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GALFER SYRUP

Active substance(s): FERROUS FUMARATE

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2. Before you use this
medicine

Galfer Syrup

FRONT FACE TOP

(ferrous fumarate)

Important information about Galfer Syrup
• This medicine is used to treat and prevent low
levels of iron in the blood due to simple
anaemia.
• It can be taken by adults and children.
Talk to your doctor….
• If you are male. See section 2.
• Children under 12 and infant dose needs to be
decided by the doctor. See section 3.
Do not use….
• If you already have other problems with your
blood or stomach. See section 2.
Now read the rest of the leaflet before you
use this medicine. It includes other
information which might be especially
important for you.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• 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.

1. What the medicine is for
Galfer Syrup 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.

Do not use 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
before.
• Are currently having iron injections.
• Or are taking dimercaprol for metal poisoning.

 Talk to your doctor if you or your
child have….

REVERSE FACE TOP

• Take this medicine before meals on an empty
stomach if possible. If Galfer Syrup upsets
your stomach, take it with or after food.
• Some foods such as tea, eggs and milk may
reduce the amount of iron absorbed by the
body. Check with the doctor or pharmacist
about which foods to avoid.
• Galfer Syrup may make your stools darker
than usual. This is a normal effect of
medicines containing iron.
• Galfer Syrup may blacken the teeth. To help
prevent this, rinse your mouth with water
after taking.
• Vitamin C and drinks containing citric acid
may increase the amount of Iron absorbed.
• If your symptoms have not started to improve after
28 days, you should ask your doctor for advice.
• Treatment should not normally carry on for
more than 3 months after the iron deficiency
has been corrected. Your doctor will advise
you when to stop.

Pregnant or breastfeeding….

You can take Galfer Syrup when pregnant or
breastfeeding. Talk to your doctor first before
using the medicine particularly if you are in
the first 3 months of pregnancy. You may also
need to take folic acid.

Children under 12 years….

Talk to your doctor or pharmacist if
you or your child are taking….

• This medicine contains 10g of liquid maltitol
per 10ml dose (calorific value 2.3kcal/g). This
may have a mild laxative effect.
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.
• It also contains sodium hydroxybenzoates
which may cause an allergic reaction
(possibly delayed).

• Antibiotics for infections such as tetracyclines
(e.g. oxytetracycline), chloramphenicol or
fluoroquinolones (e.g. ciprofloxacin).
• Penicillamine for arthritis.
• Indigestion remedies, calcium, magnesium,
zinc and other mineral supplements.
• Colestyramine mainly used for high
cholesterol.

The doctor will decide how much your child
needs to take and how often. Talk to your
doctor or pharmacist if you have not been told
how much to give your child.


Important information about some
of the ingredients

Turn over

continued….

If you forget a dose

Important things you need to know
first….

• Levodopa, carbidopa or entacapone for
Parkinsons Disease.
• Bisphosphonates for osteoporosis.
• Trientine for Wilsons Disease.
• Methyldopa for high blood pressure.
• Mycophenolate for rheumatic disease.
• Levothyroxine for thyroid problems.
• People having tests on stool samples should
tell the doctor as this medicine may turn
stools black and effect test results.

• 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 deficiency is less
common in men than women, and the causes
may need investigating further by the doctor.



3. How to use this medicine

Talk to your doctor or pharmacist
if you or your child are taking
….(continued)

Take the next dose as soon as you remember.
You can then carry on with the next dose at the
correct time.
Do not take a double dose to make up for the
one missed.

23387906

By reporting side effects you can help provide
more information on the safety of this medicine.

5. Storing this medicine

4. Possible side effects

• This product contains Iron, keep it out of the
sight and reach of children as overdose may
be fatal.
• Store in a cool place.
• Do not use after the expiry date shown on the
carton. The expiry date refers to the last day
of that month.
• Medicine should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of any unused medicine. These
measures will help to protect the environment.

Important side effects:

What is in this medicine

If you take too much
If you accidentally take too much, see a doctor
immediately.
Take the pack with you to show which medicine
you have swallowed.
Like all medicines, Galfer Syrup can have side
effects, although these don’t affect everyone.

6. Further information

The active ingredient per 5ml is:
If you think you have any of the following side
Ferrous fumarate 140mg (equivalent to 45mg
effects or symptoms, stop using this medicine
of elemental iron)
immediately and see a doctor as soon as possible.
The other ingredients are:
• Allergic reactions which cause difficulty in
Aluminium magnesium silicate,
breathing, fever, swelling of the mouth, lips or
sodium methyl parahydroxybenzoate (E219),
skin, severe rashes, itching or stomach pain.
sodium ethyl parahydroxybenzoate (E215),
Other possible side effects are:
sodium propyl parahydroxybenzoate,
• 
L
oss
of
appetite.
Dosage
citric acid (E330), liquid maltitol, chocolate and
• 
N
ausea
and
sickness.
Take this medicine by mouth
MHRA Header Box • Stomach discomfort.
peppermint flavours and purified water.
Adults, the elderly and children over 12 years:
• Constipation particularly in the elderly.
What the medicine
olours Used
Fonts Usedlooks like
Galfer
UK particularly in those with Cbowel
Product
5ml
• To prevent iron deficiency take two
• DSyrup
iarrhoea
Galfer
Syrup
is a thick brown liquid with a
Title
spoonfuls once a day.
complaints.
Helvetica
Process Black minty chocolate
flavour.
• 
D
arkening
of
the
stools.
• To treat iron deficiency take two 5ml
It is supplied in 300ml bottles.
Component
Leaflet
Keyline
(Does
not
print)
• Blackening of the teeth.
spoonfuls once or twice a day.
Marketing authorisation holder and
If you notice any of these side effects which are
Pack Size
300ml
manufacturer
usually mild, tell your doctor or pharmacist.
Children under 12 and infants
Thornton and Ross Ltd., Huddersfield,
23387906
• The doctor will decide how muchIGtoCode
give
Reporting of side effects
HD7 5QH, UK.
get any
sidex 148mm
effects, folded)
talk to your doctor,
your child. Follow the instructions
on the
210Ifx you
148mm
flat (27
Dimensions
This leaflet was last revised in February 2015.
pharmacist or nurse. This includes any possible
pharmacist’s label.
not listed
in this leaflet. You can also
• Prolonged use in children should Proof
be supervised
No.
13.02.2015
1 side effectsDate
Galfer is a trade mark of Thornton and Ross Ltd.
report side effects directly via the yellow card
by the doctor, as excessive use may lead to
scheme at: www.mhra.gov.uk/yellowcard
dangerous levels of iron in the blood.
23387906

Data Matrix: 23387906 VERIFIED

PCP Header Box
Operator

Approved by
Date

elkie.bramall

Artwork No 557708
Suf fix

CRN

11854

Reason for
Change

Alignment to STADA RSI with
consequential changes to the PIL

A

Issued by
Date

MHRA/IMB
submission Yes
required

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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