PACKAGE LEAFLET: INFORMATION FOR THE USER

FERROGRAD tablets

Ferrous Sulphate

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 haemochro-matosis 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.

Take special care with Ferrograd

•    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.

•    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:

Tetracycline antibiotics	- take these at least 2 hours before OR 3 hours after taking your Ferroarad
Quinolones and penicillamines	- take these at least 2 hours before OR 2 hours after taking your Ferroqrad
Indigestion remedies (e. g Antacid), calcium supplements, oxalates or phosphates	- take these at least 1 hour before OR 2 hours after taking your Ferrograd

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. Each tablet must be swallowed whole.

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:

•    Feeling sick

•    Vomiting

•    Stomach pain

•    Diarrhoea

•    Constipation

•    Blackened stools

•    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, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Sulphate BP 325mg (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.Mi Cervi n° 8 - 1-27010 Valle Salimbene (PV) - Italy Tel.: 0039 0382 422008 - Fax: 0039 0382 525845 e-mail: servizioclienti@teofarma.it Manufacturer TEOFARMA s.r.l.

Viale Certosa n° 8/A - 1-27100 - Pavia - Italy This leaflet was last approved in 05/2008.

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