Bicalutamide AHCL

Package leaflet: Information for the user

Bicalutamide AHCL 50 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bicalutamide AHCL contains a medicine called bicalutamide, which belongs to
a group of medicines known as "antiandrogens".
In the body, these medicines block certain effects of the male sex hormone androgen.
One of the effects of androgens is to stimulate tumour growth. Antiandrogens inhibit
tumour growth.
This medicine is used to inhibit the growth of prostate cancer and to improve quality of life
(palliative treatment).
This medicine is prescribed only for men with metastatic prostate cancer who are not
candidates for surgery, and who have either undergone complete or partial removal of
the testicles or who are receiving an LHRH agonist (a type of medicine that inhibits the
body's production of testosterone).

2. What you need to know before taking Bicalutamide AHCL

Do not take Bicalutamide AHCL:
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 (including pregnant or breastfeeding women).
• If you are already taking a medicine called cisapride or certain antihistamine medicines (terfenadine or astemizole).

Do not take Bicalutamide AHCL if any of the above conditions apply to you. If you are
not sure, consult your doctor or pharmacist before taking Bicalutamide AHCL.
Bicalutamide AHCL must not be given to children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide AHCL.

• If any of the following conditions apply to you: particular heart or blood vessel conditions, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when taking Bicalutamide AHCL tablets.
• If you are taking blood thinners or medicines to prevent blood clots.
• If you have liver problems. Your doctor will regularly check your liver function.
• If you have diabetes and are already taking an “LHRH analogue”. These include goserelin, buserelin, leuprorelin and triptorelin. The active substance in this medicine (bicalutamide) may have a negative effect on blood sugar levels. Therefore, your doctor will regularly monitor your blood sugar levels.
• If you are admitted to hospital, inform healthcare staff that you are taking Bicalutamide AHCL.
• If you are taking Bicalutamide AHCL, you and/or your partner should use a method of birth control during treatment with Bicalutamide AHCL and for 130 days after stopping treatment with Bicalutamide AHCL. Speak to your doctor or pharmacist if you have any questions about birth control.

Other medicines and Bicalutamide AHCL:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines without a prescription and herbal medicines. This is because Bicalutamide AHCL may affect how other medicines work. Some other medicines may also affect how Bicalutamide AHCL works.
Do not take Bicalutamide AHCL if you are already taking any of the following medicines:

• Cisapride (used for certain types of indigestion).
• Certain antihistamine medicines (terfenadine or astemizole). Bicalutamide AHCL 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 together with certain other medicines (e.g. methadone (used to relieve pain and in drug detoxification), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).

In addition, talk to your doctor or pharmacist if you are taking any of the following
medicines:

• Oral medicines taken to prevent blood clotting (oral anticoagulants), e.g. warfarin, coumarin derivatives.
• Cyclosporine (to suppress your immune system)
• Cimetidine (for stomach problems)
• Ketoconazole (to treat infections caused by a fungus)
• Calcium channel blockers (to treat high blood pressure or other heart conditions).

Bicalutamide AHCL with food and drinks
This medicine may be taken with or without food. This does not affect the amount
of medicine that enters the bloodstream.
Pregnancy, breastfeeding and fertility
Bicalutamide AHCL must not be taken by women, including pregnant women or women who are breastfeeding their babies.
Bicalutamide AHCL may have an effect on male fertility, which may be reversible.
Driving and using machines:
It is unlikely that Bicalutamide AHCL will affect your ability to drive or use tools or machinery. However, if you experience drowsiness, exercise caution when performing these activities.
Bicalutamide AHCL contains lactose:
Lactose is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Bicalutamide AHCL contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Bicalutamide AHCL

Take this medicine exactly as your doctor has instructed. If
you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one 50 mg tablet daily. This applies to all adult males.
• Swallow the tablet whole with a glass of 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 has told you to do so.

If you take more Bicalutamide AHCL than you should
If you take more Bicalutamide AHCL than prescribed, consult your doctor or go
immediately to the nearest hospital. Take the pack with you.
If you forget to take Bicalutamide AHCL

• If you realize you have forgotten to take your medicine at the usual time, you may take it later on the same day.
• However, if you only remember the next day that you missed a dose, skip the missed dose and take the next dose at the usual time.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Bicalutamide AHCL
Take the medicine as directed by your doctor or pharmacist. If you are
considering stopping this medicine, speak to your
doctor first.
This is because stopping or abruptly discontinuing this
medicine may cause unwanted effects.
If you have any doubts about how to use this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone gets them.
The following side effects may occur during treatment with this medicine.

