Folic Acid Colonis Oral Solution 1mg/ml

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

FOLIC ACID

Prieinama:

Colonis Pharma Limited Quantum House, Hobson Industrial Estate, Burnopfield, Country, Durham NE16 6EA, United Kingdom

ATC kodas:

B03BB01

INN (Tarptautinis Pavadinimas):

FOLIC ACID 1 mg/ml

Vaisto forma:

ORAL SOLUTION

Sudėtis:

FOLIC ACID 1 mg/ml

Recepto tipas:

POM

Gydymo sritis:

ANTIANEMIC PREPARATIONS

Autorizacija statusas:

Withdrawn

Leidimo data:

2016-09-23

Pakuotės lapelis

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLIC ACID COLONIS 1 MG/ML ORAL SOLUTION
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 ORAL SOLUTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID ORAL SOLUTION
3.
HOW TO TAKE FOLIC ACID ORAL SOLUTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FOLIC ACID ORAL SOLUTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT FOLIC ACID ORAL SOLUTION IS AND WHAT IT IS USED FOR
This medicine is called Folic acid Colonis 1mg/ml Oral Solution
(referred to in this leaflet as Folic
acid oral solution). It contains folic acid (vitamin B9), which
belongs to a group of vitamins called
‘B vitamins’. Each 1ml contains 1mg of folic acid.
Folic oral solution is used for the prevention and treatment of
conditions caused by deficiency of
folic acid:
1. Prevention of neural tube defects (abnormalities of the spine, eg.
spina bifida) in babies,
including if you have previously had a baby with this disorder.
2. Prevention and treatment of anaemia caused by folic acid
deficiency. This may occur in the
following situations.
a)
pregnancy
b)
excessive alcohol intake or poor nutrition
c)
effects of other drugs (eg. anticonvulsants, used to prevent fits)
d)
sickle cell anaemia (or other types of anaemia caused by abnormal red
blood cells)
e)
problems with absorption of folic acid from the gut (eg. tropical
sprue or coeliac disease)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID ORAL SOLUTION
DO NOT TAKE FOL

Prekės savybės

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Folic acid Colonis 1 mg/ml oral solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of oral solution contains 1 mg of folic acid.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral solution
Clear, yellow and odourless solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
For the prophylaxis of neural tube defects in case of a positive
history of previous neural
tube defects (NTD).
2.
For the prophylaxis of NTDs with no previous history of foetal neural
tube defect and no
other predisposing factors
3.
For the treatment of folate deficiency:
a.
Folate deficient megaloblastic anaemia (in pregnancy, associated with
alcoholism, drug
intake such as anticonvulsants). For the prevention of megaloblastic
anaemia, the
cobalamin status should be established before initiation of folic acid
therapy.
b.
Impaired utilization of folate i.e. use of concomitant drugs, in liver
disease, inadequate
intake (e.g. alcoholism, malnutrition etc.)
c.
Increased excretion of folate (e.g. alcoholism, haemolytic states).
4.
Folate deficiency / megaloblastic anaemia associated with haemolytic
anaemia (e.g. sickle
cell anaemia)
5.
Treatment of folate deficiency in malabsorption syndromes (parenteral
administration of
folic acid may need to be considered if oral treatment is not
effective)
(e.g.: tropical sprue. tropical sprue responds to folate supplements
in the early stages of the
disease but cobalamin status must also be checked, particularly later;
coeliac disease in
which case the necessity of supplementation with folate ceases once a
gluten free diet is
introduced; non-tropical sprue; in congenital folate malabsorption
(oral treatment may not
be effective and parental folate may therefore be required).
Cobalamin status needs to be established in all megaloblastic states
(not only in pregnancy).
Page 2 of 6
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
_Adults (including the elderly): _
_ _
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