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MercuryPharma Patient Information Leaflet

Ferrous Fumarate 210mg Tablets

The name of your medicine is Ferrous Fumarate 210mg Tablets. It will be referred to as Ferrous Fumarate Tablets for ease hereafter.

In this leaflet:

1.    What Ferrous Fumarate Tablets are and what they are used for

2.    Before you take Ferrous Fumarate Tablets

3.    How to take Ferrous Fumarate Tablets

4.    Possible side effects

5.    How to store Ferrous Fumarate Tablets

6.    Further information

1. WHAT FERROUS FUMARATE TABLETS ARE AND WHAT THEY ARE USED FOR

Ferrous Fumarate Tablets contain a form of iron called ferrous fumarate. Iron is usually found in foods and is necessary for the normal development of red blood cells.

A lack of iron affects the development of the red blood cells and causes a reduction in the number of red blood cells found in the body (iron deficiency anaemia).

Ferrous Fumarate Tablets are used to prevent or treat iron deficiency anaemia. The prevention of iron deficiency during pregnancy usually requires a combination of iron and folic acid.

2. BEFORE YOU TAKE FERROUS FUMARATE TABLETS

DO NOT take Ferrous Fumarate Tablets if:

•    You know that you are allergic to ferrous fumarate or any of the other ingredients (see section 6 of this leaflet), or to any other medicine containing iron

•    You have noticed blood in your urine

•    You suffer from any form of anaemia, other than iron deficiency anaemia, or from any other condition where your body's iron is affected (your doctor will be able to advise you)

•    You have bronze markings on your skin or you have been told that you have increased stores of iron in your tissues

•    You are suffering from a recently diagnosed stomach or duodenal ulcer

•    You are undergoing repeated blood transfusions

•    You suffer from ulcerative colitis or any other inflammatory condition of the bowels.

Speak to your doctor if any of these apply to you before you take your medicine.

Take special care with Ferrous Fumarate Tablets if:

•    You have had a stomach or duodenal ulcer in the past, or have one which is now under control with treatment

•    You have had major surgery to your stomach

•    You have problems associated with narrowing of your intestine (stricture) or out pocketing of the inner layer of your intestine (diverticular disease).

If any of these conditions apply to you, speak to your doctor before you take these tablets. Your doctor will want to watch you closely, and will advise you if any additional medicine is required to treat your condition.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effects of any of these medicines or of Ferrous Fumarate Tablets may change, particularly if you are taking:

•    Certain medicines for treating infections (e.g. chloramphenicol, tetracyclines, ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, norfloxacin)

•    Medicines containing zinc, calcium or magnesium salts

•    Levothyroxine, used for thyroid gland problems

•    Medicines used for a disease known as ‘Parkinson's disease' (e.g. levodopa, entacapone)

•    Methyl dopa, used for increase in blood pressure

•    Penicillamine used in the treatment of rheumatoid arthritis

•    Colestyramine used to reduce cholesterol and fats in the blood

•    Medicines for bone diseases (bisphosphonates)

•    Trientine, used for high copper levels in blood

•    Dimercaprol, used for various metal poisonings

•    Mycophenolate, used during change of organs (transplant).

Taking with food and drink:

Ferrous Fumarate Tablets may be taken with meals. This may help to relieve any stomach-related side effects. However, it is advisable not to take your medicine with tea, eggs or milk as this may reduce the effect of the tablets. Ferrous Fumarate Tablets should be taken with a glass of water.

Pregnancy and lactation:

If you are pregnant, planning to become pregnant or are breast feeding ask your doctor or pharmacist for advice before taking any medicine.

3. HOW TO TAKE FERROUS FUMARATE TABLETS

It is important to take your medicine at the right time. You must take it as directed by your doctor. The label will tell you how much to take and how often. If you are not sure, ask your doctor or pharmacist. The usual dose to treat Iron deficiency anaemia is one tablet two to three times a day.

The dose for prevention of anaemia is one tablet once or twice a day.

Swallow the tablets with a glass of water. You can also chew or crush the tablets. Taking Ferrous Fumarate Tablets with meals may help to relieve any stomach related side effects.

Your doctor will advise you on how long you should take the tablets. You can stop taking the tablets three months after the anaemia has been corrected. You should not take the tablets for more than six months.

Ferrous Fumarate Tablets are not suitable for use in children.

Your medicine is very dangerous if taken by young children and care should be taken to keep the medicine safely out of the reach of children. If you have to go to another doctor or to the hospital tell them you are taking Ferrous Fumarate Tablets.

If you take more Ferrous Fumarate Tablets than you should:

If you take too many tablets, contact your nearest hospital casualty department or doctor immediately. Take any remaining tablets and this leaflet with you so that the medical staff know exactly what you have taken. Your medicine is very dangerous if taken by young children and care should be taken to keep the medicine safely out of the reach of children.

Signs and symptoms of an iron overdose include nausea, vomiting, abdominal pain, diarrhoea, vomiting of blood (haematemesis), and rectal bleeding.

If you forget to take your Ferrous Fumarate Tablets:

Take your dose as soon as you remember. Then go on as before. If it is almost time for the next dose, then do not take the missed dose at all.

If you stop taking Ferrous Fumarate Tablets:

If you are having no problems with your tablets, do not stop taking them until your doctor tells you to. If you have any further questions about these tablets, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ferrous Fumarate Tablets can sometimes cause side effects, although not everybody gets them.

They might be:

•    Heartburn

•    Feeling sick or being sick

•    Diarrhoea or constipation.

Also, you might find your stools are darker in colour after you have taken this medicine. This is quite commonly seen with all iron preparations and is normal.

If these side effects get serious, or if you notice any other side effect not listed in this leaflet, please tell your doctor or pharmacist.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. STORING YOUR MEDICINE

Important warning: contains iron.

Keep out of the sight and reach of children, as overdose may be fatal.

Do not store above 25°C. Store in the original package/container in order to protect from light.

If you have any of your medicine left after finishing your treatment, return it to your pharmacist.

Do not use your medicine if the pack is damaged or after the Expiry Date stated on the carton and blister. The expiry date refers to the last day of that month.

REMEMBER

This medicine is for YOU. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.

6. FURTHER INFORMATION

The active substance is ferrous fumarate. Each tablet contains 210mg ferrous iron. Ferrous fumarate is an iron compound.

The other ingredients are maize starch, sodium lauryl sulphate, gelatin, liquid paraffin and purified water.

What Ferrous Fumarate 210mg Tablets look like and contents of pack:

Ferrous Fumarate Tablets are light brown in colour. Ferrous Fumarate Tablets are usually available in containers with child proof lids containing 100 or 1000 tablets or supplied in blisters packs of 28, 56, 84 and 112 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder:

Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer:

Kemwell AB, Rapsgatan 7, Uppsala, 75182, Sweden. This leaflet was last revised in November 2014.

101966/LF/163/02

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