5. HOW TO STORE FERSAMAL 140MG/5ML SYRUP

Important warning: contains iron.

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

Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light. Shake the bottle before use.

Replace the cap after taking your dose.

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

Do not use this medicine if the bottle is damaged or after the Expiry Date which is stated on the bottle 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.

MercuryPharma

PATIENT INFORMATION LEAFLET

Fersamal® 140mg/5ml Syrup

Ferrous Fumarate

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Fersamal 140mg/5ml Syrup carefully to get the best results from it. Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after a few days

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.

6. FURTHER INFORMATION

The active substance is ferrous fumarate. Each 5 ml spoonful contains 140mg ferrous fumarate. Ferrous fumarate is an iron compound.

The other ingredients are nipastat GL75, methyl cellulose 20, glucose liquid, sucrose, granular lecithin (97% Al), elderberry flavour (bush) C7529, sodium metabisulphite (E223) and purified water.

Nipastat GL75 contains methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate, butyl hydroxybenzoate and isobutyl hydroxybenzoate.

What Fersamal 140mg/5ml Syrup looks like and contents of pack

Fersamal Syrup is a smooth brown suspension which separates on standing with an elderberry smell. It is packed in amber glass bottles containing 200ml suspension.

Marketing authorisation holder

Mercury Pharmaceuticals Ltd.,

Capital House, 85 King William Street,

London EC4N 7BL, UK

Manufacturer:

Laleham Health and Beauty Limited.,

Fairfield, Bradshaw Lane, Greenhalgh,

Kirkham, Preston, Lancashire, PR4 3JA, UK This leaflet was last revised in May 2015.

Fersamal is a registered trademark of Mercury Pharma Group Limited.

100024/LF/139/05 GP1I0324G

In this leaflet:

1.    What Fersamal 140mg/5ml Syrup is and what it is used for

2.    Before you take Fersamal 140mg/5ml Syrup

3.    How to take Fersamal 140mg/5ml Syrup

4.    Possible side effects

5.    How to store Fersamal 140mg/5ml Syrup

6.    Further information

1. WHAT FERSAMAL 140MG/5ML SYRUP IS AND WHAT IT IS USED FOR

Fersamal Syrup contains 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 iron deficiency anaemia.

Fersamal Syrup is 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 140MG/5ML SYRUP

DO NOT take Fersamal Syrup 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.

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Take special care with Fersamal 140mg/5ml Syrup if:

•    You suffer or have suffered from a peptic ulcer

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

•    You have difficulty in absorbing certain sugars (glucose or galactose)

•    You have had some or all of your stomach removed as this may make it difficulty for you to absorb iron

•    You have diabetes.

If any of these conditions apply to you, speak to your doctor before you take this medicine. 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 Syrup 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

•    Antacids used to treat indigestion

•    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 Syrup 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 its effect.

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.

Important information about some of the ingredients of Fersamal 140mg/5ml Syrup

Fersamal Syrup contains sodium metabisulphite and parahydroxybenzoates as preservatives. Sodium metabisulphite may rarely cause severe allergic (hypersensitivity) reactions and wheezing. Parahydroxybenzoates (methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate) may cause allergic reactions (possibly delayed). This medicinal product contains less than 1mmol sodium (23mg) per dose (essentially ‘sodium - free’).

This medicine also contains Sucrose and Glucose Liquid. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE FERSAMAL 140MG/5ML SYRUP

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.

Adults and the elderly:

The usual dose to prevent Iron deficiency anaemia is one spoonful (5ml) twice a day.

Children and infants:

For children and premature infants, your doctor will decide the dose, according to the age and weight of the child and infant.

Your doctor will advise you on how long you should take the medicine, which is normally not more than six months. It is usually stopped three months after the anaemia has been corrected.

If you have to go to another doctor or to the hospital tell them you are taking Fersamal Syrup.

If you take more Fersamal 140mg/5ml Syrup than you should:

Contact your nearest hospital casualty department or doctor immediately. Take any remaining medicine and this leaflet with you so that the medical staff know exactly what you have taken.

Your medicine is very dangerous if too much is taken by young children and care should be taken to keep the medicine safely out of the reach of children.

If you forget to take your Fersamal 140mg/5ml Syrup:

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 140mg/5ml Syrup:

If you are having no problems with Fersamal Syrup, do not stop taking it until your doctor tells you to.

If you have any further questions about this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Other side effects may include:

•    stomach discomfort

•    pain in upper part of the stomach

•    vomiting sensation

•    difficulty in passing stools

•    loose stools.

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 you use Fersamal Syrup for a long time the sugar content may increase the risk of tooth decay. It may also result in blackish discolouration of the teeth. This can be reduced by daily brushing of the teeth.

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.

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Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, HPRA, etc ) and that Mercury Pharma have license approval to distribute this component for sale in the relevant market.

Accept Artwork / Reject Artwork

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Date ...............................................................................

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