Dutasteride EG

Patient Information Leaflet

Dutasteride EG 0.5 mg Soft Capsules

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Dutasteride EG is and what it is used for
2. What you need to know before taking Dutasteride EG
3. How to take Dutasteride EG
4. Possible side effects
5. How to store Dutasteride EG
6. Contents of the pack and other information

1. What Dutasteride EG is and what it is used for

The active substance is dutasteride. It belongs to a class of medicines called 5-alpha reductase inhibitors.
Dutasteride EG is used to treat men with enlarged prostate
(benign prostatic hyperplasia) – a non-malignant enlargement of the prostate gland caused by excessive production of a hormone called dihydrotestosterone.
When the prostate enlarges, it can cause urinary problems such as difficulty in passing urine and the need to urinate frequently. This may also result in a weaker and slower urine flow. If left untreated, there is a risk that urine flow may become completely blocked (acute urinary retention), which requires immediate medical treatment. In some cases, surgery may be necessary to remove or reduce the size of the prostate. Dutasteride EG reduces the production of dihydrotestosterone, thereby helping to shrink the prostate gland and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride EG may also be used in combination with another medicine called tamsulosin (used to treat symptoms of enlarged prostate).

2. What you need to know before taking Dutasteride EG

Do not take Dutasteride EG

• if you are allergic to dutasteride, to other 5-alpha reductase inhibitors, to soy, to peanuts, or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are a child or adolescent.

Tell your doctor if you think any of the above situations apply to you.
This medicine is intended for men only. It must not be taken by women, children, or adolescents.

Warnings and precautions

Talk to your doctor before taking Dutasteride EG.

• In some clinical studies, more patients taking dutasteride together with another medicine called an alpha blocker such as tamsulosin developed heart failure compared to patients treated only with dutasteride or only with an alpha blocker. Heart failure means a condition in which the heart does not pump blood as well as it should.
• Make sure your doctor is aware of any liver problems you have. If you have had any liver disease, additional monitoring may be needed while you are taking Dutasteride EG.
• Women, children, and adolescents must avoid contact with crushed or leaking capsules of Dutasteride EG, because the active ingredient can be absorbed through the skin. In case of skin contact, wash the affected area immediately with water and soap.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride EG. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may interfere with the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may reduce your fertility.
• Dutasteride EG affects the PSA test (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still recommend the test to check for prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking Dutasteride EG. Men taking Dutasteride EG should have regular PSA tests. In a clinical study conducted in men at increased risk of prostate cancer, men taking Dutasteride EG were more likely to develop a more severe form of prostate cancer compared to men not taking Dutasteride EG. The effect of Dutasteride EG on this severe form of prostate cancer is not fully understood.
• Dutasteride EG may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should talk to your doctor about these changes, as they could be signs of a serious condition, such as breast cancer.

Talk to your doctor or pharmacist if you have any questions about taking Dutasteride EG.

Other medicines and Dutasteride EG

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may interact with Dutasteride EG and increase the risk of side effects. These include:

• verapamil or diltiazem (for high blood pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketoconazole (for fungal infections)
• nefazodone (an antidepressant)
• alpha blockers (for enlarged prostate or high blood pressure).

Tell your doctor if you are taking any of these medicines. Your dose of Dutasteride EG may need to be reduced.

Dutasteride EG with food and drinks

Dutasteride EG can be taken with or without food.

Pregnancy, breastfeeding and fertility

Women must not take dutasteride.
Pregnant women (or women who may become pregnant) must not handle crushed or leaking capsules. Dutasteride can be absorbed through the skin and may interfere with the normal development of a male fetus. This is particularly risky during the first 16 weeks of pregnancy. Contact your doctor if a pregnant woman comes into contact with dutasteride.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride EG. If your partner is pregnant or could be pregnant, you must avoid exposing her to your semen.
Dutasteride EG has been shown to reduce sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.

Driving and using machines

It is unlikely that Dutasteride EG will impair your ability to drive or operate machinery.