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

• Anaemia.
• Dizziness.
• Hot flushes.
• Nausea.
• Constipation.
• Abdominal pain.
• Blood in the urine (haematuria).
• Breast development (gynaecomastia).
• Tenderness of the nipples and/or surrounding area.
• Feeling of weakness (asthenia).
• Fluid accumulation (oedema).

Common (may affect from 1 to 10 in 100 people)

• Loss of appetite.
• (Severe) low mood (depression).
• Low sex drive (reduced libido).
• Drowsiness.
• Inadequate pumping function of the heart (heart failure).
• Heart attack; cases of death have been reported.
• Digestive disorders. This may present as a feeling of fullness in the upper abdomen, stomach area pain, belching, nausea, vomiting, and heartburn (dyspepsia).
• Intestinal gas (flatulence).
• Changes in liver function (increase in certain liver enzymes (transaminases), jaundice).
• Liver and biliary disorders.
• Itching (pruritus).
• Dry skin.
• Hair loss (alopecia). Skin rash.
• Excessive hair growth (hirsutism).

Erectile dysfunction (impotence).

• Chest pain.
• Weight gain.

Uncommon (may affect from 1 to 10 in 1,000 people)

• Hypersensitivity reactions such as sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), breathing difficulties and/or itching and skin rash, often as an allergic reaction (angioedema) or itchy rash with hives (urticaria).
• Interstitial lung disease; fatal cases have been reported.

Rare (may affect from 1 to 10 in 10,000 people)

• Reduced liver function (hepatic failure); cases of death have been reported.
• Increased sensitivity of the skin to sunlight.

Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide AHCL

• This medicinal product does not require any special storage conditions.
• Keep out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the carton and blister pack after 'Exp.'. The expiry date refers to the last day of that month (e.g. mm/yyyy).
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Bicalutamide AHCL contains:
The active substance is bicalutamide.
Each film-coated tablet contains 50 mg of bicalutamide.
The other components are:
Tablet core
Monohydrate lactose
Sodium starch glycolate (type A)
Povidone K-30
Magnesium stearate.
Film coating
Hypromellose E5
Titanium dioxide E171
Macrogol 400.
Description of the appearance of Bicalutamide AHCL and package contents:
Bicalutamide 50 mg Film-coated tablets are film-coated tablets, white to off-white in colour, with 'B 50' engraved on one side and smooth on the other side.
Bicalutamide 50 mg Film-coated tablets are packed in blisters in pack sizes of 14, 20, 28, 30, 60, 84, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
This medicinal product is authorised in the European Economic Area Member States under the following names:

Package leaflet: information for the user

Bicalutamide AHCL 150 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
­ Keep this leaflet. 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. Do not give it to other people, even
if their symptoms are the same as yours, because it could be harmful.
­ If you experience any side effect, including those not listed in this leaflet, contact your
doctor or pharmacist. See section 4.
Contents of this leaflet:

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

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

Bicalutamide AHCL is a medicine containing the active substance called bicalutamide.
Bicalutamide belongs to the group of anti-androgens. Anti-androgens work against the effects of androgens (male sex hormones).
Bicalutamide is used in adult men for the treatment of non-metastatic prostate cancer when castration or other types of treatment are not indicated or are unacceptable.
It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.

2. What you need to know before taking Bicalutamide AHCL

Do not take Bicalutamide AHCL:
if you are allergic to bicalutamide or to any of the other ingredients of this
medicinal product (listed in section 6).

• if you are a woman.
• if you are already taking a medicine called cisapride (used to treat heartburn and acid reflux), terfenadine or astemizole (medicines used to treat allergies).

Bicalutamide AHCL must not be administered to children.
Do not take this medicine if any of the above conditions apply to you. If you are unsure, consult your
doctor or pharmacist before taking Bicalutamide AHCL.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide AHCL:

• if you have liver problems. Your doctor may carry out blood tests before and during treatment with bicalutamide.
• if any of the following conditions apply to you: specific heart or blood vessel conditions, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase when taking bicalutamide.
• if you are taking bicalutamide, you and/or your partner should use a contraceptive method during treatment with bicalutamide and for 130 days after stopping treatment with bicalutamide. Consult your doctor if you have any questions about contraception (see section Pregnancy, breastfeeding and fertility). If you are admitted to hospital, inform healthcare staff that you are taking bicalutamide.

