Sytron 27.5 mg iron per 5 ml Oral Solution

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

1. What Sytron is and what it is used for
2. What you need to know before you take Sytron
3. How to take Sytron
4. Possible side effects
5. How to store Sytron
6. Contents of the pack and other information

• are allergic to sodium feredetate trihydrate or any of the other ingredients of this medicine (listed in section 6, please also see end of section 2: ”Sytron contains” for important information about some of the ingredients).
• have a history of sensitivity to iron-containing preparations.
• have a disorder in which there is excessive absorption and storage of iron such as haemochromatosis or haemosiderosis.
• have repeated blood transfusions or have had them in the past.
• are currently having iron injections.

Talk to your doctor or pharmacist before taking Sytron:

• if you have haemolytic anaemia
• if you have an iron storage or absorption disease
• if you have gastrointestinal disease
• if you are having tests on your stools as iron preparations colour the faeces black and can interfere with test results

Talk to your doctor or pharmacist if a child has been taking Sytron for a long time or at high doses as this can lead to toxic accumulation in the body

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

Do not take Sytron if you:

• are currently having iron injections

Tell your doctor if you are taking any of the following:

• dimercaprol (for metal poisoning)
• iron-containing medicines or tonics
• chloramphenicol, fluoroquinolones or tetracyclines (to treat infections)
• penicillamine (for rheumatoid arthritis)
• methyldopa (for high blood pressure)
• mycophenolate (to prevent organ transplant rejection)
• levodopa, carbidopa or entacapone (for Parkinson's disease)
• bisphosphonates (for osteoporosis)
• thyroxine (for thyroid problems)
• trientine (for Wilson's Disease)
• cholestyramine (for high cholesterol)
• proton-pump-inhibitors e.g. omeprazole (for stomach ulcers)
• bicarbonates, carbonates, calcium, magnesium, zinc and other mineral supplements (indigestion and antacid remedies)

Tea, coffee, eggs, milk, ascorbic acid (vitamin c) and citric acid, may interfere with Sytron.

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

Sytron is not expected to have an effect on your ability to drive or operate machinery.

• Methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), ponceau 4R (E124) - may cause allergic reactions (possibly delayed).
• Sorbitol (sugar) - this medicine contains 1400 mg sorbitol in each dosage unit (5 ml) which is equivalent to 280 mg/ml. 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. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
• Ethanol (alcohol) - this medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in the maximum dose of 10 ml.
• Sodium(salt) – this medicine contains approximately 23 mg sodium (main component of cooking/table salt) in the maximum dose of 10 ml (2 x 5 ml spoonfuls). This is equivalent to 1.2% of the recommended daily dietary intake of sodium for an adult. However, if you are taking smaller doses e.g. 1 x 5 ml spoonful at a time or less then it contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

Adults and Elderly (over 65 years)

1 or 2 x 5 ml spoonfuls 3 times a day

Children

Depends on weight – 3 to 6 mg/kg (max 200 mg) of elemental iron* as given by your healthcare professional in 2-3 divided doses

Babies of low-birth weight who are solely breast-fed

5 mg of elemental iron* (0.9 ml given in a 1ml syringe) daily as given by your healthcare professional.

A higher dose – depending on weight – up to 2 mg/kg of elemental iron* daily as given by your healthcare professional may be required for exclusively breast-fed babies.

Babies (6 to 24 months)

1 x 2.5 ml spoonful daily

Children (2 to 5 years)

1 x 5 ml spoonful daily

Children (6 to 11 years)

1-2 x 5ml spoonfuls daily

Adolescents

2 x 5 ml spoonfuls daily

*Elemental iron is iron your body can absorb.

If you accidentally take too much Sytron or give too much to a child, tell your doctor immediately or contact your hospital. Take this leaflet, the container and any remaining Sytron with you, if you can.

An overdose may cause:

• sickness (this may have some blood in it) or make you feel sick
• stomach pains
• diarrhoea
• blood in your stools
• tiredness
• cold and sweaty skin
• fast heart beat
• high blood sugar
• high blood acidity (metabolic acidosis).

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

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: 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: sodium feredetate trihydrate (also known as sodium iron edetate) 207.5 mg/5 ml (equivalent to 27.5 mg/5 ml of elemental iron).

The other ingredients are: methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), citric acid monohydrate, saccharin sodium, glycerol, sorbitol, ethanol, ponceau 4R (E124), black cherry flavouring, water (please see end of section 2: ”Sytron contains” for important information about some of the ingredients).

Sytron is a red, sugar free, cherry-flavoured liquid supplied in amber coloured glass bottles containing 125 ml, 500 ml or 2250 ml of oral solution (not all pack sizes may be marketed).