BICALUTAMIDE STADA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Stada 50 mg film-coated tablets EFG

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

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

Contents of the pack:

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

1. What Bicalutamide Stada is and what it is used for

Bicalutamide belongs to a group of medicines called anti-androgens, which means it interferes with some of the actions of male sex hormones (androgens) in the body.

This medicine is used in the treatment of advanced prostate cancer in combination with a medicine called luteinizing hormone-releasing hormone (LHRH) analogue – an additional hormonal treatment – or together with surgical removal of the testicles.

2. What you need to know before you take Bicalutamide Stada

Do not take Bicalutamide Stada:

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines for treating allergy such as terfenadine or astemizol, or cisapride, a medicine for treating gastroesophageal reflux.

Bicalutamide should not be taken by women, nor should it be given to children or adolescents under 18 years.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicine

• If you have any liver problems. The medicine should only be taken after your doctor has carefully weighed the potential benefits and risks. If this is the case, your doctor will regularly perform liver function tests. There have been reports of death (severe liver changes and liver failure).

• If you have a lung inflammation called interstitial lung disease. The symptoms of this could include severe difficulty breathing with cough or fever. There have been reports of death.

• If you have diabetes. Combination treatment with bicalutamide and LHRH analogues may affect your blood sugar levels. Your doctor will adjust your insulin and/or anti-diabetic dose.
• If you have severe kidney problems. Caution is necessary as there is no experience with the use of bicalutamide in these cases.
• If you are taking a daily dose of 150 mg of bicalutamide and have heart disease. Your doctor may choose to check your heart function periodically.
• Tell your doctor if you have any heart or blood vessel disorders or are being treated for them, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using bicalutamide.

If any of the above situations apply to you, inform your doctor, he will take this into account during your treatment with bicalutamide.

If you are admitted to hospital, inform the medical staff that you are taking this medicine.

If you are taking bicalutamide, you and/or your partner must use a contraceptive method while you are being treated with bicalutamide and for 130 days after the end of treatment.

Other medicines and Bicalutamide Stada

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

Do not take bicalutamide with the following medicines:

• Terfenadine or astemizol (for hay fever or allergy)
• Cisapride (for stomach disorders)

If you take bicalutamide with any of the following medicines, the effect of this and the other medicines may be affected. Consult your doctor before taking any of the following medicines with bicalutamide:

• Warfarin or any similar medicine to prevent blood clotting.
• Ciclosporin (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection).
• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures or as an anesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart diseases).
• Cimetidine (for stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide may interfere with some 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 for detoxification of other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Bicalutamide should not be taken by women, including pregnant women or breastfeeding mothers.

Male fertility may be reduced temporarily due to treatment with bicalutamide, even with temporary infertility.

Driving and using machines

Bicalutamide may make you feel drowsy, so you should be careful when driving or using machines.

Bicalutamide Stada contains lactose and sodium

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

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

3. How to take Bicalutamide Stada

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are not sure, ask your doctor or pharmacist again. Your doctor will tell you how long you should take this medicine.

The recommended dose in adults is one 50 mg tablet per day.

Swallow the tablet whole with a glass of water.

Try to take the tablet at the same time each day.

If you take more Bicalutamide Stada than you should

If you have taken more than the prescribed dose, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Bicalutamide Stada

Do not take a double dose to make up for forgotten doses. Simply continue with your normal treatment.

If you stop taking Bicalutamide Stada

Do not stop taking this medicine even if you feel better, unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Skin rash, severe itching of the skin (with lumps), hives, skin peeling or blistering.

• Swelling of the face or neck, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
• Difficulty breathing or sudden worsening of breathing difficulties, possibly with cough or fever. These may be signs of interstitial lung disease.
• Blood in the urine
• Abdominal pain
• Yellowing of the skin and eyes (jaundice). These may be symptoms of liver damage.

Other possible side effects of this medicine are:

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

• Anemia
• Dizziness
• Abdominal pain, constipation, nausea (feeling sick)
• Hot flushes
• Blood in the urine
• Skin rash
• Weakness, swelling
• Increased breast size and breast tenderness. Breast size increase may not resolve spontaneously after treatment discontinuation, particularly after prolonged treatment.

Common (may affect up to 1 in 10 people)

• Weight gain
• Somnolence
• Myocardial infarction (heart attack) (deaths have been reported), heart failure
• Stomach pain, flatulence (gas)
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching
• Decreased appetite
• Chest pain
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes)
• Erectile dysfunction
• Decreased libido, depression
• Diarrhea

Uncommon (may affect up to 1 in 100 people)

• Interstitial lung disease (a lung inflammation). Deaths have been reported.
• Allergic reactions (hypersensitivity), skin swelling, hives

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

• Liver failure. Deaths have been reported.
• Vomiting
• Increased sensitivity of the skin to sunlight.

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

• Changes in the electrocardiogram (ECG) (prolongation of the QT interval).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Stada

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

This medicine does not require any special storage conditions.

Store in the original packaging.

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 stated.

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

Composition of Bicalutamide Stada

• The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other ingredients are:

Core: lactose monohydrate, povidone K-30, sodium carboxymethyl starch (type A) (potato), magnesium stearate,

Coating: hypromellose, titanium dioxide (E171), macrogol.

Appearance and packaging

This medicine is presented as white, round, biconvex film-coated tablets. Each pack contains 30 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

C/ Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Tecnimede

Quinta da Cerca, Caixaria

2565-187 Dois Portos (Portugal)

Date of last revision of this leaflet:November 2017

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