0.5 mg soft capsules 
dutasteride

1. What Avodart is and what it is used for

Avodart is used to treat men with an enlarged prostate ( benign prostatic hyperplasia ) – growth of the non- cancerous prostate gland caused by overproduction of a hormone called dihydrotestosterone .

The active substance is dutasteride. It belongs to a group of medicines called 5-alpha-reductase inhibitors.

As the prostate increases in size, it can lead to problems with urination, such as difficulty starting to urinate and the need to urinate more often. It can also cause the flow of urine to be slower or less powerful. If treatment is not given, there is a risk that the urine flow will be completely blocked ( acute urinary incontinence). This requires immediate treatment. In some situations, it is necessary to have surgery to remove the prostate or reduce its size. Avodart reduces the production of dihydrotestosterone , which causes the prostate to shrink and the symptoms to be relieved. This means that the risk of acute urinary incontinence and the need for surgical treatment is reduced.

Avodart can also be used with another medicine called tamsulosin (which is used to treat the symptoms of an enlarged prostate ).

2. What you need to know before taking Avodart

Do not take Avodart

  • if you are allergic to dutasteride, any other 5-alpha-reductase inhibitors, soy, peanuts or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe hepatic impairment.
  • If you think any of these apply to you, do not take this medicine without consulting your doctor.

This medicine should only be used by men. It should not be taken by women, children or adolescents.

Warnings and cautions

Talk to your doctor before taking Avodart.

  • Your doctor must tell you if you have liver problems. If you have had any disease that affects your liver, you may need to do some extra checks while using Avodart.
  • Women, children and adolescents should not handle leaky Avodart capsules, as the active substance may be absorbed through the skin. In case of skin contact, the area must be washed immediately with soap and water.
  • Use a condom during intercourse. Dutasteride has been found in the semen of men taking Avodart. If your partner is or may be pregnant, you must avoid her coming into contact with your semen, as dutasteride may affect the normal development of a male fetus. Dutasteride has been shown to reduce the number of sperm, the amount of semen and the motility of sperm. This can reduce your fertility .
  • Avodart affects blood tests for PSA ( prostate-specific antigen ), which is sometimes used to detect prostate cancer. Your doctor should be aware of this and may still use the test to detect prostate cancer. If you are going to take a blood test for PSA, tell your doctor that you are taking Avodart. Men taking Avodart should have their PSA tested regularly.
  • In a clinical study involving men with an increased risk of prostate cancer, men who took Avodart more often had a more severe form of prostate cancer than men who did not take Avodart. The effect of Avodart on this serious form of prostate cancer has not been established.
  • Avodart can cause breast enlargement and soreness: If this becomes bothersome or if you notice lumps in the breasts or discharge from the nipple, talk to your doctor about these changes as it may be a sign of a serious condition, such as breast cancer.
  • Contact your doctor or pharmacist if you have any questions about treatment with 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 increase the risk of side effects . Drugs covered are

  • verapamil or diltiazem (for high blood pressure )
  • ritonavir or indinavir (for HIV )
  • itraconazole or ketoconazole (against fungal infections)
  • nefazodone (an antidepressant drug)
  • 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.

Avodart with food and drink

Avodart can be taken with or without food.

Pregnancy, breastfeeding and fertility

Women who are pregnant (or may be pregnant) must not handle leaking capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. This risk is particularly pronounced during the first 16 weeks of pregnancy.

Use a condom during intercourse. Dutasteride has been found in the semen of men who use Avodart. If your partner is or may be pregnant, you must avoid her coming into contact with your semen.

Avodart can reduce the number of sperm, reduce the amount of semen and reduce the motility of the sperm. Therefore, male fertility may be impaired.

  • Ask a doctor if a pregnant woman has come into contact with dutasteride.

Driving and using machines

Avodart is unlikely to affect your ability to drive or use machines.

Avodart contains lecithin from soy

This medicine contains soy lecithin, which may contain soybean oil. If you are allergic to peanuts or soy, do not take this medicine.

3. How to take Avodart

Always take Avodart exactly as your doctor or pharmacist has told you. If you do not take it regularly, the monitoring of your PSA values ​​may be affected. Ask your doctor or pharmacist if you are unsure.

How much to take

  • The recommended dose is one capsule (0.5 mg) per day . Swallow the capsule whole with water. Do not chew or break the capsule. Contact with the contents of the capsule may cause irritation of the mouth or throat.
  • Avodart is a long-term treatment. Some men notice an early improvement in symptoms. Others may need to take Avodart for 6 months or more to take effect. Take Avodart for as long as your doctor prescribes it.

If you use more Avodart than you should  

If you have taken too many Avodart capsules, ask your doctor or pharmacist.

If you forget to take Avodart

Do not take a double dose to make up for a forgotten dose . Take the next dose as usual.

Do not stop taking Avodart without advice

Do not stop taking Avodart without talking to your doctor first. It may take up to 6 months or more before you notice any effect.

  • If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions 
Signs of allergic reactions may be

  • skin rash (which may itch)
  • hives ( hives )
  • swelling of eyelids, face, lips, arms or legs.
  • Contact your doctor immediately if you experience any of these symptoms and stop using Avodart.

Common side effects are

These can occur in up to 1 in 10 men taking Avodart:

  • inability to achieve or maintain an erection ( impotence ), this may continue after you stop taking Avodart
  • decrease in libido , this may continue after you stop taking Avodart
  • difficulty with ejaculation, e.g. decreased amount of semen released during sexual intercourse, this may continue after you stop taking Avodart
  • swollen or sore breasts ( gynecomastia )
  • dizziness when taken with tamsulosin.

Uncommon side effects are

These can occur in up to 1 in 100 men taking Avodart.

  • heart failure (the heart becomes less efficient at pumping blood around the body. You may experience symptoms such as shortness of breath, extreme fatigue, and swelling in your ankles and legs)
  • hair loss (usually from the body) or hair growth.

Has been reported

Occurs in an unknown number of users:

  • Depression
  • pain and swelling in your testicles.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Avodart

Keep this medicine out of the sight and reach of children.

Do not store above 30 ° C.

Do not use this medicine after the expiry date which is stated on the carton and on the capsules. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

Other ingredients are:

  • in the solution inside the capsule: mono- and diglycerides of octanoic acid / decanoic acid and butylhydroxytoluene (E321)
  • capsule shell: gelatin, glycerol , titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium-chain) and lecithin (may contain soybean oil).

What the medicine looks like and the contents of the pack

Avodart soft capsules are oblong, opaque, yellow, soft gelatin capsules marked GX CE2. They are supplied in pressure packs of 10, 30, 50, 60 or 90 capsules. Not all pack sizes may be available.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Manufacturer:

GlaxoSmithKline Pharmaceuticals SA

Ul. Grunwaldzka 189

60-322 Poznan

Poland

or

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

This medicinal product is authorized under the European Economic Area under the names:

Avodart – Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Netherlands, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, United Kingdom, , Czech Republic, Germany, Hungary, Austria

Avidart – Spain

Muhammad Nadeem

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