Atucare 0.5 mg/0.4 mg hard capsules

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE

Disponible depuis:

Heaton k.s. Na Pankraci 14, 140 00 Praha 4, Czech Republic

Code ATC:

G04CA52

DCI (Dénomination commune internationale):

DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

forme pharmaceutique:

HARD CAPSULE

Composition:

DUTASTERIDE 0.5 mg TAMSULOSIN HYDROCHLORIDE 0.4 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

UROLOGICALS

Descriptif du produit:

Licence number in the source country: NOT APPLICAPABLE

Statut de autorisation:

Authorised

Date de l'autorisation:

2021-02-08

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATUCARE 0.5MG/0.4 MG HARD CAPSULE S
DUTASTERIDE /TAMSULOSIN IN 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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any of the 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 Atucare is and what it is used for
2.
What you need to know before you take Atucare
3.
How to take Atucare
4.
Possible side effects
5.
How to store Atucare
6.
Contents of the pack and other information
1.
WHAT ATUCARE IS AND WHAT IT IS US E D FOR
Atucare 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.
Atucare 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 you
are not treated, 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 reduce the
prostate size and relieve the symptoms. This will reduce the risk of
acute urinary retention a

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atucare 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:
•
112 mg propylene glycol,
•
traces of lecithin (may contain soya oil)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard.
Atucare are oblong hard gelatin capsules of 24.2 mm x 7.47 mm
approximately, with brown body and obeige
cap printed with C001 in black ink.
Each hard capsule contains one dutasteride soft gelatin capsule and
tamsulosin hydrochloride modified
release pellets.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment is indicated in patients already controlled with tamsulosin
and dutasteride given
concurrently at the same level to appropriately control the symptoms
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
_ _
2
_Adults (including elderly): _
The recommended dose of Atucare is one capsule (0.5 mg/ 0.4 mg) daily.
Where appropriate Atucare may be used to substitute dual therapy
(dutasteride and tamsulosin
hydrochloride) to simplify treatment regimen.
Under prescriber criteria, change from dutasteride or tamsulosin
hydrochloride monotherapy to
Atucare could 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 pa