Combodart 0.5mg/0.4mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Available from:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC code:

G04CA52

INN (International Name):

DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Product summary:

Licence number in the source country: Latvia - 10-0254

Authorization status:

Authorised

Authorization date:

2013-12-05

Patient Information leaflet

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

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 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
3
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 impairment
(see section 4.4 and section 5.2). In
patients with severe hepa