AVODART 0.5 MG SOFT CAPSULES

Active substance: DUTASTERIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Var (15) To remove the printing ink constituents: iron oxide red (E172) as the colourant, polyvinyl acetate phthalate, propylene glycol and macrogol with consequential change in the capsule marking from (imprinted with GX CE2 on one side in red ink) to (marked with GX CE2 on one side in grey)
Var (18) 1. To remove the ECMA number 727529 and 2. To remove the manufacturers: Cardinal Health France 404; 74 rue Principale, 67930, Beinheim, France and Catalent France Beinheim S.A.; 74 rue Principale, F-67930, Beinheim, France

Assessed against the UK PL dated March 2012
500789/PL1h

®

Avodart 0.5 mg Soft Capsules
(dutasteride)

Patient Information Leaflet
®
The name of your medicine is Avodart 0.5 mg Soft Capsules,
®
throughout this leaflet it will be referred to as Avodart .
Read all of this leaflet carefully before you start using
this medicine.
- 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
®
1) What Avodart is and what it’s used for
®
2) Before you take Avodart
®
3) How to take Avodart
4) Possible side effects
®
5) How to store Avodart
6) Further information
®

1) WHAT AVODART IS AND WHAT IT’S USED FOR
®
Avodart is used to treat men with an enlarged prostate
(benign prostatic hyperplasia) - a non-cancerous growth of the
prostate gland, caused by producing too much of a hormone
called dihydrotestosterone.
The active ingredient is dutasteride. It belongs to a group of
medicines called 5-alpha reductase inhibitors.
As the prostate grows, it can lead to urinary problems, such
as difficulty in passing urine and a need to go to the toilet
frequently. It can also cause the flow of the urine to be slower
and less forceful. If left untreated, there is a risk that your
urine flow will be completely blocked (acute urinary retention).
This requires immediate medical treatment. In some situations
surgery is necessary to remove or reduce the size of the
®
lowers the production of
prostate gland. Avodart
dihydrotestosterone, which helps to shrink the prostate and
relieve the symptoms. This will reduce the risk of acute
urinary retention and the need for surgery.
®

Avodart may also be used with another medicine called
tamsulosin (used to treat the symptoms of an enlarged
prostate).
®



Women, children and adolescents must not handle
®
leaking Avodart
capsules, because the active
ingredient can be absorbed through the skin. Wash
the affected area immediately with soap and water if
there is any contact with the skin.
• Use a condom during sexual intercourse.
Dutasteride has been found in the semen of men
®
taking Avodart . If your partner is or may be pregnant,
you must avoid exposing her to your semen as
dutasteride may affect the normal development of a
male baby. Dutasteride has been shown to decrease
sperm count, semen volume and sperm motility. This
could reduce your fertility.
®
• Avodart can affect a blood test for PSA (prostatespecific antigen), which is sometimes used to detect
prostate cancer. Your doctor should be aware of this
effect and can still use the test to detect prostate
cancer. If you are having a blood test for PSA, tell your
®
doctor that you are taking Avodart . Men taking
®
Avodart should have their PSA tested regularly.
• In a clinical study of men at increased risk of prostate
®
cancer, men taking Avodart had a serious form of
prostate cancer more often than men who did not
®
®
take Avodart . The effect of Avodart on this serious
form of prostate cancer is not clear.
®
• Avodart may cause breast enlargement and
tenderness. If this becomes troublesome, or if you
notice breast lumps or nipple discharge you should
talk to your doctor about these changes as these may
be signs of a serious condition, such as breast cancer.
 Contact your doctor or pharmacist if you have any
®
questions about taking Avodart .
Taking other medicines
Tell your doctor if you’re taking, or have recently taken,
any other medicines. This includes any medicines you’ve
bought without a prescription.
®

Some medicines can react with Avodart and may make it
more likely that you’ll have side-effects. These medicines
include:
• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketaconazole (for fungal infections)
• nefazodone (an antidepressant)
• alpha-blockers (for enlarged prostate or high blood
pressure).
 Tell your doctor if you are taking any of these
®
medicines. Your dose of Avodart may need to be
reduced.
®

Food and drink with Avodart
®
Avodart can be taken with or without food.

2) BEFORE YOU TAKE AVODART
®
Do not take Avodart
• if you’re allergic (hypersensitive) to dutasteride,
other 5-alpha reductase inhibitors, soya, peanut or
®
to any of the other ingredients of Avodart
• if you have a severe liver disease.
 Tell your doctor if you think any of these apply to you.

