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DUTASTERIDE STRIDES 0.5MG CAPSULES SOFT

Active substance(s): DUTASTERIDE

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Package leaflet: Information for the patient

Dutasteride 0.5 mg Capsules, Soft
Dutasteride
Read all of this leaflet carefully before you start using 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
Dutasteride contains active ingredient 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) – non-cancerous
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 (hypersensitive) to dutasteride, other
5-alpha reductase inhibitors or any ingredients of this
medicine (listed in section 6)
 if you have a severe liver disease.
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 liver problems.
If you have had any illness affecting your liver, you may
need some additional check-ups while you are taking
Dutasteride.

Dimension - 180 x 260 mm
Font: Times New Roman
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 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 (prostatespecific 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.
This includes any medicines you have bought without a
prescription.
Some medicines can react with Dutasteride and may make it
more likely that you’ll 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 and breast-feeding and fertility
Women who are pregnant (or may be) 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.
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.
Contact your doctor for advice if a pregnant woman has
come into contact with dutasteride.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking any this medicine.

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Driving and using machines
Dutasteride is unlikely to affect your ability to drive or
operate machinery.

3. How to take Dutasteride
Always take this medicine exactly as your doctor or
pharmacist has told you. If you do not take it regularly the
monitoring of your PSA levels may be affected. Check with
your doctor or pharmacist if you are not sure.
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 then you should
Contact your doctor or pharmacist for advice if you take too
many Dutasteride capsules.
If you forget to taking Dutasteride
Do not take extra capsules to make up for a missed dose.
Just take your next dose at the usual time.
If you stop taking Dutasteride
Don’t 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 side effects (may affect up to 1 in 10 people):
 impotence (not able to achieve or maintain an erection)
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 side effects (may affect up to 1 in 100 people):
 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

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 blister, label and carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C.
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,
butylhydroxytoluene
 Capsule shell: gelatin, glycerol, glycine, citric acid
anhydrous, titanium dioxide, iron oxide (yellow)
 Imprinting ink: propylene glycol, iron oxide red,
polyvinyl acetate phthalate, macrogol 400, ammonium
hydroxide
What Dutasteride looks like and contents of the pack
Dutasteride are Yellow to pale yellow coloured, oblong
shaped soft gelatin capsules containing clear oily liquid,
imprinted with 0.5. Dimension: 18.6 mm x 6.7 mm
Dutasteride is available in blister packs containing 10, 30,
50, 60 and 90 soft gelatin capsules and HDPE bottle pack
with polypropylene closure containing 30 and 90 soft gelatin
capsules.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Strides Arcolab International Limited
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS,
United Kingdom.
Manufacturer:
Co-pharma Limited
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS,
United Kingdom.
The leaflet was last revised in
{08/2015}

Not known side effects
The 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.

Dimension - 180 x 260 mm
Font: Times New Roman
Font size: 9 points
No. of Columns: 2 Columns

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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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