FERSAMAL

Posology Each 5 ml of Fersamal syrup contains 140 mg Ferrous Fumarate which approximates to 45 mg of elemental iron – section 2 SmPC.

Prevention of iron deficiency:

Adults and elderly: Fersamal syrup one 5 ml spoonful twice a day. 5mg/day 2-5 years of age: 20-30mg/day 6-11 years of age: 30-60mg/day Older children: 60mg/day Premature infants: 5mg elemental iron per day. Iron supplementation in premature infants is only recommended in those of low birth weight who are solely breast fed.

Higher doses up to 2mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation should be commenced 4-6 weeks after birth and continued until mixed feeding is established.

Treatment of iron deficiency:

Adults and elderly: Fersamal syrup two 5 ml spoonfuls twice a day Paediatric population: Full term infants and children: 3 to 6 mg elemental iron/Kg/day given in 2 to 3 divided doses. Total daily dose should not exceed 180 mg elemental iron.

Administration to infants and children should take place under medical advice. Medical advice should be sought if symptoms do not improve after four weeks of use of this product as these symptoms may reflect an underlying disease process.

Method of administration:

Oral

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Not known: frequency cannot be estimated from the available data Gastrointestinal disorders: The commonest side effects relate to gastrointestinal irritation (nausea, epigastric pain, constipation or diarrhoea).

In the event of these ADRs, it may be helpful to reduce the dose or switch to an alternative iron salt. Darkening of stools, black discoloration of the teeth and allergic reactions (due to metabisulphite in the syrup vehicle) may also occur.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Some post-gastrectomy patients show poor absorption of iron. Care is required when treating patients with iron deficiency anaemia who have treated or controlled peptic ulceration. Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (3 months after reversal of the anaemia has been achieved).

Because anaemia due to combined iron and Vitamin B12 or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to treatment with iron alone should be screened for Vitamin B12 or folate deficiency.

Paediatric population Fersamal syrup should be kept out of the reach of children. Long-term treatment with Fersamal syrup may increase the risk of dental caries. Adequate dental hygiene must be maintained. Since Fersamal syrup contains sugar, care must be exercised when using in patients with diabetes mellitus.

Fersamal Syrup contains:

Glucose: Patients with rare Glucose galactose malabsorption should not take this medicine.

Sucrose:

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

1. Known hypersensitivity to any of the ingredients of the product. Paroxysmal nocturnal haemoglobinuria. Haemosiderosis, haemochromatosis. Active peptic ulcer. Repeated blood transfusions. Regional enteritis and ulcerative colitis. Must not be used in anaemias other than those due to iron deficiency.