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FERROUS GLUCONATE 300MG TABLETS

Active substance(s): FERROUS GLUCONATE

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4. POSSIBLE SIDE EFFECTS

Marketing Authorisation Holder: Athlone
Pharmaceuticals Limited, Ballymurray, Co.
Roscommon, Ireland.
Distributor: Almus Pharmaceuticals,
43 Cox Lane, Chessington, KT9 1SN, UK.
PL30464/0026.
This leaflet was last revised in May 2016.

Like all medicines, Ferrous Gluconate 300mg
Tablets can cause side effects, although not
everybody gets them.
STOP taking Ferrous Gluconate 300mg
Tablets and contact your doctor immediately
if you experience:
• an allergic reaction. Symptoms include
swelling of the hands, feet, ankles, face,
lips or throat, problems with breathing, skin
rash, itching or hives

A0075a/Lt3

www.pmdc.co.uk

+44 (0)1489 878780

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Date: 18.5.2016

pmdc design llp
Lower Test Studios
Sheardley Lane, Droxford
Hampshire SO32 3QY
Checked by: Paul Adams

Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams

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Patient Information Leaflet

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PHARMA CODE TBA
ALMUS CODE A0075a/Lt3

If you forget to take Ferrous Gluconate
300mg Tablets
If you forget to take a dose leave out that dose
and take the next dose when it is due. DO NOT
take a double dose to make up for the forgotten
dose. If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

What Ferrous Gluconate 300mg Tablets
contain: Active substance: Each tablet
contains 300mg ferrous gluconate equivalent to
35mg ferrous iron.
Other ingredients: sodium starch glycollate,
stearic acid, colloidal anhydrous silica, sucrose,
talc, calcium carbonate, acacia, polyvinyl
acetate phthalate, carnauba wax, white
beeswax, shellac, titanium dioxide (E171) and
ponceau 4R Red (E124).
What Ferrous Gluconate Tablets look like
and the contents of the pack
Ferrous Gluconate 300mg Tablets are red,
circular, biconvex, sugar coated tablets.
Ferrous Gluconate 300mg Tablets come in pots
containing 28, 100, 250, 500, 1000 and 5000
tablets or blister packs containing 28 tablets.
Not all pack types or sizes may be marketed.

SUPPLIER ISSUE DATE: 18.5.2016

If you take more Ferrous Gluconate 300mg
Tablets than you should
If you, or anyone else, has taken too many
tablets, contact your doctor or nearest casualty
department IMMEDIATELY. If you have taken
too much Ferrous Gluconate you may
experience nausea, vomiting, abdominal pain,
diarrhoea, high blood pressure, changes in
metabolism, coma, seizures and liver problems.

CONTENTS OF THE PACK AND
OTHER INFORMATION

Item(s):

Children less than 6 years of age
Ferrous Gluconate 300mg Tablets are NOT
recommended for children under 6 years of age.

6.

REASON FOR CHANGE: PIL safety text update

Ferrous Gluconate 300mg Tablets with food
and drink
If you drink large amounts of tea, coffee or milk

Children (aged 6-12 years)
• For the prevention of iron deficiency:
take one or two tablets daily.
• For the treatment of iron deficiency:
take three tablets daily in divided doses.

Do not take Ferrous Gluconate 300mg Tablets
after the expiry date which is stated on the pack.
The expiry date refers to the last day of that
month.
KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
Do not store above 25°C. Store in the original
container. Keep the container tightly closed.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.

DRAFT ISSUE: 5

Warnings and Precautions
Talk to your doctor or pharmacist before
taking Ferrous Gluconate 300mg Tablets:
• if you are having tests for occult (hidden)
blood in the stools, this medicine can
colour faeces black
• if you are elderly as there is an increased
risk of unwanted effects
• if you suffer from breakdown of red blood
cells (haemolytic anaemia)
• if you also have deficiency of vitamin B12
or folic acid
• if you have diabetes as these tablets
contain sugar
• if you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product
• if you have a history of stomach ulcers
• if you suffer from inflammatory bowel disease
• if you have intestinal strictures or suffer from
diverticular disease
• if you have had an operation to remove all or
part of the stomach (gastrectomy)

Adults (including the elderly) and children
over 12 years
• For the prevention of iron deficiency:
take two tablets daily.
• For the treatment of iron deficiency:
take four to six tablets daily in divided
doses.

