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FERROUS GLUCONATE 300 MG COATED TABLETS

Active substance(s): FERROUS GLUCONATE

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Intrapharm Laboratories Limited
Ferrous Gluconate Tablets BP
PL 17509/0049

16 March 2017

Package leaflet: Information for the patient

Ferrous Gluconate 300 mg Coated Tablets
Ferrous Gluconate

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.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
What is in this leaflet
1.
What Ferrous Gluconate 300 mg Coated Tablets are and what they are used for
2.
What you need to know before you take Ferrous Gluconate 300 mg Coated Tablets
3.
How to take Ferrous Gluconate 300 mg Coated Tablets
4.
Possible side effects
5.
How to store Ferrous Gluconate 300 mg Coated Tablets
6.
Contents of the pack and other information

1. What Ferrous Gluconate 300 mg Coated
Tablets are and what they are used for
• Ferrous Gluconate 300 mg Coated Tablets contain
the active substance Ferrous gluconate.
• Ferrous gluconate belongs to a group of drugs called
anti-anaemic preparations (used to treat iron
deficiency anaemia).
• Ferrous gluconate is a form of iron. Iron has an
important role in the oxygen-carrying pigment,
haemoglobin. It is involved in the formation of
myoglobin, a pigment which stores oxygen in
muscles for use during exercise.
• Ferrous gluconate is used for the prevention and
treatment of iron deficiency in adults (including the
elderly) and children aged 6 years and above.

2. What you need to know before you take
Ferrous Gluconate 300 mg Coated Tablets
Do not take Ferrous Gluconate 300 mg Coated
Tablets if you:
- are allergic to Ferrous gluconate, other iron
preparations or any of the other ingredients of this
medicine (listed in section 6)

- have a disease which causes the body to absorb
and/or store too much iron (haemochromotosis,
haemosiderosis)
- have a condition which causes loss of the protein
haemoglobin through urination
- have a hereditary blood disorder e.g. sickle-cell
disease and thalassemia
- have anaemia which is not due to a lack of iron
- receive repeated blood transfusions or iron by injection
- suffer from Crohn’s disease, active peptic ulcer or
inflammation of the colon
- have hepatitis (inflammation of the liver)
- suffer from alcoholism.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Ferrous Gluconate 300 mg Coated Tablets if you:
- suffer from breakdown of red blood cells (haemolytic
anaemia)
- have an iron absorption disorder
- have a disease affecting your stomach or intestines
- have strictures or diverticulae (intestinal narrowing/
bulges which may be accompanied by inflammation
or infection)
- are elderly.

Other medicines and Ferrous Gluconate 300 mg Coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is particularly important if you are taking medicines in the table below. Follow the instructions to help
maintain the effectiveness of each medicine:
Other Medicines

Take Ferrous Gluconate 300 mg Coated Tablets:

antacids (medicines)

… containing carbonates or magnesium
trisilicate

other medicines

… containing bicarbonates, carbonates,
oxalates or phosphates

bisphosphonates

… to treat osteoporosis

at least 2 hours before or 2 hours after bisphosphonates

eltrombopag

… to treat low blood platelet counts

at least 4 hours before or 4 hours after eltrombopag

levothyroxine

… used as hormone replacement for
thyroid problems

at least 2 hours before or 2 hours after levothyroxine

penicillamine

… to treat rheumatoid arthritis

at least 2 hours before or 2 hours after penicillamine

tetracyclines

… these are antibiotics

at least 3 hours before or 2 hours after tetracycline antibiotics

at least 1 hour before or 2 hours after taking these medicines

Please also tell your doctor or pharmacist if you are taking or have recently taken these other medicines:
Other Medicines
acetohydroxamic acid
ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin,
neomycin, nalidixic acid or oral chloramphenicol
colestyramine
dimercaprol
levodopa, carbidopa or entacapone
methyldopa
mycophenolate
proton pump inhibitors
trientine
vitamin E or calcium, aluminium and zinc salts

… to treat bladder infections
… these are antibiotics








to reduce blood cholesterol
to treat heavy metal poisoning
to treat Parkinson's disease
to treat high blood pressure
to prevent organ rejection after a transplant
to treat stomach ulcers
to treat Wilson's disease - an inherited disorder
where too much copper builds up in the body

Intrapharm Laboratories Limited
Ferrous Gluconate Tablets BP
PL 17509/0049

17 March 2016

Ferrous Gluconate 300 mg Coated Tablets with food
and drink
Coffee, tea, eggs, milk, milk products and whole grain
breads and cereals may slow down the absorption of iron.
Follow your doctor’s advice when taking Ferrous Gluconate
300 mg Coated Tablets with the food and drink listed.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Although Ferrous Gluconate 300 mg Coated Tablets may
be taken, you should check with your doctor before taking
if you are pregnant or breast-feeding.
Driving and using machines
No effects on the ability to drive and use machines have
been reported to date with Ferrous Gluconate 300 mg
Coated Tablets.
Ferrous Gluconate 300 mg Coated Tablets contain
sucrose
If you have been told by your doctor that you have an
intolerance to some sugars, check with your doctor before
taking this medicine.

