Galfer 305 mg Hard Capsules

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ferrous fumarate

Boleh didapati daripada:

Clonmel Healthcare Ltd

Kod ATC:

B03AA; B03AA02

INN (Nama Antarabangsa):

Ferrous fumarate

Dos:

305 milligram(s)

Borang farmaseutikal:

Capsule, hard

Kawasan terapeutik:

Iron bivalent, oral preparations; ferrous fumarate

Status kebenaran:

Marketed

Tarikh kebenaran:

1976-06-04

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
GALFER 305MG HARD CAPSULES
ferrous fumarate 305mg
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
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 Capsules are and what they are used for
2.
Before you take Galfer Capsules
3.
How to take Galfer Capsules
4.
Possible side effects
5.
How to store Galfer Capsules
6.
Further information
1. WHAT GALFER CAPSULES ARE AND WHAT THEY ARE USED FOR
Galfer Capsules contains ferrous fumarate which is used to replace low
levels of iron in the
blood. They are used to treat and prevent anaemia caused by iron
deficiency. This product
should only be used for the treatment of iron deficiency anaemia
diagnosed by laboratory
testing under the supervision of a doctor.
2. BEFORE YOU TAKE GALFER 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.

INFLAMMATORY BOWEL DISEASE including ULCERATIVE COLITIS or REGIONAL
ENTERITIS.

Had REPEATED BLOOD TRANSFUSIONS in the past.

ANAEMIA NOT RELATED TO LOW LEVELS OF IRON BEFORE.

Or are currently HAVING IRON INJECTIONS. TAKE SPECIAL CARE WITH GALFER CAPSULES IF YOU HAVE….

A history of stomach ulcers.

Had part or all of the stomach removed.

Vitamin deficiency particularly vitamin B12 or folic acid.

Or are A MALE, as iron defici

Ciri produk

Health Products Regulatory Authority
17 August 2023
CRN00DRJ7
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galfer 305 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Per Capsule
Ferrous Fumarate
305.0 mg
(Equivalent to 100 mg elemental iron)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Scarlet/green hard gelatin capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of iron deficiency states.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
ADULTS AND CHILDREN OVER 12 YEARS:
Prophylaxis: One capsule daily.
Treatment: One capsule twice daily.
CHILDREN UNDER 12 YEARS: Not recommended.
ELDERLY PATIENTS: The adult dose is appropriate.
PREGNANT WOMEN DURING SECOND TRIMESTER ONWARDS:
The adult dose is appropriate.
4.3 CONTRAINDICATIONS
1.
Hypersensitivity to the product or ingredients.
2.
Haemosiderosis and haemochromatosis.
3.
Active peptic ulcer.
4.
Repeated blood transfusion.
5.
Inflammatory bowel disease, including regional enteritis and
ulcerative colitis, intestinal strictures and diverticulae.
6.
Anaemias other than those due to iron deficiency.
7.
Haemoglobinopathies.
Health Products Regulatory Authority
17 August 2023
CRN00DRJ7
Page 2 of 5
8.
Concomitant use with parenteral iron.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
Patients post-gastrectomy have poor absorption of iron.
2.
Caution is advised when prescribing iron preparations to individuals
with history of a peptic ulcer.
3.
Duration of treatment should generally not exceed 3 months after
correction of the anaemia.
4.
Co-existing deficiency of vitamin B
12
or folic acid should be ruled out since combined deficiencies produce
microcytic
blood film.
5.
Iron deficiency in a male patient warrants careful investigation to
determine its cause which forms the basis of primary
treatment.
6.
Iron preparations colour the faeces black, which may interfere with
tests used for detection of occult blood in