Children
Bicalutamide AHCL must not be given to children.
Tests and monitoring
Your doctor may carry out certain blood tests to check for any changes in your blood.
Other medicines and Bicalutamide AHCL:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines without a prescription and herbal medicines. This is because bicalutamide may affect how other medicines work.
Do not take Bicalutamide AHCL if you are already taking medicines containing any of the following active substances:

• Cisapride (used to treat heartburn and acid reflux).
• Terfenadine or astemizole (medicines used to treat allergies).

Bicalutamide 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 certain other medicines (e.g. methadone (used to relieve pain and as part of drug dependence detoxification), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses).
Inform your doctor or pharmacist if you are taking medicines containing any of the following active substances:

• Midazolam (a medicine used to relieve anxiety before surgery or certain procedures, or as an anaesthetic before and during surgery). You must inform your doctor or dentist that you are taking bicalutamide if you require surgery or are very anxious in hospital.
• Warfarin (medicines used to thin the blood).
• Cyclosporine (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow). This is because bicalutamide may increase the concentration of cyclosporine in plasma, and your doctor may take blood samples to monitor this.
• Cimetidine (a medicine used to treat acid reflux or stomach ulcers).
• Ketoconazole (a medicine used to treat fungal infections).

Pregnancy and breastfeeding
Bicalutamide must not be administered to women.
Fertility
Bicalutamide may have an effect on male fertility, which may be reversible.
Driving and using machines
It is unlikely that Bicalutamide AHCL will affect your ability to drive or use tools or machinery. However, some people may occasionally feel drowsy while taking this medicine. If this occurs, consult your doctor or pharmacist.
Sunlight or ultraviolet (UV) light
Avoid excessive direct exposure to sunlight or UV rays while taking bicalutamide.
Bicalutamide AHCL contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Bicalutamide AHCL contains sodium
Bicalutamide AHCL contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Bicalutamide AHCL

Take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily. Swallow the tablet whole with a
glass of 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 has told you to stop.

Use in children
Bicalutamide AHCL must not be given to children.

If you take more Bicalutamide AHCL than you should
If you take more Bicalutamide AHCL than prescribed by your doctor, consult your doctor or go
immediately to the nearest hospital.

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

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately tell your doctor if you notice any of the following side effects – you may need
urgent medical treatment:
Allergic reactions (uncommon, may affect up to 1 in 100 people):
Symptoms may include sudden onset of:

• Rash, itching or hives on the skin.
• Swelling of the face, lips, tongue, throat and other parts of the body.
• Shortness of breath, wheezing or difficulty breathing.

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

• Severe breathlessness or sudden worsening of breathlessness. This may occur with cough or high temperature (fever). These may be signs of lung inflammation called "interstitial lung disease".

Other possible side effects:
Very common (may affect more than 1 in 10 people)

• Rash.
• Swelling and pain in the breasts.
• Feeling weak.

Common (may affect up to 1 in 10 people)

• Yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver problems or, in rare cases (affects less than 1 in 1,000 people), liver failure.
• Abdominal pain.
• Blood in the urine.
• Hot flushes.
• Feeling unwell (nausea).
• Itching.
• Dry skin.
• Erectile problems (erectile dysfunction).
• Weight gain.
• Reduced sex drive and reduced fertility.
• Hair loss.
• Hair regrowth or extra hair growth.
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale.
• Loss of appetite.
• Depression.
• Feeling sleepy.
• Indigestion.
• Dizziness.
• Constipation.
• Passing gas from the intestine (flatulence).
• Chest pain.
• Swelling.

Rare (may affect less than 1 in 1,000 people)

• Increased sensitivity of the skin to sunlight.

Not known (frequency cannot be estimated from the available data):

• Changes in ECG (prolongation of QT interval).

Your doctor may carry out blood tests to check for any changes in your blood.
Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bicalutamide AHCL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after 'Exp.'. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Bicalutamide AHCL contains:

• The active substance is bicalutamide. Each film-coated tablet contains 150 mg of bicalutamide.
• The other components are:

Tablet core
Lactose monohydrate
Sodium starch glycolate (maize)
Povidone
Magnesium stearate
Film coating
Hypromellose 5 mPas (E464)
Titanium dioxide (E171)
Macrogol (E1521)

Description of the appearance of Bicalutamide AHCL and pack contents:
Bicalutamide AHCL 150 mg tablets are film-coated, white to off-white, round, biconvex tablets, with 'IO1' engraved on one side and plain on the other side.
The tablets are available in transparent PVC-PVdC/aluminium blisters. Packs containing 7, 28, 30, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers
Accord Healthcare Polska Sp. z o.o.
Ul. Lutomierska 50,
95-200 Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park, Paola
PLA 3000, Malta
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona, Spain

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