• prolonged constipation
• vomiting
• vomiting blood (haematemesis)
High doses in some people may have an effect on the
lining of the stomach or gut, which may become narrower
or perforated. Symptoms of this are stomach pain and
bloody stools.
Other side effects:
• loss of appetite
• feeling sick
• stomach discomfort
• heartburn
• darker coloured stools than usual.
Continuous use may cause constipation and faecal
impaction which is when stools become hard and dry and
collect in your rectum, sometimes causing an obstruction
(blockage).

3. How to take Ferrous Gluconate 300 mg
Coated Tablets

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

5. How to store Ferrous Gluconate 300 mg
Coated Tablets

Swallow the tablets whole with a drink of water, preferably
1 hour before meals. Always take this medicine exactly as
your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

>>> KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN. <<<
>>> These tablets could harm them. An overdose
could be fatal. <<<

The recommended dose is normally as follows:

Store the medicine in a dry place below 250C. Keep the
tablets in the original packaging (i.e. store the blister strips
inside the carton when not in use) in order to protect from
moisture.

For children 6 to 12 years
Prevention and treatment of iron deficiency: Take 1 to 3
tablets daily (in divided doses)
If you take more Ferrous Gluconate 300 mg Coated
Tablets than you should
Contact your doctor straight away or go to the nearest
hospital casualty department. Take with you any remaining
tablets and the pack so that the medicine can be identified.
If you have taken too much Ferrous Gluconate you may
feel or be sick (possibly with blood), have stomach pain,
diarrhoea, bleeding from the bottom, lack of energy, chest
pain, breathlessness, dizziness or coma.
>>> An overdose in children could be fatal. <<<
If you forget to take Ferrous Gluconate 300 mg Coated
Tablets
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose of this medicine, take it as
soon as you remember. However, if it is almost time for the
next dose, skip the missed dose and take the next dose at
the usual time.
Taking Ferrous Gluconate 300 mg Coated Tablets with
food and drink
See Section 2.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If any of the following occur STOP TAKING the tablets
IMMEDIATELY and contact your doctor:
• an allergic reaction (symptoms may include shortness
of breath, blocked nose, rash, itching, swollen face
or lips).
• haemorrhage/blood loss (symptoms may include
being in a 'state of shock')
• circulatory failure/collapse (symptoms may include
chest pain, breathlessness or dizziness)
• severe diarrhoea

Do not use this medicine after the expiry date which is
stated on the blister strips (i.e. labelling) and carton after
‘EXP’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Ferrous Gluconate 300 mg Coated Tablets
contain
- The active substance is Ferrous gluconate
- The other ingredients are: Purified talc, Starch (potato),
Sucrose, Maize starch, Shellac, Dispersed red 15011
(which is a colourant containing Carmoisine Lake
[E122] and Ponceau 4R Lake [E124] which may
cause allergic reactions), IMS, Titanium dioxide and
Opaglos 6000 (which comprises of Carnauba wax,
Beeswax and Shellac).
What Ferrous Gluconate 300 mg Coated Tablets look
like and contents of the pack
Ferrous Gluconate 300 mg Coated Tablets are red, shiny
and round. The tablets are sugar-coated. The tablets are
presented in a child resistant blister pack with each pack
containing 28 tablets (arranged as two strips of fourteen
tablets).
Marketing Authorisation Holder and Manufacturer
Intrapharm Laboratories Limited
The Courtyard Barns, Choke Lane
Cookham Dean, Maidenhead
Berks SL6 6PT, United Kingdom
Tel. +44 (0)1628 771800
E-mail: medinfo@intrapharmlabs.com;
sales@intrapharmlabs.com
This leaflet was last revised in March 2016.
Other sources of information
Detailed information on this medicine is available
on the website of the (UK) Medicines and
Healthcare products Regulatory Agency.

PMS-910

For adults (including the elderly)
Prevention of iron deficiency: Take 2 tablets daily
Treatment of iron deficiency: Take 4 to 6 tablets daily in
divided doses

AW1503010

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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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