Galfer 140 mg/5ml Oral Suspension

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Ferrous fumarate Ph.Eur.

थमां उपलब्ध:

Clonmel Healthcare Ltd

ए.टी.सी कोड:

B03AA; B03AA02

INN (इंटरनेशनल नाम):

Ferrous fumarate Ph.Eur.

डोज़:

140 mg/5ml

फार्मास्यूटिकल फॉर्म:

Oral suspension

चिकित्सीय क्षेत्र:

Iron bivalent, oral preparations; ferrous fumarate

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

1988-07-25

सूचना पत्रक

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
GALFER 140 MG/5 ML ORAL SUSPENSION
ferrous fumarate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told 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.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you
feel worse after 28 days.
WHAT IS IN THIS LEAFLET:
1. What Galfer Oral Suspension is and what it is used for
2. What you need to know 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. Contents of the pack and other 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. WHAT YOU NEED TO KNOW 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
.
•

उत्पाद विशेषताएं

Health Products Regulatory Authority
01 July 2021
CRN00CDWF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galfer 140 mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Each 5 ml contains 140 mg Ferrous Fumarate equivalent to 45 mg
elemental iron.
Excipient(s) with known effect
Dose per 5 ml contains:
Methyl parahydroxybenzoate 4.69 mg
Ethyl parahydroxybenzoate 0.94 mg
Propyl parahydroxybenzoate 0.63 mg
Maltitol liquid 5 g
Benzyl alcohol 0.65 micrograms
Ethanol 0.117 micrograms
Sodium benzoate 2.6 micrograms
Lactose 0.023 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension (oral liquid)
This medicine is a brown liquid suspension with a chocolate/mint
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated for the prevention and treatment of iron
deficiency states.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
a) Prevention of iron deficiency:
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS:
Two 5 ml spoonfuls (10 ml) 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 15 mg Iron per day. Dosage of Galfer Oral
Suspension to be determined by the physician.
B) TREATMENT OF IRON DEFICIENCY:
ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS:
Two 5 ml spoonfuls (10 ml) 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 Oral Suspension to be determined by the
physician.
Health Products Regulatory Authority
01 July 2021
CRN00CDWF
Page 2 of 5
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 Oral Suspension to be
determined by the physician.
Administration to infants and children should take place under medical
supervision.
Medical advice should be sought if s