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Niferex Elixir Oral Solution
Tracked PIL for SPC updates to Neoates dosage
(PL 11311/0023)
Niferex Elixir Oral Solution
(100mg elemental iron per 5ml elixir, within a polysaccharide-iron complex)


Please read this leaflet carefully before you start to take this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you or your child. Do not pass it on to others. It may harm
them, even if their symptoms are the same.
If any of the side effects get serious or you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
What this medicine is and what it is used for
Before you take
How to take
Possible side effects
How to store
Further information

1. What this medicine is and what it is used for
Niferex Elixir is an iron preparation.
It is used to treat and prevent simple iron deficiency anaemia. Anaemia is a condition in which the
blood cannot carry enough oxygen around the body, because of a reduction in red blood cells. This
can make the skin pale and cause weakness or breathlessness.
Iron is necessary for the production of haemoglobin (protein in red blood cells), which carries oxygen
round the body.
2 Before you take
Do not take Niferex Elixir if:
• you are allergic to Niferex Elixir or any of the ingredients.
• you are known to have a build up of too much iron in the body (iron overload, haemosiderosis,
• you suffer from inflammation of the gut.
• you currently have a peptic ulcer.
• you suffer from breakdown of red blood cells (haemolytic anaemia).
• you have repeated blood transfusions.
Take special care with Niferex Elixir
• if you have had an operation to remove whole or part of your stomach.
• if you have a history of peptic ulcers.
• if you are known to have a lack of vitamin B12 or folic acid.
If any of the conditions listed under `Do not take’ or `Take special care’ apply to you, please
talk to your doctor or pharmacist.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without prescription.
Other medicines may interfere with the actions of Niferex Elixir, in particular the ones listed in the next

You must tell your doctor or pharmacist if you are taking any of the medicines listed below.
The absorption of both Niferex Elixir and the medicines below may be reduced, if taken together.
• medicines used to treat bacterial infections (tetracylines), such as doxycycline.

The absorption of iron may be reduced by the following:
• magnesium trisilicate, used to treat indigestion and also antacids, such as aliginates.
• trientina, used to treat excess copper in the body (Wilson’s disease).
• neomycin, antibiotic used to treat bacterial infections.
• cholestyramine, used to lower cholesterol.
Niferex Elixir may interact with the following:
• penicillamine, for rheumatoid and juvenile arthritis.
• levodopa, used to treat Parkinson’s disease.
• medicines for bone disorders (biosphosphonates), such as disodium etidronate, disodium
pamidronate and disodium clodronate.
• ciprofloxacin, norfloxacin, ofloxacin and chloramphenicol, used to treat infections.
Taking with food and drink
The absorption of Niferex Elixir may be reduced if taken with tea, eggs or milk.
Pregnancy and breast feeding
If you are pregnant, think you might be pregnant or you are breast−feeding, you must tell your doctor
and take advice before taking this medicine.
Driving and using machines
No effects of Niferex Elixir are known
Sorbitol E420. Warning about the ingredient
• Niferex Elixir contains the ingredient Sorbitol E420 (350mg/ml).
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor
before taking this medicine.
• Sorbitol E420 may cause stomach upset and diarrhoea.
3 How to take
You should always take this medicine as prescribed by your doctor. Do not take more than the
doctor told you. Follow the instructions on the pharmacist’s label. If you are not sure about
anything please ask your doctor or pharmacist.
• Niferex Elixir is for oral use
• Recommended to be taken after food
Please note: Niferex Elixir should not be taken with tea, eggs or milk.
Duration of treatment
Only take this medicine for the time period prescribed by your doctor.
Treatment should not generally be more than 3 months after your anaemia has been corrected.
Normal starting doses
The doses stated below are guidelines only.
You should always take this medicine as prescribed by your doctor.
The dose you are prescribed will depend upon the severity of your anaemia.
Each 5ml of Niferex Elixir contains 217.4mg of polysaccharide−iron complex (equivalent to 100mg of
elemental iron).

To treat iron deficiency anaemia: 5ml of Niferex Elixir once or twice a day (100 – 200mg of
elemental iron daily).
To prevent iron deficiency anaemia: 2.5ml of Niferex Elixir once a day (50mg of elemental iron
To treat iron deficiency anaemia: 5ml once or twice daily. Same dose as adults.
Pregnancy (during second and third trimester)
To treat iron deficiency anaemia: 5ml daily (100mg elemental iron daily)
Infants and children
To treat iron deficiency anaemia: 3 – 6mg/kg (maximum 200mg) of elemental iron daily, given in 2 –
3 divided doses.
To prevent iron deficiency anaemia:
Low birth weight babies solely breast fed:
5mg/day of elemental iron, started 4 - 6 weeks after birth and continued until mixed feeding is
established. Higher doses up to 2mg/kg daily might be needed to cover the needs of growing
exclusively breastfed infants.
Children from 6 months to 23 months: 2mg/kg daily
Children from 24 months to 59 months: 2mg/kg daily up to 30mg daily
Children from 5 years to 11 years: 30-60mg daily
Older Children (11 years and above): 60mg daily
Paediatric 30ml dropper bottles are available for use in children under the age of 6 months.
One drop from the paediatric dropper contains approximately 500 micrograms of elemental iron).3
times a day, or as directed by your doctor.
For children older than 6 months, the 190ml bottle should be used.
If you forget to take Niferex Elixir at the right time, take it as soon as you remember. Do not take a
double dose to make up for forgotten individual doses.
If you have taken more Niferex Elixir than you should, go to your doctor or the nearest hospital
casualty department immediately. Take this leaflet or some Niferex Elixir with you so that people will
know what you have taken. If you have taken more than is recommended, you may experience the
following symptoms, stomach pains, sickness, diarrhoea, blood in your bowel motions or vomit, and a
feeling of tiredness and weakness.
4 Possible side effects
Like all medicines, Niferex Elixir can have side effects, though it does not normally cause any
Uncommon side effects (probably affecting fewer than 1 in 100 people)
• feeling of sickness
• loss of appetite
• allergic reactions
• diarrhoea
• stomach discomfort
• vomiting
• constipation
• darker bowel motions

These side effects may be reduced by taking Niferex Elixir after food.
If any of the side effects become serious or you notice any not listed, please tell your doctor or
5 How to store
Do not store above 25°C and keep it in its original container.
Keep out of the reach and sight of children.
Do not use after the expiry date (EXP) on the label.
When you have stopped taking this medicine, unless your doctor tells you otherwise, return any
unused Niferex Elixir to the pharmacist.
6 Further information
What Niferex Elixir contains:
• Active substance: elemental iron contained within a polysaccharide−iron complex. Each 5ml of
Niferex Elixir contains 217.4mg of polysaccharide−iron complex (equivalent to 100mg of
elemental iron).
• Other ingredients: ethyl alcohol, sorbitol solution 70% (non−crystallising) E420, caramel (E150),
hydrochloric acid, purified water.
(See `warning about the ingredient sorbitol E420’, end of section 2, on page 1)
What Niferex Elixir looks like and the contents of the container:
Niferex Elixir oral solution is a dark brown liquid with a slightly sweet taste.
It is available in the following sizes:
• 30ml paediatric dropper bottle
Plastic bottle with a plastic dropper applicator and childproof screw cap.
• 190ml bottle
Glass bottle with a childproof plastic screw top.
• 240ml bottle
Plastic bottle with a childproof plastic screw top.
Marketing Authorisation Holder and
Tillomed Laboratories Ltd.
3, Howard Road,
Eaton Socon,
St Neots,
Cambs, PE19 8ET
Product Licence Number 11311/0023.
This leaflet was last revised June 2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.