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COMBODART 0.5 MG / 0.4 MG HARD CAPSULES

Active substance: TAMSULOSIN HYDROCHLORIDE

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1 What Combodart is for
and what it is used

Package Leaflet:
Information for the User

hard capsules
dutasteride/tamsulosin
hydrochloride

Read all of this leaflet carefully
before you start using this
medicine.
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. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

hard capsules
dutasteride/tamsulosin hydrochloride

A393337

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In this leaflet:
1 What Combodart is and what it is
used for
2 Before you take Combodart
3 How to take Combodart
4 Possible side effects
5 How to store Combodart
6 Further information

Combodart is used to treat men with
an enlarged prostate (benign prostatic
hyperplasia) - a non-cancerous growth
of the prostate gland, caused by
producing too much of a hormone
called dihydrotestosterone.
Combodart is a combination of two
different medicines called dutasteride
and tamsulosin. Dutasteride belongs
to a group of medicines called 5-alpha
reductase inhibitors and tamsulosin
belongs to a group of medicines called
alpha-blockers.
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. Sometimes surgery
is necessary to remove or reduce the
size of the prostate gland.
Dutasteride lowers the production of
a hormone called 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. Tamsulosin
acts by relaxing the muscles in your
prostate gland, making it easier to
pass urine and rapidly improving your
symptoms.

2 Before you take Combodart
Do not take Combodart
if you’re allergic (hypersensitive) to
dutasteride, other 5-alpha reductase
inhibitors, tamsulosin, soya, peanut
or to any of the other ingredients of
Combodart.
if you have low blood pressure which
makes you feel dizzy, lightheaded or
faint (orthostatic hypotension).
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.

Take special care with Combodart
In some clinical studies, more patients
taking dutasteride and another
medicine called an alpha-blocker like
tamulosin 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 Combodart.
Make sure your doctor knows if you
have severe problems with your kidney.
Cataract (cloudy lens) surgery. If you
are going to have surgery to remove
a cataract, your doctor may ask you
to stop taking Combodart for a while
before your operation. Tell your
eye specialist before your operation

that you are taking Combodart or
tamsulosin (or have previously taken
it). Your specialist will need to take
appropriate precautions to help
prevent complications during your
operation.
Women, children and adolescents
must not handle leaking Combodart
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
Combodart. 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.

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.

verapamil or diltiazem (for high blood
pressure)
ritonavir or indinavir (for HIV)
itraconazole or ketaconazole (for
fungal infections)
nefazodone (an antidepressant)
cimetidine (for stomach ulcers)
warfarin (for blood clotting)
erythromycin (an antibiotic used to
treat infections) in combination with
paroxetine (an antidepressant) or in
combination with terbinafine (used to
treat fungal infections)
Tell your doctor if you are taking
any of these medicines.

Combodart 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
Food and drink with Combodart
taking Combodart.
Combodart should be taken 30 minutes
after the same meal each day.

Taking other medicines

Tell your doctor if you’re taking or have
recently taken any other medicines. This
includes any medicines you’ve bought
without a prescription.
Don’t take Combodart with these
medicines:
Combodart affects a blood test for
other alpha-blockers (for enlarged
PSA (prostate-specific antigen), which
prostate or high blood pressure)
is sometimes used to detect prostate
Combodart is not recommended with
cancer. Your doctor should be aware
these medicines:
of this effect and can still use the test
ketoconazole (used to treat fungal
to detect prostate cancer. If you are
infections)
having a blood test for PSA, tell your
Some medicines can react with
doctor that you are taking Combodart.
Combodart and may make it more
Men taking Combodart should have
likely that you’ll have side effects. These
their PSA tested regularly.
medicines include:
PDE5 inhibitors (used to help achieve or
maintain an erection) such as vardenafil,
sildenafil citrate and tadalafil

Pregnancy and breast-feeding
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 Combodart. If your
partner is or may be pregnant, you must
avoid exposing her to your semen.
Combodart 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 Combodart.

Driving and using machines
Combodart makes some people feel
dizzy, so it may affect your ability to
drive or operate machinery safely.
Don’t drive or operate machinery if
you are affected in this way.

Important information about
some of the ingredients of
Combodart
This medicine contains the colouring
agent sunset yellow (E110) which may
cause allergic reactions.
This medicine contains lecithin from
soya, which may contain soya oil. If you
are allergic to peanut or soya, do not
use this medicinal product.

