Indications

Ferrous Sulfate is used for iron-deficiency anaemia.

Dosage and Administration

Usage: Oral.

The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water.

Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance.

Dosage :

Adults,Elderly: Prophylaxis,One tablet daily;Therapeutic,One tablet 2-3 times daily

Children:This presentation is not recommended.

Precautions & Warning:

Patients post-gastrectomy have poor absorption of iron. Caution is advised when prescribing iron preparations to individuals with history of peptic ulcer, and inflammatory bowel disease, including regional enteritis and ulcerative colitis. Care should be taken in patients with intestinal strictures or diverticulae. Duration of treatment should generally not exceed 3 months after correction of anaemia. Co-existing deficiency of vitamin B12 or folic acid should be ruled out since combined deficiency produces microcytic blood film. Dental caries is a definite risk following long term treatment with this product. These tablets contain sugar and should be administered with care to patients with diabetes. Patients suffering from iron overload are particularly susceptible to infection. Treatment of iron overload should be with caution.

Due to the risk of mouth ulcerations an d tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed  whole with water.

The label will state:

Contraindications

Hypersensitivity to the product and its ingredients; haemosiderosis and haemochromatosis; active peptic ulcer; repeated blood transfusion; haemolytic anaemia. Oral and parenteral iron preparations should not be used concomitantly.

Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.

Adverse Reactions:

Gastro-intestinal disorders: abdominal pain, nausea and vomiting (these are usually dose related), constipation, diarrhoea and dark stools. Contact irritation can occur with ferrous sulfate tablets resulting in erosion or ulceration, particularly if they become lodged in the upper gastrointestinal tract.

Allergic reactions have been reported.

Post-marketing: The following ADRs have been reported during post-marketing surveillance. The frequency of these reactions is considered not known (cannot be estimated from the available data).

Gastrointestinal disorders:mouth ulceration in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth. Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route.

Drug interactions:

Antacids and minera lsupplements, Antibacterials, Biphosphonates, Cholestyramine, Dimercaprol, Dopaminergics, Food Products(eg, tea, eggs or milk), Methyldopa, Mycophenolate mofetil, Penicillamine, Thyroid hormone, Trientine, Zinc can affect the absorption of iron.

Storage instructions:

Do not store above 25°C

Screw cap container: Store in original container in order to protect from moisture.

Blister packs: Store in the original package in order to protect from moisture.