Avodart
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.
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
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 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).
Before you take Avodart
Do not take Avodart
if you’re allergic (hypersensitive) to dutasteride or to any of the other ingredients of Avodart
if you’re allergic to other 5-alpha reductase inhibitors
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
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 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 Avodart.
- 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.
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.
How to take Avodart
Always take Avodart exactly as your doctor has told you to. 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.
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.
- 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.
How to store Avodart
Keep out of the reach and sight of children.
Don’t store Avodart above 30°C.
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.
Further information
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), iron oxide yellow (E172), triglycerides (medium chain), lecithin
- printed ink: iron oxide red (E172) as the colourant, polyvinyl acetate phthalate, propylene glycol and macrogol.
What Avodart looks like and contents of the pack
Avodart soft capsules are oblong opaque, yellow, soft gelatin capsules printed with GX CE2 on one side in red ink. They are available in packs of 30 capsules.
Marketing Authorisation Holder
Manufacturer:
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name: Avodart
Reference number: 19494/0006
This is a service provided by the Royal National Institute of Blind People.
Leaflet date: March 2010
Avodart is a registered trademark of the GlaxoSmithKline group of companies.
© 2010 GlaxoSmithKline group of companies
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