POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 19494/0006 .
Avodart 0.5mg soft capsules
Package Leaflet: Information for the patient
Avodart 0.5 mg soft capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 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).
2. What you need to know before you take Avodart
Do not take Avodart
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.
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:
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.
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.
3. How to take Avodart
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The signs of allergic reactions can include:
Common side effects
These may affect up to 1 in 10 men taking Avodart:
Uncommon side effects
These may affect up to 1 in 100 men taking Avodart:
Not known side effects
The frequency cannot be estimated from the available data:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Avodart
Keep this medicine out of the sight and reach of children.
Don’t store Avodart above 30°C.
Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Avodart contains
The active substance is dutasteride. Each soft capsule contains 0.5 mg dutasteride.
The other ingredients are:
What Avodart looks like and contents of the pack
Avodart soft capsules are oblong opaque, yellow, soft gelatin capsules marked with GX CE2. They are available in packs of 10, 30, 50, 60 and 90 capsules. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
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.
This leaflet was last revised in October 2017
Trade marks are owned by or licensed to the GSK group of companies
© 2017 GSK group of companies or its licensor