Patient leaflet - Niferex elixir

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 What you need to know before you take

Do not take Niferex Elixir if:

You are allergic to Niferex Elixir or any of the other ingredients of this medicine (listed in section 6).
You are known to have a build-up of too much iron in the body (iron overload, haemosiderosis, haemochromatosis).
You suffer from severe inflammation of the gut (enteritis and ulcerative colitis).
You currently have a peptic ulcer.
You suffer from a reduction of red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia).
You have repeated blood transfusions.

Warnings and precautions

Talk to your doctor before taking Niferex Elixir if:

You have had an operation to remove whole or part of your stomach.
You have a history of peptic ulcers.
You are known to have a lack of vitamin B12 or folic acid.

Other medicines and Niferex Elixir

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without prescription. This includes herbal medicines.

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.
Zinc.

The absorption of iron may be reduced by the following:

Magnesium trisilicate, used to treat indigestion and also antacids, such as aliginates. • Trientine, 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 reduce the absorption of the following medicines:

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 Niferex Elixir 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 or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

This medicine should not be taken during the first trimester of pregnancy (first 3 months) unless your doctor thinks the benefits outweigh the risks.
For the remainder of the pregnancy, your doctor may decide to continue your treatment with Niferex Elixir.

Breast-feeding

Iron is passed into breast milk but not in significant amounts.

Driving and using machines

No effects of Niferex Elixir are known.

Niferex Elixir contains sorbitol E420

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 have a mild laxative effect.

3 How to take Niferex Elixir

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Niferex Elixir is for oral use.
Recommended to be taken after food (not tea, eggs or milk – see “Taking Niferex Elixir with food and drink” section).
Treatment should not generally be more than 3 months after your anaemia has been corrected.

Adults and elderly

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 daily).

Pregnancy (during second (3-6 months) and third trimester [6-9 months])

To treat iron deficiency anaemia: 5ml daily (100mg elemental iron daily)

Use in children

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 mcgs of elemental iron).
For children older than 6 months, the 190ml bottle should be used.

To treat iron deficiency anaemia:

All paediatric age groups: 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, given in 2 or 3 divided doses.
To be 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 given in 2 or 3 divided doses.

Children from 24 months to 59 months: 2mg/kg daily up to 30mg daily given in 2 or 3 divided doses.

Children from 5 years to 11 years: 30-60mg daily given in 2 or 3 divided doses.

Older Children (11 years and above): 60mg daily given in 2 or 3 divided doses.

If you take more Niferex Elixir than you should

If you accidentally take too much, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining Niferex Elixir with you.

Symptoms of overdose include: stomach pains, feeling or being sick (nausea, vomiting), diarrhoea, blood in your bowel motions or vomit, feeling of tiredness (lethargy) and weakness. Increased blood sugar levels (hyperglycaemia) and acid in the blood (metabolic acidosis) may also occur.

If you forget to take Niferex Elixir

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Niferex Elixir

It is important that you keep taking Niferex Elixir for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, Niferex Elixir can cause side effects, although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness

Side effects

Feeling or being sick (nausea, vomiting)
Loss of appetite (anorexia)
Diarrhoea
Stomach discomfort
Constipation
Darker bowel motions

These side effects may be reduced by taking Niferex Elixir after food.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Niferex Elixir

Keep this medicine out of the sight and reach of children. • Do not use Niferex Elixir after the expiry date, which is stated on the carton/label after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6 Contents of the pack and other information

What Niferex Elixir contains:

Each 5ml of Niferex Elixir contains 217.4mg of polysaccharide−iron complex (equivalent to 100mg of elemental iron).

The other ingredients are: ethyl alcohol 96%), sorbitol solution 70% (non−crystallising) E420, caramel, hydrochloric acid, purified water.

What Niferex Elixir looks like and contents of the container:

Niferex Elixir oral solution is a dark brown liquid with a slightly sweet taste.

Niferex Elixir is available in:

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.

Not all pack sizes or pack types may be marketed.

Product Licence Number:

PL 11311/0023

Marketing Authorisation Holder:

Tillomed Laboratories Limited

220 Butterfield

Great Marlings

Luton

LU2 8DL

United Kingdom

Manufacturer:

Tillomed Laboratories Ltd.

3 Howard Road

Eaton Socon

St Neots

Cambridgeshire

PE19 8ET