BICALUTAMIDE BLUEFISH 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bicalutamide Bluefish 150 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.

• 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 Bluefish 150 mg and what is it used for
2. What you need to know before you take Bicalutamide Bluefish 150 mg
3. How to take Bicalutamide Bluefish 150 mg
4. Possible side effects
5. Storage of Bicalutamide Bluefish 150 mg
6. Contents of the pack and other information

1. What is Bicalutamide Bluefish 150 mg and what is it used for

Bicalutamide Bluefish contains the active substance bicalutamide. It belongs to a group of medicines called anti-androgens.

• Bicalutamide Bluefish 150 mg is used to treat prostate cancer.
• It works by blocking the effects of male hormones such as testosterone.

2. What you need to know before you take Bicalutamide Bluefish 150 mg

Do not take Bicalutamide Bluefish

• 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 a medicine called cisapride or certain antihistamines (terfenadine or astemizole).

Bicalutamide is contraindicated in children.

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking bicalutamide.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Bicalutamide Bluefish

• If you have liver problems. Your doctor may perform blood tests before and during treatment with bicalutamide.
• If you have any of the following: heart or blood vessel disease, including heart rhythm problems (arrhythmias), or are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when using bicalutamide.
• If you are taking bicalutamide, you and/or your partner should use contraceptives while taking this medicine and for 130 days after stopping this medicine. Inform your doctor if you have any questions about contraceptives.

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

Children and adolescents

Bicalutamide must not be given to children and adolescents.

Tests and analyses

Your doctor may perform blood tests to check for possible changes in your blood.

Using Bicalutamide Bluefish with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes those bought without a prescription and herbal medicines. This is because bicalutamide may affect the way other medicines work. Other medicines may also affect the way bicalutamide works.

Do not take bicalutamide if you are taking any of the following medicines:

• Certain antihistamines (terfenadine or astemizole).
• Cisapride (used for some types of indigestion).

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 from other medicines), moxifloxacin (an antibiotic), antipsychotics used to treat severe mental illnesses).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Oral medicines to prevent blood clots (oral anticoagulants). Medicines that thin the blood or are used to prevent blood clots. Your doctor may perform blood tests before and during treatment with bicalutamide.
• Ciclosporin (to suppress the immune system)
• Calcium channel blockers (to treat high blood pressure or certain heart conditions)
• Cimetidine (for stomach problems)
• Ketoconazole (for fungal infections)

Pregnancy, breast-feeding and fertility

Bicalutamide is contraindicated in women, including pregnant or breast-feeding women.

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

Driving and using machines

Bicalutamide is unlikely to affect your ability to drive or use machines. However, some people may occasionally feel drowsy while taking bicalutamide. If this happens, consult your doctor or pharmacist.

Sunlight or UV light

Avoid excessive direct exposure to sunlight or UV light during treatment with bicalutamide.

Bicalutamide Bluefish 150 mg contains lactose

This medicine contains lactose. Lactose is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Bicalutamide Bluefish 150 mg contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per 150 mg tablet; this is essentially "sodium-free".

3. How to take Bicalutamide Bluefish 150 mg

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

• The recommended dose is one tablet per day.
• Swallow the tablet whole with a little water.
• Try to take the tablet at the same time each day.
• Do not stop taking this medicine, even if you feel well, unless your doctor tells you to.

Use in children and adolescents

Bicalutamide must not be given to children.

If you take more Bicalutamide Bluefish 150 mg than you should

If you take more bicalutamide than you should, contact your doctor or the nearest hospital. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Bicalutamide Bluefish 150 mg

If you miss a dose, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for forgotten doses.

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

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 side effects, contact your doctor immediately, you may need urgent medical treatment:

Allergic reactions(uncommon, may affect up to 1 in 100 people)

Symptoms may include:

• Sudden onset of: skin rash, itching, or hives.
• Swelling of the face, lips, tongue, throat, or other parts of the body.
• Shortness of breath, wheezing, or difficulty breathing.

Also, tell your doctor immediately if you experience any of the following:

Common(may affect up to 1 in 10 people)

• Yellowing of the skin or the whites of the eyes (jaundice). These can be signs of liver problems or, in rare cases (may affect less than 1 in 1,000 people), liver failure.
• Abdominal pain
• Blood in your urine

Uncommon(may affect up to 1 in 100 people)

• Severe difficulty breathing or sudden worsening of breathing difficulties. This may be accompanied by coughing or a high temperature (fever). These can be signs of a lung disease called "interstitial lung disease".

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

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

Other possible side effects:

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

• Skin rash
• Breast tenderness or swelling
• Weakness

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

• Hot flushes
• Feeling sick (nausea)
• Itching
• Dry skin
• Difficulty getting an erection (erectile dysfunction)
• Weight gain
• Reduced sex drive
• Hair loss
• New hair growth or additional hair growth
• Low red blood cell count (anaemia). This can make you feel tired or look pale.
• Loss of appetite
• Depression
• Feeling sleepy
• Indigestion
• Dizziness
• Constipation
• Gas (flatulence)
• Chest pain
• Swelling

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

• Increased sensitivity of the skin to sunlight

Your doctor may perform blood tests to check for possible changes in your blood. Do not worry about the list of possible side effects. You may not get any of them.

Reporting of side effects

If you get 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 Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bicalutamide Bluefish 150 mg

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after "EXP". The expiry date refers to the last day of that 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 Bluefish

The active substance is bicalutamide. Each film-coated tablet contains 150 mg of bicalutamide.

The other ingredients are:

Core of the tablet

Lactose monohydrate, povidone K-25, sodium starch glycolate (Type A), and magnesium stearate.

Coating of the tablet

Opadry OY-S-9622 which contains Hypromellose 5 cp (E464), titanium dioxide (E171), and propylene glycol.

Appearance and packaging of the product

White, round, biconvex, and scored on one side film-coated tablets.

The score line is only to facilitate breaking and ease of swallowing and not to divide into equal doses.

The tablets are packaged in blisters in packs of: 14, 28, 30, 90, 98, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Bluefish Pharmaceuticals AB

P.O. Box 49013 100 28 Stockholm

Sweden

Manufacturer

Genepharm S.A.

Km 18 of Marathonos Avenue

153 51 Pallini Attikis

Greece

Local representative:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria Bicalutamid Bluefish 150 mg Filmtabletten

Denmark Bicalutamid Bluefish 150mg

Spain Bicalutamida Bluefish 150 mg film-coated tablets EFG

Finland Bicalutamid Bluefish 150 mg tablets, film-coated

Germany Bicalutamid Bluefish 150 mg Filmtabletten

Italy Midelut 150mg film-coated tablets

Norway Bicalutamid Bluefish 150 mg tablets, film-coated

Sweden Bicalutamid Bluefish 150 mg film-coated tablets

United Kingdom Bicalutamide 150mg film-coated tablets

Date of last revision of this leaflet: December 2019