Duspatalin capsules hard prolonged-release

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

mebeverine (mebeverine hydrochloride)

Tersedia dari:

Mylan Laboratories SAS

Kode ATC:

A03AA04 օրիգինալ դեղի առաջին դեղաձև, դեղաչափ

INN (Nama Internasional):

mebeverine (mebeverine hydrochloride)

Dosis:

200mg (30/2x15/) in blister

Bentuk farmasi:

capsules hard prolonged-release

Unit dalam paket:

200mg (30/2x15/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2021-03-10

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTIC
MEBEVERINE HYDROCHLORIDE
1
NAME OF THE MEDICINAL PRODUCT
Duspatalin 200 mg, prolonged-release capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Duspatalin200mg, prolonged- release capsules, hard:
One prolonged-release capsule, hard, contains 200 mg mebeverine
hydrochloride.
For the full list
of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Opaque white, hard gelatine capsule of size no. 1, with standard
imprint 245.
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of abdominal pain and cramps, bowel disturbances
and intestinal
discomfort related to irritable bowel syndrome.
Treatment of gastro-intestinal spasm secondary to organic diseases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Duspatalin 200mg, prolonged-release capsules, hard:
The medicinal product is taken orally.
The capsules should be swallowed with a sufficient amount of water (at
least 100 ml water).
They should not be chewed because the coating is intended to ensure a
prolonged release
mechanism (see 5.2)
_Adults:_
One capsule of 200 mg twice daily, to be given one in the morning and
one in the evening.
Duration of use is not limited.
In case of one or more dose(s) is (are) missed, the patient should
continue with the next dose as
prescribed; the missed dose(s) is (are) not to be taken in addition to
the regular dose.
_SPECIAL POPULATION_
No posology studies in elderly, renal and/or hepatic impaired patients
have been performed. No
specific risk for elderly, renal and/or hepatic impaired patients
could be identified from
available post-marketing data. No dosage adjustment is deemed
necessary in elderly, renal
and/or hepatic impaired patients.
4.3
CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.

Administration by children and adolescents below 18.
SUMMARY OF PRODUCT CHARACTERISTIC
MEBEVERINE HYDROCHLORIDE
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not applicable
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTI