Folic Acid Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Folic acid 5mg

Available from:

Viatris Limited

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Folic acid 5mg Excipient: Crospovidone Lactose Magnesium stearate Maize starch Povidone

Prescription type:

Pharmacy only

Therapeutic indications:

The treatment of megaloblastic anaemia when folate deficiency is identified as the exclusive cause. Folate deficiency is a consequence of inadequate dietary intake, malabsorption, or increased utilisation in conditions such as pregnancy, lactation, haemolyticanaemia, hyperthyroidism, exfoliative dermatitis, and chronic infection. Prophylaxis of folate deficiency resulting from renal dialysis, pregnancy and lactation when the mother is malnourished, and chronic haemolytic states such as thalassaemia major or sickle-cell anaemia. Label claim: Treatment of megaloblastic anaemia due to folate deficiency. Prevention of folate deficiency.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, 35 mL HDPE blue round bottle with 28 mm blue induction seal screw cap - 100 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, 35 mL HDPE white round bottle with 28mm green wadded screw cap - 100 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

2021-04-23

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
FOLIC ACID VIATRIS
_FOLIC ACID TABLET 5 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking FOLIC ACID
VIATRIS.
This leaflet answers some common
questions about FOLIC ACID
VIATRIS
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking FOLIC ACID
VIATRIS against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT FOLIC ACID
VIATRIS IS USED FOR
FOLIC ACID VIATRIS is used to
treat:
•
megaloblastic anaemia
when folate deficiency is
identified as the exclusive
cause. Folate deficiency is
a consequence of
inadequate dietary intake,
malabsorption, or increased
utilisation in conditions such
as pregnancy, lactation,
haemolyticanaemia,
hyperthyroidism, exfoliative
dermatitis, and chronic
infection
•
folate deficiency resulting
from renal dialysis,
pregnancy and lactation
when the mother is
malnourished, and chronic
haemolytic states such as
thalassaemia major or
sickle-cell anaemia.
FOLIC ACID VIATRIS contains the
active ingredient _folic acid._ It
belongs to the Vitamin B group of
medicines.
It works by helping in the pathways
in the body which synthesis or
convert amino acids. It is involved in
the maturing of all rapidly growing
tissues particularly those in bone
marrow and the stomach and
intestines.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available with a
doctor’s prescription or from a
pharmacy.
_This medicine is not expected to _
_affect your ability to drive a car or _
_operate machinery. _
_There is not enough information to _
_recommend the use of this medicine _
_for children under the

Summary of Product characteristics

Page 1 of 9
NEW ZEALAND DATA SHEET
FOLIC ACID VIATRIS
1. PRODUCT NAME
FOLIC ACID VIATRIS, 5 mg, tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of folic acid.
EXCIPIENT(S) WITH KNOWN EFFECT:
Lactose, maize starch, crospovidone and povidone.
Allergen Declaration: Contains sulfites and sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
7 mm, flat bevelled edged, yellow tablet with score line on one side
and blank on the other.
The score line is not intended for breaking the tablet.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
FOLIC ACID VIATRIS 5 mg tablets are indicated for the treatment of
megaloblastic anaemia when
folate deficiency is identified as the exclusive cause. Folate
deficiency is a consequence of
inadequate dietary intake, malabsorption, or increased utilisation in
conditions such as pregnancy,
lactation, haemolytic anaemia, hyperthyroidism, exfoliative
dermatitis, and chronic infection.
FOLIC ACID VIATRIS 5 mg tablets are also indicated for prophylaxis of
folate deficiency resulting
from renal dialysis, pregnancy and lactation when the mother is
malnourished, and chronic
haemolytic states such as thalassaemia major or sickle-cell anaemia.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
Approximately 400 micrograms/day of folic acid is considered a
suitable average intake. Body stores
of folate in healthy people have been reported between 5 to10 mg but
could be much higher.
Patients should remain under strict monitoring and the maintenance
dose must be adjusted
immediately in case of a risk of relapse.
Page 2 of 9
Folate is present, mostly combined with several L(+)-glutamic acid
moieties, in many foods, but in
particular, liver, kidney, yeast, nuts and leafy green vegetables.
Folic acid is readily oxidised to
unavailable forms and is easily destroyed during cooking.
As folic acid is easily absorbed, it can be administered orally with
good results apart from in
exceptionally severe disease or in severe cases of intestina