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DUTASTERIDE 0.5 MG CAPSULES SOFT

Active substance(s): DUTASTERIDE

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Package leaflet: Information for the user
DUTASTERIDE 0.5 mg CAPSULES SOFT
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Dutasteride is and what it is used for
2. What you need to know before you take Dutasteride
3. How to take Dutasteride
4. Possible side effects
5. How to store Dutasteride
6. Contents of the pack and other information
1.

What Dutasteride is and what it is used for

The active ingredient is dutasteride. It belongs to a group of medicines called 5-alpha reductase
inhibitors.
Dutasteride is used to treat men with an enlarged prostate (benign prostatic hyperplasia) - a noncancerous growth of the prostate gland, caused by producing too much of a hormone called
dihydrotestosterone.
As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to
go to the toilet frequently. It can also cause the flow of the urine to be slower and less forceful. 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. Dutasteride 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 (used to treat the symptoms of
an enlarged prostate).
2.

What you need to know before you take Dutasteride

Do not take Dutasteride if you:
 are allergic to dutasteride, other 5-alpha reductase inhibitors, soya, peanuts or to any of the other
ingredients of this medicine (listed in section 6)
 have a severe liver disease
 are a child or adolescent.
Tell your doctor if you think any of these apply to you.
This medicine is for men only. It must not be taken by women, children or adolescents.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dutasteride.










in some clinical studies, more patients taking dutasteride and another medicine called an alpha
blocker, like tamsulosin, experienced heart failure than patients taking only dutasteride or only an
alpha blocker. Heart failure means your heart does not pump blood as well as it should
make sure your doctor knows about any liver problems. If you have had any illness affecting
your liver, you may need some additional check-ups while you are taking Dutasteride
women, children and adolescents must not handle leaking Dutasteride 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
use a condom during sexual intercourse. Dutasteride has been found in the semen of men
taking Dutasteride. If your partner is or may be pregnant, you must avoid exposing her to your
semen as dutasteride may affect the normal development of a male baby. Dutasteride has been
shown to decrease sperm count, semen volume and sperm motility. This could reduce your
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 can still use the test to detect
prostate cancer. If you are having a blood test for PSA, tell your doctor that you are taking
Dutasteride. Men taking dutasteride should have their PSA tested regularly. In a clinical study of
men at increased risk of prostate cancer, men taking dutasteride had a serious form of prostate
cancer more often than men who did not take dutasteride. The effect of dutasteride on this serious
form of prostate cancer is not clear
Dutasteride may cause breast enlargement and tenderness. If this becomes troublesome or if
you notice breast lumps or nipple discharge you should talk to your doctor about these changes as
these may be signs of a serious condition, such as breast cancer.

Contact your doctor or pharmacist if you have any questions about taking Dutasteride.
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 and may make it more likely that you will have side
effects. These medicines include:
 verapamil or diltiazem (for high blood pressure)
 ritonavir or indinavir (for HIV)
 itraconazole or ketaconazole (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 may need to
be reduced.
Dutasteride with food and drink
Dutasteride can be taken with or without food.
Pregnancy, breast-feeding and fertility
Women must not take Dutasteride.
Women who are pregnant (or may be pregnant) must not handle leaking capsules. Dutasteride is
absorbed through the skin and can affect the normal development of a male baby. This is a particular
risk in the first 16 weeks of pregnancy. Contact your doctor for advice 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
Dutasteride. 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 movement.

Therefore male fertility may be reduced.
Driving and using machines
Dutasteride is unlikely to affect your ability to drive or operate machinery.
Dutasteride contains soya lecithin
This medicine contains lecithin from soya, which may contain soya oil. If you are allergic to peanuts
or soya, do not use this medicinal product.
3.

How to take Dutasteride

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure. If you do not take it regularly, the monitoring of your PSA levels
may be affected.
How much to take:
The recommended dose is one capsule (0.5 mg) taken once a day. Swallow the capsules whole with
water. Do not chew or break open the capsule. Contact with the contents of the capsules may make
your mouth or throat sore.
Dutasteride is a long term treatment. Some men notice an early improvement in their symptoms.
However, others may need to take Dutasteride for 6 months or more before it begins to have an effect.
Keep taking Dutasteride for as long as your doctor tells you.
If you take more Dutasteride than you should
Contact your doctor or pharmacist for advice if you take too many Dutasteride capsules.
If you forget to take Dutasteride
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
If you stop taking Dutasteride
Do not stop taking Dutasteride without talking to your doctor first. It may take up to 6 months or more
for you to notice an effect.
If you have any 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 reaction
The signs of allergic reactions can include:
 skin rash (which can be itchy)
 hives (like a nettle rash)
 swelling of the eyelids, face, lips, arms or legs.
Contact your doctor immediately if you get any of these symptoms, and stop using Dutasteride.
Common: may affect up to 1 in 10 men taking Dutasteride
 not able to achieve or maintain an erection (impotence)*, *this may continue after you stop taking
Dutasteride
 decreased sex drive (libido)*, * this may continue after you stop taking Dutasteride
 difficulty with ejaculation*, * this may continue after you stop taking Dutasteride
 breast enlargement or tenderness (gynecomastia)
 dizziness when taken with tamsulosin.
 
Uncommon: may affect up to 1 in 100 men taking Dutasteride



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


 
Not known: frequency cannot be estimated from the available data
 depressed mood
 pain and swelling in your testicles. 
 
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Dutasteride

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 carton or the foil blister, after
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture. 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Dutasteride contains




The active substance is dutasteride.
Each soft capsule contains 0.5 mg dutasteride.
The other ingredients are:
 inside the capsule: glycerol monocaprylocaprate (type I), butylhydroxytoluene (E321)
 capsule shell: gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172),
triglycerides (medium chain), lecithin (may contain soya oil) (E322) and purified water.

What Dutasteride looks like and contents of the pack
Dutasteride soft capsules are size 6, oblong, opaque and yellow, soft gelatin capsules containing an
oily and yellowish liquid.
They are available in packs of 10, 30, 60 and 90 capsules. Not all pack sizes may be marketed.
Soft capsules dimensions are: 19 ± 0.8 mm x 6.9 ± 0.4 mm.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Cyndea Pharma S.L., Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31, Olvega
42110, Soria, Spain
*OR

Galenicum Health S.L., Avda. Cornellá 144, 7º-1a, Edificio Lekla, Esplugues de Llobregat, 08950
Barcelona, Spain
*OR
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
*OR
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143, Germany
This leaflet was last revised in 09/2016
PL 00289/2045
* Only the actual site of batch release will appear on the printed version of the leaflet

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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