BICALUTAMIDE ALMUS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Almus50 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 and other information

1. What is Bicalutamide Almus and what is it used for
2. What you need to know before you take Bicalutamide Almus
3. How to take Bicalutamide Almus
4. Possible side effects
5. Storage of Bicalutamide Almus

Contents of the pack and other information

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

Bicalutamide Almus 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 (daily dose of 50 mg) in combination with a medicine called luteinizing hormone-releasing hormone (LHRH) analogue - an additional hormonal treatment - or in combination with surgical removal of the testicles.

It is also used in the treatment of prostate cancer without metastasis, in cases where there is a high risk of progression (daily dose of 150 mg). It can be used alone or in combination with other therapeutic methods such as surgical removal of the prostate gland or radiotherapy.

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

Do not take Bicalutamide Almus:

• If you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman.
• If you are taking terfenadine or astemizole, which are used to treat allergies, or cisapride, which is used to treat heartburn and acid reflux.

Bicalutamide should not be given to children and adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bicalutamide Almus:

• If you have any liver problems. The medicine should only be taken after your doctor has carefully considered the possible benefits and risks. If this is the case, your doctor will need to perform regular liver function tests. Serious liver damage and liver failure have been reported.

• If you have a lung disease called interstitial lung disease. Symptoms of this could include severe difficulty breathing with cough or fever. Serious cases, including death, have been reported.

• If you are taking any other medicines, including those obtained without a prescription. In particular, if you are taking medicines that thin the blood or medicines to prevent blood clots.
• If you have diabetes. The combined treatment of bicalutamide with LHRH analogues may affect your blood sugar levels. Your doctor will need to adjust your insulin dose and/or your anti-diabetic medicines.
• 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 decide 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 applies to you, inform your doctor, he will take it into account during your treatment with Bicalutamide.

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

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

Consult your doctor if you have any questions about contraceptive methods.

Children and adolescents

This medicine must not be given to children and adolescents under 18 years of age.

Taking Bicalutamide Almus with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including those obtained without a prescription and herbal products.

Do not take bicalutamide with the following medicines:

• Terfenadine or astemizole (for hay fever or allergy).
• Cisapride (for stomach problems).

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:

• In particular, tell your doctor if you are taking blood-thinning medicines such as warfarin.
• 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 (to treat 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 detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Please note that these warnings may also apply to medicines that you have used some time ago.

Pregnancy, breast-feeding and fertility

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

This medicine must not be taken by women, including pregnant or breast-feeding women.

Bicalutamide may have an effect on male fertility which may be reversible.

Driving and using machines

This medicine may make you feel drowsy. Be careful when driving or using machines.

Bicalutamide Almus contains lactose.

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

3. How to take Bicalutamide Almus

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

• The recommended dose for adults is 1 tablet a day (equivalent to 50 mg of bicalutamide) or 3 tablets a day (equivalent to 150 mg of bicalutamide).
• Swallow the tablet(s) whole with a glass of water.
• Try to take the tablet(s) at the same time each day.

If you take more Bicalutamide Almus than you should

If you take more than you should, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone 91 562 04 20, indicating the medicine and the amount taken).

If you forget to take Bicalutamide Almus

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

If you stop taking Bicalutamide Almus

Do not stop taking this medicine 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.

If you notice any of the following serious side effects, tell your doctor immediately or go to the casualty department of your nearest hospital. These serious side effects are very rare.

• Severe skin rash, itching, lumps, hives, skin peeling or blistering.
• Swelling of the face or neck, lips, tongue and/or throat, which may cause difficulty in 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 include:

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

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Flushing.
• Blood in the urine.
• Skin rash.
• Weakness, swelling.
• Breast enlargement and breast tenderness. Breast enlargement may not resolve spontaneously after stopping therapy, particularly after prolonged treatment.

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

• Weight gain.
• Somnolence.
• Heart attack (including deaths), heart failure.
• Indigestion, flatulence (wind).
• Hair loss (alopecia), excessive hair growth/re-growth, dry skin, itching.
• Loss of appetite.
• Chest pain.
• Liver toxicity, elevated liver enzymes, jaundice (yellowing of the skin and eyes).
• Erectile dysfunction.
• Decreased libido.
• Depression.

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

• Interstitial lung disease (a lung disease). Serious cases, including death, have been reported.
• Allergic reactions (hypersensitivity), skin swelling, urticaria.

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

• Liver failure. Serious cases, including death, have been reported.
• 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 get any side effects, talk to your doctor, pharmacist or nurse. 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: www.notificaram.es.

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

5. Storage of Bicalutamide Almus

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

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 Almus

The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.

The other ingredients (excipients) are:

Core:lactose monohydrate, crospovidone, povidone, magnesium stearate. Coating:Opadry II 85F28751 (polyvinyl alcohol, macrogol 3000, titanium dioxide, and talc)

Appearance ofBicalutamide Almusand pack contents

White, oblong, biconvex film-coated tablets.

Each pack contains 30 tablets in PVC/PVdC/Aluminium blisters.

Marketing authorisation holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80 Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer

Tecnimede - Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria. 2565-187 Dois Portos (Portugal)

Date of last revision of this leaflet:June 2021

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