Folic Acid 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

ATC code:

A11JC

INN (International Name):

FOLIC ACID 5 mg

Pharmaceutical form:

TABLET

Composition:

FOLIC ACID 5 mg

Prescription type:

POM

Therapeutic area:

VITAMINS

Authorization status:

Authorised

Authorization date:

2023-07-20

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLIC ACID 5MG TABLETS
Folic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
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 5 mg Tablets are and what they are used for
2.
What you need to know before you take Folic Acid 5 mg Tablets
3.
How to take Folic Acid 5 mg Tablets
4.
Possible side effects
5.
How to store Folic Acid 5 mg Tablets
6.
Contents of the pack and other information
1. WHAT FOLIC ACID 5 MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Folic Acid 5 mg Tablets. It contains
folic acid which belongs to a group of
vitamins called ‘B vitamins’.
Folic acid 5 mg Tablets are used to treat the following:
-
Anaemia which can be caused by:
-
a lack of vitamins
-
pregnancy
-
gastrectomy (a portion or all of your stomach has been surgically
removed).
-
An illness called ‘Sprue’. In this illness parts of your food
cannot be absorbed by the gut.
-
Pellagra (a vitamin deficiency) - the symptoms include dermatitis,
inflammation of the tongue, diarrhoea,
disorientation, depression and confusion.
-
As an adjunct (i.e., taken in combination with other medicines) in the
management of pernicious anaemia
(your body is unable to absorb vitamin B
12
properly from your food).
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID 5 MG TABLETS
DO NOT TAKE FOLIC ACID 5 MG TABLETS
-
if you are allergic (hypersensitive) to folic acid or any of the other
ingredients of this medicine (listed in
section 6). Signs of an allergic reaction include a rash, itching or
sho

Summary of Product characteristics

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Folic Acid 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Folic Acid 5 mg.
Excipient(s) with known effect
Contains up to 97.10 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Yellow to orange-yellow, speckled, round, biplane tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an essential ingredient for the production and maturation of red
blood cells, in particular in such
conditions as megaloblastic anaemia of infancy and of pregnancy,
nutritional macrocytic anaemia,
pellagra, sprue, post gastrectomy anaemia. As an adjunct in the
management of pernicious anaemia.
Treatment of folic acid deficiency refractory to dietary measures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
The usual daily dose is 10 to 20 mg with a maintenance dose of 2.5 –
10 mg.
Children
The usual daily dose is 5 - 15 mg.
Method of administration
Oral.
4.3
CONTRAINDICATIONS
Folic acid should not be used as the only treatment of pernicious
anaemia since alone it will not
prevent the development of subacute combined degeneration of the
spinal cord.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Page 2 of 4
A rise in the reticulocyte count, induced by folic acid, may mask
vitamin B
12
deficiency. Prior to
treatment of megaloblastic anaemia, it should be ensured that this
disorder is not as a result of vitamin
B
12
deficiency, as there is a risk of irreversible neurological disorders.
The aetiology of megaloblastic
anaemia must be elucidated prior to initiating treatment.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is advised for patients under therapy for folate-dependent
tumours when taking folic acid.
Even in cases of life-threatening megaloblastic anaemia, the
possibility of vitamin B
12
deficiency must
be ruled out prior to initiating treatment, due to the risk of
irreversible neurological disorders (by
obtaining serum a