Pregnancy and breast-feeding
Women who are pregnant (or may be) must not handle
leaking capsules. Dutasteride is absorbed through the skin
and can affect the normal development of a male baby. This
is a particular risk in the first 16 weeks of pregnancy.

This medicine is for men only. It must not be taken by
women, children or adolescents.

Use a condom during sexual intercourse. Dutasteride has
®
been found in the semen of men taking Avodart . If your
partner is or may be pregnant, you must avoid exposing her to
your semen.

®

Take special care with Avodart
• In some clinical studies, more patients taking
dutasteride and another medicine called an alphablocker, like tamsulosin experienced heart failure than
patients taking only dutasteride or only an alphablocker. Heart failure means your heart does not pump
blood as well as it should.
• Make sure your doctor knows about liver
problems. If you have had any illness affecting your
liver, you may need some additional check-ups while
®
you are taking Avodart .

®

Avodart has been shown to reduce sperm count, semen
volume and sperm movement. Therefore male fertility may be
reduced.
 Contact your doctor for advice if a pregnant woman
has come into contact with dutasteride.
Driving and using machines
®
Avodart is unlikely to affect your ability to drive or operate
machinery.
Continued overleaf

Important information about some of the ingredients of
®
Avodart
This medicine contains lecithin from soya, which may contain
soya oil. If you are allergic to peanut or soya, do not use this
medicinal product.
®

3) HOW TO TAKE AVODART
®
Always take Avodart exactly as your doctor has told you
to. If you do not take it regularly the monitoring of your PSA
levels may be affected. Check with your doctor or pharmacist
if you are not sure.
How much to take
The usual dose is one capsule (0.5 mg) taken once a day.
Swallow the capsules whole with water. Do not chew or break
open the capsule. Contact with the contents of the capsules
may make your mouth or throat sore.
®

Avodart is a long term treatment. Some men notice an early
improvement in their symptoms. However, others may need to
®
take Avodart for 6 months or more before it begins to have
®
an effect. Keep taking Avodart for as long as your doctor tells
you.
®

If you take too much Avodart
Contact your doctor or pharmacist for advice if you take too
®
many Avodart capsules.
®

If you forget to take Avodart
Don’t take extra capsules to make up for a missed dose. Just
take your next dose at the usual time.
®

Don’t stop Avodart without advice
®
Don’t stop taking Avodart without talking to your doctor first.
It may take up to 6 months or more for you to notice an effect.
 If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
®
Like all medicines, Avodart can cause side effects,
although not everybody gets them.
Very rare allergic reaction
The signs of allergic reactions can include:
• skin rash (which can be itchy)
• hives (like a nettle rash)
• swelling of the eyelids, face, lips, arms or legs.
 Contact your doctor immediately if you get any of
®
these symptoms, and stop using Avodart .
Common side effects
®
These may affect up to 1 in 10 men taking Avodart :
• impotence (not able to achieve or maintain an erection)
• decreased sex drive (libido)
• difficulty with ejaculation
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.

®

5) HOW TO STORE AVODART
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package.
®

Don’t use Avodart after the expiry date which is stated on the
carton or the foil blister strip. The expiry date refers to the last
day of that month.
®

If you have any unwanted Avodart capsules, don’t dispose of
them in waste water or household rubbish. Take them back to
your pharmacist, who will dispose of them in a way that won’t
harm the environment.
If you notice any sign of discolouration or deterioration of the
capsules, please consult your pharmacist.
6) FURTHER INFORMATION
®
What Avodart contains
The active substance is dutasteride. Each soft capsule
contains 0.5mg dutasteride.
The other ingredients are:
• inside the capsule: mono and diglycerides of caprylic/
capric acid and butylated hydroxytoluene (E321).
• capsule shell: gelatin, glycerol, titanium dioxide (E171),
iron oxide yellow (E172), triglycerides (medium chain),
lecithin
®

What Avodart looks like and contents of the pack
®
Avodart soft capsules are yellow, opaque, oblong, gelatin
capsules marked with GX CE2 in grey.
They are available in blister packs of 30 capsules.
Product Licence Holder:
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St. James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A., UI. Grunwaldzka 189,
60-322 Poznan, Poland.
®

Avodart 0.5 mg Soft Capsules
PL No: 18067/0196

POM

®

Avodart
is
a
registered
trademark
GlaxoSmithKline group of Companies.

of

the

th

This leaflet was revised on 18 October 2013.
Other formats:
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

