Folic Acid 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FOLIC ACID

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

B03BB01

INN (International Name):

FOLIC ACID 5 mg

Pharmaceutical form:

TABLET

Composition:

FOLIC ACID 5 mg

Prescription type:

POM

Therapeutic area:

ANTIANEMIC PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-08-23

Patient Information leaflet

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 AND 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 PRECAUTIONS
Talk to your doctor before taking Folic Acid Tablets:
• if you_ _are undergoing haemodialysis due to kidney failure
• if you_ _are receiving a coronary stent (a tube that

Summary of Product characteristics

Page 1 of 5 

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Folic Acid 5mg
_ _
Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Folic Acid 5mg 

For excipients see 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 

_ _
_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 

Page 2 of 5 

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 

4.3 
CONTRAINDICATIONS 

Known hypersensitivity to folic acid. 
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