COMPOSITION :
Each sustained release capsule contains :
Dried Ferrous Sulphate B.P. 150 mg equivalent to 47 mg elemental Iron.
Folic acid B.P. 0.5 mg.
DESCRIPTION :
Fefosan sustained release capsule contains Ferrous Sulphate which is formulated to release Iron which
is an essential constituent of hemoglobin. Iron is vital for normal erythropoiesis and 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 in the body.
Folic acid is required for nucleoprotein synthesis and maintenance of normal erythropoiesis. Folic acid
stimulates production of red and white blood cells and platelets in certain megaloblastic anemias.
INDICATIONS :
Fefosan is a haematinic preparation for 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 prophylactic measure.
RESTRICTIONS ON USE :
Contraindications
Hypersensitivity to the product, or those 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.
DRUG INTERACTION :
- Absorption of both Iron and tetracyclines is diminished when they are taken concomitantly by mouth.
- Iron absorption may be impaired by concomitant administration of antacid or penicillamine. Such
potential interactions can be reduced by separating administration of each product by several hours .
ADVERSE EFFECTS :
Dark stools, nausea and gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation
and diarrhea are sometimes encountered.
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, diarrhea and haematemesis, within more severe cases, coma,
convulsions and shock. Acute renal failure and acute hepatic necrosis may develop. Gastric lavage
should be carried out in early stages, or if this is not possible, vomiting should be induced. Give oral
desferrioxamine (2 g for children or 5 g for adults) and demulcents. If serum Iron levels at 4 hours or
more post-ingestion are over 5 mg/L in children or 8 mg/L in adults, or if the patient is in shock or coma,
intramuscular or intravenous desferrioxamine should be used according to instructions for this product.
Symptomatic and supportive measures should be given as required.
STORAGE INSTRUCTIONS :
Store below 30ºC, in a dry place and protect from light.
PRESENTATIONS :
Fefosan Capsule : Pack of 20 capsules and hospital packs of different sizes .