Uncommon side effects
®
These may affect up to 1 in 100 men taking Avodart :
• heart failure (heart becomes less efficient at pumping
blood around the body. You may have symptoms such
as shortness of breath, extreme tiredness and swelling
in your ankles and legs).
• hair loss (usually from the body) or hair growth
 If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

500789/PL1h

503950/PL1h

Dutasteride 0.5 mg Soft Capsules

Patient Information Leaflet
The name of your medicine is Dutasteride 0.5 mg Soft
Capsules, throughout this leaflet it will be referred to as
Dutasteride.
Read all of this leaflet carefully before you start using
this medicine.
- 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1) What Dutasteride is and what it’s used for
2) Before you take Dutasteride
3) How to take Dutasteride
4) Possible side effects
5) How to store Dutasteride
6) Further information
1) WHAT DUTASTERIDE IS AND WHAT IT’S USED FOR
Dutasteride is used to treat men with an enlarged
prostate (benign prostatic hyperplasia) - a non-cancerous
growth of the prostate gland, caused by producing too much
of a hormone called dihydrotestosterone.
The active ingredient is dutasteride. It belongs to a group of
medicines called 5-alpha reductase inhibitors.
As the prostate grows, it can lead to urinary problems, such
as difficulty in passing urine and a need to go to the toilet
frequently. It can also cause the flow of the urine to be slower
and less forceful. If left untreated, there is a risk that your
urine flow will be completely blocked (acute urinary retention).
This requires immediate medical treatment. In some situations
surgery is necessary to remove or reduce the size of the
prostate gland. Dutasteride lowers the production of
dihydrotestosterone, which helps to shrink the prostate and
relieve the symptoms. This will reduce the risk of acute
urinary retention and the need for surgery.
Dutasteride may also be used with another medicine called
tamsulosin (used to treat the symptoms of an enlarged
prostate).
2) BEFORE YOU TAKE DUTASTERIDE
Do not take Dutasteride
• if you’re allergic (hypersensitive) to dutasteride,
other 5-alpha reductase inhibitors, soya, peanut or
to any of the other ingredients of Dutasteride.
• if you have a severe liver disease.
 Tell your doctor if you think any of these apply to you.
This medicine is for men only. It must not be taken by
women, children or adolescents.
Take special care with Dutasteride
• In some clinical studies, more patients taking
dutasteride and another medicine called an alphablocker, like tamsulosin experienced heart failure than
patients taking only dutasteride or only an alphablocker. Heart failure means your heart does not pump
blood as well as it should.
• Make sure your doctor knows about liver
problems. If you have had any illness affecting your
liver, you may need some additional check-ups while
you are taking Dutasteride.



Women, children and adolescents must not handle
leaking Dutasteride capsules, because the active
ingredient can be absorbed through the skin. Wash
the affected area immediately with soap and water if
there is any contact with the skin.
• Use a condom during sexual intercourse.
Dutasteride has been found in the semen of men
taking Dutasteride. If your partner is or may be
pregnant, you must avoid exposing her to your semen
as dutasteride may affect the normal development of a
male baby. Dutasteride has been shown to decrease
sperm count, semen volume and sperm motility. This
could reduce your fertility.
• Dutasteride can affect a blood test for PSA
(prostate-specific antigen), which is sometimes used to
detect prostate cancer. Your doctor should be aware of
this effect and can still use the test to detect prostate
cancer. If you are having a blood test for PSA, tell your
doctor that you are taking Dutasteride. Men taking
Dutasteride should have their PSA tested regularly.
• In a clinical study of men at increased risk of prostate
cancer, men taking Dutasteride had a serious form of
prostate cancer more often than men who did not
take Dutasteride. The effect of Dutasteride on this
serious form of prostate cancer is not clear.
• Dutasteride may cause breast enlargement and
tenderness. If this becomes troublesome, or if you
notice breast lumps or nipple discharge you should
talk to your doctor about these changes as these may
be signs of a serious condition, such as breast cancer.
 Contact your doctor or pharmacist if you have any
questions about taking Dutasteride.
Taking other medicines
Tell your doctor if you’re taking, or have recently taken,
any other medicines. This includes any medicines you’ve
bought without a prescription.
Some medicines can react with Dutasteride and may make it
more likely that you’ll have side-effects. These medicines
include:
• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketaconazole (for fungal infections)
• nefazodone (an antidepressant)
• alpha-blockers (for enlarged prostate or high blood
pressure).
 Tell your doctor if you are taking any of these
medicines. Your dose of Dutasteride may need to be
reduced.
Food and drink with Dutasteride
Dutasteride can be taken with or without food.
Pregnancy and breast-feeding
Women who are pregnant (or may be) must not handle
leaking capsules. Dutasteride is absorbed through the skin
and can affect the normal development of a male baby. This
is a particular risk in the first 16 weeks of pregnancy.
Use a condom during sexual intercourse. Dutasteride has
been found in the semen of men taking Dutasteride. If your
partner is or may be pregnant, you must avoid exposing her to
your semen.
Dutasteride has been shown to reduce sperm count, semen
volume and sperm movement. Therefore male fertility may be
reduced.
 Contact your doctor for advice if a pregnant woman
has come into contact with dutasteride.
Driving and using machines
Dutasteride is unlikely to affect your ability to drive or operate
machinery.
Continued overleaf

