Galfer 305 mg Hard Capsules

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Ferrous fumarate

Mevcut itibaren:

Thornton & Ross Limited

ATC kodu:

B03AA; B03AA02

INN (International Adı):

Ferrous fumarate

Doz:

305 milligram(s)

Farmasötik formu:

Capsule, hard

Reçete türü:

Product not subject to medical prescription

Terapötik alanı:

Iron bivalent, oral preparations; ferrous fumarate

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

1976-06-04

Bilgilendirme broşürü

PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
532025
11407
Addition of reporting of side
effects in line with QRD template.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
28's
24176606
210mm x 148mm
3
18.09.2014
Process Black
Keyline (Does not print)
Galfer 305mg Hard Capsules Irish
(Custom)
Helvetica
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
532025
11407
Addition of reporting of side
effects in line with QRD template.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
28's
24176606
210mm x 148mm
3
18.09.2014
Process Black
Keyline (Does not print)
Galfer 305mg Hard Capsules Irish
(Custom)
Helvetica
FRONT FACE
REVERSE FACE
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

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Galfer 305 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Active Ingredients
Per Capsule
Ferrous Fumarate
305.0 mg
(Equivalent to 100 mg elemental iron)
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.
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4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should only be used for the treatment of iron deficiency
anaemia diagnosed by laboratory testing under the
supervision of a medical doctor.
4.5 INTERACTION WITH OTHER