stopping bicalutamide. Talk to your doctor or pharmacist if you have any questions about birth control.

Other medicines and Bicalutamida Accord

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Bicalutamida Accord may affect the way other medicines work. Also, 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)
• Certain antihistamines (terfenadine or astemizole)

Bicalutamide may interfere with some medicines used to treat rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of rhythm disorders when used with other medicines (e.g., methadone (used for pain relief and detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Oral medicines to prevent blood clots (e.g., warfarin, coumarin derivatives)
• Cyclosporine (to suppress your immune system)
• Cimetidine (for stomach problems)
• Ketoconazole (to treat fungal infections)
• Calcium channel blockers (to treat high blood pressure or heart problems)

Taking Bicalutamida Accord with food and drinks

You can take this medicine with or without food. This does not affect the amount of medicine that is absorbed and reaches the bloodstream.

Pregnancy, breastfeeding, and fertility

Bicalutamida Accord should not be taken by women, including pregnant or breastfeeding women.

Bicalutamida Accord may have an effect on male fertility that can be reversible.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use any tools or machines. However, if you feel drowsy, be careful with these activities.

Bicalutamida Accord contains lactose

Lactose is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Bicalutamida Accord contains sodium

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

3. How to take Bicalutamida Accord

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

• The recommended dose is one 50 mg tablet per day. This applies to all adult men.
• Swallow the tablet whole with a glass of water.
• Try to take the tablet at the same time each day.
• Do not stop taking this medicine even if you feel well, unless your doctor tells you to.

If you take more Bicalutamida Accord than you should

If you take more bicalutamide tablets than your doctor has prescribed, talk to your doctor or go to the hospital immediately. Take the pack with you.

If you forget to take Bicalutamida Accord

• If you realize you have forgotten to take this medicine at the usual time, you can take it later the same day.
• However, if you realize you have forgotten to take the medicine the next day, skip the missed dose and take the next dose as usual.
• Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Bicalutamida Accord

Take this medicine as your doctor or pharmacist has told you. If you are thinking of stopping treatment, talk to your doctor first. This is because stopping the use of this medicine suddenly may cause side effects.

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

4. Possible side effects

Like all medicines, Bicalutamida Accord can cause side effects, although not everybody gets them.

The following side effects may occur when taking this medicine.

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

• Anemia.
• Dizziness.
• Hot flushes.
• Nausea.
• Constipation.
• Abdominal pain.
• Blood in the urine (hematuria).
• Breast development (gynecomastia).
• Sensitivity in the nipples and/or around them.
• Feeling weak (asthenia).
• Fluid retention (edema).

Common(may affect up to 1 in 10 people)

• Loss of appetite.
• Severe depression.
• Decreased sexual desire (reduced libido).
• Drowsiness.
• Heart failure.
• Heart attack; deaths have been reported.
• Indigestion. This can be felt as a feeling of fullness in the upper abdomen, pain in the stomach area, belching, nausea, vomiting, and heartburn (dyspepsia)
• Flatulence (gas).
• Changes in kidney function (increased liver enzymes (transaminases), jaundice).
• Bile and liver disorders.
• Itching (pruritus).
• Dry skin.
• Hair loss (alopecia).
• Rash.
• Excessive hair growth (hirsutism)
• Erectile dysfunction (impotence).
• Chest pain.
• Weight gain.

Uncommon(may affect up to 1 in 100 people)

• Hypersensitivity reactions such as sudden fluid accumulation in the skin and mucous membranes (e.g., throat or tongue), breathing difficulties, and/or itching and rash, often as an allergic reaction (angioedema) or skin rash with intense itching and hives (urticaria).
• Interstitial lung disease; cases with fatal outcomes have been reported.

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

• Liver failure (hepatic failure); fatal cases have been reported.
• Increased sensitivity of the skin to sunlight.

Not known(frequency cannot be estimated from the available data)

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

Your doctor may perform blood tests to check for 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 side effects, talk to your doctor, pharmacist, or nurse, even if it is an side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamida Accord

• No special storage conditions are required.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pack and on the blister strips after EXP. The expiry date is the last day of the month stated.

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 Bicalutamida Accord

The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.

The other ingredients (excipients) are:

Core of the tablet:

lactose monohydrate

potato starch glycolate sodium (Type A)

povidone K-30

magnesium stearate

Coating:

hypromellose E5

titanium dioxide (E-171)

macrogol 400

Appearance of the product and contents of the pack

Bicalutamida Accord are white to off-white, round, biconvex tablets, marked with "B 50" on one face and smooth on the other face.

Bicalutamida Accord is available in blister packs of 14, 20, 28, 30, 60, 84, 90, 98, or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Manufacturer

Accord Healthcare

Polska Sp.z.o.o,

ul.Lutomierska

50,95-200 Pabianice,

Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009,

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names

Member StateMedicine name

Germany Bicalutamide Accord 50 mg film-coated tablets

Belgium Bicalutamide Accord Healthcare 50 mg film-coated tablets/

filmomhulde tabletten/ filmtabletten

Bulgaria Bicalutamide Accord 50mg film-coated tablets

Cyprus Bicalutamide Accord 50mg film-coated tablets

Slovakia Bikalutamid Accord 50 mg film-coated tablets

Spain Bicalutamida Accord 50 mg film-coated tablets EFG

Estonia Bicalutamide Accord 50 mg film-coated tablets

Ireland Bicalutamide 50mg film-coated tablets

Italy Bicalutamide Accord 50 mg film-coated tablets

Latvia Bicalutamide Accord 50 mg film-coated tablets

Lithuania Bicalutamide Accord 50 mg film-coated tablets

Malta Bikalutamide 50mg film-coated tablets

Netherlands Bicalutamide Accord 50mg film-coated tablets

Poland Bicalutamide Accord

Portugal Bicalutamida Accord 50 mg film-coated tablets

United Kingdom Bicalutamide 50 mg film-coated tablets

Romania Bicalutamida Accord 50 mg film-coated tablets

Date of last revision of this leaflet: November 2022.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.