Skip to Content

UK Edition. Click here for US version.

COMBODART 0.5 MG / 0.4 MG HARD CAPSULES

Active substance(s): DUTASTERIDE / TAMSULOSIN HYDROCHLORIDE / DUTASTERIDE / TAMSULOSIN HYDROCHLORIDE / DUTASTERIDE / TAMSULOSIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

A456606
GSK-ContractMfg-Eur-DEU-Germany-Catalent

United Kingdom-GBR
Combodart

Package leaflet:
Information for the patient

A456606

2

N/A

N/A
N/A
2

0

hard capsules
dutasteride/tamsulosin hydrochloride

194

0

hard capsules
dutasteride/tamsulosin
hydrochloride

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. Do not pass it on to others.
It may harm them, even if their
symptoms 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.

N/A

K

hat Combodart is
1 W
and what it is used for

What is in this leaflet

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

2 What you need to know before you take Combodart
Do not take Combodart:

• 
Cataract (cloudy lens) surgery. If you
are going to have surgery to remove
• if you’re a woman (because this
a cataract, your doctor may ask you
medicine is for men only).
to stop taking Combodart for a while
• if you’re a child or adolescent less
before your operation. Tell your eye
than 18 years old.
specialist before your operation that
• if you’re allergic to dutasteride,
you are taking Combodart or
other 5-alpha reductase inhibitors,
Combodart is a combination of two
tamsulosin (or have previously taken
tamsulosin, soya, peanut or to any
different medicines called dutasteride
it). Your specialist will need to take
of the other ingredients of this
and tamsulosin. Dutasteride belongs
appropriate precautions to help
medicine (listed in section 6).
to a group of medicines called 5-alpha • if you have low blood pressure which
prevent complications during your
reductase inhibitors and tamsulosin
operation.
makes you feel dizzy, lightheaded or
belongs to a group of medicines called
faint (orthostatic hypotension).
• 
Women, children and adolescents
alpha-blockers.
• 
if you have a severe liver disease.
must not handle leaking Combodart
If you think any of these apply to you,
As the prostate grows, it can lead to
capsules, because the active
don’t take this medicine until you
urinary problems, such as difficulty in
ingredient can be absorbed through
have checked with your doctor.
passing urine and a need to go to the
the skin. Wash the affected area
toilet frequently. It can also cause the
immediately with soap and water
Warnings and precautions
flow of the urine to be slower and less
if there is any contact with the skin.
Talk to your doctor before taking
forceful. If left untreated, there is a
Combodart.
• 
Use a condom during sexual
risk that your urine flow will be
• In some clinical studies, more
intercourse. Dutasteride has been
completely blocked (acute urinary
patients taking dutasteride and
found in the semen of men taking
retention). This requires immediate
another medicine called an
Combodart. If your partner is or may
medical treatment. Sometimes surgery
alpha-blocker, like tamulosin
be pregnant, you must avoid
is necessary to remove or reduce the
experienced heart failure than
exposing her to your semen as
size of the prostate gland.
patients taking only dutasteride or
dutasteride may affect the normal
Dutasteride lowers the production of a
only an alpha-blocker. Heart failure
development of a male baby.
hormone called dihydrotestosterone,
means your heart does not pump
Dutasteride has been shown to
which helps to shrink the prostate and
blood as well as it should.
decrease sperm count, semen
relieve the symptoms. This will reduce
volume and sperm motility. This
• 
Make sure your doctor knows about
the risk of acute urinary retention and
could reduce your fertility.
liver problems. If you have had any
the need for surgery. Tamsulosin acts
illness affecting your liver, you may
• 
Combodart affects a blood test for
by relaxing the muscles in your
need some additional check-ups
PSA (prostate-specific antigen),
prostate gland, making it easier to
while you are taking Combodart.
which is sometimes used to detect
pass urine and rapidly improving your
prostate cancer. Your doctor should
• 
Make sure your doctor knows if you
symptoms.
be aware of this effect and can still
have severe problems with your
use the test to detect prostate
kidney.
cancer. If you are having a blood
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.

Some medicines can react with
Combodart and may make it more
likely that you’ll have side effects.
These medicines include:
• 
PDE5 inhibitors (used to help
• In a clinical study of men at
achieve or maintain an erection)
increased risk of prostate cancer,
such as vardenafil, sildenafil citrate
men taking dutasteride had a
and tadalafil
serious form of prostate cancer
• 
verapamil or diltiazem (for high
more often than men who did not
blood pressure)
take dutasteride. The effect of
• 
ritonavir or indinavir (for HIV)
dutasteride on this serious form of
• 
itraconazole or ketoconazole (for
prostate cancer is not clear.
fungal infections)
• 
Combodart may cause breast
• 
nefazodone (an antidepressant)
enlargement and tenderness. If this • 
cimetidine (for stomach ulcers)
becomes troublesome, or if you
• 
warfarin (for blood clotting)
notice breast lumps or nipple
• 
erythromycin (an antibiotic used to
discharge you should talk to your
treat infections)
doctor about these changes as these • 
paroxetine (an antidepressant)
may be signs of a serious condition, • 
terbinafine (used to treat fungal
such as breast cancer.
infections)
• 
diclofenac (used to treat pain and
Contact your doctor or pharmacist if
inflammation)
you have any questions about taking
Combodart.
Tell your doctor if you are taking
any of these medicines.
test for PSA, tell your doctor that
you are taking Combodart. Men
taking Combodart should have their
PSA tested regularly.

