Bicalutamide Teva-Ratiopharm 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bicalutamida Teva-ratiopharm 50 mg film-coated tablets EFG

bicalutamide

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• 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 it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Bicalutamida Teva-ratiopharm belongs to the group of antiandrogens. Antiandrogens work against the effects of androgens (male sex hormones).

Bicalutamida Teva-ratiopharm 50 mg is used for the treatment of advanced prostate carcinoma. It is taken together with another medicine known as a luteinizing hormone-releasing hormone (LHRH) analogue—a supplementary hormonal treatment—or in conjunction with 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 regimens.

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

Do not take Bicalutamida Teva-ratiopharm

• if you are allergic (hypersensitive) to bicalutamide or to 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).

Bicalutamida Teva-ratiopharm must not be given to women, children, or adolescents.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Bicalutamida Teva-ratiopharm.

• if you have moderate or severe impairment of liver function. The medicine should only be taken after your doctor has carefully considered the potential benefits and risks. In such cases, your doctor should regularly perform liver function tests (bilirubin, transaminases, alkaline phosphatase). If severe liver dysfunction occurs, treatment with Bicalutamida Teva-ratiopharm must be discontinued. Cases of death have been reported.
• if you have diabetes and are taking an “LHRH analogue”. These include goserelin, buserelin, leuprorelin, and triptorelin. You may need to monitor your blood glucose levels more frequently.
• if you have severe impairment of kidney function. The medicine should only be taken after your doctor has carefully considered the potential benefits and risks.
• if you have a heart disease. In such cases, your doctor should regularly perform tests to monitor your heart function.
• if you have any heart or blood vessel problems, including heart rhythm disorders (arrhythmias), or if you are being treated with medicines for these conditions. The use of Bicalutamida Teva-ratiopharm may increase the risk of heart rhythm problems.

Use of Bicalutamida Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Bicalutamida Teva-ratiopharm must not be taken together with the following medicines:

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

If you take Bicalutamida Teva-ratiopharm together with any of the following medicines, the effect of bicalutamide and/or the other medicines may be altered. Talk to your doctor before taking any of the following medicines together with Bicalutamida Teva-ratiopharm:

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

Bicalutamida Teva-ratiopharm may interfere with some medicines used to treat heart rhythm disorders (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 certain serious mental illnesses).

Pregnancy, breast-feeding and fertility

Pregnancy

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

Fertility

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

Driving and using machines

Bicalutamide is unlikely to affect your ability to drive or use tools or machines. However, there is a possibility that the tablets may cause dizziness or drowsiness. If you are affected by these symptoms, you should not drive or operate machinery.

Bicalutamida Teva-ratiopharm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Bicalutamida Teva-ratiopharm contains sodium

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

3. How to take Bicalutamide Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will personally determine the appropriate dose for you.

The usual dose for the treatment of

• advanced prostate carcinoma is 1 tablet once daily.
• non-metastatic prostate cancer is 3 tablets once daily.

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 nearest hospital as quickly as possible.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 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; wait until the next scheduled dose.

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 instructed you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects:

Contact your doctor or pharmacist immediately if you experience any of the following serious adverse 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):

• impairment of liver function that may cause yellowing of the skin and whites of the eyes (jaundice)

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

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

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

• Liver failure (severe deterioration of liver function) which may 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):

• Changes in ECG (QT prolongation)

Other adverse effects:

Inform your doctor if any of the following adverse effects affect you:

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

• Reduction in the number of red blood cells which may make the skin pale and cause weakness or difficulty breathing,
• dizziness,
• abdominal pain,
• constipation,
• nausea (feeling unwell),
• feeling of weakness,
• skin rash,
• breast enlargement and breast tenderness,
• hot flushes,
• oedema,
• chest pain

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

• Loss of appetite, decreased appetite,
• diabetes mellitus,
• decreased sexual desire, erection problems,
• depression,
• somnolence,
• chest pain, musculoskeletal pain,
• myocardial infarction (fatal cases have been reported), heart failure,
• diarrhoea,
• 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaram.es. By reporting adverse 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 stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in 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. Package contents and other information

Composition of Bicalutamida Teva-ratiopharm

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

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

Appearance of the medicinal product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

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, The Netherlands

TEVA PHARMA B.V.

Swensweg 5, 2031 GA

Haarlem, The Netherlands

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

Germany: Bicalutamid-ratiopharm 50 mg Filmtabletten

Spain: Bicalutamida Teva-ratiopharm 50 mg comprimidos recubiertos con película EFG

Italy: Bicalutamide ratiopharm 50 mg compresse rivestite con film

Luxembourg: Bicalutamid-ratiopharm 50 mg Filmtabletten

Date of the most recent review of this leaflet: October 2020

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/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68689/P_68689.html

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