DUTASTERIDE 0.5 MG Soft capsules

Зміст інструкції

1. Dutasteride Accord 0.5 mg soft capsules
   1. What is Dutasteride Accord and what is it used for
   2. What you need to know before taking Dutasteride Accord
   3. How to take Dutasteride Accord
   4. Possible side effects
   5. How to store Dutasteride Accord
   6. Package Contents and Other Information

Dutasteride Accord 0.5 mg soft capsules

Equivalent Medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

The active ingredient is dutasteride. It belongs to a class of drugs called 5-alpha reductase inhibitors.

Dutasteride Accord is used to treat male subjects with enlarged prostate( benign prostatic hyperplasia) - a non-cancerous increase in the volume of the prostate, due to excessive production of a hormone called dihydrotestosterone.
If the prostate increases in volume, it can lead to urinary problems such as difficulty passing urine and the need to urinate frequently. This can also result in a slower and weaker urine flow. If left untreated, there is a risk that the urine flow may become completely blocked ( acute urinary retention). This requires immediate medical treatment.
In some cases, surgery may be necessary to remove or reduce the volume of the prostate.
Dutasteride Accord reduces the production of dihydrotestosterone, which helps to decrease the volume of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery.
Dutasteride Accord can be used with another medicine called tamsulosin (used in the treatment of symptoms of prostate enlargement).

2. What you need to know before taking Dutasteride Accord

Do not takeDutasteride Accord

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

If you believe that any of these conditions apply to you, do not take this medicine until you have checked with your doctor.

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

Warnings and precautions
Talk to your doctor before taking Dutasteride Accord.

• Make sure your doctor is aware of any liver problems you have.If you have had any liver disease, further checks may be needed while you are taking Dutasteride Accord.
• Women, children and adolescentsshould avoid contact with broken capsules of Dutasteride Accord, because the active ingredient is absorbed through the skin. If contact with the skin occurs, immediately wash the affected areawith water and soap.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men treated with Dutasteride Accord. If your partner is or may become pregnant, she must avoid exposure to your semen as dutasteride may impair the normal development of a male child. Dutasteride has been shown to reduce sperm count, semen volume and sperm motility. This may decrease your fertility.
• Dutasteride Accord 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 prescribe the test to find out if you have prostate cancer. If you need to have a PSA test, tell your doctor that you are taking Dutasteride Accord. Men taking Dutasteride Accord shouldhave the PSA test regularly.
• In a clinical study conducted on men at increased risk of prostate cancer, men taking Dutasteride Accord had more frequently a severe form of cancerof the prostatecompared to men who were not taking Dutasteride Accord. The effect of Dutasteride Accord on this severe form of prostate cancer is unclear.
• Dutasteride Accord may cause enlargement and tenderness of the breasts. If this becomes concerning, or if you notice the presence of breast lumpsor 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 pharmacistif you have any questions about taking Dutasteride Accord.

Other medicines and Dutasteride Accord
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Some medicines can interact with Dutasteride Accord and may increase the possibility of
having 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)
• alpha blockers(for enlarged prostate or high blood pressure).

Tell your doctorif you are taking any of these medicines. It may be necessary to reduce the dose that
you take of Dutasteride Accord.

Dutasteride Accord with food and drink
Dutasteride Accord can be taken with or without food.

Pregnancy, breastfeeding and fertility
Women who are pregnant (or who may become pregnant) should not handle broken
capsules.Dutasteride is absorbed through the skin and can interfere with the normal development of
a male child. This is particularly risky in the first 16 weeks of pregnancy.

Use a condom during sexual intercourse.Dutasteride has been found in the semen
of men who were taking Dutasteride Accord. If your partner is pregnant or may become pregnant, she must
avoid contact with your semen.
Dutasteride Accord has been shown to reduce sperm count, semen volume and the
movement of sperm. Therefore, male fertility may decrease.

Ask your doctorif a pregnant woman has come into contact with dutasteride.

Driving and using machines
It is unlikely that Dutasteride Accord will affect your ability to drive or use machines.

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

3. How to take Dutasteride Accord

Take this medicine following exactly the instructions of your doctor or pharmacist. If you do not take it regularly, the control of PSA levels may be affected. If you have any doubts, consult your doctor or pharmacist.

How much Dutasteride Accord to take

• The recommended dose is one capsule (0.5 mg) to be taken once a day.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 Accord is long-term. Some individuals notice an early improvement of symptoms. However, others may need to take Dutasteride Accord for 6 months or more before it begins to take effect. Continue to take Dutasteride Accord for as long as your doctor tells you to.

If you take more Dutasteride Accord than you should
If you take more capsules of Dutasteride Accord than prescribed, contact your doctor or pharmacist for advice.

If you forget to take Dutasteride Accord
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Do not interrupt the treatment with Dutasteride Accord without consulting a doctor
Do not stop taking Dutasteride Accord without first consulting your doctor. It may take 6 months or more before you notice an improvement.

If you have further questions on the use of this medicine, 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 include:

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

Contact your doctor immediatelyif you experience any of these symptoms and stop
taking Dutasteride Accord.
Common side effects

These may affect up to 1 in 10 people treated with Dutasteride Accord:

• inability to achieve or maintain an erection (impotence) *this may continue after you stop taking Dutasteride Accord
• decreased sexual desire (libido) *this may continue after you stop taking Dutasteride Accord
• difficulty with ejaculation *this may continue after you stop taking Dutasteride Accord
• breast enlargement or tenderness (gynaecomastia)
• dizziness with the intake of tamsulosin.

Uncommon side effects

These may affect up to 1 in 100 people treated with Dutasteride Accord:

• 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 of the ankles and legs)
• hair loss (usually from the body) or hair growth.

Side effects with unknown frequency
The frequency cannot be estimated on the basis of the available data:

• depressed mood
• pain and swelling of the testicles.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dutasteride Accord

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 package and blister after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30° C.
Store in the original container to protect from moisture.
Do not dispose of any medicine in waste water 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 Accord Contains
The active ingredient is dutasteride.
Each soft capsule contains 0.5 mg of dutasteride.
The other ingredients are:

• capsule content: glyceryl monocaprylocaprate (Type I), butylhydroxytoluene (E321).
• capsule shell: gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), soybean lecithin (E-322), purified water.

Description of the Appearance of Dutasteride Accord and Package Contents
Dutasteride Accord soft capsules are soft gelatin capsules, opaque, yellow in colour, oblong in shape, of
size 6, containing an oily and yellowish liquid. They are available in packs of 10, 30, 50,
60 and 90 capsules.
Not all pack sizes may be marketed.
The size of the soft capsules is: 19 ± 0.8 mm x 6.9 ± 0.4 mm.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers:
Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda,31
Olvega, 42110 Soria
Spain
Galenicum Health S.L.
Avda. Cornellá 144, 7º-1ª, Edificio LEKLA
Esplugues de Llobregat
08950 Barcelona
Spain
Accord Healthcare Limited
Sage House
319 Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola PLA 3000
Malta