Midelut

Package leaflet: Information for the user

Midelut 50 mg film-coated tablets

Bicalutamide
Generic medicine
Please 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 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Midelut is and what it is used for

Midelut contains bicalutamide, which belongs to the class of antiandrogens.

• Midelut is indicated for the treatment of prostate cancer.
• The medicine works by blocking the effects of male hormones such as testosterone.

2. What you need to know before taking Midelut

Do not take Midelut

• if you are allergic to bicalutamide or to any of the other ingredients of this medicine (listed in section 6).
• if you are already taking a medicine containing cisapride or certain antihistamines (terfenadine or astemizole).
• if you are a woman.

Midelut must not be administered to children.
Do not take Midelut if any of these conditions apply to you. If you are unsure, speak with your doctor or pharmacist before taking Midelut.
Warnings and precautions
Talk to your doctor or pharmacist before taking Midelut:

• if you have any heart or blood vessel disorders, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of Midelut.
• if you are taking blood thinners or medicines to prevent blood clots.
• if you have liver disease.
• if you have diabetes and are already taking an LHRH analogue. These include goserelin, buserelin, leuprorelin, and triptorelin.
• if you are admitted to hospital, inform the medical staff that you are taking Midelut.
• if you are taking Midelut 50 mg, you and your partner must use a contraceptive method during treatment and for the 130 days following discontinuation of Midelut. Consult your doctor if you have any doubts about contraception.

Other medicines and Midelut
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal products, as Midelut may affect how other medicines work. Likewise, some other medicines may affect how Midelut works.
Do not take Midelut if you are already taking any of the following medicines:

• certain antihistamines (terfenadine or astemizole)
• cisapride (used for certain types of indigestion)

Midelut 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 together with certain other medicines [e.g., methadone (used as a painkiller and as part of drug addiction detoxification treatment), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses].
Additionally, inform your doctor or pharmacist if you are taking any of the following medicines:

• oral medicines used to prevent blood clots (oral anticoagulants), e.g., warfarin
• cyclosporine (to suppress the immune system)
• calcium channel blockers (for the treatment of hypertension or certain heart conditions)
• cimetidine (for stomach problems)
• ketoconazole (for the treatment of fungal infections)

Pregnancy, breastfeeding, and fertility
Midelut must not be taken by women, including pregnant women or breastfeeding mothers.
Midelut may affect male fertility, which may be reversible.
Driving and using machines
It is unlikely that Midelut will affect your ability to drive or operate tools or machinery. However, if you experience drowsiness, be cautious when performing these activities.
Midelut contains lactose
Midelut contains lactose monohydrate, which 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.
Midelut contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg tablet, and is therefore essentially sodium-free.

3. How to take Midelut

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose for an adult is one tablet per day.
• 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 tells you to.

If you take more Midelut than you should
If you take more Midelut than prescribed by your doctor, contact a doctor immediately or go to the nearest hospital.
If you forget to take Midelut
If you forget to take 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 have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Allergic reactions
These are 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 or other parts of the body.
• Shortness of breath, difficulty breathing or breathing problems.

If this occurs, seek medical advice immediately.
Also contact your doctor immediately if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people):

• Abdominal pain.
• Blood in the urine.

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 (may affect up to 1 in 1,000 people), liver failure.

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

• Severe shortness of breath or sudden worsening of breathing difficulties. This may be accompanied by coughing or high temperature (fever). These may be signs of lung inflammation known as 'interstitial lung disease'.

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

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

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

• Dizziness
• Constipation
• Feeling unwell (nausea)
• Breast swelling or tenderness
• Feeling weak
• Swelling
• Hot flushes
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale.

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Reduced sex drive
• Depression
• Drowsiness
• Indigestion
• Flatulence
• Hair loss
• Regrowth of hair or excessive hair growth
• Dry skin
• Itching
• Rash
• Inability to achieve an erection (impotence)
• Weight gain
• Chest pain
• Reduced heart function
• Heart attack

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

• Increased sensitivity of the skin to sunlight

Your doctor may prescribe blood tests to monitor certain blood parameters.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
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 Midelut

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 stated on the blister pack and carton. The expiry date refers to the last day of that month.
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. Package contents and other information

What Midelut contains:

• The active substance is bicalutamide. Each film-coated tablet contains 50 mg of bicalutamide.

Inside the tablet:
The excipients are: monohydrate lactose, povidone K-25, sodium starch glycolate (type A), magnesium stearate.
Coating film:
Opadry OY-S-9622 containing hypromellose 5cp (E464), titanium dioxide (E171), and propylene glycol.

Description of the appearance of Midelut and package contents
Midelut is supplied as white, round, biconvex, film-coated tablets. The tablets are packaged in blisters containing 14, 28, 30, 90, 98, or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Sophos Biotech S.r.l.
Via Modica, 6
20143 Milan, Italy

Manufacturer
Genepharm S.A.
18th km Marathonos Avenue
153 51 Pallini Attikis
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark Bicalutamid Bluefish
Ireland Bicalutamide 50 mg film-coated tablets
Austria Bicalutamid Bluefish 50 mg Filmtabletten
Germany Bicalutamid Bluefish 50 mg Filmtabletten
Spain Bicalutamida Bluefish 50 mg Comprimidos recubiertos con película EFG
Italy Midelut 50 mg Compresse rivestite con film
Norway Bicalutamid Bluefish 50 mg Filmdrasjertetabletter
Sweden Bicalutamid Bluefish 50 mg Filmdrageradetabletter

Package leaflet: Information for the user

Midelut 150 mg film-coated tablets

Bicalutamide
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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, 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 Midelut is and what it is used for
2. What you need to know before taking Midelut
3. How to take Midelut
4. Possible side effects
5. How to store Midelut
6. Contents of the pack and other information

1. What Midelut is and what it is used for

Midelut contains bicalutamide, which belongs to the class of antiandrogens.

