Fersaday 100mg Tablets

1. Name Of The Medicinal Product

Fersaday 100mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 322.0mg Ferrous Fumarate BP

3. Pharmaceutical Form

Film-coated Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis and treatment of iron deficiency states.

4.2 Posology And Method Of Administration

Adults and the elderly: One tablet daily (the foil enclosing the tablet is printed with days of the week in sequence).

In severe or refractory iron deficiency, one tablet may be given twice a day.

Children: Fersaday tablets are not intended for the treatment of children.

Method of administration: Oral

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. Ferasday tablets 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 needed when treating patients with iron deficiency anaemia in patients with treated or controlled peptic ulceration. Duration of treatment of uncomplicated iron deficiency anaemia should not usually exceed 6 months (or 3 months after reversal of the anaemia has been achieved).

Since anaemia due to combined iron and vitamin B12 or folate deficiencies may be microcytic in type, patients with microytic anaemia resistant to therapy with iron alone should be screened for vitamin B12 or folate deficiency. Fersaday tablets should be kept out of the reach of children.

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Iron reduces the absorption of penicillamine. Absorption of both iron antibiotic may be reduced if Fersaday is given with tetracycline. Concurrent administration of antacids may reduce absorption of iron. 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.

4.6 Pregnancy And Lactation

Administration of Fersaday tablets 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

Gastro-intestinal disorders have been reported including gastro-intestinal discomfort, anorexia, nausea, vomiting, constipation, diarrhoea, darkening of the stools may occur.

4.9 Overdose

Acute overdosage with oral iron requires emergency treatment. In young children 200-250mg ferrous fumerate is considered to be extremely dangerous. Symptoms and signs of abdominal pain, vomiting and diarrhoea appear within 60 minutes. Cardiovascular collapse with coma may follow. Some improvement may occur after this phase in some patients, and may be followed by 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% sodium bicarbonate solution by mouth.

Dissolve 2 grams of desferrioxamine mesylate in 2 or 3ml of water for injections and give intramuscularly. A solution of 5 grams desferrioxamine mesylate in 50 to 100ml of fluid may be left in the stomach. If desferrioxamine is not available, leave 300ml of 1% to 5% sodium bicarbonate in the standard. Fluid replacement is essential.

Recovery may be complicate by long term sequelae, such as hepatic necrosis, pyloric sterosis, 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 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

Once in the stomach, the acid conditions of the gastric contents cause the dissociation of ferrous fumerate and ferrous ions are liberated. These ions are absorbed through 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 is passed onto the iron stores in the liver, spleen, and bone marrow.

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

Iron is lost from the body through loss of cells i.e, urine, faeces, hair, skin, sputum, nails, sloughing of 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

Tablet Core

Maize Starch BP

Sodium Lauryl Sulphate BP

Gelatin BP

Paraffin Liquid BP

Purified Water BP

Film Coating

Hydroxypropyl Methylcellulose USP

Acetylated Monoglyceride

Opaspray Buff K1-3618

Dichloromethane

Industrial Methylated Spirit BP

Purified Water BP

6.2 Incompatibilities

None

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Protect from light.

Do not store above 30^oC.

6.5 Nature And Contents Of Container

Cartons containing two blister packs of 14 tablets, prepared from opaque PVC film and tempered aluminium foil. 28 tablets in each carton and dispensing pack of 1000 tablets in Polypropylene container with tamper evident low density polyethylene cap.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Goldshield Group Plc

Trading as Goldshield Pharmaceuticals,

NLA Tower,

Croydon,

Surrey CR0 OXT

8. Marketing Authorisation Number(S)

PL 10972/0041

9. Date Of First Authorisation/Renewal Of The Authorisation

07/01/2009

10. Date Of Revision Of The Text

24/02/2009