Enterofuryl capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

nifuroxazide

Available from:

Bosnalijek d.d.

ATC code:

A07AX03

INN (International Name):

nifuroxazide

Dosage:

100mg

Pharmaceutical form:

capsules

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-21

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
ENTEROFURYL
®
100 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ENTEROFURYL
®
100 mg capsule contains:
Nifuroxazide
100.00 mg
See section 6.1. for excipients.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Oblong, hard gelatin capsules made of body and cap. Capsules are
yellow.
Capsule size is 2.
Capsule content is yellow granulate or mildly compressed granulate
that disintegrates upon slight
pressure.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Acute bacterial diarrhea without of aggravation of the general
condition, fever, intoxication signs.
4.2.DOSAGE AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
The medicine is intended for oral administration.
_DOSAGE _
Children from 6 to 18 years of age: 200 mg of nifuroxazide (2
capsules) 3 - 4 times a day with
dosing interval of 6 - 8 h. Totally 600 - 800 mg of nifuroxazide a
day.
Adults: 200 mg of nifuroxazide (2 capsules) 4 times a day with dosing
interval of 6 h. Totally 800
mg of nifuroxazide a day.
The duration of treatment is 5 – 7 days but not more than 7 days.
If no improvement occurs within the first 3 days of treatment, the
patient should consult a doctor.
4.3. CONTRAINDICATIONS
•
Hypersensitivity to nifuroxazide, nitrofuran derivatives and other
ingredients of the product;
•
Age under 6 years (for this pharmaceutical form);
•
Intolerance
to
fructose,
glucose-galactose
malabsorption
or
saccharose-isomaltase
insufficiency.
4.4.SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In diarrhea treatment rehydration therapy should be conducted
simultaneously with nifuroxazide
therapy. In case of bacterial diarrhea with the signs of systemic
lesion (aggravation of the general
condition, fever, intoxication or infection signs) a medical
consultation is required in order for a
decision to be made on whether to use antibacterial systemic agents.
In case of expression of the
symptoms of hypersensitivity (dyspnea, rush, itch) the treatment with
nifuroxazide should be
discontinued. Alcohol consumption is forbidden du