Omnic Ocas tablets prolonged-release coated

Pajjiż: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

tamsulosin (tamsulosin hydrochloride)

Disponibbli minn:

Astellas Pharma Europe B.V.

Kodiċi ATC:

G04CA02

INN (Isem Internazzjonali):

tamsulosin (tamsulosin hydrochloride)

Dożaġġ:

0,4mg

Għamla farmaċewtika:

tablets prolonged-release coated

Unitajiet fil-pakkett:

(10/1x10/) in blister, (30/3x10/) in blister

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2015-09-18

Karatteristiċi tal-prodott

Omnic Ocas 0.4 (Astellas) CTD Module 1
tamsulosin hydrochloride 0.4 mg Section 1‐3‐1: Product information
Prolonged release tablets (film‐coated) 0.4 mg
Page 1 of 11
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.
Excipients: For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated, prolonged release tablet.
Approximately 9 mm in diameter, round, bi-convex, yellow to
brownish-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 tamsulosine in children <18 years have not
been established.
Currently available data are described in section 5.1
Omnic Ocas 0.4 (Astellas) CTD Module 1
tamsulosin hydrochloride 0.4 mg Section 1‐3‐1: Product information
Prolonged release tablets (film‐coated) 0.4 mg
Page 2 of 11
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 α1-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 o