HOW TO STORE FERROUS
GLUCONATE 300mg TABLETS

VERSION: 3 (KENT/ATHLONE)

DO NOT take Ferrous Gluconate 300mg
Tablets:
• if you are allergic (hypersensitive) to
ferrous gluconate, medicines containing
iron or any of the other ingredients in this
medicine (See section 6)
• if you have a build up of too much iron in
the body (haemochromatosis)
• if you suffer from iron storage
(haemosiderosis) or absorption
(haemoglobinuria)
• if you have anaemia not caused by Iron
deficiency
• if you receive regular blood transfusions or
iron by IV infusion (drip)
• if you have an ulcer of the stomach or
small intestine

Other medicines and Ferrous Gluconate
300mg Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
prescription especially any of the medicines
listed below:
• antibiotics (used to treat bacterial
infections) e.g. tetracyclines,
flouroquinlones, chloramphenicol or
neomycin. Do not take these medicines
for two hours before and after taking
Ferrous Gluconate 300mg Tablets
• zinc salts
• penicillamine (used in the treatment of
rheumatoid arthritis)
• antacids (used to treat indigestion) and
mineral supplements e.g. calcium,
magnesium, bicarbonates, carbonates,
oxalates, or phosphates. Do not take these
medicines for two hours before and after
taking Ferrous Gluconate 300mg Tablets
• trientine (used to treat conditions of too
much copper in the body e.g. Wilson’s
disease) Do not take these medicines for
two hours before and after taking Ferrous
Gluconate 300mg Tablets
• cholestyramine, used to reduce blood
cholesterol and control diarrhoea
• levodopa, carbidopa, co-careldopa and
entacapone (used in the treatment of
Parkinson’s disease)
• thyroxine, a thyroid hormone. Do not take
these medicines for two hours before and
after taking Ferrous Gluconate 300mg
Tablets
• bisphosphonates (used in the treatment
of bone diseases e.g. osteoporosis). Do
not take these medicines for two hours
before and after taking Ferrous Gluconate
300mg Tablets
• methyldopa (used in the treatment of
high blood pressure)
• mycophenolate, a drug given after an
organ transplant
• proton pump inhibitors, e.g. omeprazole,
used to treat stomach ulcers
• dimercaprol (used in the treatment of
heavy metal poisoning)

Always take this medicine as described in this
leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure. Do not take more than the
recommended dose.
• Take the tablets about 1 hour before
meals with water.

5.

10193 / UK
Ferrous Gluconate
300mg

2.

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE FERROUS
GLUCONATE 300mg TABLETS

If any of the conditions listed above apply to you
please talk to your doctor or pharmacist.

3.

HOW TO TAKE FERROUS
GLUCONATE 300mg TABLETS

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the yellow card
scheme at www.mhra.gov.uk/yellowcard. By
reporting side effects, you can help provide
more information on the safety of this medicine.

Project:

Ferrous Gluconate 300mg Tablets are used for
the treatment and prevention of iron deficiency.
Ferrous Gluconate is a form of iron. Iron is
necessary for the production of haemoglobin
(protein in red blood cells), which carries oxygen
around the body. Iron is involved in the
formation of myoglobin, a pigment that stores
oxygen in muscles for use during exercise.

After correction of iron deficiency, duration of
treatment should generally not exceed 3
months. Long term use of this product may
cause tooth decay and infections.

Ferrous Gluconate 300mg Tablets contain
ponceau 4R Red (E124) and sucrose.
• Ponceau 4R Red (E124): may cause
allergic reactions.
• Sucrose: If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor before
taking this medicine.

Colours used:

1.

WHAT FERROUS GLUCONATE
300mg TABLETS ARE AND WHAT
THEY ARE USED FOR

Driving and using machines
No effects of Ferrous Gluconate 300mg Tablets
are known.

Almus UK

WHAT IS IN THIS LEAFLET
1. What Ferrous Gluconate 300mg Tablets are and what they are used for
2. What you need to know before you take Ferrous Gluconate 300mg Tablets
3. How to take Ferrous Gluconate 300mg Tablets
4. Possible side effects
5. How to store Ferrous Gluconate 300mg Tablets
6. Contents of the pack and other information

Pregnancy and breast-feeding
During the first 12 weeks of pregnancy only take
Ferrous Gluconate 300mg Tablets if your doctor
has specifially recommended it.
This medicine may be taken during pregnancy
and while breast-feeding if you are at risk of
developing iron deficiency anaemia.

Client:

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
has told you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
• 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.

PHARMACODE
TO BE
INSERTED

FERROUS GLUCONATE 300mg TABLETS

Other less serious side effects include:
• nausea
• vomiting
• heartburn
• abdominal pain
• diarrhoea
• constipation
• lack or loss of appetite
• dark coloration of stools
Contact irritation can occur with ferrous
gluconate tablets resulting in erosion or
ulceration, particularly if they become lodged in
the upper gastrointestinal tract (oesophagus,
stomach and duodenum).
If any of the side effects become serious or you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

REVISED ARTWORK FOR MHRA APPROVAL

or eat eggs at the same time as taking Ferrous
Gluconate 300mg Tablets, your body may
absorb less of the iron contained in the tablets
which can reduce the effects of ferrous
gluconate. If you are worried that you are not
getting the full effect of ferrous gluconate speak
to your doctor or pharmacist.

DIMENSIONS 146 x 300 mm

PATIENT INFORMATION LEAFLET

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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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