Folic Acid 2.5mg/5ml Oral Solution

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Folic acid

Prieinama:

Wockhardt UK Limited

ATC kodas:

B03BB; B03BB01

INN (Tarptautinis Pavadinimas):

Folic acid

Dozė:

2.5 mg/5ml

Vaisto forma:

Oral solution

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Folic acid and derivatives; folic acid

Autorizacija statusas:

Not marketed

Leidimo data:

2010-05-28

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLIC ACID 2.5MG/5ML ORAL SOLUTION
Folic Acid 2.5mg/5ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS
MEDICINE.

Keep this leaflet. You may need to read it again while you are
receiving your
treatment.

If you have any further questions, please ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed
in this leaflet, please tell you doctor or pharmacist.
IN THIS LEAFLET:
1. What Folic Acid Oral Solution is and what it is used for
2. 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. Further information
1.
WHAT FOLIC ACID ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Folic Acid Oral Solution, which contains
folic acid, a
vitamin essential in the production and maintenance of new cells.
Folic Acid Oral Solution is used in the treatment of:

anaemia due to a lack of folic acid in adults and children

anaemia in pregnancy

anaemia associated with alcoholism

anaemia, as a side effect from medicines used to control fitting

anaemia due to damaged red blood cells e.g. Sickle Cell anaemia

sprue (tropical and non-tropical) – a disorder where essential
nutrients are not
absorbed from the diet.

coeliac disease, a disorder caused by gluten in the diet
2.
BEFORE YOU TAKE FOLIC ACID ORAL SOLUTION
YOU SHOULD NOT TAKE FOLIC ACID ORAL SOLUTION IF YOU:

are allergic (hypersensitive) to folic acid, hydroxybenzoate esters or
to any of the
other ingredients in Folic Acid Oral Solution (see section 6, Further
information)

have cancer (unless you have anaemia due to a deficiency of folic
acid)
TALK TO YOUR DOCTOR BEFORE TAKING FOLIC ACID ORAL SOLUTION IF YOU:

are receiving a coronary stent (a tube that is inserted

Prekės savybės

Health Products Regulatory Authority
01 May 2019
CRN008JN2
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folic Acid 2.5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Folic Acid 2.5mg/5ml
Excipients:
Methyl hydroxybenzoate (E218)
Ethyl hydroxybenzoate (E214)
Propyl hydroxybenzoate (E216)
Phenylalanine
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
A clear, yellow, solution with a strawberry flavour and odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Folate deficient megaloblastic anaemia
2. Folate deficient megaloblastic anaemia in infants
3. Treatment of folate deficiency in malabsorption syndromes
(parenteral administration of folic acid may need to be
considered if oral treatment is not effective)
3.1 Tropical sprue. Tropical sprue responds to folate supplements in
the early stages of the disease but cobalamin status must
also be checked, particularly later.
3.2 Coeliac disease. The necessity of supplementation with folate
ceases once a gluten free diet is introduced.
3.3 Non-tropical sprue. In congenital folate malabsorption, oral
treatment may not be effective and parental folate may
therefore be required.
4. Megaloblastic anaemia in pregnancy
5. Megaloblastic anaemia associated with alcoholism
6. Megaloblastic anaemia associated with anti-convulsant therapy
7. Folic acid deficiency/megaloblastic anaemia associated with
haemolytic anaemia e.g. Sickle Cell Anaemia
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Children (persons aged 12 years and younger):
May be given 5 mg to 15 mg daily, in divided doses, according to the
severity of the deficiency state.
Adults:
Initial dose of 10 mg to 20 mg daily, in divided doses, for 14 days or
until a haemopotoietic response has been obtained.
Maintenance dose is 2.5 mg to 10 mg daily.
Prophylactic dose in pregnancy 0.5 mg (1ml) daily.
Elderly:
Health Products Regulatory Authority
01 May 2019
CRN008JN2
Page 2 of 5
As for adults.
4.3 CONTRAINDICATIO