Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ferrous sulfate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
e Ironorm Drops? Do not use if: 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. Warnings and precautions 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). If you have recently given birth treatment is not normally required more than 1 or 2 months after childbirth. Other medicines and Ironorm Drops? 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. Pregnancy and breast-feeding? 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. Driving and using machines Ironorm Drops do not affect your ability to drive or operate machinery. Important information about some of the ingredients in Ironorm Drops 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.
Ironorm Drops? Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Read these instructions carefully because the dose depends both on age and the reason for treatment. Do not exceed the prescribed dose.
H0028-6
Ironorm Drops Oral Solution
PROPHYLACTIC DOSAGE: 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). THERAPEUTIC DOSAGE: 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 take more Ironorm Drops than you should 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. If you forget to take Ironorm Drops 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. 4. Possible side effects? Like all medicines, this medicine can cause side effects, although not everybody gets them. The elderly may suffer from severe constipation in which case they should discontinue treatment immediately and seek medical advice. Ironorm Drops can stain the teeth black during treatment. This can be reduced with regular brushing. The staining is not permanent and will fade when your treatment is over. The following side effects have also been reported to the ingredients of Ironorm Drops: Frequency unknown: constipation stomach pain loss of appetite diarrhoea nausea darkening of stools vomiting allergic reactions. If you experience any unexpected side effects not mentioned above, or the side effect (as listed) is severe or persists for more than a few days, discontinue use of the medicine and consult your doctor. Reporting of side effects. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
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.
Ironorm Drops? Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. Do not use this medicine after the expiry date which is stated on the bottle. Store below 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
. What Ironorm Drops contain: 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. What Ironorm Drops look like and contents of the pack: 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. Marketing Authorisation Holder and Manufacturer: The marketing authorisation owner is: Wallace Manufacturing Chemists Ltd., 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF, UK. The manufacturer is: Laleham Health and Beauty Ltd., Bradshaw Lane, Greenhalgh, Kirkham, Lancashire PR4 3JA, UK. or Laleham Health and Beauty Ltd., Sycamore Park, Alton, GU23 2PR, UK. PL 0400/0010R This leaflet was last revised in December 2020
Ironorm Drops Oral Solution comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Ironorm Drops Oral Solution is ferrous sulfate.
Medicines with the same active substance, strength and form include: Galfer Syrup. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Ironorm Drops Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For prevention and treatment of iron deficiency anaemias.
Oral administration.
Prophylactic:
A daily dose of 5 mg of elemental iron as prophylactic iron supplementation for babies of low birth weight who are solely breast-fed is recommended. Higher doses up to 2mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation is started 4-6 weeks after birth and continued until mixed feeding is established.
Older infants and children to 6 years: 0.5 – 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 – 4.8 ml per day (60 – 120 mg of elemental iron)
Therapeutic:
Paediatric: 0.12ml to 0.24ml (3mg – 6mg elemental iron) per kg body weight, up to a maximum of 8ml (200mg elemental iron) given daily in two or three divided doses.
Adults: 4.0 ml once or twice per day (100 – 200 mg elemental iron)
• Hypersensitivity to the product or ingredients
• Haemosiderosis and haemocromatosis
• Active peptic ulcer
• Repeated blood transfusion
• Regional enteritis and ulcerative colitis
• Haemolytic anaemias
• Patients post-gastrectomy have poor absorption of iron.
• Caution is advised when prescribing iron preparations to individuals with history of peptic ulcer.
• Duration of treatment should generally not exceed 1-2 months after end of pregnancy.
• Coexisting deficiency of dietary vitamin B12 should be ruled out since combined deficiency produces microcytic blood film.
• Care should be taken in patients with intestinal strictures and diverticulae.
• Caution is required in the elderly where there is an increased risk of faecal impaction.
• The label will state “Important warning: Contains iron. Keep out of the reach and sight of children, as overdose may be fatal”. This will appear on the front of the pack within a rectangle in which there is no other information.
• Iron and tetracyclines interfere with absorption of each other.
• Absorption of iron is impaired by penicillamine, antacids, cholestyramine, tea, eggs and milk.
• Chloramphenicol delays plasma clearance of iron, incorporation of iron into red blood cells by interfering with erythropoiesis.
Administration of drugs during the first trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained and Ironorm should not be administered unless clearly indicated.
The medicine is considered unlikely to impair the ability to drive or to operate machinery safely.
Anorexia, nausea, vomiting, gastrointestinal discomfort, reversible dental staining, constipation, diarrhoea, dark stools and allergic reactions. The product contains metabisulfite as a preservative which can precipitate allergic reactions and bronchospasm in susceptible individuals.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:
Website: www.mhra.gov.uk/yellowcard
Iron overdosage is an acute emergency requiring urgent medical attention. An acute intake of 75mg/Kg of elemental iron is considered extremely dangerous in young children. Serum iron levels should be monitored.
Symptoms and signs include abdominal pain, diarrhoea and vomiting (haematemesis is a possibility) within 1 - 2 hours, followed by cardiovascular collapse and coma in some patients. Recovery follows this phase and in some patients this continues; in others, deterioration occurs in about 15 hours characterised by diffuse vascular congestion, pulmonary oedema, convulsion, hypothermia, renal failure, shock, metabolic acidosis, coagulopathy and/or hypoglycaemia. Treatment consists of supportive and symptomatic measures. Vomiting should be induced if the patient presents early and gastric lavage should be considered using a solution of desferrioxamine. Parenteral injection of 2g desferrioxamine should be given IV or IM and 5g of desferrioxamine in 50 - 100ml of fluid may also be left in the stomach.
Recovery may be complicated by long term effects such as hepatic necrosis, toxic encephalitis and CNS damage, and pyloric stenosis.
Ask anything about Ironorm Drops Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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