Omnic 0,4, 0.4mg modified-release capsules, hard

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

TAMSULOSIN HYDROCHLORIDE

Доступно од:

Astellas Pharmaceuticals A.E.B.E 6-8 Agisilaou Str., 151 23 Marousi, Athens,, Greece

АТЦ код:

G04CA02

INN (Међународно име):

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Фармацеутски облик:

MODIFIED-RELEASE HARD CAPSULE

Састав:

TAMSULOSIN HYDROCHLORIDE 0.4 mg

Тип рецептора:

POM

Терапеутска област:

UROLOGICALS

Статус ауторизације:

Authorised

Датум одобрења:

2006-01-18

Информативни летак

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMNIC 0,4, 0.4 MG MODIFIED RELEASE CAPSULES, HARD
tamsulosin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Omnic 0,4 is and what it is used for
2.
Before you take Omnic 0,4
3.
How to take Omnic 0,4
4.
Possible side effects
5.
How to store Omnic 0,4
6.
Further information
1.
WHAT OMNIC 0,4 IS AND WHAT IT IS USED FOR
The active ingredient in Omnic 0,4 is tamsulosin. This is a selective
α
1A/1D
-adrenoceptor antagonist. It
reduces tension of the smooth muscles in the prostate and the urethra,
enabling urine to pass more
readily through the urethra and facilitating urination. In addition,
it diminishes sensations of urge.
Omnic 0,4 is used in men for the treatment of the complaints of the
lower urinary tract associated with
an enlarged prostatic gland (benign prostatic hyperplasia
).
These complaints may include difficulty
urinating (poor stream), dribbling, urgency and having to urinate
frequently at night as well as during
the day.
2.
BEFORE YOU TAKE OMNIC 0,4
DO NOT TAKE OMNIC 0,4
-
if you are allergic (hypersensitive) to tamsulosin or to any of the
other ingredients in Omnic
0,4. Hypersensitivity may present as sudden local swelling of the soft
tissues of the body (e.g.
the throat or tongue), difficult breathing and / or itching and rash
(angioedema).
-
if you suffer from severe liver problems.
-
if you suffer from fainting due to reduced blood pressure when
changing posture (going to sit or
stand up).
TAKE SPECIAL CARE WITH OMNIC 0,4
-
Periodic medical examinations are necessary to monitor

Карактеристике производа

1. NAME OF THE MEDICINAL PRODUCT
Omnic 0,4, 0.4 mg, modified release capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains as active ingredient tamsulosin hydrochloride
0.4 mg.
Excipient(s):
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Modified release capsule, hard
Orange/olive-green coded 0.4 and logo and 701
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lower urinary tract symptoms (LUTS) associated with benign prostatic
hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
One capsule daily, to be taken after breakfast or the first meal of
the day.
The capsule must be swallowed whole and must not be crunched or
chewed, as this interferes
with the modified release of the active ingredient.
No dose adjustment is warranted in renal impairment. No dose
adjustment is warranted in
patients with mild to moderate hepatic insufficiency (see also 4.3
Contraindications).
_ _
_Paediatric population _
There is no relevant indication for use of Omnic in children.
The safety and efficacy of tamsulosine in children <18 years have not
been established.
Currently available data are described in section 5.1
4.3 CONTRAINDICATIONS
Hypersensitivity to tamsulosin hydrochloride, including drug-induced
angioedema or to any
of the excipients.
A history of orthostatic hypotension.
Severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other α
1
-adrenoceptors antagonists, a reduction in blood pressure can occur in
individual cases during treatment with Omnic 0,4, as a result of
which, rarely, syncope can
occur. At the first signs of orthostatic hypotension (dizziness,
weakness), the patient should
sit or lie down until the symptoms have disappeared.
Before therapy with Omnic
0,4 is initiated, the patient should be examined in order to exclude
the presence of other conditions, which can cause the same symptoms as
benign prostatic
hyperplasia. Digital rectal examination and, when necessary,
determination of prostate
specific antigen (P