Folic Acid tablets

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

folic acid

MAH:

CP Pharmaceuticals Ltd.

ATC_code:

B03BB01

INN:

folic acid

dosage:

5mg

pharmaceutical_form:

tablets

units_in_package:

(28/2x14/) in blister

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2018-04-18

PIL

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
• Removed pre-printed L.I.No. from pg1/2
pg1/2
PACKAGE LEAFLET
INFORMATION FOR THE USER
FOLIC ACID 5MG TABLETS
Read all of this
leaflet carefully
before you start
taking this
medicine.
− Keep this leaflet.
You may need to
read it again.
− If you have any further questions, ask your doctor
or pharmacist.
− This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
− If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Folic Acid Tablets are and what they are
used for
2. What you need to know before you take Folic
Acid Tablets
3. How to take Folic Acid Tablets
4. Possible side effects
5. How to store Folic Acid Tablets
6. Contents of the pack and other information
1. WHAT FOLIC ACID TABLETS ARE AN
WHAT THEY ARE USED FOR
The name of your medicine is Folic Acid Tablets,
which contains folic acid, a vitamin essential in the
production and maintenance of new cells.
Folic Acid Tablets are used in the treatment and
prevention of:
• anaemia due to a lack of folic acid in adults and
children
• anaemia in pregnancy
• anaemia, as a side effect from treatment with
certain medicines
• anaemia due to damaged red blood cells
• anaemia in patients on kidney dialysis.
Folic acid Tablets can also be given to some women
before and during pregnancy to prevent spina bifida
(an abnormality of the spine) in babies, which can
be caused by deficiency of this vitamin.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FOLIC ACID TABLETS
DO NOT TAKE FOLIC ACID TABLETS:
• if you are allergic to folic acid or to any of the other
ingredients of this medicine (listed in section 6).
• if you have cancer (unless you have anaemia due
to a deficiency of folic acid)
WARNINGS AND PREC

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Folic Acid 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Folic Acid 5mg
Excipients with known effect
Lactose
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Plain yellow, biconvex tablet with break-line on one face and CP on
the reverse.
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
Posology
_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.
_Paediatric population_
Over 1 year :
As adult dose
Up to 1 year: 500µg/kg daily
Method of administration
The tablets are for oral use.
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 of the
spinal cord.
Therefore a full clinical diagnosis should be made before initiating
treatment.
Folate should not be routinely used in patients receiving coronary
stents.
Caut