Folic acid 5mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Folic acid

Disponibil de la:

Dalkeith Laboratories Ltd

Codul ATC:

B03BB01

INN (nume internaţional):

Folic acid

Dozare:

5mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 09010200; GTIN: 5039290001072

Prospect

Package leaflet:
Information for the user
FOLIC ACID TABLETS BP 5 MG
This medicine will be called Folic Acid Tablets
in this leaflet.
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, pharmacist or nurse.
•
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, pharmacist or nurse. 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 belongs to the Vitamin B group. It is
necessary for the normal production of blood
cells. Folic Acid Tablets may be used:
To treat:
•
Folate deficiency anaemia caused by poor
diet, poor absorption of food (such as in
coeliac disease or a digestive disorder
called sprue) or increased use of folate in
the body (as in pregnancy)
To prevent:
•
Folate deficiency caused by some
medicines (e.g. those used to treat
epilepsy such as phenytoin, phenobarbital
and primidone)
•
Folate deficiency caused by long-term red
blood cell damage or kidney dialysis
•
Neural tube defects in babies (e.g. spina
bifida), where women are at risk of having
an affected child.
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)
•
You have an untreated vitamin B12
deficiency such as in certain anaemias
and lifelong vegetarians
•
You are suffering from pe

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Folic Acid Tablets BP 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Folic Acid hydrate 5 mg
Excipients with known effect
50.4 mg lactose & 2.8 mg sucrose per tablet
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets
Plain yellow, round uncoated tablets.
4
CLINICAL PARTICULARS
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 blood cells.
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.
For the prophylaxis of drug induced folate deficiency e.g. caused by
administration of phenytoin, phenobarbital and primidone. (See section
4.5).
For the prophylaxis against folate deficiency in chronic haemolytic
states or in
renal dialysis.
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