Package Leaflet: Information for the User

Bicalutamida Teva-ratiopharm 50 mg Film-Coated Tablets

bicalutamida

Read 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

2. What you need to know before you start taking Bicalutamida Teva-ratiopharm

3. How to take Bicalutamida Teva-ratiopharm

4. Possible side effects

5. Storage of Bicalutamida Teva-ratiopharm

6. Contents of the pack and additional information

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

Bicalutamida Teva-ratiopharm 50 mg is used for theadvanced prostate cancer treatment. It is taken along with another medication known as a luteinizing hormone-releasing hormone (LHRH) analog - an additional hormone therapy - or accompanying testicular removal by surgery.

It is also used in adult men for theprostate cancer treatment without metastasis,when castration or other types of treatments are not indicated or are unacceptable.

It must be used in combination with prostate radiation therapy or prostate surgery at the beginning of treatment programs.

Do not take Bicalutamida Teva-ratiopharm

• if you are allergic (hypersensitive) to bicalutamida or to any of the other components of this medication (listed in section 6),
• if you take terfenadina (for hay fever or allergy), astemizol (for hay fever or allergy) or cisaprida (for stomach disturbances).

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

Warnings and precautions

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

• if you have any moderate or severe liver function impairment. The medication should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor should perform regular liver function tests (bilirubin, transaminases, alkaline phosphatase). If severe liver function impairment appears, treatment with Bicalutamida Teva-ratiopharm must be interrupted. Fatal cases have been reported.
• if you have diabetes and are taking an “LHRH analogue”. These include goserelina, buserelina, leuprorelina and triptorelina. You may need to control your blood glucose levels more frequently.
• if you have severe renal function impairment. The medication 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 should perform regular heart function tests.
• If you have any heart or blood vessel problems,including heart rhythm problems (arrhythmia) or if you are being treated with medications for those problems. You may increase the risk of heart rhythm problems by usingBicalutamida Teva-ratiopharm.

Use of Bicalutamida Teva-ratiopharm with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/used recently or may have to take/use any other medication.Bicalutamida Teva-ratiopharmmust not be taken with the following medications:

• terfenadina or astemizol (for hay fever or allergy).
• cisaprida (for stomach disturbances).

If you take Bicalutamida Teva-ratiopharm with any of the following medications, the effect of bicalutamida, as well as that of the other medications may be influenced. Talk to your doctor before taking any of the following medications with Bicalutamida Teva-ratiopharm:

• warfarina or similar medications to prevent blood clots.
• ciclosporina (used to suppress the immune system to prevent and treat organ transplant rejection).
• cimetidina (to treat stomach ulcers).
• ketoconazol (used to treat fungal infections in skin and nails).
• calcium channel blockers (to treat high blood pressure).

Bicalutamida Teva-ratiopharmmay interfere with some medications used to treat heart rhythm problems (e.g. quinidina, procainamida, amiodarona and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g. metadona (used for pain relief and as part of drug addiction detoxification), moxifloxacino (an antibiotic), antipsychotics used for some severe mental illnesses).

Pregnancy, breastfeeding and fertility

Pregnancy

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

Fertility

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

Driving and operating machinery

It is unlikely that bicalutamida will affect your ability to drive or use any tools or machines. However, there is a possibility that the tablets may make you feel dizziness or drowsiness. If you are affected by these symptoms, you must not drive vehicles or operate machines.

Bicalutamida Teva-ratiopharm contains lactose

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

Bicalutamida Teva-ratiopharm contains sodium

This medication contains less than 23 mg of sodium (1mmol) per coated tablet; this 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.

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.
• prostate cancer without metastasis is 3 tablets once a day.

Read the instructions before taking the medication.

Tablets should be swallowed whole with some liquid. Try to take your medication approximately at the same hour every day.

If you take more Bicalutamida Teva-ratiopharm than you should

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

Carry the remaining tablets or the packaging with you so that the doctor can identify that you have taken them.

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

If you forget to take Bicalutamida Teva-ratiopharm

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Bicalutamida Teva-ratiopharm

Do not stop taking this medication even if you feel well unless your doctor has instructed you to do so.

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

Like all medicines, this medicine may cause side effects,although not everyone will experience them.

Severe side effects:

Contact your doctor or pharmacist immediately if you experience any of the following severe 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 deterioration that may cause yellowing of the skin and the white 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 the appearance of lumps,
• Severe difficulty breathing or sudden worsening of breathing difficulty, possibly with cough or fever. Some patients taking bicalutamide develop an inflammation of the lungs called interstitial lung disease. Fatal cases have been reported.

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

• Liver failure (severe liver function deterioration) that may be associated with the following symptoms (affect less than 1 in 10 patients): jaundice, itching, nausea, loss of appetite, easy bruising on the skin, and drowsiness. Fatal cases have been reported.

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

• ECG changes (prolongation of QT)

Other side effects:

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

Very common(may affect more than1 in 10 people):

• Reduction in the number of red blood cells that may cause pale skin 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 10people):

• Loss of appetite, decreased appetite

• Diabetes mellitus,
• Decreased libido, erectile dysfunction,
• Depression,
• Drowsiness,
• Chest pain, muscle skeletal pain,
• Myocardial infarction (fatal cases have been reported), heart failure
• Diarrhea,
• Indigestion,
• Gas (flatulence),
• Blood test changes 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 100people):

• High blood sugar levels
• Difficulty breathing

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

• Vomiting.
• Increased skin sensitivity to sunlight.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish Medicines and Medical Devices Agency's Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packagingafter“CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions

Do not use Bicalutamida Teva-ratiopharm if you observe any visible sign of deterioration in the tablets.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

CompositionBicalutamide Teva-ratiopharm

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

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

Appearance of the product and contents of the package

Bicalutamide Teva-ratiopharm is a film-coated tablet of white to off-white color, round biconvex shape, 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.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible 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 authorized in the member states of the European Economic Area with the following names:

Germany:Bicalutamid-ratiopharm 50 mg Filmtabletten

Spain:Bicalutamide Teva-ratiopharm 50 mg film-coated tablets

Italy:Bicalutamide ratiopharm 50 mg film-coated tablets

Luxembourg:Bicalutamid-ratiopharm 50 mg Filmtabletten

Last review date of this leaflet October 2020

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/