Folic acid 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Folic acid

Available from:

Crescent Pharma Ltd

ATC code:

B03BB01

INN (International Name):

Folic acid

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010200; GTIN: 5017123648137

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLIC ACID TABLETS BP 5MG
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.
•
Ask your doctor or pharmacist if you need more information or advice.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their symptoms 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
Folic Acid is a vitamin used to treat a lack of folic acid in the
body, which results in a reduction of red
blood cells and the presence of large abnormal red blood cells
(folate-deficient megaloblastic anaemia).
Folic Acid Tablets are also used to prevent anaemia in chronic red
blood cell breakup (haemolytic) states
or in kidney dialysis
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID TABLETS
DO NOT TAKE FOLIC ACID TABLETS IF YOU HAVE:
•
an allergy (hypersensitivity) to folic acid or any of the other
ingredients of this
medicine (listed in section 6).
•
an untreated vitamin B12 deficiency - e.g. in certain anaemias and
life long
vegetarians
•
pernicious anaemia (caused by vitamin B12 deficiency)
•
a cancerous disease
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you take this medicine if
you:
•
if you are undergoing haemodialysis due to kidney failure
•
if you are receiving a coronary stent (a tube that is inserted in the
artery that
leads to the heart, in order to stop blockages)
•
suffer from epilepsy
•
have a folate dependent tumour

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Folic Acid 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of folic acid.
Excipients with known effect:
Each tablet contains 50.4 mg lactose and 2.8 mg sucrose
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Plain yellow, round uncoated tablets.
4.1
THERAPEUTIC INDICATIONS
Folic acid is a component of the B group of vitamins and is necessary
for the normal
production and maturation of red blood cells.
1. For the treatment of folate-deficient megaloblastic anaemia due to
malnutrition,
malabsorption syndromes (such as coeliac disease or sprue) and
increased utilisation
as in pregnancy. It should not be used alone in undiagnosed
megaloblastic anaemia
including in infancy, pernicious anaemia or macrocytic anaemia of
unknown
aetiology, unless administered with adequate amounts of
hydroxocobalamin.
2. For the prophylaxis of drug induced folate deficiency e.g. caused
by administration
of phenytoin, phenobarbital and primidone. (See section 4.5).
3. For the prophylaxis against folate deficiency in chronic haemolytic
states or in
renal dialysis.
4. For the prevention of neural tube defects for woman planning a
pregnancy and
known to be at risk. (See section 4.6).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (including the elderly)
_In folate deficient megaloblastic anaemia_: 5mg daily for 4 months;
up to 15mg
daily may be necessary for malabsorption states.
_In drug induced folate deficiency: _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 underlying disease.
_Prevention of neural tube defects in women known to be at risk : _5mg
daily
started before conception and continued throughout the first
trimester.
Pregnancy:
_In established folate deficiency: _5mg daily continued to term
_Paediatric population_
For young children a more suitable dosage f