Leaflet: Information for the user

Bicalutamida Accord 50 mg film-coated tablets EFG

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms of illness as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Bicalutamida Accord 4. Possible side effects.

5. Storage of Bicalutamida Accord

6. Contents of the pack and additional information.

This medication contains a substance called bicalutamida, which belongs to a group of medications known as: “anti-androgens”.

These medications 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 medication is used to inhibit tumor growth in the prostate and improve quality of life (palliative treatment).

• This medication is usedonlyin men with metastatic prostate cancer that is not operable and in those who have had their testicles completely or partially removed or in those who are taking an LHRH agonist (a type of medication that prevents the body from forming testosterone).

Do not take Bicalutamida Accord:

• if you are allergic to bicalutamida or any of the other ingredients of this medication (listed in section 6).
• if you are a woman (including pregnant women or breastfeeding women).
• if you are already taking a medication called cisaprida or certain antihistamine medications (terfenadina or astemizol).

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

Bicalutamida should not be administered to children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take bicalutamida

• if you have: any heart or blood vessel condition, including heart rhythm problems (arrhythmia), or if you are being treated with medications for these conditions. The risk of heart rhythm problems may increase when bicalutamida is used.
• if you are taking anticoagulants or medications to prevent blood clots.
• if you have liver disorders. Your doctor will want to monitor your liver function regularly.
• if you have diabetes and are already taking analogues of the luteinizing hormone-releasing hormone (LHRH). This includes, goserelina, buserelina, leuprorelina, and triptorelina. The active substance of this medication (bicalutamida) 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 bicalutamida, you and/or your partner must use contraception while taking bicalutamida and for 130 days after stopping bicalutamida. Speak with your doctor or pharmacist if you have any questions about birth control.

Other medications and Bicalutamida Accord

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications obtained without a prescription and herbal medications. This is because Bicalutamida may affect the way other medications work. Also, other medications may affect the way bicalutamida works.

Do not take bicalutamida if you are already taking any of the following medications:

• Cisaprida (used for some types of indigestion)
• Certain antihistamine medications (terfenadina or astemizol)

Bicalutamida may interfere with some medications used to treat heart rhythm problems (for example: quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (for example: metadona (used for pain relief and for detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses).

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

• Oral medications to prevent blood clots (anticoagulants orals)e.g. warfarina, cumarin derivatives.
• Ciclosporina (to suppress your immune system)
• Cimetidina (for stomach problems)
• Ketoconazol (to treat fungal infections)
• Calcium channel blockers (for the treatment of high blood pressure or some heart conditions)

Taking Bicalutamida Accord with food and drinks

You can take this medication with or without food. This does not affect the amount of medication that will be absorbed and reach the bloodstream.

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machinery

This medication 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 certain sugars, contact them before taking this medication.

Bicalutamida Accord contains sodium

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

Follow exactly the administration instructions for this medication as 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 every day.
• Do not stop taking this medication even if you feel well, unless your doctor tells you to.

If you take more Bicalutamida Accord than you should

If you take more bicalutamida tablets than your doctor prescribed, speak with your doctor or go to the hospital immediately. Bring the packaging with you.

If you forget to take Bicalutamida Accord

• If you realize you have forgotten to take this medication at the usual time, you can take it later the same day.
• Despite this, if you realize you have forgotten to take the medication the next day, omit 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 interrupt treatment with Bicalutamida Accord

Take this medication as directed by your doctor or pharmacist. If you are thinking of interrupting treatment, speak with your doctor first. This is because suddenly stopping the use of this medication may lead to adverse effects.

If you have any doubts about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medicines, Bicalutamida Accord may cause side effects, although not everyone will experience them.

The following side effects may occur when using this medication.

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

• Anemia.
• Dizziness.
• Hot flashes.
• Nausea.
• Constipation.
• Abdominal pain.
• Blood in the urine (hematuria).
• Development of breasts (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 (abatimiento).
• Decreased libido.
• Drowsiness.
• Insufficient heart pumping (heart failure).
• Heart attack; fatalities have been reported.
• Indigestion. This may manifest as a feeling of fullness in the upper abdomen, stomach pain, belching, nausea, vomiting, and heartburn (dyspepsia).
• Flatulence (gas).
• Changes in kidney function (elevation of certain liver enzymes (transaminases), jaundice).
• Biliary and liver changes.
• 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 accumulation of fluid 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 intense itching and hives (urticaria).
• Pulmonary interstitial disease; fatal cases have been reported.

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

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

Unknown(the frequency cannot be calculated from the 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 worry about this list of side effects. You may not experience any of them.

Reporting of side effects

If you experience side effects, consult your doctor, hospital pharmacist, or nurse, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• No special conditions are required for its conservation.
• Keep out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging and on the blister strips after CAD.Theexpiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Bicalutamida Accord

The active ingredient is bicalutamida. Each tablet contains 50 mg of bicalutamida.

The other components (excipients) are:

Core of the tablet:

lactose monohydrate

potato starch glycolate sodium (Type A)

povidone K-30

magnesium stearate

Covering:

hypromellose E5

dióxido de titanio (E-171)

macrogol 400

Appearance of the product and contents of the package

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 presented in blisters of14, 20, 28, 30, 60, 84, 90, 98 or 100tablets. It is possible that not all package sizes are marketed.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Responsible for manufacturing

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 with the following names

Member State NameMedicine Name

GermanyBicalutamide Accord 50 mg Filmtabletten

BelgiumBicalutamide Accord Healthcare 50 mg comprimés pelliculés/

filmomhulde tabletten/ filmtabletten

BulgariaBicalutamide Accord 50mg Film-coated Tablets

CyprusBicalutamide Accord 50mg Film-coated Tablets

SlovakiaBikalutamid Accord 50 mg filmom obalené tablety

SpainBicalutamida Accord 50 mg comprimidos recubiertos con

película EFG

EstoniaBicalutamide Accord 50mg õhukese polümeerikattega

tabletid

IrelandBicalutamide 50mg Film-coated Tablets

ItalyBicalutamide Accord 50 mg Pellicolarivestiti

LithuaniaBicalutamide Accord 50 mg plevele dengtos tabletes

MaltaBikalutamide 50mgFilm-coatedTablets

NetherlandsBicalutamide Accord 50mg Filmomhulde Tabletten

PolandBicalutamide Accord

PortugalBicalutamida Accord 50mg comprimidos revestidos por

película

United KingdomBicalutamide 50 mg Film-coated Tablets

RomaniaBicalutamida Accord 50 mg, comprimate filmate

Last review date of this leaflet: November 2022.

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