Fersamal 140mg / 5ml Syrup

1. Name Of The Medicinal Product

Fersamal 140mg/5ml Syrup

2. Qualitative And Quantitative Composition

Each 5ml of syrup contains approximately 140mg ferrous fumarate BP (45mg elemental iron).

3. Pharmaceutical Form

Syrup

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis and treatment of iron deficiency states.

For prophylaxis during pregnancy, a combination of iron and folic acid is usually recommended.

4.2 Posology And Method Of Administration

Adults and the elderly:

a) Iron deficiency anaemia- Fersamal syrup two 5 ml spoonfuls twice a day

b) prophylaxis- Fersamal syrup one 5 ml spoonful twice a day.

Children: Full term infants and young children-half to one 5ml spoonful twice a day.

Premature infants: 0.6ml/kg/ day to 2.4 ml/kg/day.

Method of administration: Oral

Rationale:

Taking into account the content of elemental iron and the referenced recommended daily doses of the same in deficiency states and for prophylaxis, the Fersamal dosing is in need of revision.

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

Recommended doses:

(a) Iron deficiency anaemia: 100 to 200 mg elemental iron per day – reference (1) BNF (2) G&G. This equates most closely to Fersamal syrup two 5 ml spoonfuls twice a day.

(b) Prophylaxis: ferrous sulphate 200 mg once or twice a day (reference BNF) i.e. 60 to 120 mg elemental iron per day. This equates most closely to Fersamal syrup one 5ml spoonful twice a day.

4.3 Contraindications

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.

4.4 Special Warnings And Precautions For Use

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.

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Iron reduces the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) (give at least 2 hours apart), moxifloxacin, mycophenolate, norfloxacin, ofloxacin, zinc. Absorption of both iron and antibiotic may be reduced if Fersamal 140mg/5ml is given with tetracycline. Absorption of oral iron is reduced by calcium salts, Magnesium salts (as magnesium trisilicate), Trientine.

Chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis. Some inhibition of iron absorption may occur if it is taken with cholestyramine, tea, eggs or milk.

Avoid concomitant use of iron with dimercaprol.

Oral iron antagonises hypotensive effect of methyldopa.

4.6 Pregnancy And Lactation

Administration during the first trimester of pregnancy may be undesirable.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

4.9 Overdose

Acute overdosage of oral iron requires emergency treatment. In young children, 200 to 250mg/kg ferrous fumarate is considered to be extremely dangerous.

Symptoms and signs of abdominal pain, vomiting and diarrhoea occur within 60 minutes of ingestion of an overdose.

Cardiovascular collapse and coma may follow. Some spontaneous improvement may occur after this, and in some patients there is recovery. In other patients, after about 16 hours, deterioration may occur with diffuse vascular congestion, pulmonary oedema, convulsions, anuria, hypothermia, severe shock, metabolic acidosis, coagulation abnormalities, or hypoglycaemia.

Vomiting should be induced immediately, followed by parenteral injection of desferrioxamine mesylate and then gastric lavage. In the meantime, it is useful to give milk and/or 5% bicarbonate solution by mouth.

Desferrioxamine mesylate is given intramuscularly - dissolve 2 gm desferrioxamine mesylate in 2 or 3 ml of water for injection.

A solution of 5 gm desferrioxamine mesylate in 50 to 100 ml of fluid may be left in the stomach. If desferrioxamine is not available, leave 300ml of 1% to 5% sodium bicarbonate solution in the stomach. Fluid replacement is essential. Recovery may be complicated by long term sequelae, such as hepatic necrosis, pyloric stenosis, or acute toxic encephalitis which may cause CNS damage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Iron is an essential constituent of the body, and is necessary for haemoglobin formation and for the oxidative processes of living tissues. Iron and iron salts should be given for the treatment or prophylaxis of iron deficiency anaemias. Preparations of iron are administered by mouth, by intramuscular or intravenous injection.

Soluble ferrous salts are most effective by mouth. Ferrous fumarate is an easily absorbed source of iron for replacement therapy. It is a salt of ferrous iron with an organic acid and is less irritant to the gastro-intestinal tract than salts with inorganic acids.

5.2 Pharmacokinetic Properties

In the acid conditions of the gastric contents, ferrous fumarate is dissociated and ferrous ions are liberated. These ions are absorbed in the proximal portion of the duodenum.

The ferrous iron absorbed by the mucosal cells of the duodenum is oxidised to the ferric form, and this is bound to protein to form Ferritin.

Ferritin in the mucosal cells releases iron into the blood, where it is bound to transferrin and passed into the iron stores - liver, spleen, and bone marrow.

These stores are a reserve of iron for synthesis of haemoglobin, myoglobin, and iron containing enzymes.

Iron is lost from the body through loss of cells in urine, faeces, hair, skin, sputum, nails, and mucosal cells, and through blood loss.

Ferrous fumarate has the same pattern of absorption and excretion as dietary iron.

5.3 Preclinical Safety Data

No further data.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Nipastat GL 75

Methylcellulose 20 BP

Liquid glucose BPC

Granulated sugar BP

Granular lecithin (97% A1)

Elderberry flavour (Bush C7529)

Sodium metabisulphite BP

Purified water BP

6.2 Incompatibilities

None.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Protect from light. Store below 25°C.

6.5 Nature And Contents Of Container

Amber glass bottle with polypropylene cap and melinex/pulpboard/aluminium wad containing 200 ml of Fersamal 140mg/5ml syrup.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

NLA Tower, 12-16 Addiscombe Road

Croydon, Surrey, CR0 0XT,

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0223

9. Date Of First Authorisation/Renewal Of The Authorisation

02/12/1993

10. Date Of Revision Of The Text

29/06/2010