Omnic capsules modified-release

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:

capsules modified-release

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 0,4 (Tamsulosin hydrochloride) Astellas CTD Module 1.3.1
Modified release capsules, hard 0.4 mg Summary of Product
Characteristics
Page 1 of 9
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.
Omnic 0,4 (Tamsulosin hydrochloride) Astellas CTD Module 1.3.1
Modified release capsules, hard 0.4 mg Summary of Product
Characteristics
Page 2 of 9
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 disappear