Folic acid Thame 2.5mg/5ml Sugar Free Oral Solution

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

FOLIC ACID

Prieinama:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

ATC kodas:

B03BB

INN (Tarptautinis Pavadinimas):

FOLIC ACID 2.5 mg/5ml

Vaisto forma:

ORAL SOLUTION

Sudėtis:

FOLIC ACID 2.5 mg/5ml

Recepto tipas:

POM

Gydymo sritis:

ANTIANEMIC PREPARATIONS

Autorizacija statusas:

Authorised

Leidimo data:

2019-04-11

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FOLIC ACID THAME 2.5MG/5ML SUGAR FREE ORAL SOLUTION
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.
The name of your medicine is Folic acid Thame 2.5mg/5ml Sugar Free
Oral Solution but it will be
referred to as ‘Folic acid’ throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Folic acid is and what it is used for
2.
What you need to know before you take Folic acid
3.
How to take Folic acid
4.
Possible side effects
5.
How to store Folic acid
6.
Contents of the pack and other information
1. WHAT FOLIC ACID IS AND WHAT IT IS USED FOR
Folic acid belongs to a group of vitamins called ‘B vitamins’.
Folic acid is used for the following:

anaemia which can be caused by:
▪
a lack of vitamins in adults and children
▪
pregnancy
▪
an addiction to alcohol
▪
a medicine that is used to control fits

sickle cell anaemia or other anaemias caused by a lack of red blood
cells

illnesses called ‘Tropical and Non-tropical Sprue’. In these
illnesses parts of your food
cannot be absorbed by the gut

coeliac disease. This is an illness where your body cannot digest
gluten.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID
DO NOT TAKE FOLIC ACID IF:

you are allergic (hypersensitive) to folic acid or any of the other
ingredients in this medicine
(listed in Section 6 below)
Signs of an allergic reaction include a rash, itching or shortness of
breath

you have a tumour or cancer.
If any of the above apply to you, do not take this medicine and talk
t

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Folic acid Thame 2.5mg/5ml Sugar Free Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 2.5mg folic acid.
_Excipients with known effect _
Each 5ml of oral solution contains 9mg of methyl parahydroxybenzoate
(E218).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral Solution
A clear yellow colour solution with strawberry odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Folate deficient megaloblastic anaemia
2.
Folate deficient megaloblastic anaemia in infants
3.
Malabsorption syndromes
i
Tropical sprue
ii
Coeliac disease
iii
Non-tropical sprue
4.
Megaloblastic anaemia in pregnancy
5.
Megaloblastic anaemia associated with alcoholism
6.
Megaloblastic anaemia associated with anti-convulsant therapy
7.
Haemolytic anaemias e.g. sickle cell anaemia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Children:
May be given 5mg to 15mg daily, in divided doses, according to the
severity of the deficiency state.
Adults:
Initial dose of 10mg to 20mg daily, in divided doses, for 14 days or
until a haematopoietic response
has been obtained.
Maintenance dose is 2.5mg to 10mg daily.
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Prophylactic dose in pregnancy 0.5mg (1ml) daily.
Elderly:
As for adults.
METHOD OF ADMINISTRATION
For oral administration only.
4.3
CONTRAINDICATIONS
Known hypersensitivity to folic acid.
Known hypersensitivity to hydroxybenzoate esters.
Patients with folate dependent tumours.
Patients with malignant disease, unless megaloblastic anaemia due to
folic acid deficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If folic acid is used indiscriminately, there is a danger that
patients with pernicious anaemia and
other
B
12
deficiency
states,
despite
a
haematological
remission,
may
develop
irreparable
neurological lesions. Therefore a full clinical diagnosis should be
made before initiating treatment.
Folic acid is removed by haemodialysis.
Excipient warnings
This product contains methy