Other medicines and Combodart
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.

Combodart with food and drink

Don’t take Combodart with these
medicines:
• 
other alpha-blockers (for enlarged
prostate or high blood pressure)

Pregnancy, breast-feeding and
fertility

Combodart is not recommended with
these medicines:
• 
ketoconazole (used to treat fungal
infections)

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

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

Combodart contains the colouring
agent Sunset Yellow (E110) which may
cause allergic reactions.
Combodart contains lecithin from
soya. If you are allergic to peanut or
soya, do not use this medicinal
product.

Combodart must not be taken by women.
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.

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 10pt
Leading: 12pt
Horizontal Scale: 100%
Smallest text size: 10pt
Microtext: No

Page 1 of 2

2

GSK-ContractMfg-Eur-DEU-Germany-Catalent

United Kingdom-GBR
Combodart
N/A
N/A

N/A
N/A
2
K

194

Always take Combodart exactly as
Like all medicines, this medicine
your doctor or pharmacist has told
can cause side effects, although
you to. If you do not take it regularly
not everybody gets them.
the monitoring of your PSA levels may
be affected. Check with your doctor or Allergic reaction
pharmacist if you are not sure.
The signs of allergic reactions can
include:
How much to take
• 
skin rash (which can be itchy)
The recommended dose is one capsule • 
hives (like a nettle rash)
taken once a day, 30 minutes after the • 
swelling of the eyelids, face, lips,
same 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 and
the capsules may make your mouth or fainting
throat sore.
Combodart can cause dizziness,

If you take more Combodart
than you should

Contact your doctor or pharmacist for
advice if you take too many
Combodart capsules.
0

If you forget to take Combodart
Do not take a double dose to make up
for a forgotten dose. Just take your
next dose at the usual time.

0

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.

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.
* In a small number of people some
of these events may continue after
you stop taking Combodart.

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).

Other side effects

Other side effects have occurred in a
small number of men, but their exact
frequency is not known (the frequency
cannot be estimated from available
data):
• abnormal or fast heartbeat
Uncommon side effects
(arrhythmia or tachycardia or atrial
These may affect up to 1 in 100 men
fibrillation)
• heart failure (heart becomes less
• shortness of breath (dyspnoea)
efficient at pumping blood around
• depression
the body. You may have symptoms
• pain and swelling in your testicles
lightheadedness and on rare occasions
such as shortness of breath, extreme • nose bleeds
fainting. Take care when moving from
tiredness and swelling in your ankles • severe skin rash
a lying down or sitting position to
and legs.)
• changes in vision (blurred vision or
sitting or standing, particularly if you
• low blood pressure on standing
visual impairment)
wake up in the night, until you know
• fast heartbeat (palpitations)
• dry mouth
how this medicine affects you. If you
• constipation, diarrhoea, vomiting,
feel dizzy or lightheaded at any time
Reporting of side effects
feeling sick (nausea)
during treatment, sit or lie down until
If you get any side effects, talk to your
• weakness or loss of strength
the symptoms pass.
doctor or pharmacist. This includes any
• headache
possible side effects not listed in this
Serious skin reactions
• itchy, blocked or runny nose (rhinitis)
leaflet. You can also report side effects
The signs of serious skin reactions can
• skin rash, hives, itching.
directly via the Yellow Card Scheme at:
include:
• hair loss (usually from the body) or
www.mhra.gov.uk/yellowcard. By
• 
a widespread rash with blisters and
hair growth.
reporting side effects you can help
peeling skin, particularly around the
provide more information on the
Rare side effects
mouth, nose, eyes and genitals
These may affect up to 1 in 1,000 men safety of this medicine.
(Stevens-Johnson syndrome).
• swelling of the eyelids, face, lips,
Contact a doctor immediately if
arms or legs (angioedema)
you get these symptoms, and stop
• fainting.
using Combodart.

ow to store
5 HCombodart
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 and the bottle. The expiry date
refers to the last day of that month.
Don’t store Combodart 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 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-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.

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

Manufacturer:

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

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.
This leaflet was last revised in
April 2017
Trade marks are owned by or licensed
to the GSK group of companies
© 2017 GSK group of companies or its
licensor

• black print ink (SW-9010 or SW-9008):
shellac, propylene glycol, iron oxide
black (E172), potassium hydroxide
(in Black Ink SW-9008 only).

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.

A456606

3 How to take Combodart 4 Possible side effects

A456606

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 10pt
Leading: 12pt
Horizontal Scale: 100%
Smallest text size: 10pt
Microtext: No

Page 2 of 2

Expand Transcript

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.

Hide