OMNIC OCAS 0.4

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

TAMSULOSIN HYDROCHLORIDE

Disponible des:

CTS LTD

Codi ATC:

G04CA02

formulario farmacéutico:

TABLETS PROLONGED RELEASE, FILM COATED

Composición:

TAMSULOSIN HYDROCHLORIDE 0.4 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS

Grupo terapéutico:

TAMSULOSIN

Área terapéutica:

TAMSULOSIN

indicaciones terapéuticas:

Lower urinary tract symptoms ( LUTS) associated with benign prostatic hyperplasia (BPH).

Data d'autorització:

2022-01-31

Informació per a l'usuari

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
OMNIC OCAS 0.4
Prolonged-release film-coated
tablets
The active ingredient and its quantity per dosage unit:
Tamsulosin Hydrochloride 0.4 mg/tablet
For a list of the inactive and allergenic ingredients in the
preparation - see section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
The medicine is not intended for children or adolescents below the age
of 18
.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of functional disorders of
the lower
urinary tract associated with benign prostatic hyperplasia (BPH).
THERAPEUTIC GROUP: Selective alpha
1A/1D
-adrenoreceptor antagonist.
The mode of action of the active ingredient of the preparation is to
reduce tension
of the smooth muscles in the prostate and urethra, enabling urine to
pass more
readily through the urethra and thereby facilitating urination. In
addition, it
diminishes sensations of urge.
2. BEFORE USING THE MEDICINE:
X XDO NOT USE THE MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient tamsulosin or to
any of the
other ingredients contained in the medicine. Hypersensitivity may
present as
sudden local swelling of the soft tissues of the body (e.g., the
throat or
tongue), difficulty in breathing and/or itching and rash (angioedema).
•
you suffer from severe liver problems.
•
you suffer from fainting due to decreased blood pressure when changing
posture, for example when transitioning to a standing or sitting
position. ! SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
•
Consult with the doctor before taking the medicine.
•
In rare cases, as wit

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Omnic Ocas 0.4
®
, prolonged release tablets, film-coated
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release film-coated tablet contains 0.4 mg tamsulosin
hydrochloride.
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated, prolonged release tablet.
(Oral Controlled Absorption System, OCAS).
Approximately 9 mm in diameter, round, bi-convex, yellow, film-coated
and debossed with the
code ‘04’.
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 tablet daily.
Omnic Ocas 0,4 can be taken independently of food.
The tablet must be swallowed whole and not be crunched or chewed as
this interferes with the
prolonged release of the active substance.
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 Ocas 0.4 in children.
The safety and efficacy of tamsulosin in children <18 years have not
been established. Currently
available data are described in section 5.1.
4.3 CONTRA-INDICATIONS
Hypersensitivity to tamsulosin hydrochloride, including drug induced
angioedema or to any of the
excipients listed in section 6.1.
A history of orthostatic hypotension.
Severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other α
1
-adrenoceptor antagonists, a reduction in blood pressure can occur in
individual
cases during treatment with Omnic Ocas 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 Ocas 0,4 is initiated, the patient should be
examined in order to
exclude the presence of other conditions, which