BICALUTAMIDE TEVA-RATIOPHARM 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Teva-ratiopharm 50 mgfilm-coated tablets EFG

bicalutamide

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Bicalutamide Teva-ratiopharm is and what it is used for

Bicalutamide Teva-ratiopharm belongs to a group of antiandrogens. Antiandrogens act against the effects of male sex hormones (androgens).

Bicalutamide Teva-ratiopharm 50 mg is used for the treatment of advanced prostate cancer. It is taken together with another medicine known as a luteinizing hormone-releasing hormone (LHRH) analogue - an additional hormonal treatment - or accompanying surgical removal of the testicles.

It is also used in adult men for the treatment of non-metastatic prostate cancer, when castration or other types of treatments are not indicated or are unacceptable.

It should be used in combination with radiotherapy or prostate surgery at the beginning of treatment programs.

2. What you need to know before you take Bicalutamide Teva-ratiopharm

Do not take Bicalutamide Teva-ratiopharm

• if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of this medicine (listed in section 6),
• if you are taking terfenadine (for hay fever or allergy), astemizole (for hay fever or allergy), or cisapride (for stomach disorders).

Bicalutamide Teva-ratiopharm should not be given to women, children, and adolescents.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamide Teva-ratiopharm.

• if you have moderate or severe liver function disorders. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor must regularly perform liver function tests (bilirubin, transaminases, alkaline phosphatase). If severe liver function disorders occur, treatment with Bicalutamide Teva-ratiopharm must be discontinued. Fatal cases have been reported.
• if you have diabetes and are taking an "LHRH analogue". These include goserelin, buserelin, leuprorelin, and triptorelin. You may need to check your blood sugar levels more often.
• if you have severe kidney function disorders. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks,
• if you have heart disease. If this is the case, your doctor must regularly perform heart function tests.
• If you have any heart or blood vessel problems, including heart rhythm problems (arrhythmia) or if you are being treated with medicines for these problems. It may increase the risk of heart rhythm problems when using Bicalutamide Teva-ratiopharm.

Use of Bicalutamide Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Bicalutamide Teva-ratiopharmshould not be taken with the following medicines:

• terfenadine or astemizole (for hay fever or allergy).
• cisapride (for stomach disorders).

If you take Bicalutamide Teva-ratiopharm with any of the following medicines, the effect of bicalutamide, as well as the other medicines, may be affected. Talk to your doctor before taking any of the following medicines with Bicalutamide Teva-ratiopharm:

• warfarin or similar medicines to prevent blood clots.
• ciclosporin (used to suppress the immune system to prevent and treat organ rejection in organ or bone marrow transplants).
• cimetidine (to treat stomach ulcers).
• ketoconazole (used to treat fungal infections of the skin and nails).
• calcium channel blockers (to treat high blood pressure).

Bicalutamide Teva-ratiopharmmay interfere with some of the 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 as part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy, breastfeeding, and fertility

Pregnancy

Bicalutamide is contraindicated in women and should not be taken by pregnant or breastfeeding women.

Fertility

Bicalutamide may induce a period of subfertility or infertility in men.

Driving and using machines

Bicalutamide is unlikely to affect your ability to drive or use any tools or machines. However, there is a possibility that the tablets may make you feel dizzy or sleepy. If you are affected by these symptoms, do not drive vehicles or operate machines.

Bicalutamide Teva-ratiopharm contains lactose

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

Bicalutamide Teva-ratiopharm contains sodium

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

3. How to take Bicalutamide Teva-ratiopharm

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

Your doctor will personally indicate the suitable dose for you.

The usual dose for the treatment of

• advanced prostate cancer is 1 tablet once a day.
• non-metastatic prostate cancer is 3 tablets once a day.

Read the instructions before taking the medicine.

The tablets should be swallowed whole with some liquid. Try to take your medicine at approximately the same time each day.

If you take more Bicalutamide Teva-ratiopharm than you should

If you have taken too many tablets, contact your doctor or the nearest hospital as soon as possible.

Take the remaining tablets or the package with you so that the doctor can identify what you have taken.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 5620420.

If you forget to take Bicalutamide Teva-ratiopharm

If you forget to take your daily dose, do not take it when you remember and wait until the next intake.

Do not take a double dose to make up for forgotten doses.

If you stop taking Bicalutamide Teva-ratiopharm

Do not stop taking this medicine even if you feel well, unless your doctor has told you to do so.

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.

Serious side effects:

Contact your doctor or pharmacist immediately if you experience any of the following serious side effects.

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

• abdominal pain
• blood in the urine

Common(may affect up to 1 in 10 people)

• liver function disorders that can cause yellowing of the skin and the whites of the eyes (jaundice),

Uncommon(may affect up to 1 in 100 people)

• severe allergic reactions that can cause swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing or breathing, or severe itching of the skin with the appearance of lumps,
• severe difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking bicalutamide develop a lung inflammation called interstitial lung disease. Fatal cases have been reported.

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

• liver failure (severe liver function disorders) that can be associated with the following symptoms (affecting less than 1 in 10 patients): jaundice, itching, nausea, loss of appetite, easy bruising, and somnolence. Fatal cases have been reported.

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

• ECG changes (QT prolongation)

Other side effects:

Tell your doctor if any of the following side effects affect you:

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

• reduction in the number of red blood cells that can make the skin pale and cause weakness or difficulty breathing,
• dizziness,
• abdominal pain
• constipation,
• nausea (discomfort),
• feeling of weakness,
• skin rash
• breast enlargement and breast tenderness,
• hot flashes,
• edema,
• chest pain

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

• loss of appetite, decreased appetite

• diabetes mellitus,
• decreased sexual desire, erection problems,
• depression,
• sleepiness,
• chest pain, muscle skeletal pain,
• myocardial infarction (fatal cases have been reported), heart failure
• diarrhea,
• indigestion,
• gas (flatulence),
• changes in blood tests related to liver function.
• hair loss,
• excessive hair growth/re-growth of hair,
• dry skin,
• skin rash,
• sweating,
• weight gain.

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

• high blood sugar levels
• difficulty breathing

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

• vomiting.
• Increased sensitivity of the skin to sunlight.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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) through the website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Teva-ratiopharm

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 packaging after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use Bicalutamide Teva-ratiopharm if you notice any visible signs of deterioration in the tablets.

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

CompositionBicalutamide Teva-ratiopharm

• The active substance is bicalutamide. One film-coated tablet contains 50 mg of bicalutamide.

• The other ingredients are: lactose monohydrate, povidone (K-30), croscarmellose sodium, laurilsulfate sodium, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate. The film coating contains hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), and macrogol 4000.

Appearance and packaging

Bicalutamide Teva-ratiopharm is a white to off-white, round, biconvex film-coated tablet, engraved with "93" on one side and "220" on the other.

Transparent blister packs of 20, 28, 30, 30 x 1, 60, 90, 98, 100, 100 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig Merckle Strasse, 3

89143 Blaubeuren (Germany)

TEVA Pharmaceutical Works Private Limited,

Pallagi út 13

4042 Debrecen, Hungary

Teva Nederland BV

Swensweg 5 , 2031 GA

Haarlem , Netherlands.

TEVA PHARMA B.V.

Swensweg 5 , 2031 GA

Haarlem , Netherlands.

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

Germany: Bicalutamid-ratiopharm 50 mg Filmtabletten

Spain: Bicalutamida Teva-ratiopharm 50 mg film-coated tablets EFG

Italy: Bicalutamide ratiopharm 50 mg film-coated tablets

Luxembourg: Bicalutamid-ratiopharm 50 mg Filmtabletten

Date of last revision of this leaflet October 2020

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