Bicalutamide Pensa 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bicalutamida pensa 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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

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

2. What you need to know before taking Bicalutamida pensa

Do not take Bicalutamida pensa

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

Bicalutamida pensa must not be administered to children and adolescents under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bicalutamida pensa.

• If you have any liver disorder or liver disease. The medicine should only be taken after your doctor has carefully considered the potential benefits and risks. If this applies to you, your doctor should perform regular liver function tests. Deaths due to severe liver changes and liver failure have been reported.
• If you have a lung inflammation called interstitial lung disease. Symptoms may include severe shortness of breath with cough or fever. Deaths have been reported.
• If you are taking any other medicines, including those obtained without a prescription. In particular, if you are taking blood-thinning medicines or medicines used to prevent blood clots.
• If you have diabetes. Combined treatment with bicalutamide and LHRH analogues may alter your blood sugar levels. Your doctor should adjust your dose of insulin and/or antidiabetic medicines.
• If you have severe kidney problems. Caution is necessary, as there is no experience with the use of bicalutamide in such cases.

Inform your doctor if you have any heart or blood vessel condition or are being treated for one, including medicines to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when taking Bicalutamida pensa.

If any of the above situations apply to you, inform your doctor, who will take them into account during your treatment with Bicalutamida pensa.

If you are admitted to hospital, inform healthcare staff that you are taking Bicalutamida pensa 50 mg tablets.

If you are taking Bicalutamida pensa, you and/or your partner must use an effective method of contraception during treatment and for 130 days after stopping treatment.

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

Children and adolescents

Bicalutamida pensa must not be administered to children and adolescents under 18 years of age.

Other medicines and Bicalutamida pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, and herbal products.

Do not take bicalutamide together with the following medicines:

• Terfenadine or astemizole (for hay fever or allergies).
• Cisapride (for stomach disorders).

If you take Bicalutamida pensa together with any of the following medicines, the effect of these medicines and/or bicalutamide may be affected. Consult your doctor before taking any of the following medicines together with bicalutamide:

• In particular, inform your doctor if you are taking blood-thinning medicines such as warfarin.
• Cyclosporine (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 anaesthetic before and during surgery).
• Calcium channel blockers (e.g., diltiazem or verapamil. These medicines are used to treat high blood pressure or certain heart conditions).
• Cimetidine (to treat stomach ulcers).
• Ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamida pensa may interfere with some 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 with other medicines (e.g., methadone (used for pain relief and detoxification from other drugs), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

Bicalutamida pensa must not be taken by women, including pregnant women or breastfeeding mothers.

Bicalutamida pensa may have an effect on male fertility, which may be reversible.

Driving and using machines:

Bicalutamida pensa may make you feel drowsy, so you should be cautious when driving or operating machinery.

Bicalutamida pensa contains lactose

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

3. How to take Bicalutamida pensa

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist.

Usual dose:

• The recommended dose for adults is 1 tablet daily.
• Swallow the tablet whole with water.
• Try to take the tablet at the same time each day.

If you take more Bicalutamida pensa than you should

If you take more than the prescribed dose, contact your doctor or nearest hospital immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 5620420.

If you forget to take Bicalutamida pensa

Do not take a double dose to make up for missed doses; simply continue with your regular treatment schedule.

If you stop taking Bicalutamida pensa

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

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 experiences them.

If you notice any of the following symptoms, inform your doctor immediately or go to the nearest hospital emergency department. These adverse effects are very serious.

• Skin rash, severe skin itching (with lumps), hives, skin peeling, or formation of blisters or crusts.
• 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 problems, 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 adverse effects of this medicine are:

Very common: in more than 1 in every 10 patients

• Anaemia.
• Dizziness.
• Abdominal pain, constipation, nausea (feeling sick).
• Hot flush.
• 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: in between 1 and 10 out of every 100 patients

• Weight gain.
• Drowsiness.
• Heart attack (fatalities have been reported), heart failure.
• Indigestion, flatulence (gas).
• Hair loss (alopecia), excessive hair growth/regrowth of hair, dry skin, itching.
• Decreased appetite.
• Chest pain.
• Liver toxicity, elevated levels of transaminases (liver enzymes), jaundice (yellowing of skin and eyes).
• Erectile dysfunction.
• Decreased sexual desire.
• Depression.

Uncommon: in between 1 and 10 out of every 1,000 patients

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

Rare: in between 1 and 10 out of every 10,000 patients

• ?Liver failure. Fatalities have been reported.
• Increased sensitivity to sunlight.

Frequency not known: cannot be estimated from available data

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide pensa

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

No special storage conditions are required.

Store in the original packaging.

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

Medicines must not be disposed of via wastewater or household waste. Any unused medicines and waste materials, including packaging, should be returned to the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bicalutamida pensa

• The active ingredient is bicalutamide. Each tablet contains 50 mg of bicalutamide.
• The other components are: Core: lactose monohydrate, povidone K-30, sodium starch glycolate (from potato), magnesium stearate. Coating: hypromellose, macrogol, titanium dioxide.

Appearance of Bicalutamida pensa and contents of the pack

Film-coated tablets, white in colour, round and biconvex.

Each pack contains 30 film-coated tablets packed in a blister.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Tecnimede, S.A.

Quinta da Cerca

Caixaria 2565-187 Dois Portos

Portugal

Date of the most recent revision of this leaflet: June 2020

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