Galfer FA 305 mg / 0.35 mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ferrous fumarate; Folic acid

Available from:

Clonmel Healthcare Ltd

ATC code:

B03AD; B03AD02

INN (International Name):

Ferrous fumarate; Folic acid

Dosage:

305 mg/0.35 milligram(s)

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Iron in combination with folic acid; ferrous fumarate

Authorization status:

Not marketed

Authorization date:

1976-06-04

Patient Information leaflet

CF/REG/96/2
PRODUCT NAME
Galfer FA 305mg/0.35mg Hard Capsules
PACKAGING TYPE
Leaflet
CATEGORY/PL NO.
PA 610/13/1
TEXT REVISION NO.
0
PAGE #
1 of 4
COMPONENT
PACK SIZE
IG CODE:
CURRENT V#: NEW V#:
REVISED BY:
DATE:
AUTHORISED BY:
DATE:
Leaflet
28’s
9279682
1803
1903
CRN
DESCRIPTION
15907
Transfer license to Clonmel for Brexit
PACKAGE LEAFLET: INFORMATION FOR THE USER
GALFER FA 305MG/0.35MG HARD CAPSULES
ferrous fumarate
folic acid
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Galfer FA Capsules carefully
to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need any more information or advice.

You must contact your doctor if your symptoms worsen or do not
improve.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Galfer FA Capsules are and what they are used for
2.
Before you take Galfer FA Capsules
3.
How to take Galfer FA Capsules
4.
Possible side effects
5.
How to store Galfer FA Capsules
6.
Further information
1. WHAT GALFER FA CAPSULES ARE AND WHAT THEY ARE USED FOR
Galfer FA Capsules contain ferrous fumarate which is used to replace
low levels of iron in the blood. They
also contain folic acid.
They are used to treat and prevent anaemia during pregnancy caused by
iron deficiency.
They can also be used to prevent megaloblastic anaemia caused by
deficiencies in vitamin B
12
or folic acid
after the first 13 weeks of pregnancy.
2. BEFORE YOU TAKE GALFER FA CAPSULES
DO NOT TAKE THE MEDICINE IF YOU HAVE….

An ALLERGY to any of the ingredients listed in section 6.

Other PROBLEMS WITH IRON IN THE BLOOD (including conditions that lead
to iron building up in soft
tissues, or problems with red blood cells).

A STOMACH ULCER or other STOMACH OR BOWEL PROBLEM.

Had REPEATED BLOOD TRANSFUSIONS in the

Summary of Product characteristics

Health Products Regulatory Authority
09 July 2019
CRN008YWN
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galfer FA 305 mg / 0.35 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Per Capsule
Ferrous Fumarate
305.0
mg
(Equivalent to 100mg elemental iron)
Folic Acid
350
micrograms
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Scarlet/yellow hard gelatin capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of iron deficiency anaemia in
pregnancy and for the prevention of megaloblastic anaemia of
pregnancy, after the first 13 weeks.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults only: One capsule daily after the first 13 weeks of pregnancy
and the first month post partum.
4.3 CONTRAINDICATIONS
1.
Use in non-pregnant patients.
2.
Use in children.
3.
The diagnosis of pernicious anaemia should be excluded before use of
this preparation.
4.
Use in patients with megaloblastic anaemia due to vitamin B
12
deficiency.
5.
Use in patients with anaemias other tan those due to iron deficiency.
6.
Hypersensitivity to any of the ingredients.
7.
Use in patients with haemosiderosis, haemochromatosis and
haemoglobinopathies.
8.
Use in patients with inflammatory bowel disease, including regional
enteritis and ulcerative colitis, intestinal strictures and
diverticulae.
9.
Concomitant use with parenteral iron.
10.
Use in patients with active peptic ulcer.
Health Products Regulatory Authority
09 July 2019
CRN008YWN
Page 2 of 5
11.
Use in patients who require repeated blood transfusion.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1. Iron preparations colour the faeces black, which may interfere with
tests used for detection of occult blood in the stools.
2. Iron preparations should be used with caution in patients with
erythropoietic protoporphyria.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
1. The absorption of iron salts is decreased in the