Ferrograd 325mg Prolonged release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ferrous sulphate

Available from:

Teofarma S.R.L.

ATC code:

B03AA; B03AA07

INN (International Name):

Ferrous sulphate

Dosage:

325 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Iron bivalent, oral preparations; ferrous sulfate

Authorization status:

Marketed

Authorization date:

1980-04-01

Patient Information leaflet

PACKAGE LEAFLET : INFORMATION FOR THE
USER
FERROGRAD 325 MG
PROLONGED-RELEASE TABLETS
DRIED FERROUS
SULPHATE
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 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. What Ferrograd Tablets are and what they are used for
2. Before you take Ferrograd Tablets
3. How to take Ferrograd Tablets
4. Possible side effects
5. How to store Ferrograd Tablets
6. Further information
1. WHAT FERROGRAD TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your tablets is Ferrograd Prolonged-Release Tablets.
Ferrograd are prolonged release, film coated tablets
which contain the active ingredient dried Ferrous Sulphate.
Ferrograd is an iron supplement. Its use is described below.
WHAT IS FERROGRAD USED FOR?
Ferrograd is an iron supplement used to prevent and treat
iron-deficiency anaemia. Ferrograd 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 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 several hours and reduces the likelihood of
stomach irritation. The controlled-release system consists of a
harmless plastic honeycomb with thousands of narrow
passages containing iron. As the tablet passes through the stomach and
gut the iron is released and the empty
honeycomb is passed out in the stools.
2. BEFORE YOU TAKE FERROGRAD TABLETS
DO NOT T

Summary of Product characteristics

Health Products Regulatory Authority
22 May 2023
CRN00DKC4
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ferrograd 325mg Prolonged release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Dried Ferrous Sulphate 325mg (elemental iron
105mg)
Excipients with known effect:
Each tablet contains 19.4mg lactose monohydrate and sunset yellow FCF
(E110).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Circular, biconvex, red film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of iron deficiency anaemias.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: The recommended dosage is one tablet daily before food.
CHILDREN: Not recommended for children under 12 years. Above this age,
as for adults.
ELDERLY: As for adults. The sustained release tablet and its plastic
inert matrix may cause a safety hazard in some elderly or
other patients suffering from delayed intestinal transit.
METHOD OF ADMINISTRATION:
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.
Health Products Regulatory Authority
22 May 2023
CRN00DKC4
Page 2 of 5
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Use in patients with intestinal diverticular disease or any intestinal
obstruction.
Use in patients with haemochromatosis and iron overload syndromes.
Use in patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The label will state "Important warning: Contains iron. Keep out of
reach and sight of children, as overdose may be fatal". This
will appear on the front of the pack within a rectangle in which there
is no other information.
As with all iron preparations, this product should be u