Combodart 0.5mg/0.4mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tamsulosin hydrochloride; Dutasteride

Available from:

Recordati Pharmaceuticals Ltd

ATC code:

G04CA52

INN (International Name):

Tamsulosin hydrochloride; Dutasteride

Dosage:

400microgram ; 500microgram

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040100; GTIN: 5000123112760

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COMBODART 0.5 MG/0.4 MG 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.
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
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

Summary of Product characteristics

OBJECT 1
COMBODART 0.5 MG / 0.4 MG HARD CAPSULES
Summary of Product Characteristics Updated 19-Dec-2017 |
GlaxoSmithKline UK
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).
Excipients with known effect:
Each capsule contains lecithin (which may contain soya oil) and Sunset
Yellow (E 110). Each capsule
contains ≤0.1 mg sunset yellow.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
Oblong, hard-shell 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
4.1 Therapeutic indications
Treatment of moderate to severe symptoms of benign prostatic
hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in
patients with moderate to severe
symptoms of BPH.
For information on effects of treatment and patient populations
studied in clinical trials please see section
5.1.
4.2 Posology and method of administration
Posology
_Adults (including elderly)_
The recommended dose of Combodart is one capsule (0.5 mg/ 0.4 mg) once
daily.
Where appropriate, Combodart may be used to substitute concomitant
dutasteride and tamsulosin
hydrochloride in existing dual therapy to simplify treatment.
Where clinically appropriate, direct change from dutasteride or
tamsulosin hydrochloride monotherapy to
Combodart may be considered.
_Renal impairment_
The effect of renal impairment on dutasteride-tamsulosin
pharmacokinetics has not been studied. No
adjustment in dosage is anticipated for patients with renal impairment
(see section 4.4 and 5.2).
_Hepatic impairment_
The effect of hepatic impairment on dutasteride-tamsulosin
pharmacokinetics has not been studied so
caution should be used in patients with mild to moderate hepatic