Dutasteride EG contains soy lecithin

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

3. How to take Dutasteride EG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. If you do not take it regularly, monitoring of PSA levels may be affected.
How much medicine to take

• The recommended dose is one capsule (0.5 mg) taken once daily. Swallow the capsules whole with water. Do not chew or open the capsules. Contact with the capsule contents may irritate the mouth or throat.
• Treatment with Dutasteride EG is long-term. Some patients may notice an early improvement in symptoms. However, others may need to take Dutasteride EG for 6 months or longer before it starts to work. Continue taking Dutasteride EG for as long as your doctor tells you to.

If you take more Dutasteride EG than you should
If you take more capsules than prescribed, contact your doctor or pharmacist for advice.
If you forget to take Dutasteride EG
Do not take a double dose to make up for the missed dose. Simply take the next dose at your usual time.
If you stop taking Dutasteride EG
Do not stop taking Dutasteride EG without first consulting your doctor. It may take 6 months or longer before you notice an improvement.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Allergic reaction
Signs of allergic reactions may include:

• rash (which may be itchy)
• hives
• swelling of the eyelids, face, lips, arms or legs. Contact your doctor immediately if you experience any of these symptoms and stop taking Dutasteride EG.

Common side effects
These may affect up to 1 in 10 people treated with Dutasteride EG:

• inability to achieve or maintain an erection (impotence), *this condition may persist even after stopping treatment with Dutasteride EG;
• decreased sexual desire (libido), *this condition may persist even after stopping treatment with Dutasteride EG;
• problems with ejaculation, *this condition may persist even after stopping treatment with Dutasteride EG;
• breast enlargement or tenderness (gynecomastia);
• dizziness when taking tamsulosin.

Uncommon side effects
These may affect up to 1 in 100 people treated with Dutasteride EG:

• heart failure (the heart pumps blood around the body less efficiently. Symptoms may include shortness of breath, extreme tiredness, and swollen ankles and legs);
• hair loss (usually from the body) or hair growth.

Side effects of unknown frequency
Frequency cannot be estimated from the available data:

• depressed mood;
• pain and swelling of the testicles.

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your
doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dutasteride EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and blister after EXP. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dutasteride EG contains
The active substance is dutasteride.
Each soft capsule contains 0.5 mg of dutasteride.
The other components are:

• Inside the capsule: glycerol monocaprylocaprate (type I), butylhydroxytoluene (E321).
• Capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), saturated medium-chain triglycerides, lecithin (may contain soybean oil) (E322), and purified water.

Description of the appearance of Dutasteride EG and pack contents
Dutasteride EG soft capsules are opaque, yellow, elongated soft gelatin capsules containing a yellowish oily liquid.
They are available in white opaque aluminum - PVC/PVDC blister packs containing 10, 30, 50, 60, 90, and 100 capsules.
Not all pack sizes may be marketed.
Dimensions of the soft capsules: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milan, Italy

Manufacturers
STADA Nordic ApS, Marielundvej 46A, 2730 Herlev - Denmark
Galenicum Health S.L., Avda. Cornellá 144, 7º-1ª, Edificio Lekla, Esplugues de Llobregat, 08950 Barcelona - Spain
STADA Arzneimittel AG, Stadastrasse 2-18, 6118 Bad Vilbel - Germany
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Vienna - Austria
Centrafarm Services B.V., Nieuwe Donk 9, NL-4879 AC Etten-Leur - Netherlands
Cyndea Pharma, S.L, Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31, Olvega, 42110, Soria - Spain
Pharmadox Healthcare, Ltd., KW20A Kordin Industrial Park, Paola, PLA 3000 - Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Malta: Dutasterid STADA 0.5 mg Kapsula, ratba
Austria: Dutasterid STADA 0.5 mg Weichkapseln
Croatia: Dutasterid STADA 0.5 mg meke kapsule
Spain: Dutasterida STADA 0.5 mg cápsulas blandas EFG
Finland: Dutasteride STADA 0.5 mg pehmeät kapselit
Italy: Dutasteride EG
France: Dutasteride EG 0.5 mg, capsule molle
Netherlands: Dutasteride CF 0.5 mg, zachte capsules
Portugal: Dutasterida Ciclum
Romania: Maxtrid 0.5 mg capsule moi
Slovenia: Dutasterid STADA 0.5 mg mehke kapsule