Folic Acid 5mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

folic acid

Available from:

Arpimed LLC

ATC code:

B03BB01

INN (International Name):

folic acid

Dosage:

5mg

Pharmaceutical form:

tablets

Units in package:

(48/2x24/)blisters; (50/5x10) blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-12-25

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTIC (SPC)
FOLIC ACID
5 MG TABLETS
1.1 BRAND NAME – FOLIC ACID
1.2 INTERNATIONAL NON-PROPERTY NAME - FOLIC ACID
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet_ _of _Folic acid, 5 mg _contains:
_ACTIVE INGREDIENT: _folic acid – 5 mg;
_For a full list of excipients, see section 6.1. _
3. PHARMACEUTICAL FORM
Tablets. Yellow scored on one side and beveled on both sides
cylindrical tablets with a few small
darker spots, the end surface of which are flat.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Folic acid is indicated for the treatment of megaloblastic anaemia due
to folic acid deficiency. It is
also used for prophylaxis in chronic haemolytic states, in renal
dialysis, and in drug induced folate
deficiency.
Folic acid is used for the prevention of recurrence of neural tube
defects.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
IN FOLATE DEFICIENT MEGALOBLASTIC ANAEMIA:
5mg daily for 4 months
Up to 15mg daily may be necessary for malabsorption states
FOR PROPHYLAXIS IN CHRONIC HAEMOLYTIC STATES OR IN RENAL DIALYSIS:
5mg every 1-7 days depending on diet and underlying disease.
IN DRUG INDUCED FOLATE DEFICIENCY:
5mg daily
PREVENTION OF RECURRENCE OF NEURAL TUBE DEFECTS
5mg daily starting before conception and continuing throughout the
first trimester of pregnancy is
recommended.
_Children_
Over 1 year : As adult dose
Up to 1 year: 500µg/kg daily
For dosage and administration of children with various weights it
should use Folic acid 1 mg tablets
too.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Patients with malignant disease, unless megaloblastic anaemia due to
folic acid deficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Folic
acid
should
not
be
administered
for
treatment
of
pernicious
anaemia
or
undiagnosed
megaloblastic anaemia without sufficient amounts of cyanocobalamin
(vitamin B
12
) as folic acid
alone will not prevent and may precipitate development of subacute
combined degeneration