PACKAGE LEAFLET: INFORMATION FOR THE USER

FERROGRAD C tablets

Ferrous Sulphate and Vitamin C

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 C is and what it is used for

2.    Before you take Ferrograd C

3.    How to take Ferrograd C

4.    Possible side effects

5.    How to store Ferrograd C

6.    Further information

1.    What Ferrograd C is and what it is used for

Ferrograd C is an iron supplement used to prevent and treat iron-deficiency anaemia and vitamin C deficiency when the two are present together. The added vitamin C helps the body to adsorb the iron.

2.    Before you take Ferrograd C Do not take Ferrograd C 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 C

•    Before taking this tablet speak to your doctor if you are elderly or suffering from any bowel problem as the plastic coating of the tablet may not be suitable

•    Ferrograd is not recommended for children under 12 years old. Acute iron poisoning is a serious risk in the paediatric population.

•    Your stools may turn black whilst taking Ferrograd C. If you have a test for the detection of blood in your stools, tell your doctor you are taking Ferrograd C as black stools may cause an incorrect result to the test.

Before taking Ferrograd C consult your doctor

-    if you are diabetic as Ferrograd C may stop your urine sugar test sticks from working properly. 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 C 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 C 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 C
Quinolones and penicillamines	- take these at least 2 hours before OR 2 hours after taking your Ferroqrad C
Indigestion remedies (e. g Antacid), calcium supplements, oxalates or phosphates	- take these at least 1 hour before OR 2 hours after taking your Ferrograd C

If you are not sure, please check with your doctor or pharmacist.

Taking Ferrograd C with food and drink

Ferrograd C 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 C tablets should NOT be taken if you are pregnant, trying to get pregnant or are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ferrograd C has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Ferrograd C

This product contains the colour E124, which can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

3.    How to take Ferrograd C

Always take Ferrograd C 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 C should not be given to children under 12 years old.

If you take more Ferrograd C than you should

If you accidentally take more than one tablet in one day or if a child has taken the tablets, you should seek medical advice urgently. In children overdose may be fatal.

If you forget to take Ferrograd C

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 C can cause side effects, although not everybody gets them.

You may experience some of the following effects:

•    Allergic reactions have been reported with Ferrograd C ranging from rashes to, in rare cases, difficulty in breathing, fainting and swelling of the face and throat which may need emergency treatment.

•    Feeling sick

•    Vomiting

•    Stomach pain

•    Diarrhoea

•    Constipation

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 C 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 325 mg (equivalent to 105 mg elemental iron) as the active ingredient in a prolonged release Gradumet® form and Vitamin C (equivalent to 500 mg ascorbic acid).

-    The other ingredients are methylacrylate methylmethacrylate copolymer, magnesium stearate, povidone, polyethylene glycol 400 & 8000, maize starch, purified talc, ethylcellulose, hdroxypropylmeth-ylcellulose, titanium dioxide and dye Red Ponceau 4R Lake (E124).

What Ferrograd C looks like and contents of the pack

Ferrograd C prolonged release, film coated tablets are ovoid, biconvex, two layered, red tablets. Ferrograd C is provided in carton pack containing 30 tablets in blister packs.

Marketing Authorisation Holder TEOFARMA s.r.l.

Via F.lli 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 07/2009.

Cod. 000000