Avodart 0.5mg Soft Capsules
1. What Avidart is and what it is used for
PACKAGE LEAFLET: INFORMATION FOR THE USER AVIDART® 0.5MG SOFT CAPSULES
(dutasteride)
This product is available as the above name but will be
referred to as Avidart throughout this leaflet.
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.
What is in this leaflet:
1 What Avidart is and what it is used for
2 What you need to know before you take Avidart
3 How to take Avidart
4 Possible side effects
5 How to store Avidart
6 Contents of the pack and other information
Avidart 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. Avidart 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.
Avidart 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 Avidart
Do not take Avidart
• 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.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Avidart. 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.
• Avidart 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 Avidart. Men taking Avidart should have their PSA tested regularly.
• In a clinical study of men at increased risk of prostate cancer, men taking Avidart had a serious form of prostate cancer more often than men who did not take Avidart. The effect of Avidart on this serious form of prostate cancer is not clear.
• Avidart 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 Avidart.
Other medicines and Avidart
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines can react with Avidart 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 Avidart may need to be reduced.
Avidart with food and drink
Avidart 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 Avidart. If your partner is or may be pregnant, you must avoid exposing her to your semen. Avidart 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.
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Warnings and Precautions
Talk to your doctor before taking Avidart.
• 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 Avidart.
• Women, children and adolescents must not handle leaking Avidart 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.
Driving and using machines
Avidart is unlikely to affect your ability to drive or operate machinery.
Avidart 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 Avidart 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.
Avidart is a long term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Avidart for 6 months or more before it begins to have an effect. Keep taking Avidart for as long as your doctor tells you.
If you take more Avidart than you should
Contact your doctor or pharmacist for advice if you take too many Avidart capsules.
If you forget to take Avidart
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
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.
Don't store Avidart above 30°C.
Don't use Avidart 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 Avidart 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.
Don't stop Avidart without advice
Don't stop taking Avidart 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.
■ 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 Avidart.
■ Common side effects
These may affect up to 1 in 10 men taking Avidart:
• not able to achieve or maintain an erection (impotence), this may continue after you stop taking Avidart • decreased sex drive (libido), this may continue after you stop taking Avidart
• difficulty with ejaculation, this may continue after you stop taking Avidart
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.
What Avidart contains
The active ingredient is: Dutasteride. Each soft capsule contains 0.5mg of the active ingredient dutasteride.
The other ingredients are: Each capsule also includes mono and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321) in the solution inside the capsule shell. The capsule shell contains gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), medium chain triglycerides and lecithin.
What Avidart looks like and contents of the pack
Oblong opaque yellow, gelatin capsules marked with 'GX CE2' in grey and are available in packs of 30 capsules.
Manufacturer
GlaxoSmithKline Pharmaceuticals S.A. Ul. Grunwaldzka 189 60-322 Poznan, Poland.
Product Licence holder: G Pharma Ltd, Salford M50 2PU.
PL No: 16369/0040
POM
Avidart 0.5mg Soft Capsules 11/08/2015
‘Avidart’ is a registered trademark of the GlaxoSmithKline Group of Companies.
Uncommon side effects
These may affect up to 1 in 100 men taking Avidart:
• 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.