📌 COMPOSITION

• Dried Ferrous Sulphate B.P. 150 mg equivalent to 47 mg elemental Iron.
• Folic Acid B.P. 0.5 mg.

📌 DESCRIPTION

Fefosan (Ferrous Sulphate) is a sustained‑release capsule formulated to release most of the iron in the small intestine, where absorption is greater than in the stomach, in order to avoid gastric irritation. Iron is an essential constituent of haemoglobin, vital for normal erythropoiesis and the oxygen‑transport capacity of the blood. Iron is also involved in myoglobin synthesis and serves as a cofactor for many heme and non‑heme‑iron‑dependent enzymes necessary for various oxidation‑reduction reactions in the body. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid stimulates the production of red and white blood cells and platelets in certain megaloblastic anaemias.

📌 INDICATIONS

Fefosan is a haematinic preparation for the prophylaxis of iron and folic acid deficiencies during pregnancy.

📌 DOSAGE AND ADMINISTRATION

One Fefosan sustained‑release capsule a day during pregnancy. Some pregnant patients may need a higher dose as a prophylactic measure.

📌 RESTRICTIONS ON USE

Contraindications

Hypersensitivity to the product, or in patients with iron overload.

Precautions

• Ferrous sulphate should be taken with care in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia.
• Fefosan should not be used during the first trimester of pregnancy.

Use in Pregnancy and Lactation

Fefosan is used during pregnancy for the prophylaxis of iron and folic acid deficiencies, but should not be used during the first trimester. There is insufficient information on its use during lactation; it is recommended to consult a physician.

📌 DRUG INTERACTIONS

• Absorption of both iron and tetracyclines is diminished when they are taken concomitantly by mouth.
• Iron absorption may be impaired by concomitant administration of antacids or penicillamine. Such potential interactions can be reduced by separating the administration of each product by several hours.

📌 ADVERSE EFFECTS

Dark stools, nausea and gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea may sometimes occur.

📌 OVERDOSAGE

Iron overdosage is dangerous, particularly in children, and requires immediate attention. Treatment is necessary if more than 30 mg elemental iron per kilogram of body weight has been ingested. Symptoms may include abdominal pain, vomiting, diarrhoea and haematemesis. In more severe cases, coma, convulsions and shock may occur. Acute renal failure and acute hepatic necrosis may develop. Gastric lavage should be carried out in the early stages, or if this is not possible, vomiting should be induced. Oral desferrioxamine should be given. Serum iron levels should be monitored. In severe cases, intravenous desferrioxamine should be administered, along with symptomatic and supportive measures as required.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place, protect from light.

📌 PHARMACEUTICAL FORMS

• Fefosan Capsules: Pack of 20 capsules and hospital packs of different sizes.