Avodart

• Relieves urinary symptoms of an enlarged prostate gland
• Intended solely for use in men
• Take once daily

Avodart is used to treat men with an enlarged prostate gland, a condition called benign prostatic hyperplasia (BPH). BPH is a non-cancerous growth of the prostate gland, caused by producing too much of a hormone called dihydrotestosterone.

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 contains the active ingredient dutasteride. It belongs to a group of medicines called 5-alpha reductase inhibitors. 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 to treat the symptoms of an enlarged prostate.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

• The recommended dose is one capsule (0.5 mg) taken once a day.

The capsules should be swallowed whole with some water. Do not chew or break open the capsule. Contact with the contents of the capsules may make your mouth or throat sore. Avodart can be taken with or without food.

Avodart is a long-term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Avodart for six months or more before it begins to have an effect. Keep taking Avodart for as long as your doctor tells you.

Alcohol/driving

Avodart is unlikely to affect your ability to drive or operate machinery. There are no dietary restrictions with this medicine.

If you take more or less Avodart than you should

If you have taken more Avodart capsules than you should, contact your doctor or pharmacist immediately.

If you missed a dose, do not take a double dose to make up for a forgotten one. Just take your next dose at the usual time.

Don’t stop taking Avodart without talking to your doctor first. It may take up to six months or more for you to notice an effect.

Avodart is not suitable for everyone. Do not take this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Avodart contains').
• You are allergic to other 5alpha reductase inhibitors.
• You have severe liver disease.

This medicine is for adult men only. It must not be taken by women, children or adolescents.

When should this medicine be used with extreme caution?

There are warnings associated with Avodart.

• Make sure your doctor knows about liver problems. If you have had any illness affecting your liver, you may need some additional checkups while you are taking Avodart.
• Women, children and adolescentsmust not handle leaking Avodart capsules, because the active ingredient can be absorbed through the skin. Wash the affected area immediatelywith 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 affects a blood test for PSA(prostatespecific antigen), which is sometimes used to detect prostate cancer. If you are having a blood test for PSA, tell your doctor that you are taking Avodart.

Pregnancy and breastfeeding

Talk to your doctor if you are pregnant, planning to conceive or breastfeeding.

Women who are (or may be) pregnant 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.

Other medicines and Avodart

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that do not require 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 ketoconazole (for fungal infections).
• Nefazodone (an antidepressant).
• Alphablockers (for enlarged prostate or high blood pressure).

Talk to your doctor if you are taking any of these medicines. Your dose of Avodart may need to be adapted.

Medicines can cause side effects, although some people may not experience any. This also applies to Avodart. Side effects that are known to be associated with this medicine include:

Allergic reactions (rare)

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 (may affect up to 1 in 10 men taking Avodart):

• Impotence (inability to achieve or maintain an erection).
• Decreased sex drive (loss of libido).
• Ejaculation difficulties.
• Breast enlargement or tenderness (gynecomastia).
• Dizziness when taken with tamsulosin.

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:

• Capsule content: 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.
• Printing ink: iron oxide red (E172) as colorant, polyvinyl acetate, propylene glycol, macrogol.

The manufacturers of Avodart are:

Catalent France Beinheim S.A.

74 rue Principale

F-67930 Beinheim

France

GlaxoSmithKline Pharmaceuticals S.A.

Ul. Grunwaldzka 189

60-322 Poznan

Poland

Glaxo Wellcome GmbH & Co. KG

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

Read the package leaflet before use. The official package leaflet of Avodart is available for download here.