• Midelut is indicated for the treatment of prostate cancer.
• The medicine works by blocking the effects of male hormones such as testosterone.

2. What you need to know before taking Midelut

Do not take Midelut

• 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 already taking a medicine containing cisapride or certain antihistamines (terfenadine or astemizole).

Midelut must not be administered to children.
Do not take Midelut if any of these conditions apply to you. If you are unsure, speak with your doctor or pharmacist before taking Midelut.
Warnings and precautions
Talk to your doctor or pharmacist before taking Midelut.

• if you have liver problems. Your doctor may order blood tests before and during treatment with Midelut.
• if you suffer from any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of Midelut.
• if you are taking Midelut 150 mg, you and your partner must use a contraceptive method during treatment and for 130 days after stopping Midelut. Consult your doctor if you have any doubts about contraception.

If you are hospitalized, inform the medical staff that you are taking Midelut.
Children and adolescents
Midelut must not be given to children or adolescents.
Tests and monitoring
Your doctor may prescribe blood tests to monitor for possible changes in blood parameters.
Other medicines and Midelut
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal products, as Midelut may affect how other medicines work. Likewise, some other medicines may affect how Midelut works.
Do not take Midelut if you are already taking any of the following medicines:

• certain antihistamines (terfenadine or astemizole)
• cisapride (used for certain types of indigestion)

Midelut 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 as a painkiller and in drug detoxification treatment), moxifloxacin (an antibiotic), antipsychotics used for severe mental illnesses].
Tell your doctor or pharmacist if you are taking any of the following medicines:

• oral medicines used to prevent blood clots (oral anticoagulants). Blood thinners or medicines to prevent blood clots. Your doctor may order blood tests before and during treatment with Midelut 150 mg.
• ciclosporin (to suppress the immune system).
• calcium channel blockers (for treatment of high blood pressure or certain heart conditions).
• cimetidine (for stomach problems).
• ketoconazole (for treatment of fungal infections).

Pregnancy, breastfeeding and fertility
Midelut must not be taken by women, including pregnant women or breastfeeding mothers.
Midelut may affect male fertility, which may be reversible.
Driving and using machines
It is unlikely that Midelut will affect your ability to drive or operate tools or machinery. However, some people may feel drowsy while taking Midelut. If this occurs, seek advice from your doctor or pharmacist.
Sunlight or ultraviolet (UV) light
Avoid excessive direct exposure to sunlight or UV light during treatment with Midelut 150 mg.
Midelut 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.
Midelut contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 150 mg tablet and is therefore essentially "sodium-free".

3. How to take Midelut

Always use 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. Take the tablet at the same time of day, if possible.
Do not stop taking this medicine even if you feel well, unless your doctor tells you to do so.
Use in children and adolescents
Midelut must not be given to children.
If you take more Midelut than you should
If you take more Midelut than prescribed by your doctor, contact a doctor immediately or go
to the nearest hospital.
If you forget to take Midelut
If you forget to take a dose, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.
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 experiences them.
Contact your doctor immediately 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 or other parts of the body.
• Difficulty breathing, shortness of breath or breathing problems.

Also, contact your doctor immediately if you notice any of the following effects:
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 (affecting less than 1 in 1,000), liver failure.
• Abdominal pain.
• Blood in the urine.

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

• Severe shortness of breath or sudden worsening of breathing. This may present with a cough or high temperature (fever). These may be signs of lung inflammation known as 'interstitial lung disease'.

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

• Changes in ECG trace (QT interval prolongation).

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

• Rash
• Breast swelling and tenderness
• Feeling weak

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

• Hot flushes
• Feeling unwell (nausea)
• Itching
• Dry skin
• Erectile problems (erectile dysfunction)
• Weight gain
• Reduced sex drive
• Hair loss
• Hair regrowth or excessive hair growth
• Low red blood cell levels (anaemia). This may make you feel tired or look pale
• Loss of appetite
• Depression
• Drowsiness
• Indigestion
• Dizziness
• Constipation
• Flatulence
• Chest pain
• Swelling

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

• Increased sensitivity of the skin to sunlight

Your doctor may prescribe blood tests to monitor certain blood parameters.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
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 Midelut

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 stated on the blister and carton. The expiry date refers to the last day of that month.
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. Package contents and other information

What Midelut contains:

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

Tablet core:
The excipients are: monohydrate lactose, povidone K-25, sodium starch glycolate (type A), magnesium stearate.
Coating film:
Opadry OY-S-9622 containing hypromellose 5cp (E464), titanium dioxide (E171) and propylene glycol.
Description of the appearance of Midelut and package contents
Midelut is supplied as white, round, biconvex, film-coated tablets with a break-line on one side. The break-line facilitates breaking the tablet for easier swallowing; it is not intended for dividing the tablet into equal doses.
The tablets are packed in blisters containing 14, 28, 30, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sophos Biotech S.r.l.
Via Modica, 6
20143 Milano
Manufacturer
Genepharm S.A.
18th km Marathonos Avenue
153 51 Pallini Attikis
Greece
This medicinal product is authorized in the European Economic Area countries under the
following names:
Denmark Bicalutamid Bluefish
Ireland Bicalutamide 150 mg film-coated tablets
Austria Bicalutamid Bluefish 150 mg Filmtabletten
Germany Bicalutamid Bluefish 150 mg Filmtabletten
Spain Bicalutamida Bluefish 150 mg Comprimidos recubiertos con película EFG
Italy Midelut 150 mg Compresse rivestite con film
Norway Bicalutamid Bluefish 150 mg Filmdrasjertetabletter
Sweden Bicalutamid Bluefish 150 mg Filmdrageradetabletter