Vitamin C 250mg tablets

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Fitxa tècnica Fitxa tècnica (SPC)
08-02-2017

ingredients actius:

ascorbic acid

Disponible des:

Arpimed LLC

Codi ATC:

A11GA01

Designació comuna internacional (DCI):

ascorbic acid

Dosis:

250mg

formulario farmacéutico:

tablets

Unidades en paquete:

(10/1x10/) blister

tipo de receta:

OTC

Estat d'Autorització:

Registered

Data d'autorització:

2015-04-30

Fitxa tècnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
VITAMIN C
250 AND 500MG TABLETS
1.1BRAND NAME – Vitamin C
1.2GENERIC NAME -Ascorbic Acid
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg of ascorbic acid.
Each tablet contains 250mg of ascorbic acid.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Round biconvex white tablets scored on one side; odorless. (Vitamin C,
250mg tablets).
Slightly violet round biconvex tablets of white color; odorless.
(Vitamin C, 500mg 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 formsаre unsuitable for prophylactic use.
_Therapeutic:_Not less than 250mg daily in divided doses._ _
Children under 6 years:
These unit dosages formsare unsuitable for children under 6 years.
4.3 CONTRAINDICATIONS
Hypersensitivity to ascorbic acid.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Increased intake of ascorbic acid over a prolonged period may result
in an
increase in renal clearance of ascorbic acid and deficiency may result
if it is
withdrawn rapidly.
Large doses are associated with the formation of renal calcium oxalate
calculi.
Ascorbic acid should be given with care to patients with
hyperoxaluria.
The administration of therapeutic doses may interfere with Clinistix
test for
glucosuria giving a false negative result.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Concomitant administration of aluminium-containing antacids may
increase
urinaryaluminium elimination. Concurrent administration of antacids
and
ascorbic acid is not recommended, especially in patients with renal
insufficiency.
Concurrent use of ascorbic acid with barbiturates or primidone may
increase
the urinary excretion of ascorbic acid.
Concurrent use with cellulose sodium phosphate may result in
metabolism of
ascorbic acid to oxalate.
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