Important information about some of the ingredients of
Dutasteride
This medicine contains lecithin from soya, which may contain
soya oil. If you are allergic to peanut or soya, do not use this
medicinal product.
3) HOW TO TAKE DUTASTERIDE
Always take Dutasteride exactly as your doctor has told
you to. If you do not take it regularly the monitoring of your
PSA levels may be affected. Check with your doctor or
pharmacist if you are not sure.
How much to take
The usual dose is one capsule (0.5 mg) taken once a day.
Swallow the capsules whole with water. Do not chew or break
open the capsule. Contact with the contents of the capsules
may make your mouth or throat sore.
Dutasteride is a long term treatment. Some men notice an
early improvement in their symptoms. However, others may
need to take Dutasteride for 6 months or more before it
begins to have an effect. Keep taking Dutasteride for as long
as your doctor tells you.
If you take too much Dutasteride
Contact your doctor or pharmacist for advice if you take too
many Dutasteride capsules.
If you forget to take Dutasteride
Don’t take extra capsules to make up for a missed dose. Just
take your next dose at the usual time.
Don’t stop Dutasteride without advice
Don’t stop taking Dutasteride without talking to your doctor
first. It may take up to 6 months or more for you to notice an
effect.
 If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Dutasteride can cause side effects,
although not everybody gets them.
Very rare allergic reaction
The signs of allergic reactions can include:
• skin rash (which can be itchy)
• hives (like a nettle rash)
• swelling of the eyelids, face, lips, arms or legs.
 Contact your doctor immediately if you get any of
these symptoms, and stop using Dutasteride.
Common side effects
These may affect up to 1 in 10 men taking Dutasteride:
• impotence (not able to achieve or maintain an erection)
• decreased sex drive (libido)
• difficulty with ejaculation
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.

5) HOW TO STORE DUTASTERIDE
Keep out of the sight and reach of children.
Do not store above 30°C. Store in the original package.
Don’t use Dutasteride after the expiry date which is stated on
the carton or the foil blister strip. The expiry date refers to the
last day of that month.
If you have any unwanted Dutasteride capsules, don’t dispose
of them in waste water or household rubbish. Take them back
to your pharmacist, who will dispose of them in a way that
won’t harm the environment.
If you notice any sign of discolouration or deterioration of the
capsules, please consult your pharmacist.
6) FURTHER INFORMATION
What Dutasteride contains
The active substance is dutasteride. Each soft capsule
contains 0.5mg dutasteride.
The other ingredients are:
• inside the capsule: mono and diglycerides of caprylic/
capric acid and butylated hydroxytoluene (E321).
• capsule shell: gelatin, glycerol, titanium dioxide (E171),
iron oxide yellow (E172), triglycerides (medium chain),
lecithin
What Dutasteride looks like and contents of the pack
Dutasteride soft capsules are yellow, opaque, oblong, gelatin
capsules, marked with GX CE2 in grey.
They are available in blister packs of 30 capsules.
Product Licence Holder:
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St. James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A., UI. Grunwaldzka 189,
60-322 Poznan, Poland.
Dutasteride 0.5 mg Soft Capsules
PL No: 18067/0196

POM

th

This leaflet was revised on 18 October 2013.
Other formats:
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

Uncommon side effects
These may affect up to 1 in 100 men taking Dutasteride:
• heart failure (heart becomes less efficient at pumping
blood around the body. You may have symptoms such
as shortness of breath, extreme tiredness and swelling
in your ankles and legs).
• hair loss (usually from the body) or hair growth
 If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

503950/PL1h

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)