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Ferrous Fumarate 210mg Tablets

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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 Fersamal® 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. Fersamal® 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 Fersamal® Tablets.


mr

Mercury Pharma


Patient Information Leaflet

Fersamal® 210mg Tablets

Ferrous Fumarate


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



Base Label:    30mm x 100mm

Leaflet Page 1: 30mm x 65mm

Right Hand Opening Zl

Overall Leaflet Size: 30 x 493

Page Sizes: 65 62 61    61    61    61    62 60


Please leave a minimum of 3mm at top and bottom of each page.

A minimum of 3mm margin is required left and right of each page also.


If you take more Fersamal® 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 Fersamal® 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 Fersamal® 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, Fersamal® 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.


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 this medicine if the pack is damaged or after the Expiry Date which is stated on the label after 'EXP'. 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 Fersamal® 210mg Tablets look like and contents of pack

Each tablet is light brown in colour.

Fersamal® Tablets are usually available in containers with child proof lids containing 100 or 1000 tablets or supplied in blisters packs of 28, 56 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:

Custom Pharmaceuticals, Tecore House, Conway Street, Hove, East Sussex, BN3 3LW.

This leaflet was last revised in December 2013.    100025/LF/4



In this leaflet:

1.    What Fersamal® Tablets are and what they are used for

2.    Before you take Fersamal® Tablets

3.    How to take Fersamal® Tablets

4.    Possible side effects

5.    How to store Fersamal® Tablets

6.    Further information


1. WHAT FERSAMAL® TABLETS ARE AND WHAT THEY ARE USED FOR


Fersamal® 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).

Fersamal® 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 FERSAMAL® TABLETS


DO NOT take Fersamal® 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 nave 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 Fersamal® 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 outpocketing 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 Fersamal® 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

Fersamal® Tablets may be taken with meals. This may help to relieve any stomach-realated 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. Fersamal® 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 FERSAMAL® 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.


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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 Fersamal® 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. Fersamal® 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 Fersamal® Tablets.


mr

Mercury Pharma


Patient Information Leaflet

Fersamal® 210mg Tablets

Ferrous Fumarate


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



Base Label:    30mm x 100mm

Leaflet Page 1: 30mm x 65mm

Right Hand Opening Zl

Overall Leaflet Size: 30 x 493

Page Sizes: 65 62 61    61    61    61    62 60


Please leave a minimum of 3mm at top and bottom of each page.

A minimum of 3mm margin is required left and right of each page also.


If you take more Fersamal® 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 Fersamal® 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 Fersamal® 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, Fersamal® 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.


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 this medicine if the pack is damaged or after the Expiry Date which is stated on the label after 'EXP'. 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 Fersamal® 210mg Tablets look like and contents of pack

Each tablet is light brown in colour.

Fersamal® Tablets are usually available in containers with child proof lids containing 100 or 1000 tablets or supplied in blisters packs of 28, 56 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:

Custom Pharmaceuticals, Tecore House, Conway Street, Hove, East Sussex, BN3 3LW.

This leaflet was last revised in December 2013.    100025/LF/4


100 Tablets

Fersamal®

210mg Tablets

Ferrous Fumarate


IMPORTANT WARNING: Contains iron. Keep out of the sight and reach of children, as overdose may be fatal.


Each tablet contains 210 mg ferrous fumarate (approximately 69 mg of elemental Iron).

To be taken by moulhi.

Dosage: Adult - one tablet three times daily or use as directed by your doctor.

Read the package leaflet before use.

Keep out of the sight and reach of children.

Do not store above 25°C.

Store in the original package in order to protect from light.


Space for Pharma code

Marketing Authorisation Holder: Mercury

Pharmaceuticals Ltd.,    ^s

Capital House,

85 King William Street,

London EC4N 7BL, UK Fersamal is a register trademark of Mercury

PL 12762/0226 100025/LB/4


In this leaflet:

1.    What Fersamal® Tablets are and what they are used for

2.    Before you take Fersamal® Tablets

3.    How to take Fersamal® Tablets

4.    Possible side effects

5.    How to store Fersamal® Tablets

6.    Further information


1. WHAT FERSAMAL® TABLETS ARE AND WHAT THEY ARE USED FOR


Fersamal® 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).

Fersamal® 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 FERSAMAL® TABLETS


DO NOT take Fersamal® 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 Fersamal® 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 outpocketing 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 Fersamal® 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

Fersamal® Tablets may be taken with meals. This may help to relieve any stomach-realated 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. Fersamal® 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 FERSAMAL® 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.