Alfa Normix tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rifaximin

Available from:

Alfasigma S.p.A.

ATC code:

A07AA11

INN (International Name):

rifaximin

Dosage:

200mg

Pharmaceutical form:

tablets film-coated

Units in package:

(12/1x12/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
ALFA NORMIX
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_One film-coated tablet contains: _
Rifaximin 200 mg
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of gastrointestinal disorders sustained by
Rifaximin-sensitive bacteria such as acute
gastrointestinal
infections,
traveler’s
diarrhea,
intestinal
overgrowth
syndrome,
hepatic
encephalopathy, symptomatic uncomplicated diverticular disease of the
colon and chronic bowel
inflammation.
Prophylaxis of infective complications in colorectal surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years of age: from 1 film-coated tablet
every 8 hours to 2 film- coated
tablets every 8 - 12 hours (equal to 600 - 1200 mg of Rifaximin)
The duration of treatment should not exceed 7 days and should be
determined by the clinical
response of the patients.
In the cases in which repeated courses of treatment are required, each
course of treatment should be
separated by a wash-out period of 20 to 40 days.
The total duration of the intermittent therapy should be determined by
the adequacy of the clinical
response of the patients.
DOSES MAY BE MODIFIED IN QUANTITY AND FREQUENCY, ACCORDING TO THE
PHYSICIAN’S ADVICE.
Method of administration Orally
with a glass of water.
Rifaximin can be administered with or without food.
Elderly
No dosage adjustment is necessary as the safety and efficacy data of
ALFA NORMIX showed no
differences between the elderly and the younger patients.
Hepatic impairment
No dosage adjustment is necessary for patients with hepatic
insufficiency (see section 5.2). Renal
impairment
Although dosing change is not anticipated, caution should be used in
patients with impaired renal
function (see section 5.2).
Paediatric Population
The safety and efficacy of rifaximin in children younger than 12 years
of age have not been established.
Currently available data are described in section 5.1, but no dosage
recommen