Ironorm Drops Oral Solution

1. What are Ironorm Drops and what are they used for?
2. What you need to know before you use Ironorm Drops?
3. How to use Ironorm Drops?
4. Possible side effects?
5. How to store Ironorm Drops?
6. Contents of the pack and other information.

• you are sensitive to any of the ingredients (full list provided in section 6)
• you suffer from an inherited condition of abnormal iron metabolism
• you have an active peptic ulcer
• you are undergoing repeated blood transfusions
• you suffer from a severe stomach upset or ulcerative colitis
• you have been diagnosed with a haemolytic anaemia which are anaemias that cause break down of the red blood cells.

Talk to your doctor or pharmacist before taking Ironorm Drops if:

• you have had a recent operation on your stomach
• you have previously suffered from a peptic ulcer
• you are already receiving treatment for other forms of anaemia
• you suffer from intestinal blockages
• you are elderly (there is an increased risk of intestinal blockage).

• treatment is not normally required more than 1 or 2 months after childbirth.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines. This is because Ironorm Drops may affect the amount of these medicines in your blood:

• tetracyclines, a type of antibiotic
• antacids
• cholestyramine, used to remove bile from the gut. It is sometimes used to reduce blood cholesterol levels
• penicillamine, a treatment for rheumatoid arthritis and a few other rare inherited conditions.

Also tell your doctor or pharmacist if you are taking any of the following medicine as it upsets iron metabolism:

• chloramphenicol, a type of antibiotic.

You should also be aware that:

• tea, eggs and milk will reduce absorption of the iron.

If you are pregnant or think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine. Ironorm Drops should only be used during pregnancy, especially during the first trimester, after careful assessment by a medical doctor.

Ironorm Drops do not affect your ability to drive or operate machinery.

In addition to the active ingredient, some of the other ingredients in Ironorm Drops may affect some individuals:

• metabisulfite can cause allergic reactions (such as skin rash and fluid retention) and bronchospasm (asthma-like difficulty in breathing) in susceptible individuals
• sorbitol, this medicine contains 2075 mg sorbitol in each 4.8ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
• This medicine contains 623 mg propylene glycol in each 4.8ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.

If you experience an allergic reaction then discontinue use of the medicine and consult your doctor.

Infants 4 – 6 weeks to mixed feeding:

0.2 ml per day

(5.0 mg ELEMENTAL IRON).

Higher doses of up to 0.08 ml per kg body weight (2.0 mg ELEMENTAL IRON per kg) might be needed to cover the needs of growing, exclusively breastfed, infants.

Older infants and children to 6 years:

0.5 to 1.2 ml per day

(12.5 – 30 mg ELEMENTAL IRON).

Older children:

2.4 ml per day (60 mg ELEMENTAL IRON).

Adults and Elderly:

2.4 to 4.8 ml per day

(60 – 120 mg ELEMENTAL IRON).

Paediatric:

0.12 ml to 0.24 ml (3 – 6 mg ELEMENTAL IRON) per kg body weight, up to a maximum of 8 ml (200 mg ELEMENTAL IRON) given daily in two or three divided doses.

Adults:

4.0 ml once or twice per day (100 – 200 mg ELEMENTAL IRON).

If you have taken a possible overdose then you should seek medical advice immediately. If possible you should take any remaining medicine, packaging and this leaflet with you provided it doesn’t cause a delay.

Do not take a double dose to make up for a forgotten dose. If you have missed a dose then wait until your next dose is due.

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

The active substance is ferrous sulfate. Each 1ml of the syrup contains 125mg of ferrous sulfate which is equivalent to 25mg of elemental iron. The other ingredients are sorbitol solution, disodium edetate, ascorbic acid, sodium metabisulfite, propylene glycol, orange flavouring and purified water.

Ironorm Drops are a green to yellow syrup supplied in glass bottles of 15ml with a calibrated syringe. It is normal for the drops to darken on storage.

The marketing authorisation owner is:

The manufacturer is:

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