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COMBODART 0.5 MG / 0.4 MG HARD CAPSULES

Active substance: TAMSULOSIN HYDROCHLORIDE

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A369637
GSK-ContractMfg-Eur-DEU-Germany-Catalent

United Kingdom-GBR
Combodart

V4

Package leaflet:
Information for the User

A369637

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2

K

Page 1 of 2

hard capsules
dutasteride/tamsulosin hydrochloride

N/A

TYPE SIZE: 10/12
HORIZONTAL SCALE: 100%

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.

194

FRONT PAGE

1 What Combodart is for
and what it is used

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.

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.

• 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.

• Women, children and adolescents
• Combodart may cause breast
must not handle leaking Combodart
enlargement and tenderness. If this
capsules, because the active ingredient
becomes troublesome, or if you notice
can be absorbed through the skin.
breast lumps or nipple discharge
Wash the affected area immediately
you should talk to your doctor about
with soap and water if there is any
these changes as these may be signs
contact with the skin.
of a serious condition, such as breast
• Use a condom during sexual
cancer.
intercourse. Dutasteride has been
Contact your doctor or pharmacist
found in the semen of men taking
if you have any questions about
Combodart. If your partner is or may
taking Combodart.
be pregnant, you must avoid exposing

• ritonavir or indinavir (for HIV)
• itraconazole or ketaconazole (for
fungal infections)
• nefazodone (an antidepressant)
• cimetidine (for stomach ulcers)
• warfarin (for blood clotting)
Tell your doctor if you are taking
any of these medicines.

Food and drink with Combodart

Combodart should be taken 30 minutes
after the same meal each day.

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.
Pregnancy and breast-feeding
This medicine contains lecithin from
Women who are pregnant (or may
soya, which may contain soya oil. If you
be) must not handle leaking capsules.
Dutasteride is absorbed through the skin are allergic to peanut or soya, do not
Take special care with Combodart
and can affect the normal development use this medicinal product.
In some clinical studies, more patients
of a male baby. This is a particular risk
taking dutasteride and another
in the first 16 weeks of pregnancy.
medicine called an alpha-blocker like
her to your semen as dutasteride may Taking other medicines
Use a condom during sexual
tamulosin experienced heart failure
affect the normal development of
Tell your doctor if you’re taking, or have intercourse. Dutasteride has been found
than patients taking only dutasteride
a male baby. Dutasteride has been
recently taken, any other medicines.
in the semen of men taking Combodart.
or only an alpha-blocker. Heart failure
shown to decrease sperm count,
This includes any medicines you’ve
If your partner is or may be pregnant,
means your heart does not pump blood
semen volume and sperm motility.
bought without a prescription.
you must avoid exposing her to your
as well as it should.
This could reduce your fertility.
Don’t take Combodart with these
semen.
• Make sure your doctor knows about
• Combodart affects a blood test for
medicines:
Combodart has been shown to reduce
liver problems. If you have had any
PSA (prostate-specific antigen), which
• other alpha blockers (for enlarged
sperm count, semen volume and sperm
illness affecting your liver, you may
is sometimes used to detect prostate
prostate or high blood pressure)
movement. Therefore male fertility may
need some additional check-ups while
cancer. Your doctor should be aware
be reduced.
Some medicines can react with
you are taking Combodart.
of this effect and can still use the test
Contact your doctor for advice if
Combodart and may make it more
to detect prostate cancer. If you are
a pregnant woman has come into
likely that you’ll have side effects. These
• Make sure your doctor knows if you
having a blood test for PSA, tell your
contact with Combodart.
medicines include:
have severe problems with your kidney.
doctor that you are taking Combodart. • PDE5 inhibitors (used to help achieve
• Cataract (cloudy lens) surgery. If you
Men taking Combodart should have
or maintain an erection) such as
are going to have surgery to remove
their PSA tested regularly.
vardenafil, sildenafil citrate
a cataract, your doctor may ask you
and tadalafil
to stop taking Combodart for a while
• verapamil or diltiazem (for high blood
before your operation. Tell your
pressure)
eye specialist before your operation

4

GSK-ContractMfg-Eur-DEU-Germany-Catalent

United Kingdom-GBR
Combodart
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194

N/A

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, light-headedness
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.

Don’t stop Combodart without
advice

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.

BACK PAGE
TYPE SIZE: 10/12
HORIZONTAL SCALE: 100%

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Serious skin reactions

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.

Common side effects

These may affect up to 1 in 10 men
taking Combodart:
• impotence (not able to achieve or
maintain an erection)
• decreased sex drive (libido)
• difficulty with ejaculation
• breast enlargement or tenderness
(gynecomastia)
• dizziness.

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 heart beat (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.

Very rare side effects

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.

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

5 How to store
Combodart
Keep out of the reach and sight 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

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-diglycerides 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).

Marketing Authorisation Holder Other formats:
To listen to or request a copy of this
and Manufacturer
GlaxoSmithKline UK Limited,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT.

leaflet in Braille, large print or audio
please call, free of charge:

Manufacturer:
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2
73614 Schorndorf
Germany

Please be ready to give the following
information:

This medicinal product is
authorised in the Member
States of the EEA under the
following names:

Duodart – Austria, Bulgaria, Cyprus,
Czech republic, Finland, Germany,
Greece, Hungary, Iceland, Norway,
Poland, Romania, Slovak republic,
Spain
Combodart – Belgium, Denmark,
Estonia, France, Italy, Ireland, Latvia,
Lithuania, Luxembourg, Netherlands,
Malta, Portugal, Slovenia, UK

0800 198 5000 (UK Only)

Product name:
Combodart
Reference number:
19494/0046
This is a service provided by the Royal
National Institute of Blind People.
Leaflet date: April 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.

A369637

3 How to take Combodart 4 Possible side effects

A369637

V4

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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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