Folic Acid 400 microgram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Folic acid

Available from:

Alissa Healthcare Research Limited

ATC code:

B03BB; B03BB01

INN (International Name):

Folic acid

Dosage:

400 microgram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Folic acid and derivatives; folic acid

Authorization status:

Not marketed

Authorization date:

2018-06-14

Patient Information leaflet

IE/H/0468/001/DC
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLIC ACID 400 MICROGRAM TABLETS
Folic Acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
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
4.
How to store Folic Acid Tablets
6.
Contents of the pack and other information
1.
WHAT FOLIC ACID TABLETS ARE AND WHAT THEY ARE USED FOR
Folic acid is a member of the Vitamin B group it is the active
ingredient of Folic Acid Tablets. It is
essential for good health and is present in fresh and processed foods.
You should use this medicines if you are trying to become pregnant or
think you are pregnant and also
for the first three months of your pregnancy.
Folic Acid is necessary for the development and growth of healthy
cells and tissues. It is vital for the
development and proper function of the central nervous system.
Folic acid is used to help prevent babies being born with neural tube
defects such as Spina Bifida.
The neural tube is part of the nervous system and is located in the
spine. The baby’s neural tube
develops during the early stages of pregnancy and it is at this
particular critical stage that neural tube
defects such as Spina Bifida can occur.
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 any of the other ingredients of
this medicine (listed in section 6)

Summary of Product characteristics

Health Products Regulatory Authority
21 July 2020
CRN009SPX
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folic Acid 400 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 micrograms folic acid (as folic acid
hydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Off white to yellowish, round, bevelled-edged, convex tablet, 7 mm in
diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Folic Acid is indicated for the prevention of first occurrence neural
tube defects in the foetus.
For use by women who are planning a pregnancy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult females
One tablet (0.4mg) daily.
Supplementation should begin by taking one tablet (0.4 mg) daily prior
to conception and be continued for at least the first 12
weeks of pregnancy.
Method of administration
Oral.
The tablets should be swallowed with water.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Folic acid should not be given alone in the treatment of Addisonian
pernicious anaemia and other vitamin B12 deficiency
states, as this may precipitate the onset of subacute combined
degeneration of the spinal cord. Patients with malignant disease,
unless megaloblastic anaemia due to folic acid deficiency.
Should not be taken by people with folate dependant tumours.
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 B12) 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.
Women with pre-existing diabetes, obesity, family history of neural
tube defects, or previous pregnancy affected by neural tube
defect have an increased risk of having a pregnancy affected b