Vitamin C tablets

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

ascorbic acid

Commercializzato da:

Arpimed LLC

Codice ATC:

A11GA01

INN (Nome Internazionale):

ascorbic acid

Dosaggio:

500mg

Forma farmaceutica:

tablets

Confezione:

(20) in plastic container

Tipo di ricetta:

OTC

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2017-05-31

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
VITAMIN C
250 AND 500MG TABLETS
1.1 BRAND NAME – Vitamin C
1.2 GENERIC 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 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
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Ascorbic acid should not be given to patients with hyperoxaluria.
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withdrawn rapidly (see section 4.8).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.
Patients with rare hereditary problems of galactose intolerance, total
lactase deficiency or
glucose-galactose m