MIDELUT 50 mg Film-Coated Tablets

Зміст інструкції

1. Midelut 50 mg film-coated tablets
   1. What is Midelut and what is it used for
   2. What you need to know before you take Midelut
   3. How to take Midelut
   4. Possible side effects
   5. How to store Midelut
   6. Contents of the pack and other information
2. Midelut 150 mg film-coated tablets
   1. What is Midelut and what is it used for
   2. What you need to know before you take Midelut
   3. How to take Midelut
   4. Possible side effects
   5. How to store Midelut
   6. Contents of the pack and other information

Midelut 50 mg film-coated tablets

Bicalutamide
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Midelut and what is it 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 you take Midelut

Do not take Midelut

• if you are allergic to bicalutamide or 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 should not be administered to children.
Do not take Midelut if any of these conditions apply to you. If you are unsure, talk to your
doctor or pharmacist before taking Midelut.

Warnings and precautions
Talk to your doctor or pharmacist before taking 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 the treatment of these disorders. 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, tell 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 130 days after stopping Midelut. Talk to 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 can influence the way other medicines work. Also, some other medicines
can affect the way 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 can interfere with some medicines used to treat heart rhythm disorders (e.g.
quinidine, procainamide, amiodarone and sotalol) or can increase the risk of heart rhythm problems when used with some other medicines [e.g. methadone (used as
a painkiller and as part of drug detoxification treatment), moxifloxacin
(an antibiotic), antipsychotics used for serious mental illnesses].
Also, tell 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 diseases)
• 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 mothers breastfeeding
at the breast.
Midelut may have effects on 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 feel drowsy, be careful when performing these activities.

Midelut contains lactose
Midelut contains lactose monohydrate, which is a type of sugar. If your doctor has diagnosed
you with intolerance to certain sugars, contact him/her before taking this medicine.

Midelut contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg tablet, therefore it is
essentially sodium-free.

3. How to take Midelut

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

• The recommended dose for an adult is one tablet a day.
• Swallow the tablet whole with a sip 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 as soon as possible 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 as usual.
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 everybody gets them.

Allergic reactions
These are uncommon (may affect up to 1 in 100 people):
Symptoms can include the sudden onset of:

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

If this happens, consult a doctor immediately.

Also tell your doctor immediately if you notice any of the following effects:

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

• Abdominal pain.
• Blood in your urine.

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

• Yellowing of the skin or the white part of the eyes (jaundice). These can be signs of problems with the liver or, in rare cases (may affect up to 1 in 1,000), liver failure.

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

• Severe shortness of breath or worsening of breathlessness. This may present with a cough or with a high temperature (fever). These can be signs of inflammation of the lungs called 'interstitial lung disease'.

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

• Changes in ECG tracing (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 tenderness or enlargement
• Feeling weak
• Swelling
• Hot flushes
• Low levels of red blood cells (anaemia). This can make you feel tired or look pale.

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Reduced sexual drive
• Depression
• Feeling sleepy
• Indigestion
• Flatulence
• Hair loss
• Hair regrowth or excessive hair growth
• Dry skin
• Itching
• Skin rash
• Inability to get an erection (impotence)
• Weight gain
• Chest pain
• Reduced heart function
• Heart attack

Rare (may affect up to 1 in 1000 people)

• Increased sensitivity of the skin to sunlight

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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 particular storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Midelut contains:

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

Inside the tablet:
The excipients are: lactose monohydrate, povidone K-25, sodium starch glycolate (type A), magnesium
stearate.

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

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

Marketing Authorisation Holder
Nextad Pharma S.r.l.
Via Giuseppe Gioachino Belli, 86
00193 Roma

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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
Italy Midelut 50 mg Film-coated tablets
Norway Bicalutamid Bluefish 50 mg Filmdrasjertabletter
Sweden Bicalutamid Bluefish 50 mg Filmdrageradetabletter

Midelut 150 mg film-coated tablets

Bicalutamide
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Midelut and what is it 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 you take Midelut

Do not take Midelut

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

Midelut should not be given to children.
Do not take Midelut if any of these conditions apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Midelut.

Warnings and precautions
Talk to your doctor or pharmacist before taking Midelut.

• if you have problems with your liver. Your doctor may prescribe 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 disorders. 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. Talk to your doctor if you have any questions about contraception.

If you are admitted to hospital, tell the medical staff that you are taking Midelut.

Children and adolescents
Midelut should not be given to children or adolescents.

Tests and checks
Your doctor may prescribe blood tests to check for changes in your blood parameters.

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 can affect the way other medicines work. Also, some other medicines
can affect the way 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 with some other medicines [e.g. methadone (used as
a pain reliever and as part of 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 prescribe blood tests before and during treatment with Midelut 150 mg.
• cyclosporine (to suppress the immune system).
• calcium channel blockers (for the treatment of hypertension or certain heart diseases).
• 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 mothers who are breastfeeding.
Midelut may have effects on male fertility, which may be reversible.

Driving and using machines
It is unlikely that Midelut will affect your ability to drive or use tools or machines. In
any case, some people may feel sleepy while taking Midelut. If this happens,
ask your doctor or pharmacist for advice.

Sunlight or ultraviolet (UV) light
Avoid excessive direct exposure to sunlight or UV rays during therapy 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 them before taking this medicine.

Midelut contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 150 mg tablet, therefore it is
essentially sodium-free.

3. How to take Midelut

Always use this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist. The recommended dose is one tablet per day.
Swallow the tablet whole with a sip of water. If possible, 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
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 as soon as possible 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 as usual.
Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 the sudden onset of:

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

Also inform 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 the white part of the eyes (jaundice). These may be signs of problems with the liver 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 worsening of breathlessness. This may manifest with a cough or with a high temperature (fever). These may be signs of inflammation of the lungs called 'interstitial lung disease'.

Not known (frequency cannot be estimated based on available data):

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

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

• Skin rash
• Breast swelling and tenderness
• Feeling of weakness

Common (may affect up to 1 in 10 people)

• Hot flushes
• Feeling unwell (nausea)
• Itching
• Dry skin
• Problems with erection (erectile dysfunction)
• Weight gain
• Reduced sexual desire
• Hair loss
• Regrowth of hair or excessive hair growth
• Low levels of red blood cells (anemia). This may make you feel tired or look pale
• Loss of appetite
• Depression
• Feeling sleepy
• Indigestion
• Dizziness
• Constipation
• Flatulence
• Chest pain
• Swelling

Rare (may affect less than 1 in 1000 people)

• Increased sensitivity of the skin to sunlight

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the blister and the carton. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Midelut contains:

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

Inside the tablet:
The excipients are: lactose monohydrate, povidone K-25, sodium starch glycolate (type A), magnesium
stearate.

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

Description of the appearance of Midelut and contents of the pack
Midelut is supplied as white, round, biconvex, film-coated tablets with
a notch on one side. The notch facilitates breaking and subsequent swallowing; it is not for
dividing the tablet into equal doses.
The tablets are packaged in blisters of 14, 28, 30, 90, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Nextad Pharma S.r.l.
Via Giuseppe Gioachino Belli, 86
00193 Rome

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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 Film-coated tablets
Norway Bicalutamid Bluefish 150 mg Filmdrasjertabletter
Sweden Bicalutamid Bluefish 150 mg Filmdrageradetabletter