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FERROGRAD TABLETS 300MG

Active substance(s): DRIED FERROUS SULPHATE / DRIED FERROUS SULPHATE / DRIED FERROUS SULPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FERROGRAD tablets
Ferrous Sulfate

Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Ferrograd is and what it is used for
2. Before you take Ferrograd
3. How to take Ferrograd
4. Possible side effects
5. How to store Ferrograd
6. Further information

1. What Ferrograd is and what it is used for
Ferrograd is an iron supplement used to prevent and treat iron-deficiency anaemia. Iron is critical (essential)
for your body to produce normal blood red cells. Ferrograd is formulated with an inert porous matrix (Gradumet) to release iron gradually and reduce (limit) the gastro-intestinal irritation occurring with iron supplements.

2. Before you take Ferrograd
Do not take Ferrograd if you
- have an intestinal blockage
- have been told by your doctor that you have a disease of the bowels known as diverticular disease
- suffer from a rare inherited problem involving the way your blood cells use iron known as haemochromatosis or haemosiderosis
- are receiving repeated blood transfusions
- are already being treated with iron injections
- are already taking medicines containing iron.
You should check with your doctor or pharmacist if you are not sure.
Warnings and precautions
• Before taking this tablet speak to your doctor if you suffer from bowel strictures (resulting in difficult intestinal transit) as the inert core tablet may not be suitable for you.
• Ferrograd is not recommended for children under 12 years old. Acute iron poisoning is a serious risk in
the paedriatic population.
• Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or
kept in the mouth but swallowed whole with water. If you cannot follow this instruction or have difficulty
swallowing, please contact your doctor.
• Your stools may turn black whilst taking Ferrograd. If you have a test for the detection of blood in your
stools, tell your doctor you are taking Ferrograd as black stools may cause an incorrect result to the test.
Taking other medicines
Please tell your doctor or pharmacist if you are taking any of the following medicines, or any medicines
bought without a prescription, as Ferrograd may stop these from working properly:
• antibiotics: tetracyclines, quinolones or chloramphenicol
• a penicillamine (for metal poisoning or rheumatoid arthritis)
• indigestion remedies
• zinc - containing preparations
If your doctor tells you that you can continue taking Ferrograd with the above medication, please take note
of the following advice:
- take these at least 2 hours before OR 3 hours after taking your
Tetracycline antibiotics
Ferrograd
- take these at least 2 hours before OR 2 hours after taking your
Quinolones and penicillamines
Ferrograd
Indigestion remedies (e. g Antacid),
- take these at least 1 hour before OR 2 hours after taking your
calcium supplements, oxalates or
Ferrograd
phosphates
If you are not sure, please check with your doctor or pharmacist.
Taking Ferrograd with food and drink
Ferrograd tablets may not work as well if they are taken around the same time as the following foods: tea,
coffee, eggs, milk or milk products, wholegrain bread and cereals, and any high fibre food. Make sure you
take your tablets at least 1 hour before or 2 hours after eating any of these foods.

Pregnancy and breast-feeding
Ferrograd Tablets are not suitable if you are pregnant since they do not contain folic acid. Ask your doctor
or pharmacist for advice before taking any medicine.
Driving and using machines
Ferrograd has no influence on the ability to drive and use machines.
Important information about some of the ingredients of Ferrograd
Ferrograd tablet contains the colouring agent E110, which may cause allergic reactions.

3. How to take Ferrograd
Always take Ferrograd exactly as your doctor has told you. You should check with your doctor if you are
not sure.
Adults and children over 12 years: The usual dose is one tablet a day on an empty stomach.
Swallow the tablet whole with water. Do not suck, chew or keep the tablet in your mouth.
Children: Ferrograd is not recommended for children under 12 years old.
If you take more Ferrograd than you should
If you (or someone else) take a lot of tablets at the same time, or if you suspect a child has taken the
tablets, you should contact the nearest hospital or tell your doctor immediately. In children iron poisoning is
accidental and may be fatal.
Symptoms of an overdose include nausea, vomiting, abdominal pain, diarrhoea and blood loss in the faeces.
Low blood pressure (hypotension), nervous system depression (ranging from reduced attention to coma) and
liver failure occur later.
If you forget to take Ferrograd
If you forget to take a tablet for one or more days, carry on taking one each day. Do not take more than one
tablet a day.

4. Possible side effects
Like all medicines, Ferrograd can cause side effects, although not everybody gets them.
You may experience some of the following effects:
• Nausea
• Vomiting
• Abdominal pain or discomfort
• Blackening of stools
• Diarrhoea
• Constipation
Not known (frequency cannot be estimated from the available data)
• Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth).
Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat,
oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages
of the lungs) if the tablet enters the airways.
• An allergic reaction ranging from itchy skin rash, to, in rare cases, swelling of the face, tongue or throat,
or difficulty in breathing, fainting. If any of the side effects get serious.

Reporting of side effects
If you get any side effects tell your doctor, nurse 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.

5. How to store Ferrograd
Store in a dry place below 25°C.
Keep out of the reach and sight of children, your medicine could harm them.
Do not use Ferrograd after the expiry date which is stated on the carton and on the edge of the strip of
tablets. If the tablets are out of date, return them to your pharmacist and, if necessary, obtain more tablets.

6. Further information
What Ferrograd contains
- The active substance is Dried Ferrous Sulfate 325 mg (equivalent to 105 mg elemental iron) as the active
ingredient in a prolonged release Gradumet® form.
- The other ingredients are methylacrylate methylmethacrylate copolymer, lactose, povidone, magnesium stearate, hydroxypropylmethylcellulose, ethylcellulose, sodium saccharin, triethyl citrate, sorbitan
monooleate, castor oil, titanium dioxide, dye Red FD & C No.3 (E127), and dye Yellow FD & C No.6 (E110).
What Ferrograd looks like and contents of the pack
Ferrograd prolonged release, film coated tablets are circular, biconvex, red tablets.
Ferrograd is provided in carton pack containing 30 tablets in blister packs.
Marketing Authorisation Holder
TEOFARMA s.r.l. - Via F.lli Cervi n° 8 - I-27010 Valle Salimbene (PV) - Italy
Fax: 0039 0382 525845 - e-mail: servizioclienti@teofarma.it
Manufacturer
TEOFARMA s.r.l. - Viale Certosa n° 8/A - I-27100 - Pavia - Italy
This leaflet was last approved in 06/2017.
Cod. 01FOFEGUK_ (GB)

F_Ferrograd_Ing_Ver_Min.indd 1-2

27/06/17 07:28

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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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