Always take Combodart exactly as
Like all medicines, Combodart
your doctor has told you to. If you do can cause side effects, although
not take it regularly the monitoring of not everybody gets them.
your PSA levels may be affected. Check
Allergic reaction
with your doctor or pharmacist if you
The signs of allergic reactions can
are not sure.
include:
How much to take
skin rash (which can be itchy)
The usual dose is one capsule taken
hives (like a nettle rash)
once a day, 30 minutes after the same
swelling of the eyelids, face, lips,
meal each day.
arms or legs.
Contact your doctor immediately
How to take
if you get any of these symptoms,
Swallow the capsules whole with
and stop using Combodart.
water. Do not chew or break open the
capsule. Contact with the contents of
Dizziness, lightheadedness
the capsules may make your mouth or and fainting
throat sore.
Combodart can cause dizziness,
lightheadedness and on rare occasions
If you take too much
fainting. Take care when moving from
Combodart
a lying down or sitting position to
Contact your doctor or pharmacist
sitting or standing, particularly if you
for advice if you take too many
wake up in the night, until you know
Combodart capsules.
how this medicine affects you. If you
If you forget to take Combodart feel dizzy or lightheaded at any time
during treatment, sit or lie down until
Don’t take extra capsules to make up
the symptoms pass.
for a missed dose. Just take your next
dose at the usual time.

Serious skin reactions

Don’t stop Combodart without
advice

The signs of serious skin reactions
can include:
a widespread rash with blisters and
peeling skin, particularly around
the mouth, nose, eyes and genitals
(Stevens-Johnson syndrome).
Contact a doctor immediately if
you get these symptoms and stop
using Combodart.

Don’t stop taking Combodart without
talking to your doctor first.
If you have any further questions
on the use of this product, ask your
doctor or pharmacist.

Common side effects

Very rare side effects

These may affect up to 1 in 10 men
taking Combodart:
not able to achieve or maintain an
erection (impotence)*
decreased sex drive (libido)*
difficulty with ejaculation*
breast enlargement or tenderness
(gynecomastia)
dizziness.
* In a small number of people some
of these events may continue after
you stop taking Combodart.

These may affect up to 1 in 10,000 men
persistent painful erection of the
penis (priapism)
serious skin reactions
(Stevens-Johnson syndrome).
If any of the side effects gets
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor
or pharmacist.

Uncommon side effects
These may affect up to 1 in 100 men
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.)
low blood pressure on standing
fast heartbeat (palpitations)
constipation, diarrhoea, vomiting,
feeling sick (nausea)
weakness or loss of strength
headache
itchy, blocked or runny nose (rhinitis)
skin rash, hives, itching
hair loss (usually from the body) or
hair growth.

Rare side effects
These may affect up to 1 in 1,000 men
swelling of the eyelids, face, lips,
arms or legs (angioedema)
fainting.

Not known side effects
The frequency cannot be estimated
from available data:
abnormal or fast heartbeat
(arrhythmia or tachycardia or
atrial fibrillation)
shortness of breath (dyspnoea)
depression
pain and swelling in your testicles.

5 How to store
Combodart
Keep out of the sight and reach of
children.
Don’t use Combodart after the expiry
date which is stated on the carton and
the bottle. The expiry date refers to
the last day of that month.
Don’t store Combodart above 30°C.
If you have any unwanted Combodart
capsules, don’t dispose of them in
waste water or household rubbish.
Take them back to your pharmacist,
who will dispose of them in a way that
won’t harm the environment.

6 Further information
What Combodart contains

Marketing authorisation holder

The active substances are dutasteride
and tamsulosin hydrochloride. Each
capsule contains 0.5 mg dutasteride
and 0.4 mg tamsulosin hydrochloride.
The other ingredients are:
hard capsule shell: hypromellose,
carrageenan (E407), potassium
chloride, titanium dioxide (E171),
iron oxide red (E172), sunset yellow
(E110), carnauba wax, maize starch.
inside the hard capsule:
mono-di-glycerides of caprylic/capric
acid and butylhydroxytoluene (E321),
gelatin, glycerol, titanium dioxide
(E171), iron oxide yellow (E172),
triglycerides (medium chain), lecithin
(may contain soya oil), cellulose,
microcrystalline, methacrylic acid ethyl acrylate copolymer (containing
polysorbate 80 and sodium
laurilsulfate), talc, triethyl citrate.
black print ink (SW-9010 or
SW-9008): shellac, propylene glycol,
iron oxide black (E172), potassium
hydroxide (in Black Ink SW-9008
only).

GlaxoSmithKline UK Limited,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT

Manufacturer
Catalent Germany Schorndorf GmbH,
Steinbeisstrasse 2, 73614 Schorndorf,
Germany

Other formats:
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name
Combodart
Reference number
19494/0046
This is a service provided by the Royal
National Institute of Blind People.
Leaflet date: June 2013
Combodart is a registered trademark
of the GlaxoSmithKline group of
companies
© 2013 GlaxoSmithKline group of
companies. All rights reserved

What Combodart looks like and
contents of the pack
This medicine is an oblong hard
capsule with a brown body and an
orange cap printed with GS 7CZ in
black ink. They are available in packs
of 7, 30 and 90 capsules. Not all pack
sizes may be marketed.
A393337

3 How to take Combodart 4 Possible side effects

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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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