Ferrograd Folic 325mg/0.35mg Prolonged release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ferrous sulphate; Folic acid

Available from:

Teofarma S.R.L.

ATC code:

B03AD; B03AD03

INN (International Name):

Ferrous sulphate; Folic acid

Dosage:

325 mg/0.35 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Iron in combination with folic acid; ferrous sulfate

Authorization status:

Marketed

Authorization date:

1980-04-01

Patient Information leaflet

PACKAGE
LEAFLET:
INFORM ATION FOR THE
USER
FERROGRAD
FOLIC 325 MG/0.35
MG
PROLONGED-RELEASE TABLETS
DRIED FERROUS SULPHATE/FOLIC
ACID
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
-
This medicine is available without prescription. However, you still
need to take Ferrograd Folic Tablets carefully to
get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve
after 4 weeks.
-
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor
or pharmacist.
WHAT IS IN THIS LEAFLET:
1. W hat Ferrograd Folic Tablets are and what they are used for
2. Before you take Ferrograd Folic Tablets
3. How to take Ferrograd Folic Tablets
4. Possible side effects
5. How to store Ferrograd Folic Tablets
6. Further information
1. WHAT FERROGRAD FOLIC TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your tablets is Ferrograd Folic Prolonged-Release Tablets.
Ferrograd Folic are prolonged release, film
coated tablets. The active ingredients in Ferrograd Folic are: Dried
Ferrous Sulphate and Folic Acid.
Ferrograd Folic is a combined iron and folic acid supplement. Its use
is described below.
WHAT IS FERROGRAD FOLIC USED FOR?
Ferrograd Folic is an iron and folic acid supplement used to prevent
and treat iron-deficiency anaemia and to prevent
anaemia due to folic acid deficiency. Ferrograd Folic should only be
used for the prevention and treatment of iron-
deficiency anaemia diagnosed by laboratory testing under the
supervision of a medical doctor. Ferrograd Folic can be
used by pregnant women, but only after the first thirteen weeks of
pregnancy. A controlled-release system in the tablet
allows release of the iron over a number of hours and reduces the
likelihood of stomach irritation. The controlled-release
system consists of a harmless plastic hon

Summary of Product characteristics

Health Products Regulatory Authority
28 January 2019
CRN008LVN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrograd Folic 325mg/0.35mg Prolonged release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Dried Ferrous Sulphate 325 mg (elemental iron 105 mg)
Folic Acid 0.35mg (350 micrograms)
Excipients with known effect:
Each tablet contains 2 mg Dye Red Ponceau 4R Lake (E124), 30 mg
sucrose and 257
mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Circular biconvex, 2 layered, red and yellow film-coated tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prophylaxis and treatment of iron and folic acid deficiencies
and if used in
pregnancy should be used after the first 13 weeks of pregnancy only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: The recommended dosage is one tablet daily before food.
CHILDREN: Not applicable.
ELDERLY: As for adults. The sustained release tablet and its inert
plastic matrix may
cause a safety hazard in some elderly or other patients suffering from
delayed
intestinal transit.
* Medical advice should be sought if symptoms do not improve after
four weeks of
use of this product as these symptoms may reflect on underlying
disease process.
METHOD OF ADMINISTRATION:
Health Products Regulatory Authority
28 January 2019
CRN008LVN
Page 2 of 7
The tablets should not be sucked, chewed or kept in the mouth, but
swallowed whole
with water. Tablets should be taken before meals or during meals,
depending on
gastrointestinal tolerance.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Ferrograd Folic should not be used in the presence of megablastic
anaemia due to
primary vitamin B12 deficiency or any undiagnosed anaemia.
Use in patients with intestinal diverticular or any intestinal
obstruction.
• Individuals with haemochromatosis and iron overload syndromes.
Patients with rare hereditary