Dutasteride 0.5mg Soft Capsules
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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
S0238 LEAFLET Avodart 20150914
PACKAGE LEAFLET: INFORMATION FOR THE USER AVODART® 0.5mg SOFT CAPSULES
(dutasteride)
The name of your medicine is Avodart 0.5mg Soft Capsules but will be referred to as Avodart throughout the following leaflet.
What is in this leaflet:
1. What Avodart is and what it is used for
2. What you need to know before you take Avodart
3. How to take Avodart
4. Possible side effects
5. How to store Avodart
6. Contents of the pack and other information
1. WHAT AVODART IS AND WHAT IT IS 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 dihyd rotesto ste ro ne.
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).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVODART
Do not take Avodart
• if you’re allergic to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or to any of the other ingredients of this medicine (listed in section 6)
• if you have a severe liver disease.
^ If you think any of these apply to you, don’t take this medicine until you have checked with your doctor.
This medicine is for men only. It must not be taken by women,
children or adolescents.
Warnings and Precautions
Talk to your doctor before taking 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.
Other medicines and Avodart
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
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.
Avodart with food and drink
Avodart can be taken with or without food.
Pregnancy, breast-feeding and fertility
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.
Avodart contains lecithin from soya
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 or pharmacist 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 recommended 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 more Avodart than you should
Contact your doctor or pharmacist for advice if you take too many Avodart capsules.
If you forget to take Avodart
Do not take a double dose to make up for a forgotten 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, this medicine 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
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.
5. HOW TO STORE AVODART
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Avodart contains
• Each capsule contains 0.5mg of the active ingredient, dutasteride.
• Avodart Capsules also contain the following inactive ingredients: mono- and di-glycerides of caprylic/capric acid, butylated hydroxytoluene, gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium chain triglycerides, lecithin.
What Avodart looks like and contents of the pack
Avodart Capsules are soft, oblong, opaque, light yellow capsules,
marked ‘GX CE2'.
Avodart Capsules are available as blister packs of 30 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA01DX.
Manufacturer
This product is manufactured by GlaxoSmithKline Pharmaceuticals
S.A., ul. Grunwaldzka 189, 60-322 Poznan, Poland.
| POM | PL 19488/0238
Leaflet revision date: 14 September 2015
Avodart is a registered trademark of the GlaxoSmithKline group of companies.
S0238 LEAFLET Avodart 20150914
Not know n 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.
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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
S0238 LEAFLET Dutasteride 20150914
PACKAGE LEAFLET: INFORMATION FOR THE USER DUTASTERIDE 0.5mg SOFT CAPSULES
The name of your medicine is Dutasteride 0.5mg Soft Capsules but will be referred to as Dutasteride Capsules throughout the following leaflet.
What is in this leaflet:
1. What Dutasteride Capsules are and what they are used for
2. What you need to know before you take Dutasteride Capsules
3. How to take Dutasteride Capsules
4. Possible side effects
5. How to store Dutasteride Capsules
6. Contents of the pack and other information
1. WHAT DUTASTERIDE CAPSULES ARE AND WHAT THEY ARE USED FOR
Dutasteride Capsules 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 Capsules 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 Capsules may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUTASTERIDE CAPSULES
Do not take Dutasteride Capsules
• if you’re allergic to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or to any of the other ingredients of this medicine (listed in section 6)
• if you have a severe liver disease.
^ If you think any of these apply to you, don’t take this medicine until you have checked with your doctor.
This medicine is for men only. It must not be taken by women,
children or adolescents.
Warnings and Precautions
Talk to your doctor before taking Dutasteride Capsules.
• 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 Capsules.
• Women, children and adolescents must not handle leaking Dutasteride Capsules 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 Capsules. 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 Capsules 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 Capsules. Men taking Dutasteride Capsules should have their PSA tested regularly.
• In a clinical study of men at increased risk of prostate cancer, men taking Dutasteride Capsules had a serious form of prostate cancer more often than men who did not take Dutasteride Capsules. The effect of Dutasteride Capsules on this serious form of prostate cancer is not clear.
• Dutasteride Capsules 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 Capsules.
Other medicines and Dutasteride Capsules
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines can react with Dutasteride Capsules 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 Capsules may need to be reduced.
Dutasteride Capsules with food and drink
Dutasteride Capsules can be taken with or without food.
Pregnancy, breast-feeding and fertility
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 Capsules. If your partner is or may be pregnant, you must avoid exposing her to your semen.
Dutasteride Capsules 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 Capsules is unlikely to affect your ability to drive or operate machinery.
Dutasteride Capsules contains lecithin from soya
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 CAPSULES
Always take Dutasteride Capsules exactly as your doctor or pharmacist 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 recommended 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 Capsules is a long term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Dutasteride Capsules for 6 months or more before it begins to have an effect. Keep taking Dutasteride Capsules for as long as your doctor tells you.
If you take more Dutasteride Capsules than you should
Contact your doctor or pharmacist for advice if you take too many Dutasteride Capsules capsules.
If you forget to take Dutasteride Capsules
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
Don’t stop Dutasteride Capsules without advice
Don't stop taking Dutasteride Capsules 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.
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.
5. HOW TO STORE DUTASTERIDE CAPSULES
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 Capsules.
Common side effects
These may affect up to 1 in 10 men taking Dutasteride Capsules:
• not able to achieve or maintain an erection (impotence), this may continue after you stop taking Dutasteride Capsules
• decreased sex drive (libido), this may continue after you stop taking Dutasteride Capsules
• difficulty with ejaculation, this may continue after you stop taking Dutasteride Capsules
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.
Uncommon side effects
These may affect up to 1 in 100 men taking Dutasteride Capsules:
• 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
What Dutasteride Capsules contains
• Each capsule contains 0.5mg of the active ingredient, dutasteride.
• Dutasteride Capsules Capsules also contain the following inactive ingredients: mono- and di-glycerides of caprylic/capric acid, butylated hydroxytoluene, gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium chain triglycerides, lecithin.
What Dutasteride Capsules looks like and contents of the pack
Dutasteride Capsules Capsules are soft, oblong, opaque, light yellow capsules, marked ‘GX CE2'.
Dutasteride Capsules Capsules are available as blister packs of 30 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Wembley, HA01DX.
Manufacturer
This product is manufactured by GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189, 60-322 Poznan, Poland.
POM PL 19488/0238
Leaflet revision date: 14 September 2015
S0238 LEAFLET Dutasteride 20150914