Dutasteride Sandoz GmbH

Package leaflet: Information for the user

Dutasteride Sandoz GmbH 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dutasteride Sandoz GmbH is and what it is used for

The active substance is dutasteride, which belongs to a class of medicines called 5-alpha reductase inhibitors.
Dutasteride Sandoz GmbH is used to treat men with enlarged prostate
(benign prostatic hyperplasia) – a non-cancerous increase in prostate size caused by excessive production of a hormone called dihydrotestosterone.
When the prostate enlarges, it can lead to 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 becomes completely blocked (acute urinary retention). This requires immediate medical treatment.
In some cases, surgery may be necessary to remove or reduce the size of the prostate. Dutasteride reduces the production of dihydrotestosterone, thereby decreasing prostate volume and relieving symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention.
Dutasteride may be used in combination with another medicine called tamsulosin (used in the treatment of symptoms related to enlarged prostate).

2. What you need to know before taking Dutasteride Sandoz GmbH

Do not take Dutasteride Sandoz GmbH

• 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

If you think any of the above apply to you, consult your doctor.
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 Sandoz GmbH.

• 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 that 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.
• Women, children and adolescents must avoid contact with damaged or leaking capsules of Dutasteride Sandoz GmbH, because the active substance 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 this medicine. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume and sperm motility. This may reduce fertility.
• Dutasteride affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and may still order the test to check whether you have prostate cancer. If you are to have a PSA test, inform your doctor that you are taking dutasteride. Men taking dutasteride should have regular PSA tests. In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride developed more frequently a more severe form of prostate cancer compared to men not taking it. The effect of dutasteride on this severe form of prostate cancer is not clear.
• Dutasteride 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 may be signs of a serious condition, such as breast cancer.

Ask your doctor or pharmacist if you have any questions about taking Dutasteride Sandoz GmbH.
Other medicines and Dutasteride Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with dutasteride 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).

Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Dutasteride Sandoz GmbH you are taking.
Dutasteride Sandoz GmbH with food and drink
Dutasteride Sandoz GmbH can be taken with or without food.
Pregnancy, breastfeeding and fertility
Women must not take Dutasteride Sandoz GmbH.
Pregnant women (or women who may be pregnant) must not handle damaged or leaking capsules. Dutasteride is 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. Consult your doctor if a pregnant woman has been exposed to dutasteride.
Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride. If your partner is pregnant or could 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.
Driving and using machines
It is unlikely that Dutasteride Sandoz GmbH will affect your ability to drive or use machinery.
Dutasteride Sandoz GmbH contains soya lecithin.
This medicine contains soya lecithin which may contain soya oil. If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Dutasteride Sandoz GmbH

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 Dutasteride Sandoz GmbH 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 is long-term. Some individuals may notice an early improvement in symptoms. However, others may need to take dutasteride for 6 months or longer before it starts to work. Continue taking dutasteride for as long as your doctor tells you to.

If you take more Dutasteride Sandoz GmbH than you should
If you take more capsules of Dutasteride Sandoz GmbH than prescribed, contact your doctor or pharmacist for advice.
If you forget to take Dutasteride Sandoz GmbH
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
If you stop taking Dutasteride Sandoz GmbH
Do not stop taking Dutasteride Sandoz GmbH 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 everybody gets them.
Allergic reaction
Contact your doctor immediately and stop taking dutasteride if you experience any of the
following symptoms.
Signs of allergic reactions may include:

• rash (which may be itchy)
• hives
• swelling of the eyelids, face, lips, arms or legs.

Common side effects
May affect up to 1 in 10 men treated with dutasteride:

• inability to achieve or maintain an erection (impotence), which may continue after stopping dutasteride
• decreased sexual desire (libido), which may continue after stopping dutasteride
• problems with ejaculation, which may continue after stopping dutasteride
• breast enlargement or tenderness (gynecomastia)
• dizziness with tamsulosin intake.

Uncommon side effects
May affect up to 1 in 100 men treated with dutasteride:

• heart failure (the heart becomes less efficient at pumping blood around the body. Symptoms may include shortness of breath, extreme tiredness, and swelling of the 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.

Reporting of side effects
If you get any side effects, 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 Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store 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 Sandoz GmbH contains
The active substance is dutasteride.
Each soft capsule contains 0.5 mg of dutasteride.
The other components are:

• Capsule contents: glycerol monocaprylocaprate (type I), butylated hydroxytoluene (E321)
• Capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, lecithin (may contain soybean oil) (E322), and purified water

Description of the appearance of Dutasteride Sandoz GmbH and contents of the pack
The capsules are soft gelatin capsules, size 6, oblong, opaque, yellow in colour, containing a yellowish oily liquid. They are available in packs of 10, 30, 60 or 90 capsules. Not all pack sizes may be marketed.
Dimensions of soft capsules: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorization Holder
Marketing Authorization Holder: Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria
Legal representative in Italy: Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Galenicum Health S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla, Esplugues de Llobregat, 08950 Barcelona - Spain
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
LEK Pharmaceuticals d.d.
Verovškova ulica 57, 1526 Ljubljana, Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium Quedute 0.5 mg soft capsules
Bulgaria Кведут 0,5 mg меки капсули
Cyprus Quedute 0.5 mg μαλακές κάψουλες
Denmark Quedute 0.5 mg
Estonia Quedute
France Dutasteride Adair 0.5 mg soft capsules
Ireland Quedute 0.5 mg soft capsules
Italy Dutasteride Sandoz GmbH
Latvia Quedute 0.5 mg mīkstās kapsulas
Lithuania Quedute 0.5 mg minkštosios kapsulės
Luxembourg Quedute 0.5 mg capsule molle
Netherlands Dutasteride Adair 0.5 mg zachte capsules
Portugal Quedute 0.5 mg cápsulas moles
Romania Avaterid 0.5 mg capsule moi
Slovenia Testadart 0.5 mg mehke kapsule
Spain Quedute 0.5 mg capsulas blandas EFG