Composition:

Each film coated tablet contains Ferrous fumarate 322mg( equivalent to 106.26 Iron element) and Folic acid 0.35 mg.

Mechanism of action:

- There is evidence that a daily intake of 100mg of elemental iron in the ferrous form is adequate to prevent development of iron deficiency in expectant mothers.

- The daily folate requirement rises steeply during the final trimester of pregnancy.

- To ensure normal tissue folate levels in the mother after delivery a daily supplement of about 300 micrograms is required during the second and third trimester of pregnancy.

Indications:

•  Folic Mammy tablets are indicated during the second and the third trimester of pregnancy for prophylaxis against iron deficiency and megaloblastic anaemia of pregnancy.

•  Folic Mammy tablets are not intended as a treatment for established megaloblastic anaemia.

Doses:

Adults: It is usual to begin therapy with Folic Mammy tablets about the thirteenth week of pregnancy either as routine prophylaxis or selectively if the haemoglobin concentration is less than 11g/100ml (less than 75% normal).

One tablet should be taken daily by mouth.

Children: Not applicable.

Overdose:

Symptoms: Symptoms and sign of abdominal pain, vomiting and diarrhea within 60 minutes. Cardiovascular collapse with coma may follow. Some improvement may occur after this phase which in some patients, is followed by recovery. In others, after 16 hours, deterioration may occur involving diffuse vascular congestion, pulmonary oedema, convulsions, anuria, hypothermia, severe shock, metabolic acidosis, coagulation abnormalities and hypoglycaemia

Management: Vomiting should be induced immediately, followed as soon as possible by parenteral injection of desferrioxamine mesylate and then gastric lavage. In the meantime, it is useful to give milk and/or 55 sodium bicarbonate solution by mouth.

Dissolve 2g desferrioxamine mesylate in 2 to 3ml of water for injections and give intramuscularly. A solution of 5g desferrioxamine 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 stomach. Fluid replacement is essential.

Children: Acute overdose of oral iron requires emergency treatment. In young children 200-250mg/kg ferrous Fumarate is considered to be extremely dangerous.

Side Effects:

•  Gastro-intestinal disorders include: gastro-intestinal discomfort, anorexia, nausea, vomiting, constipation, diarrhea, darkening of the stools may occur.
• Rarely allergic reqctions may occur.                                                                                              

Contraindications:

Hypersensitivity to the product, vitamine B₁₂ deficiency, paroxysmal nocturnal haemoglobinuria, haemosiderosis, haemochromatosis, active peptic ulcer, repeated blood transfusion, regional enteritis and ulcerative colitis.

Folic Mammy must not be used in the treatment of anaemia other than those due to iron deficiency.

Drug Interactions:

• Iron reduces the absorption of penicillamine. Iron compounde impair the bioavailability of fluoroguinolones, levodopa, carbidopa, thyroxine and bisphosphates.
• Absorption of both iron and antibiotic may be reduced if pregnant care is given with tetracycline.
• Absorption of both iron and zinc are reduced if taken concomitantly.
• Concurrent administration of antacids may reduce absorption of iron. Co-trimoxazole, chloramphenicol, sulphasalazine, aminopterin, methotrexate, pyrimethamine or sulphonamides may interfere with folate metabolism.
• Serum levels of anticonvulsant drugs may be reduced by administration of folate.
• Oral chloramphenicol delays plasma iron clearance.
• Some inhibition of iron absorption may occur if it is taken with cholestyramine, trientine, tea, eggs and milk.
• Administration of oral iron may increase blood pressure in patients receiving methyldopa.
• Coffee may be a factor in reducing iron bioavailability.
• Neomycin may alter the absorption of iron.

Precautions:

• Some post-gastrectomy patients show poor absorption of iron.
• Care is needed when treating iron deficiency anaemia in patients with treated or controlled peptic ulceration.
•  Caution should be exercised when administrating folic acid to patients who may have folate dependent tumours.
•  Since anaemia due to combined iron and vitamin B₁₂ or folate deficiencies may be microcytic in type, patients with microcytic anaemia resistant to therapy with iron alone should be screedned for vitamin B₁₂ or folate deficiency.
•  Pregnant care should be kept out of reach of children.

Use in Pregnancy or Lactation:

pregnancy : The use of Folic Mammy tablets may be considered during the first trimester of pregnancy , if necessary.

Licensed for use in second and third trimester of pregnancy for prophylaxis against iron deficieny and megaloblastic anemia of pregnancy. 

Lactation: it is un known  whether folic acid and ferrous fumarate metabolites are excreted in human milk .

Pharmacokinetic Properties:

Absorption: Iron is absorbed chiefly in the duodenum and jejunum. Folic acid is absorbed mainly from the proximal part of the small intestine. Absorption being aided by the acid secretion of the stomach and being more readily effected when iron is in the ferrous state. Folic acid rapidly appears in the blood, where it is extensively bound to plasma proteins.

Distribution: The amounts of Folic Acid absorbed from normal diets are rapidly distributed in body tissues.

Metabolism: When larger amounts are absorbed, a high proportion is metabolised in the liver to other active forms of folate and a proportion is stored as reduced and methylated folate.

Elimination: Larger amounts of folate are rapidly excreted in the urine and about 4 to 5 micrograms is excreted in the urine daily.