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Patient Information Leaflet Ferrous Fumarate 140mg/5ml Oral Suspension

THE NAME OF YOUR MEDICINE IS:

Ferrous Fumarate 140mg/5ml Oral Suspension.

ACTIVE INGREDIENT:

The active ingredient in Ferrous Fumarate 140mg/5ml Oral Suspension is 140mg Ferrous Fumarate, in each 5ml spoonful. It is an oral iron preparation. Ferrous Fumarate 140mg/5ml Oral Suspension is a smooth brown suspension which separates on standing, with an elderberry odour. It is packed in amber glass bottles with polypropylene cap with melinex/pulpboard/aluminium foil wad. The bottle contains 200ml of suspension.

WHAT ELSE IS IN YOUR MEDICINE?

As well as the active ingredient Ferrous Fumarate 140mg/5ml Oral Suspension also contains nipastat GL75, methylcellulose 20, glucose liquid, sucrose granulated, granular lecithin, elderberry flavor (bush C7529), sodium metabisulphite (E223), water purified.

This medicinal product contains 4g of glucose per 5 ml spoonful when taken according to the dosage recommendations, each dose supplies up to 8g of glucose. It also contains 0.25g of sucrose per 5ml spoonful. When taken according to the dosage recommendations, each dose supplies up to 0.5g of sucrose. This product is unsuitable if you have a hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose isomaltase deficiency.

Ferrous Fumarate 140mg/5ml Oral Suspension is made for the Product Licence Holder, Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK

PL 12762/0083

by Laleham Health and Beauty Limited, Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire, PR4 3JA, UK.

WHAT IS THIS MEDICINE USED FOR?

This medicine is taken by mouth to treat or prevent iron deficiency. For prevention of deficiency during pregnancy, a combination of iron and folic acid is usually recommended.

BEFORE TAKING YOUR MEDICINE.

DO NOT TAKE Ferrous fumarate 140mg/5ml oral suspension 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 suffer from anaemia other than those due to deficiency of iron

•    you have been told that you have nocturnal haemoglobinuria (a constituent of red blood cells in your urine during the night), haemosiderosis (excessive amount of iron in your body), or haemochromatosis (a hereditary excessive amount of iron in your body)

•    you got a inflammation or ulcer in stomach

•    you are receiving repeated blood transfusions

•    you are receiving iron by an injection Speak to your doctor if any of these apply to you before you take your medicine.

Take special care with Ferrous Fumarate Oral Suspension if:

•    you suffer from inflammatory or diseased conditions of the gut or intestine.

•    you have a blood disease [hemoglobinopathies]

•    you have been told by your doctor that you have an intolerance to some sugars, or diabetes mellitus as it contains glucose, sucrose.

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. Especially:

•    Antibiotics (i.e. chloramphenicol and tetracycline antibiotics such as tetracycline), ciprofloxacin, moxifloxacin, levofloxacin, norfloxacin, ofloxacin

•    Medicines containing zinc salts, carbonates, bicarbonates, oxalates or phosphates.

•    Penicillamine used in the treatment of rheumatoid arthritis

•    Medicine which prevent the loss of bone mass, used to treat osteoporosis and similar diseases e.g. Bisphosphonate

•    Medicines used in the treatment of brain disorders like Parkinson's disease Entacapone, levodopa

•    Mycophenolate, a drug used to prevent the rejection of a new organ introduced in the body

•    Levothyroxine, used in the management of thyroid problems

•    Magnesium salts (as magnesium trisilicate), for acidity

•    Calcium salt for treatment of conditions of bones and teeth

•    Trientine, used for the management of a condition called Wilson's Disease (a disease in which there is too much copper in the body)

•    Cholestyramine which removes bile acids (digestive juice secreted by the liver) from the body

•    Dimercaprol, used for the treatment of metal poisoning

•    Methyldopa used for the management of high blood pressure

Pregnancy and breast-feeding

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

Food and drink

Ferrous Fumarate oral suspension should not be taken with the following products: tea, coffee, milk or milk products, cereals, dietary fibre, eggs and whole grains. These products can reduce the absorption of iron. Meat and products containing vitamin C can increase the absorption of iron. Follow the advice of your dietician or doctor when taking Ferrous Fumarate oral suspension with any of the food or drink listed.

Important information about some of the ingredients of Ferrous Fumarate 140mg/5ml Oral Suspension:

Sodium metabisulphite, one of the ingredients in your medicine, can cause allergic-type reactions, including rashes, sweating, swelling of limbs and difficulty in breathing in susceptible people, especially those with a history of asthma or allergy.

Glucose, one of the ingredients in your medicine may be harmful to the teeth.

This product contains parahydroxybenzoates, may cause allergic reactions (possibly delayed), and exceptionally difficulty in breathing

TAKING YOUR MEDICINE:

•    It is important to take your medicine as directed on the label of this medicine. This tells you how much to take and how often to take it.

•    Adults and the elderly Treatment:Two 5 ml spoonfuls twice a day.

Prevention: One 5 ml spoonful twice a day.

Full term infants and young children, Half to one 5ml spoonfuls of syrup twice a day Premature Infants,

•    The usual dosage is 0.6ml/kg/day but some may require 2.4ml/kg/day.

•    Treatment is usually not longer than 6 months but it may be stopped 3 months after the Anaemia has

been corrected.

•    If you forget to take a dose, take the next dose at the normal time.

DO NOT TAKE MORE THAN THE RECOMMENDED DOSE.

If a large amount has been taken, contact your doctor, or the nearest hospital casualty department as soon as possible. Over dosage requires emergency treatment. In young children, doses of 200 250mg/kg ferrous fumarate are considered extremely dangerous.

WHILE TAKING YOUR MEDICINE:

•    If you have to go to a doctor or hospital, tell them that you are taking Ferrous Fumarate 140mg/5ml Oral Suspension.

•    If you have to be treated with other medicine, or want to treat yourself with any other medicines, tell the doctor or pharmacist that you are taking Ferrous Fumarate 140mg/5ml Oral Suspension. Some medicines, such as antibiotics and antacids, can interfere with iron absorption.

AFTER TAKING YOUR MEDICINE.

As with all medicines, they sometimes cause unwanted effects in some people. If you are worried about any unwanted effects, stop taking this medicine, and tell your doctor or pharmacist.

The following unwanted effects have been reported:

•    an allergic reaction e.g. itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

•    stomach discomfort

•    feeling sick or being sick

•    discoloration of teeth

•    constipation, diarrhoea and blackened stools

HOW TO STORE YOUR MEDICINE:

•    Do not store above 25°C.

•    Keep the bottle in outer carton in order to protect from light.

•    Shake the bottle before use.

•    Replace the cap after taking out your dose.

•    Keep out of the reach and sight of children.

•    Do not use this medicine if the bottle is damaged.

•    Do not use this medicine after the “Expiry Date” printed on the pack.

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

Date of Leaflet Revision: September 2016