Galfer 140 mg/5ml Oral Suspension

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Ferrous fumarate Ph.Eur.

Dostopno od:

Thornton & Ross Limited

Koda artikla:

B03AA; B03AA02

INN (mednarodno ime):

Ferrous fumarate Ph.Eur.

Odmerek:

140 mg/5ml

Farmacevtska oblika:

Oral suspension

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

Iron bivalent, oral preparations; ferrous fumarate

Status dovoljenje:

Marketed

Datum dovoljenje:

1988-07-25

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR
THE USER
GALFER 140MG/5ML ORAL
SUSPENSION
ferrous fumarate
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 Oral
Suspension 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 Oral Suspension is and what it
is used for
2. Before you take Galfer Oral Suspension
3. How to take Galfer Oral Suspension
4. Possible side effects
5. How to store Galfer Oral Suspension
6. Further information
1. WHAT GALFER ORAL
SUSPENSION IS AND WHAT IT
IS USED FOR
Galfer Oral Suspension contains ferrous fumarate
which is used to replace low levels of iron in the
blood. It is 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
ORAL SUSPENSION
DO NOT TAKE THE MEDICINE IF YOU OR
YOUR CHILD 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 past.
•
ANAEMIA NOT RELATED TO LOW LEVELS OF IRON.
•
Are currently HAVING IRON INJECTIONS
.
•
Or are taking dimercaprol for metal poisoning.
TAKE SPECIAL CARE WITH GALFER ORAL
SUSPENSION IF YOU OR YOUR CHILD HAVE….
• A family history of conditions that lead to
iron building up or iron overload in the blood.
• A history of stomach ulcers.
• H

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galfer 140 mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Each 5ml contains 140mg Ferrous Fumarate equivalent
to 45 mg elemental iron.
Excipients:
each 5ml
contains 6.250mg Nipasept
sodium (containing sodium methyl
parahydroxybenzoate (E219),
sodium ethyl
parahydroxybenzoate
(E215),
sodium propyl
parahydroxybenzoate
(E217)
and
5.0g
of
Liquid
Maltitol E965)).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension (oral liquid)
A brown liquid suspension with a chocolate/mint odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This product is indicated for the prevention and treatment of iron
deficiency states.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
a) Prevention of iron deficiency:
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS:
Two 5ml spoonfuls (10ml) taken once daily.
INFANTS AND YOUNG CHILDREN (UNDER 12 YEARS):
1-2 mg elemental Iron per Kg body weight per day. Maximum dose not to
exceed 15mg Iron per day. Dosage of Galfer
Syrup to be determined by the physician.
b) Treatment of iron deficiency:
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS:
Two 5ml spoonfuls (10ml) taken twice daily.
INFANTS LESS THAN ONE MONTH OLD:
2-4 mg elemental iron per Kg body weight per day. To be taken in
divided doses. Maximum dose not to exceed 15 mg
Iron per day. Dosage of Galfer Syrup to be determined by the
physician.
INFANTS OVER ONE MONTH OLD AND CHILDREN UNDER 12 YEARS:
3-6 mg elemental
Iron per Kg body weight
per day.
To be taken in divided doses.
Dosage of Galfer Syrup to be
determined by the physician.
Administration to infants and children should take place under medical
supervision.
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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___