BICALUTAMIDE SANDOZ 50 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Bicalutamide Sandoz 50 mg film-coated tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Bicalutamida Sandoz belongs to a group of medicines called anti-androgens. 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 tumour stages described as "locally advanced", or as
• combination therapy in tumour stages described as "advanced", and is used together with other treatments such as, for example, surgical castration or medicines that reduce the levels of androgens in the body.

2. What you need to know before taking Bicalutamida Sandoz

Do not take Bicalutamida Sandoz

• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6),
  • if you are a woman, child, or adolescent,
  • if you are taking other medicines containing terfenadine, astemizole, or cisapride (see below “Taking Bicalutamida Sandoz with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before starting bicalutamide:

• if you have any liver problems. Levels of bicalutamide in your blood may increase. Your liver function may need to be monitored periodically,
• if you have diabetes,
• if you have any cardiovascular disease, including heart rhythm disorders (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with bicalutamide treatment,
• if you are taking bicalutamide, you and/or your partner must use an effective contraceptive method during treatment with bicalutamide 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking any of the following medicines, it is especially important to inform your doctor:

• terfenadine or astemizole (for hay fever or allergies) or cisapride (for stomach disorders). See section “Do not take Bicalutamida Sandoz”,
• oral medicines used to prevent blood clotting (oral anticoagulants),
• cyclosporine (used to suppress the immune system to prevent and treat rejection of organ or bone marrow transplants),
• calcium channel blockers (used to treat high blood pressure or certain heart conditions),
• cimetidine (used to treat stomach ulcers),
• ketoconazole (used to treat fungal infections of the skin and nails),
• oral medicines to prevent blood clots (oral anticoagulants). Anticoagulants or medicines to prevent blood clots. Your doctor may perform blood tests before and during your treatment with bicalutamide.

Bicalutamida Sandoz may interfere with certain 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 together with other medicines (e.g. methadone (used to relieve pain and as part of drug addiction treatment), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

Pregnancy, breastfeeding and fertility

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

Bicalutamide may lead to reduced fertility or infertility for a period of time.

Driving and using machines

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

Bicalutamida Sandoz contains lactose

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

Bicalutamida Sandoz contains sodium

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

3. How to take Bicalutamide Sandoz

Follow exactly the administration instructions for this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Depending on your general health status, the usual adult dose is one 50 mg tablet daily (combined therapy), or three 50 mg tablets once daily (monotherapy).

• Swallow the tablets whole with water.
• You may take these tablets with or without food.
• Try to take the tablets at the same time each day.

If you take more Bicalutamide Sandoz than you should

If you have taken more bicalutamide than you should, consult your doctor or go immediately to the nearest hospital, or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bicalutamide Sandoz

If you forget to take your dose, take it as soon as you remember, and then take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Bicalutamide Sandoz

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

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 will experience them.

Serious adverse effects:

You must contact your doctor immediately if you notice any of the following serious adverse effects.

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

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

Uncommon serious adverse effects (may affect up to 1 in 100 patients):

• severe allergic reactions causing swelling of the face or throat or severe skin itching with appearance of lumps,
• severe difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or fever. Some patients taking Bicalutamide Sandoz develop lung inflammation known as interstitial lung disease.

Frequency not known (cannot be estimated from available data):

• changes in ECG (QT interval).

Other adverse effects:

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

Very common adverse effects (may affect more than 1 in 10 patients):

• breast tenderness or enlargement,
• weakness,
• skin rashes, very common in monotherapy but common (less than 1 in 10 patients) in combination therapy,
• reduction in red blood cells which may lead to paleness of the skin and cause weakness or shortness of breath.

Very common in combination therapy but common in monotherapy:

• hot flushes,
• dizziness,
• abdominal pain, constipation, nausea (feeling unwell),
• oedema,
• presence of blood in the urine.

Common adverse effects (may affect up to 1 in 10 patients):

• loss of appetite,
• decreased libido,
• problems achieving an erection (erectile dysfunction),
• depression,
• drowsiness,
• indigestion, flatulence (gas),
• hair loss, excessive body hair,
• dry skin, itching,
• weight gain,
• changes in blood tests related to liver function,
• heart attack, heart failure,
• chest pain.

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

• 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Sandoz

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamida Sandoz

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

• The other components are:

• Tablet core: lactose monohydrate, sodium carboxymethylstarch (type A) (derived from potato starch), povidone K 30 (E1201), maize starch and magnesium stearate (E572).

• Tablet coating: methylcellulose, titanium dioxide (E171) and glyceryl triacetate (E1518).

Appearance of the product and contents of the pack

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

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

Carton packs of unit-dose PVC/Aclar/Al blisters may contain 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 under 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

Date of the most recent revision of this leaflet: February 2019

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/