Vitamin C-Asteria tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ascorbic acid

Available from:

Hankook Korus Pharm Co.

ATC code:

A11GA01

INN (International Name):

ascorbic acid

Dosage:

500mg

Pharmaceutical form:

tablets

Units in package:

(100/10x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-09-25

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vitamin C –Asteria, Tab. 500mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg of ascorbic acid.
Excipient(s): for the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White oval tablets.
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of scurvy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration:
Oral
Dose
Adults (including the elderly) and children over 6 years:
_Prophylactic: _25 – 75 mg daily.
Note: Thеsе unit dosages forms аre unsuitable for prophylactic use.
_Therapeutic: _Not less than 250mg daily in divided doses. Maximum of
1000mg daily.
Children under 6 years:
These unit dosage forms are unsuitable for children under 6 years.
4.3 CONTRAINDICATIONS
Ascorbic acid should not be given to patients with hyperoxaluria.
Children under 6 years old.
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS
Increased intake of ascorbic acid over a prolonged period may result
in an increased renal
clearance of ascorbic acid, and deficiency may result if the intake is
reduced or withdrawn
rapidly (see section 4.8).
Interference with serological testing Ascorbic acid may interfere with
tests and assays for
urinary glucose, giving false-negative results with methods utilising
glucose oxidase with
indicator
(e.g.
Labstix,
Tes-Tape)
and
false-positive
results
with
neocuproine
methods.
Estimation of uric acid by phosphotungstate or uricase with copper
reduction and measurement
of creatinine in non-deproteinised serum may also be affected. High
doses of ascorbic acid may
give false-negative readings in faecal occult blood tests.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION.
Ascorbic acid increases the renal excretion of amphetamine. The plasma
concentration of
ascorbate is decreased by smoking and oral contraceptives. Ascorbic
acid increases the
absorption of iron.