Dutasteride 0.5 Mg Soft Capsules
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Avodarf
0.5 mg soft capsules (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.
The name of your medicine is Avodart 0.5 mg soft capsules but will be referred to as Avodart throughout this patient information leaflet.
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
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 prostate gland. Avodart 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.
Avodart may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).
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.
This medicine is for men only. It must not
be taken by women, children or adolescents.
Take special care with Avodart
• In some clinical studies, more patients taking dustasteride and another medicine called an alpha-blocker, like tamsulosin experienced heart failure than patients taking only dustasteride or only an alpha-blocker. 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.
• 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 affects 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 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 recentlytaken, 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 ordiltiazem (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.
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 Avodart. If your partner is or may be pregnant, you must avoid exposing her to your semen.
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.
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.
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.
Like all medicines, Avodart can cause side
effects, although not everybody gets them.
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:
• not able to achieve or maintain an erection (impotence), this may continue after you stop taking Avodart
• decreased sex drive (libido), this may continue after you stop taking Avodart
• difficulty with ejaculation, this may continue after you stop taking Avodart
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.
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
Not known side effects
The frequency cannot be estimated from the available data:
• depressed mood
• pain and swelling in your testicles
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not store Avodart above 30°C.
Do not 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.
POM
What Avodart contains
The active substance is dutasteride.
Each soft capsule contains 0.5 mg 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), yellow iron oxide (E172), medium chain triglycerides, lecithin (may contain soya oil).
What Avodart looks like and contents of the pack
Avodart soft capsules are opaque, yellow, oblong, soft gelatin capsules marked with GX CE2 in grey colour. They are available in packs of 30 capsules.
Manufactured by:
GlaxoSmithKline Pharmaceuticals S.A.
Ul. Grunwaldzka 189 60-322 Poznan,
Poland
Or
Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe Germany
Procured from within the EU & repackaged by PL Holder: Kosei Pharma UK Ltd,
956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL
Avodart® 0.5 mg soft capsules, PL: 39352/0204
Avodart® is a registered trademark of the GlaxoSmithKline group of companies.
Leaflet date: 13.01.2014
LJU IdOlt^riUt; Package Leaflet: Information for the User
0.5 mg soft capsules
Dutasteride
0.5 mg soft capsules
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.
The name of your medicine is Dutasteride
0.5 mg soft capsules but will be referred to as
Dutasteride throughout this patient information
leaflet.
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
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).
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 dustasteride and another medicine called an alpha-blocker, like tamsulosin experienced heart failure than patients taking only dustasteride or only an alpha-blocker. 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 affects 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 recentlytaken, 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 ordiltiazem (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.
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.
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.
Like all medicines, Dutasteride can cause side effects, although not everybody gets them.
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:
• not able to achieve or maintain an erection (impotence), this may continue after you stop taking Avodart
• decreased sex drive (libido), this may continue after you stop taking Avodart
• difficulty with ejaculation, this may continue after you stop taking Avodart
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin. 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
Not known side effects
The frequency cannot be estimated from the available data:
• depressed mood
• pain and swelling in your testicles
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not store Dutasteride above 30°C.
Do not 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.
What Dutasteride contains
The active substance is dutasteride.
Each soft capsule contains 0.5 mg 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), yellow iron oxide (E172), medium chain triglycerides, lecithin (may contain soya oil).
What Dutasteride looks like and contents of the pack
Dutasteride soft capsules are opaque, yellow, oblong, soft gelatin capsules marked with GX CE2 in grey colour. They are available in packs of 30.
Manufactured by:
GlaxoSmithKline Pharmaceuticals S.A.
Ul. Grunwaldzka 189 60-322 Poznan,
Poland
Or
Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe Germany
Procured from within the EU & repackaged by PL Holder: Kosei Pharma UK Ltd,
956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL