Folic Acid 400 microgram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Folic Acid

Available from:

Clonmel Healthcare Ltd

ATC code:

B03BB; B03BB01

INN (International Name):

Folic Acid

Dosage:

400 microgram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Folic acid and derivatives; folic acid

Authorization status:

Not marketed

Authorization date:

1997-05-30

Patient Information leaflet

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 has
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 400 microgram Tablets are and what they are used
for
2. What you need to know before you take Folic Acid 400 microgram
Tablets
3. How to take Folic Acid 400 microgram Tablets
4. Possible side effects
5. How to store Folic Acid 400 microgram Tablets
6. Contents of the pack and other information
1. WHAT FOLIC ACID 400 MICROGRAM TABLETS ARE AND WHAT THEY ARE USED
FOR
Folic Acid is a member of the vitamin B group. It is essential for
good health. Folic acid is
required for the manufacture of nucleic acids (such as DNA), the
genetic material of cells. It is
vital for the development and proper function of the central nervous
system.
Folic acid 400 microgram tablets are indicated for the prevention of
first time neural tube defects
in the foetus. The neural tube is part of the nervous system and is
located within the spine. Neural
tube defects cause stillbirth, neonatal death and severe disabilities
such as Spina Bifida. It is for
use by women who are planning a pregnancy.
Studies have shown that over 70% of first time neural tube defects
such as Spina Bifida can be
prevented by taking folic acid (0.4mg) daily.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID 400 MICROGRAM
TABLETS
DO NOT TAKE FOLIC ACID 400 MICROGRAM 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

PART II
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.
Excipient: Lactose monohydrate 50 mg per tablet.
_For full list of excipients, see section 6.1_
3 PHARMACEUTICAL FORM
Tablet.
Pale-yellow, circular, biconvex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Folic Acid 400 microgram Tablets are indicated for the prevention of
first occurrence neural tube defects (including
Spina Bifida) in the foetus.
For use by women who are planning a pregnancy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adult females
One tablet (400 micrograms) daily.
Supplementation should begin at least 14 weeks before the woman
conceives and be continued for at least the first 12
weeks of pregnancy.
Administration
Route of administration:
Oral.
The tablets should be swallowed with water.
4.3 CONTRAINDICATIONS
○
Hypersensitivity to folic acid or any of the excipients.
○
Vitamin B
12
deficiency
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is advised for patients under therapy for folate-dependent
tumours when taking folic acid.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency of glucose-galactose
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malabsorption should not take this medicine.
4.5