Bicalutamide Accord 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bicalutamide Accord 50 mg film-coated tablets EFG

Read the entire leaflet carefully before you start using 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 only, and you should not give it 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.

Contents of the leaflet

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

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

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

These medicines block some of the effects of male sex hormones, androgens, in the body. One of the effects of androgens is to stimulate tumour growth. Anti-androgens inhibit tumour growth.

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

• This medicine is used only in men with metastatic prostate cancer that cannot be surgically treated, who have undergone complete or partial removal of the testicles, or who are taking a LHRH agonist (a type of medicine that prevents the body from producing testosterone).

2. What you need to know before starting to take Bicalutamide Accord

Do not take Bicalutamida Accord:

• if you are allergic to bicalutamide or to 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 antihistamine medicines (terfenadine or astemizole).

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

Bicalutamide must not be administered to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bicalutamide

• if you have: any condition affecting the heart or blood vessels, including problems with heart rhythm (arrhythmia), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when bicalutamide is used.
• if you are taking anticoagulants or medicines to prevent blood clots.
• if you have liver problems. Your doctor will want to monitor your liver function regularly.
• if you have diabetes and are already taking analogues of luteinizing hormone-releasing hormone (LHRH). This includes goserelin, buserelin, leuprorelin, and triptorelin. The active substance in this medicine (bicalutamide) may have a negative effect on your blood sugar levels. Therefore, your doctor will want to monitor your blood sugar levels regularly.
• if you visit a doctor, inform the medical team that you are taking Bicalutamida Accord.
• if you are taking bicalutamide, you and/or your partner must use contraception while taking bicalutamide and for 130 days after stopping bicalutamide. Speak with your doctor or pharmacist if you have any questions about birth control.

Other medicines and Bicalutamida Accord

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Bicalutamida may affect how other medicines work. Also, other medicines may affect how bicalutamide works.

Do not take bicalutamide if you are already taking any of the following medicines:

• Cisapride (used for certain types of indigestion)
• Certain 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 for pain relief and detoxification from other drugs), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

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

• Oral medicines to prevent blood clots (oral anticoagulants), 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 certain heart problems)

Taking Bicalutamida Accord with food and drinks

You may take this medicine with or without food. This does not affect the amount of medicine absorbed into your bloodstream.

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

This medicine is unlikely to affect your ability to drive or operate tools or machinery. However, if you feel drowsy, take care when performing these activities.

Bicalutamida Accord contains lactose

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

Bicalutamida Accord contains sodium

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

3. How to take Bicalutamide Accord

Follow exactly the instructions for administering this medicine as given by your doctor. If in 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 Bicalutamide Accord than you should

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

If you forget to take Bicalutamide Accord

• If you realize you have forgotten to take the medicine at the usual time, you may take it later the same day.
• However, if you realize you have forgotten to take the medicine only the following 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 forgotten dose.

If you stop taking Bicalutamide Accord

Take this medicine as your doctor or pharmacist has instructed. If you are considering stopping treatment, speak to your doctor first. This is because suddenly stopping the use of this medicine may lead to adverse effects.

If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Bicalutamide Accord can cause adverse effects, although not everyone experiences them.

The following adverse effects may occur when using this medicine.

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

• Anaemia.
• Dizziness.
• Hot flushes.
• Nausea.
• Constipation.
• Abdominal pain.
• Blood in the urine (haematuria).
• Breast development (gynaecomastia).
• Tenderness of the nipples and/or surrounding area.
• Feeling of weakness (asthenia).
• Fluid retention (oedema).

Common (may affect up to 1 in 10 people)

• Loss of appetite.
• Low mood (severe) (depression).
• Decreased sexual desire (reduced libido).
• Drowsiness.
• Inadequate pumping of the heart (heart failure).
• Heart attack; deaths have been reported.
• Indigestion. This may present as a feeling of fullness in the upper abdomen, stomach area pain, burping, nausea, vomiting, and heartburn (dyspepsia).
• Flatulence (gas).
• Changes in kidney function (increase in certain liver enzymes (transaminases), jaundice).
• Biliary and liver disorders.
• Itching (pruritus).
• Dry skin.
• Hair loss (alopecia).
• Skin 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 skin rash, often as an allergic reaction (angioedema) or skin rash with intense itching and hives (urticaria).
• Interstitial lung disease; fatal cases have been reported.

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

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

Not known (frequency cannot be estimated from available data)

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

Your doctor may perform blood tests to monitor any changes in your blood.

Do not be alarmed by this list of adverse effects. You may not experience any of them.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, hospital pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide 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 packaging and on the blister strips after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamide Accord

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

The other components (excipients) are:

Tablet core:

monohydrate lactose
sodium starch glycolate from potato (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

Bicalutamide Accord are white to off-white, round, biconvex tablets, marked with “B 50” on one side and smooth on the other.

Bicalutamide Accord is available in blisters 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, 6th floor
08039 Barcelona, Spain

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 medicinal product is authorized in the European Economic Area member states under the following names:

Member State Medicinal Product Name

Germany Bicalutamide Accord 50 mg Filmtabletten
Belgium Bicalutamide Accord Healthcare 50 mg comprimés pelliculés / filmomhulde tabletten / filmtabletten
Bulgaria Bicalutamide Accord 50mg Film-coated Tablets
Cyprus Bicalutamide Accord 50mg Film-coated Tablets
Slovakia Bikalutamid Accord 50 mg filmom obalené tablety
Spain Bicalutamida Accord 50 mg comprimidos recubiertos con película EFG
Estonia Bicalutamide Accord 50 mg õhukese polümeerikattega tabletid
Ireland Bicalutamide 50mg Film-coated Tablets
Italy Bicalutamide Accord 50 mg Pellicolarivestiti
Latvia Bicalutamide Accord 50 mg apvalkotas tabletes
Lithuania Bicalutamide Accord 50 mg plevele dengtos tabletes
Malta Bikalutamide 50mg Film-coated Tablets
Netherlands Bicalutamide Accord 50mg Filmomhulde Tabletten
Poland Bicalutamide Accord
Portugal Bicalutamida Accord 50 mg comprimidos revestidos por película
United Kingdom Bicalutamide 50 mg Film-coated Tablets
Romania Bicalutamida Accord 50 mg, comprimate filmate

Date of the most recent review of this leaflet: November 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.