Leaflet: information for the patient

Bicalutamide Sandoz 50 mg film-coated tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms 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 is Bicalutamide Sandoz and what it is used for

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

3. How to take Bicalutamide Sandoz

4. Possible side effects

5. Storage of Bicalutamide Sandoz

6. Contents of the pack and additional information

Bicalutamida Sandoz belongs to a group of medicines called antiandrogens. It interferes with some of the actions of male sex hormones.

Bicalutamida Sandoz is used to treat prostate cancer. It is also used as:

- monotherapy in stages of the tumor known as “locally advanced” or, as,

-combined therapy in stages of the tumor known as “advanced”, and it is used in conjunction with other treatments such as, for example, surgical castration or medications that reduce the levels of androgens in the body.

Do not take Bicalutamida Sandoz

- if you are allergic to bicalutamida or any of the other ingredients of this medication (listed in section 6),

• if you are a woman, child, or adolescent,
• if you are taking other medications that contain terfenadina, astemizol, or cisaprida (see below “Taking Bicalutamida Sandoz with other medications”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take bicalutamida:

-if you have any liver problems. Your liver function may be monitored periodically,

-if you have diabetes,

- if you have any cardiovascular disease, including heart rhythm problems (arrhythmias), or are being treated with medications for these conditions. The risk of heart rhythm problems may increase with bicalutamida treatment,

- if you are taking bicalutamida, you and/or your partner must use a contraceptive method while you are on treatment with bicalutamida and for 130 days after the end of treatment. Consult your doctor if you have any questions about contraceptive methods.

Taking Bicalutamida Sandoz with other medications

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

If you are taking any of the following medications, it is especially important to mention it:

• terfenadina or astemizol (for hay fever or allergies) or cisaprida (for stomach disorders). See the section “Do not take Bicalutamida Sandoz”,
• oral medications to prevent blood clotting (oral anticoagulants),
• ciclosporina (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection),
• calcium channel blockers (to treat high blood pressure or certain heart conditions),
• cimetidina (to treat stomach ulcers),
• ketoconazol (used to treat fungal skin and nail infections),
• oral medications to prevent blood clots (oral anticoagulants). Your doctor may perform blood tests before and during your treatment with bicalutamida

Bicalutamida Sandoz may interact 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 to relieve pain and for part of the treatment of drug addiction), moxifloxacino (an antibiotic), antipsychotics used for severe mental illnesses).

Pregnancy, breastfeeding, and fertility

Bicalutamida is not used in women. Therefore, Bicalutamida Sandoz should not be taken by women, including pregnant women or breastfeeding mothers.

Bicalutamida may lead to limited fertility or infertility for a period of time.

Driving and operating machinery

These tablets may make you feel dizzy or drowsy. If you are affected in this way, do not drive or operate machinery.

Bicalutamida Sandoz contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Bicalutamida Sandoz 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. Consult your doctor or pharmacist if you have any doubts.

Depending on your general health status, the usual dose in adults is one 50 mg tablet per day (combined therapy), or three 50 mg tablets once a day (monotherapy).

-Swallow the tablets whole with water.

-You can take these tablets with or without food.

-Try to take the tablets at the same time every day.

If you take moreBicalutamida Sandozthan you should

If you have taken more bicalutamida than you should, consult your doctor or go to the nearest hospital immediately, or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Bicalutamida Sandoz

If you forget to take the medication, take the dose when you remember and, then, take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Bicalutamida Sandoz

Do not stop taking your tablets, even if you feel well, unless your doctor tells you to.

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Severe side effects:

You should contact your doctor immediately if you notice any of the following severe side effects.

Frequent severe side effects(may affect up to 1 in 10 patients):

• Yellowing of the skin or the white part of the eyes caused by liver problems or liver failure in rare cases (may affect up to 1 in 1,000 patients).

Rare severe side effects(may affect up to 1 in 100 patients):

• Severe allergic reactions that cause swelling of the face or throat 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 Bicalutamida Sandoz develop a lung inflammation called interstitial lung disease.

Unknown frequency (cannot be estimated from available data):

• Changes in the ECG (QT interval).

Other side effects:

The frequency of some side effects depends on whether bicalutamida is used in combination therapy or monotherapy.

Very frequent side effects(may affect more than 1 in 10 patients):

Frequent in combination therapy but frequent in monotherapy we can find:

Frequent side effects(may affect up to 1 in 10 patients):

Rare side effects(may affect up to 1 in 1,000 patients)

Reporting 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 System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of 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 ofBicalutamida Sandoz

• The active ingredient is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide.
• The other components are:

Appearance of the product and contents of the package

White and round film-coated tablet, with an approximate diameter of 7mm.

The carton packages with PVC/Aclar/Al blisters may contain 10, 28, 30, 56, 84, 90 or 100 film-coated tablets.

The carton packages with unit dose blisters may contain 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

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

Austria:Bicalutamid "Hexal" 50 mg - Filmtabletten

Denmark:Bicalutamid HEXAL

Finland:Bicalutamid Hexal

France:BICALUTAMIDE GNR 50 mg, comprimé pelliculé

Germany:Bicalutamid HEXAL 50 mg Filmtabletten

Ireland:Biluta 50 mg Film-Coated Tablets

Italy:BICALUTAMIDE HEXAL 50 mg compresse rivestite con film

Luxembourg:Bicalutamid HEXAL 50 mg Filmtabletten

Netherlands:Bicalutamide 50 mg, filmomhulde tabletten

Poland:BicaHEXAL 50

Spain:Bicalutamida Sandoz 50 mg comprimidos recubiertos con película EFG

Last review date of this leaflet:February 2019

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