Galfer FA 305 mg / 0.35 mg Hard Capsules

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Ferrous fumarate; Folic acid

متاح من:

Thornton & Ross Limited

ATC رمز:

B03AD; B03AD02

INN (الاسم الدولي):

Ferrous fumarate; Folic acid

جرعة:

305 mg/0.35 milligram(s)

الشكل الصيدلاني:

Capsule, hard

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

Iron in combination with folic acid; ferrous fumarate

الوضع إذن:

Marketed

تاريخ الترخيص:

1976-06-04

نشرة المعلومات

MHRA HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
Leaflet
28's
92796831803
210 x 148mm
2
12.04.2018
Galfer FA 305mg/0.35mg Hard
Capsules Irish (Strides)
Helvetca LT
9pt
16pt
Process Black
Keyline (Non-printing)
POINT SIZES USED
MIN MAX
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 past.
•
ANAEMIA NOT RELATED TO LO

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galfer FA 305 mg / 0.35 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Active Substance
Per Capsule
Ferrous Fumarate
305.0
mg
(Equivalent to 100mg elemental iron)
Folic Acid
350
micrograms
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.
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
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_6_
_/_
_0_
_7_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2