Dutasteride

• Relieves urinary symptoms of an enlarged prostate gland
• Intended solely for use in men
• Swallow capsule whole

Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors. This medicine is used to treat men with an enlarged prostate gland (benign prostatic hyperplasia, BPH). BPH is a non-cancerous growth of the prostate gland, caused by producing too much of a hormone called dihydrotestosterone.

An enlarged prostate can compress the urethra and cause urinary problems, such as:

• Difficulty passing urine.
• Increased need to urinate.
• Slower or less forceful flow of the urine. 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.

This medicine 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.

Dutasteride may also be used with another medicine called tamsulosin to treat the symptoms of an enlarged prostate gland.

Always take this medicine exactly as your doctor or pharmacist has told you. Some men notice an early improvement in their symptoms. However, others may need to take Dutasteride for several months or more before it begins to have an effect. In most cases, this medicine is used long term.

Dosage

The recommended dose is one capsule (0.5 mg) taken once a day. Always take this medicine regularly. If you do not take it regularly the monitoring of your PSA levels may be affected.

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

Alcohol/driving

Dutasteride 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 Dutasteride than you should

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

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.

Always consult your doctor before stopping the treatment.

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

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

This medicine is only suitable for use in men. It should not be used by women, children and adolescents.

When should this medicine be used with extreme caution?

There are warnings associated with Dutasteride. Talk to your doctor or pharmacist before taking Dutasteride capsules if:

• You are taking an alphablocker in combination with Dutasteride. In some clinical studies, more patients taking dutasteride and an alpha-blocker (like tamsulosin) experienced heart failure than patients taking only dutasteride or only an alpha-blocker.
• You have or have had a liver disease. Make sure your doctor knows about liver problems. You may need some additional checkups while you are taking Dutasteride capsules.

Other warnings include:

• Women, children and adolescentsmust 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.
• Dutasteride 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 this medicine. Men taking Dutasteride capsules should have their PSA tested regularly.
• Dutasteride capsules may cause breast enlargement and tenderness. If this becomes troublesome, or if you notice breast lumps or nipple dischargeyou should talk to your doctor about these changes as these may be signs of a serious condition, such as breast cancer.
• In a clinical study of men at increased risk of prostate cancer, men taking Dutasteride capsules had a serious form of prostate cancermore often than men who did not take Dutasteride capsules. The effect of Dutasteride capsules on this serious form of prostate cancer is not clear.

Pregnancy, breastfeeding and fertility

Women who are (or may be) pregnant must not handle leaking capsules as Dutasteride may affect the normal development of a male baby. This is a particular risk in the first 16 weeks of pregnancy. Contact yourdoctor for advice immediately if a pregnant woman has come into contact with dutasteride.

Use a condom during sexual intercourse.Dutasteride has been found in the semen of men taking this medicine. If your partner is or may be pregnant, you must avoid exposing her to your semen.

Dutasteride has been shown to reduce sperm count, semen volume and sperm motility. Therefore, male fertility may be reduced.

Other medicines and Dutasteride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can react with Dutasteride capsules and may make it more likely that you will have side effects. Your dose of Dutasteride may need to be reduced.

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).

All medications can cause side effects, although some people may not experience any. The following are some of the side effects that are known to be associated with this medicine:

• Severe allergic reactions such as itchy skin rash, hives, and swelling of the eyelids, face, lips, arms or legs. Contact your doctor immediately if you get any of these symptoms.

Other side effects include:

Common(may affect up to 1 in 10 men)

• Sexual problems such as impotence, loss of libido and ejaculation problems. These symptoms 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 men)

• Heart failure.
• Hair loss (usually from the body) or hair growth.

See the package leaflet for a full list of possible side effects. Consult a doctor or pharmacist if you experience side effects, also if the side effects are not listed on the package leaflet.

The active substance in this medicine is dutasteride. Each soft capsule contains 0.5 mg dutasteride.

The other ingredients are: butylhydroxytoluene (E321) and glycerol monocaprylocaprate, medium-chain triglycerides, purified water.

The capsule shell contains gelatin (160 Bloom), glycerol (E422), iron oxide yellow (E172) and titanium dioxide (E171).

The manufacturers of TEVA Dutasteride are:

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13

4042 Debrecen

Hungary

TEVA UK Ltd

Brampton Road, Hampden Park

Eastbourne, East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

74770 Opava-Komarov

Czech Republic

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Read the package leaflet before use.