Rutacid tablets chewable

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

hydrotalcite

Available from:

KRKA d.d.

ATC code:

A02AD04

INN (International Name):

hydrotalcite

Dosage:

500mg

Pharmaceutical form:

tablets chewable

Units in package:

(20/2x10/) in blister, (60/6x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-11-27

Summary of Product characteristics

1.3.1
Hydrotalcite
SPC, Labeling and Package Leaflet
AM
SmPCPIL116083_1
14.08.2018 – Updated: 14.08.2018
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Rutacid 500 mg chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 500 mg hydrotalcite.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Tablets are round, white or almost white with beveled edges and with a
slight peppermint odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rutacid tablets eliminate or relieve symptoms associated with
excessive gastric acid secretion:
-
belching, heartburn,
-
burning pain in the stomach,
-
inflammation of the lining of the stomach (gastritis), which is a
result of stress, improper diet,
excessive consumption of alcohol or nonsteroidal anti-inflammatory
drugs.
Rutacid tablets promote the healing of gastric and duodenal ulcers and
are also effective in the
maintenance treatment of chronic ulcer disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The chewable tablets should not be swallowed whole but should be
chewed thoroughly.
_Adults _
The recommended dose is 1 to 2 tablets 3 to 4 times daily, usually one
hour after a meal and at
bedtime, or when the above-mentioned problems occur.
_Elderly _
No dosage adjustment is required.
_Patients with impaired renal function _
Patients with impaired renal function can take Rutacid only for a
short time and at lower doses (see
section 4.4).
_Patients with impaired liver function _
No dosage adjustment is required.
_Children _
The recommended dose for children aged 6 to 12 years is half the adult
dose (½ to 1 tablet) taken 3 to
4 times daily, usually one hour after a meal and at bedtime, or when
problems occur.
Rutacid is not recommended for use in children under 6 years of age
because its safety and efficacy
have not been established.
1.3.1
Hydrotalcite
SPC, Labeling and Package Leaflet
AM
SmPCPIL116083_1
14.08.2018 – Updated: 14.08.2018
Page 2 of 5
4.3
CONTRAINDICATIONS
Hypersensitivity to the active su