Combodart 0.5 mg/0.4 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dutasteride; Tamsulosin hydrochloride

Available from:

Imbat Limited

ATC code:

G04CA; G04CA52

INN (International Name):

Dutasteride; Tamsulosin hydrochloride

Dosage:

0.5 mg/0.4 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Alpha-adrenoreceptor antagonists; tamsulosin and dutasteride

Authorization status:

Authorised

Authorization date:

2012-02-10

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COMBODART
® 0.5 MG/0.4 MG HARD CAPSULES
(dutasteride / tamsulosin hydrochloride)
Your medicine is available using the above name but will be
referred to as Combodart throughout this leaflet.
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.
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
1.
WHAT COMBODART IS AND WHAT IT IS USED FOR
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
dihydrotestostero

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Combodart 0.5 mg/0.4 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin
hydrochloride, (equivalent to 0.367 mg
tamsulosin).
Excipient(s) with known effect
Each capsule contains lecithin (which may contain soya oil) and Sunset
Yellow (E 110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
_Product imported from Poland, Bulgaria and Hungary_
Oblong, hard capsules with a brown body and an orange cap imprinted
with GS 7CZ in black ink.
Each hard capsule contains tamsulosin hydrochloride modified release
pellets and one dutasteride soft gelatin capsule.
4 CLINICAL PARTICULARS
As per PA1077/118/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/118/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Hard Capsule Shell:
Hypromellose
Carrageenan (E407)
Potassium Chloride
Titanium Dioxide (E171)
Iron Oxide Red (E172)
Sunset Yellow (E110)
Carnauba Wax
Maize Starch
Contents in Dutasteride Soft Capsule:
Mono-di-glycerides of caprylic/capric acid
Butylhydroxytoluene (E321)
Soft Capsule Shell:
Gelatin
Glycerol
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Titanium dioxide (E171)
Iron Oxide Yellow (E172)
Triglycerides, medium chain
Lecithin (may contain soya oil)
Tamsulosin Pe