Folic Acid Crescent 5mg Tablets

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

FOLIC ACID

Disponível em:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

Código ATC:

B03BB01

DCI (Denominação Comum Internacional):

FOLIC ACID 5 mg

Forma farmacêutica:

TABLET

Composição:

FOLIC ACID 5 mg

Tipo de prescrição:

POM

Área terapêutica:

ANTIANEMIC PREPARATIONS

Resumo do produto:

Licence number in the source country: NOT APPLICAPABLE

Status de autorização:

Authorised

Data de autorização:

2020-02-28

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOLIC ACID CRESCENT 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 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 full name of your medicine is Folic Acid Crescent 5mg Tablets but
within the leaflet it will be
referred to as Folic Acid Tablets.
These tablets contain the active substance folic acid. Folic acid is
the chemical name for Vitamin
B9. It is necessary for the normal production of blood cells.
Folic Acid Tablets are used for the treatment of certain types of
anaemia. They are also used to help
prevent the breakdown of red blood cells which can occur as a result
of renal (kidney) dialysis or
certain other conditions.
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 any of the other ingredients of this
medicine (listed in section
6).
•
You are suffering from pernicious anaemia or any other vitamin B12
deficiency unless you
have already been treated with a drug called hydroxocobalamin.
•
You have cancer.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Folic Acid Tablets if
you:
•
have a folate dependent tumour
•
are pregnant
•
have any

Características técnicas

PAGE 1 OF 5
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Folic Acid Crescent 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
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Folic acid is necessary for the normal production and maturation of
blood cells, and is
used in the treatment of nutritional megaloblastic anaemias eg.
following gastrectomy
and the megaloblastic anaemia of pregnancy. It may also be used
prophylactically in
chronic haemolytic states or in renal dialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For nutritional megaloblastic anaemia in adults: 1 tablet daily for up
to 4 months is
usually sufficient. A dose of 15 mg (3 tablets) daily may be required
where
malabsorption exists.
A maintenance dose of 5 mg every 1 to 7 days may also be required.
_Paediatric population_
In children over 1 year of age, the dose is as for adults.
Method of Administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
PAGE 2 OF 5
Folic acid should never be given alone in the treatment of Addisonian
pernicious
anaemia (and other Vitamin B
12
deficiency), because it may precipitate the onset of
subacute combined degeneration of the spinal cord
Folic acid should not be used in malignant disease unless
megaloblastic anaemia
owing to folate deficiency is an important complication.
Long-term folate therapy is contraindicated in any patient with
untreated cobalamin
deficiency. This can be untreated pernicious anaemia or other cause of
cobalamin
deficiency, including lifelong vegetarians. In elderly people, a
cobalamin absorption
test should be done before long-term folate therapy. Folate given to
such patients for
3 months or longer has precipitated cobal