Folic acid 5mg/5ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Folic acid

Available from:

Colonis Pharma Ltd

ATC code:

B03BB01

INN (International Name):

Folic acid

Dosage:

1mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010200; GTIN: 5060380960368

Patient Information 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 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 acid 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:
■
pregnancy
■
excessive alcohol intake or poor nutrition
■
effects of other drugs (eg. anticonvulsants,
used to prevent fits)
■
sickle cell anaemia (or other types of
anaemia caused by abnormal red
blood cells)
■
problems with absorption of folic acid
from the gut (e.g. tropical sprue or
coeliac disease).
2. What you need to know before
you take Folic acid oral solution
DO NOT TAKE FOLIC ACID ORAL SOLUTION:
■
If you are allergic (hypersensitive) to folic
acid or any o

Summary of Product characteristics

OBJECT 1
FOLIC ACID COLONIS 1MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 05-Jan-2018 | Colonis
Pharma Ltd
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).
4.2 Posology and method of administration