Dutasteride

The prostate, a gland located at the base of a man’s bladder, around the urethra, grows as men age. This growth is caused by producing too much of a hormone called dihydrotestosterone. As the prostate grows, it can lead to urinary problems. If left untreated, there is a risk that your urine flow will be completely blocked (acute urinary retention).

Dutasteride lowers the production of dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms.

 How to take Dutasteride 

Swallow the capsules whole with water. Do not chew or break open the capsule. Dutasteride can be taken with or without food.

Dutasteride is a long-term treatment. You may need to take it for three to six months or more before it begins to have an effect. Keep taking this medicine daily even if your symptoms do not seem to be improving.

 Dosage 

Your doctor will recommend the dose for you. Keep taking this medicine for as long as your doctor tells you. The recommended dose in adults is:

• One capsule once daily.

 Taken too much/forgot to take/stop taking Dutasteride 

Contact your doctor or pharmacist for advice if you take too many capsules.

If you forget to take a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the forgotten one.

Do not stop using Dutasteride without talking to a doctor first.

Do not use Dutasteride if:

• You are allergic to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or to any of the other ingredients of this medicine (see section ‘What Dutasteride contains’).
• You have a severe liver disease.

 When should Dutasteride be used with caution? 

There are warnings associated with Dutasteride.

• Talk to your doctor before taking this medicine if you have or have had liver problems.
• Dutasteride affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Men taking this medicine should have their PSA tested regularly.
• Women, children and adolescents must not handle leaking 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.
• The active ingredient dutasteride can affect the normal development of a male baby. Dutasteride can pass into semen. If your partner is or may be pregnant, you must avoid exposing her to your semen and use a condom during sexual intercourse. If a woman who is pregnant comes into contact with crushed or broken capsules, speak to a doctor.
• Dutasteride has been shown to reduce sperm count, semen volume and sperm movement. Therefore male fertility may be reduced (see the package leaflet for more information).

This list is not exhaustive. For more information about warnings, see the package leaflet.

 Pregnancy/breastfeeding 

This medicine is only intended for men.

 Driving and operating machines 

This medicine does not affect your reaction time.

Other medicines and Dutasteride Tell your doctor if you are taking, have recently taken or might take any other medicines. This is important, because Dutasteride is known to interact with other medicines (see the package leaflet for more information). Your doctor will have a list of medicines that you should avoid mixing Dutasteride with.

Like all medicines, this medicine can cause side effects, although some people may not experience any.

Serious side effects

Contact your doctor immediately if you get serious side effects or signs of a severe allergic reaction (see the package leaflet for a list of symptoms).

Other side effects that are known to be associated with this medicine include:

Common (may affect up to 1 in 10 users):

• Inability to achieve or maintain an erection (this may continue after you stop taking this medicine).
• Decreased sex drive (this may continue after you stop taking this medicine).
• Difficulty with ejaculation, such as a decrease in the amount of semen released during sex (this may continue after you stop taking this medicine).
• Breast enlargement or tenderness.
• Dizziness when taken with tamsulosin.

Uncommon (may affect up to 1 in 100 users):

• Heart failure (see the package leaflet for symptoms).
• Hair loss (usually from the body) or hair growth.

This list is not exhaustive. For a list of all possible side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The active substance in this medicine is dutasteride. Each soft capsule contains 0.5 mg dutasteride. The other ingredients are:

• Inside the capsule: glycerol monocaprylocaprate (type 1) and butylated hydroxytoluene (E321)
• Capsule shell: gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), triglycerides (medium chain), soybean lecithin (E322) and purified water.

 How to store this medicine 

Keep medicines out of reach of children at all times. Don’t store this medicine above 30°C.