Ferrograd C 325mg/500mg Prolonged release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ferrous sulfate; Sodium ascorbate

Available from:

Teofarma S.R.L.

ATC code:

B03AA; B03AA07

INN (International Name):

Ferrous sulfate; Sodium ascorbate

Dosage:

325 mg/500 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 C 325 MG/500 MG
PROLONGED-RELEASE TABLETS
DRIED FERROUS SULPHATE/VITAMIN
C
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 C 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 C Tablets are and what they are used for
2. Before you take Ferrograd C Tablets
3. How to take Ferrograd C Tablets
4. Possible side effects
5. How to store Ferrograd C Tablets
6. Further information
1. WHAT FERROGRAD C TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your tablets is Ferrograd C Prolonged-Release Tablets.
Ferrograd C are prolonged release, film coated
tablets. The active ingredients in Ferrograd C are: Dried Ferrous
Sulphate and Vitamin C (Ascorbic Acid), as sodium
ascorbate.
Ferrograd C is a combined iron and vitamin C supplement. Its use is
described below.
WHAT IS FERROGRAD C USED FOR?
Ferrograd C is an iron supplement used to prevent and treat
iron-deficiency anaemia and vitamin C deficiency when the
two are present together. Ferrograd C 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 C should only be taken by pregnant
women after the first 13 weeks of pregnancy. The added vitamin C helps
the body to absorb the iron. 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 plas

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 C 325mg/500mg Prolonged release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Dried Ferrous Sulphate
325.0 mg (elemental iron 105 mg)
Sodium ascorbate
562.4 mg (ascorbic acid/Vitamin C 500 mg)
Excipients with known effect:
Each tablet contains 23.4mg Dye Red Ponceau 4R Lake (E124)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Ovoid, biconvex, two layered, red film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of iron deficiency anaemia and for
the simultaneous treatment of vitamin C deficiency.
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.
* Medical advice should be sought if symptoms do not improve after
four weeks of use of this product as these symptoms may
reflect an underlying disease process.
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.
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.
• Individuals with haemochromatosis and iron overload syndromes.
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 n