Dutasteride 0.5mg Soft Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER AVODART® 0.5mg SOFT CAPSULES
(dutasteride)
Read all of this leaflet carefully before you start using 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.
What is in this leaflet:
1. What Avodart® 0.5mg Soft Capsules are and what they are used for
2. What you need to know before you take Avodart® 0.5mg Soft Capsules
3. How to take Avodart® 0.5mg Soft Capsules
4. Possible side effects
5. How to store Avodart® 0.5mg Soft Capsules
6. Contents of the pack and other information
1. WHAT AVODART® 0.5MG SOFT CAPSULES ARE AND WHAT THEY ARE USED FOR
Avodart® 0.5mg Soft Capsules are 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® 0.5mg Soft Capsules lower 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® 0.5mg Soft Capsules may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).
2. BEFORE YOU TAKE AVODART® 0.5MG SOFT CAPSULES Do not take Avodart® 0.5mg Soft 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 Avodart® 0.5mg Soft Capsules
• In some clinical studies, more patients taking dutasteride and another medicine called an alpha-blocker, like tamsulosin experienced heart failure than patients taking only dutasteride 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® 0.5mg Soft Capsules.
• Women, children and adolescents must not handle leaking Avodart® 0.5mg Soft 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® 0.5mg Soft 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.
• Avodart® 0.5mg Soft Capsules 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 Avodart® 0.5mg Soft
Capsules. Men taking Avodart® 0.5mg Soft Capsules should have their PSA tested regularly.
• In a clinical study of men at increased risk of prostate cancer, men taking Avodart® 0.5mg Soft Capsules had a serious form of prostate cancer more often than men who did not take Avodart® 0.5mg Soft Capsules. The effect of Avodart® 0.5mg Soft Capsules on this serious form of prostate cancer is not clear.
• Avodart® 0.5mg Soft 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 Avodart® 0.5mg Soft Capsules.
Other medicines and Avodart® 0.5mg Soft Capsules
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines can react with Avodart® 0.5mg Soft 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 Avodart® 0.5mg Soft Capsules may need to be reduced.
Avodart® 0.5mg Soft Capsules with food and drink
Avodart® 0.5mg Soft 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 Avodart® 0.5mg Soft Capsules. If your partner is or may be pregnant, you must avoid exposing her to your semen. Avodart® 0.5mg Soft Capsules have 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® 0.5mg Soft Capsules are unlikely to affect your ability to drive or operate machinery.
Avodart® 0.5mg Soft 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 AVODART® 0.5MG SOFT CAPSULES
Always take Avodart® 0.5mg Soft 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 (0.5mg) 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® 0.5mg Soft Capsules are a long term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Avodart® 0.5mg Soft Capsules for 6 months or more before it begins to have an effect. Keep taking Avodart® 0.5mg Soft Capsules for as long as your doctor tells you.
If you take more Avodart® 0.5mg Soft Capsules than you should
Contact your doctor or pharmacist for advice if you take too many Avodart® 0.5mg Soft Capsules.
Don't take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
Don’t stop Avodart® 0.5mg Soft Capsules without advice
Don't stop taking Avodart® 0.5mg Soft 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.
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® 0.5mg Soft Capsules.
Common side effects
These may affect up to 1 in 10 men taking Avodart® 0.5mg Soft Capsules:
• not able to achieve or maintain an erection (impotence), this may continue after you stop taking Avodart® 0.5mg Soft Capsules
• decreased sex drive (libido), this may continue after you stop taking Avodart® 0.5mg Soft Capsules
• difficulty with ejaculation, this may continue after you stop taking Avodart® 0.5mg Soft Capsules
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.
Uncommon side effects
These may affect up to 1 in 100 men taking Avodart® 0.5mg Soft 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
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 AVODART® 0.5MG SOFT CAPSULES
• Do not store above 30°C. Store the capsules in the original pack.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on both the carton and blister label. The expiry date refers to the last day of that month.
• If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your capsules show signs of deterioration or discolouration, 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® 0.5mg Soft Capsules contain
Each capsule contains 0.5mg of the active ingredient 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® 0.5mg Soft Capsules looks like and the contents of the pack
Each oblong opaque, yellow, soft gelatin capsule is marked with ‘GX CE2' Avodart® 0.5mg Soft Capsules are available as blister packs of 30 capsules.
Who manufactured your medicine
Avodart® 0.5mg Soft Capsules are manufactured by GlaxoSmithKline Pharmaceuticals S.A. Ul. Grunwaldzka 189, 60-322 Poznan, Poland. Procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0426 |POM|
Revision Date: 25.08.2015 Leaflet Reference: AVO500
Avodart is a registered trademark of the GlaxoSmithKline group of companies
PACKAGE LEAFLET: INFORMATION FOR THE USER DUTASTERIDE 0.5mg SOFT CAPSULES
(dutasteride)
Read all of this leaflet carefully before you start using 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.
What is in this leaflet:
1. What Dutasteride 0.5mg Soft Capsules are and what they are used for
2. What you need to know before you take Dutasteride 0.5mg Soft Capsules
3. How to take Dutasteride 0.5mg Soft Capsules
4. Possible side effects
5. How to store Dutasteride 0.5mg Soft Capsules
6. Contents of the pack and other information
1. WHAT DUTASTERIDE 0.5MG SOFT CAPSULES ARE AND WHAT THEY ARE USED FOR
Dutasteride 0.5mg Soft Capsules are 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 0.5mg Soft Capsules lower 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 0.5mg Soft Capsules may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).
2. BEFORE YOU TAKE DUTASTERIDE 0.5MG SOFT CAPSULES Do not take Dutasteride 0.5mg Soft 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 0.5mg Soft Capsules
• In some clinical studies, more patients taking dutasteride and another medicine called an alpha-blocker, like tamsulosin experienced heart failure than patients taking only dutasteride 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 0.5mg Soft Capsules.
• Women, children and adolescents must not handle leaking Dutasteride 0.5mg Soft 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 0.5mg Soft 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 0.5mg Soft Capsules 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 0.5mg Soft Capsules. Men taking Dutasteride 0.5mg Soft Capsules should have their PSA tested regularly.
• In a clinical study of men at increased risk of prostate cancer, men taking Dutasteride 0.5mg Soft Capsules had a serious form of prostate cancer more often than men who did not take Dutasteride 0.5mg Soft Capsules. The effect of Dutasteride 0.5mg Soft Capsules on this serious form of prostate cancer is not clear.
• Dutasteride 0.5mg Soft 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 0.5mg Soft Capsules.
Other medicines and Dutasteride 0.5mg Soft Capsules
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines can react with Dutasteride 0.5mg Soft 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 0.5mg Soft Capsules may need to be reduced.
Dutasteride 0.5mg Soft Capsules with food and drink
Dutasteride 0.5mg Soft 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 0.5mg Soft Capsules. If your partner is or may be pregnant, you must avoid exposing her to your semen.
Dutasteride 0.5mg Soft Capsules have 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 0.5mg Soft Capsules are unlikely to affect your ability to drive or operate machinery.
Dutasteride 0.5mg Soft 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 0.5MG SOFT CAPSULES
Always take Dutasteride 0.5mg Soft 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 (0.5mg) 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 0.5mg Soft Capsules are a long term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Dutasteride 0.5mg Soft Capsules for 6 months or more before it begins to have an effect. Keep taking Dutasteride 0.5mg Soft Capsules for as long as your doctor tells you.
If you take more Dutasteride 0.5mg Soft Capsules than you should
Contact your doctor or pharmacist for advice if you take too many Dutasteride 0.5mg Soft Capsules.
Don't take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
Don’t stop Dutasteride 0.5mg Soft Capsules without advice
Don't stop taking Dutasteride 0.5mg Soft 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.
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 0.5mg Soft Capsules.
Common side effects
These may affect up to 1 in 10 men taking Dutasteride 0.5mg Soft Capsules:
• not able to achieve or maintain an erection (impotence), this may continue after you stop taking Dutasteride 0.5mg Soft Capsules
• decreased sex drive (libido), this may continue after you stop taking Dutasteride 0.5mg Soft Capsules
• difficulty with ejaculation, this may continue after you stop taking Dutasteride 0.5mg Soft 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 0.5mg Soft 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
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 0.5MG SOFT CAPSULES
• Do not store above 30°C. Store the capsules in the original pack.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on both the carton and blister label. The expiry date refers to the last day of that month.
• If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your capsules show signs of deterioration or discolouration, 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.
What Dutasteride 0.5mg Soft Capsules contain
Each capsule contains 0.5mg of the active ingredient 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 0.5mg Soft Capsules looks like and the contents of the pack
Each oblong opaque, yellow, soft gelatin capsule is marked with ‘GX CE2' Dutasteride 0.5mg Soft Capsules are available as blister packs of 30 capsules.
Who manufactured your medicine
Dutasteride 0.5mg Soft Capsules are manufactured by GlaxoSmithKline Pharmaceuticals S.A. Ul. Grunwaldzka 189, 60-322 Poznan, Poland. Procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0426 |POM|
Revision Date: 25.08.2015 Leaflet Reference: DUT500