Composition

Each Capsule contains-

Iron (ΙΙΙ) Hydroxide Polymaltose Complex 188 mg

Folic Acid 0.5 mg

Thiamine Hydrochloride 5 mg

Riboflavin 2 mg

Pyridoxine Hydrochloride 2 mg

Nicotinamide 20 mg

Zinc Sulphate Monohydrate 61.80 mg

Indications

This is indicated for the treatment and prophylaxis of Zinc, Iron, Folic Acid, B-vitamins deficiency especially during pregnancy and lactation.

Therapeutic Class

Iron & Vitamin Combined preparations

Pharmacology

In this preparation, Iron is present as Iron Polymaltose Complex, a novel Iron preparation, which contains nonionic Ferric Iron and Polymaltose in a stable complex. This facilitates a controlled absorption of the Iron when it comes in contact with the mucosal cell surface. Being non-ionic, Iron Polymaltose Complex is more stable than conventional Iron form. Folic acid helps in the proper development of the baby. Zinc keeps enzymes working and helps metabolize proteins. Vitamins are essential for building up tissue and the release of energy from the breakdown of foods.

Dosage & Administration

One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.

Interaction

As Iron Polymaltose is non-ionic in nature, no interaction has been found with other drugs or food. Zinc of this formulation may interfere with absorption of fluoroquinolone antibiotics and Tetracycline. Angiotensin-converting enzyme inhibitors may cause Zinc depletion.

Contraindications

Disturbances in Iron utilization (lead anemia), thalassemia. Hypersensitivity or intolerance to Iron and overloading of Iron in the body. Hypersensitivity to any of the components of this formulation.

Side Effects

Generally well tolerated. Occasionally gastrointestinal irritations, such as sensation of repletion, pressure in the epigastric region, nausea, itching, dizziness, constipation or diarrhea can occur. A yellow orange fluorescence or discoloration of the urine may occur.

Pregnancy & Lactation

Use in Pregnancy:

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus adminstration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic Acid is justified during the remainder of pregnancy.

Precautions & Warnings

As with all Iron preparations, a dark coloration of the stool may occur. This is without clinical significance. Caution should be taken before concurrent administration of this formulation with fluoroquinolones and Tetracycline.

Overdose Effects

No intoxication or Iron overloading has been reported in case of overdose. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed with administration of more than 200 mg Pyridoxine for very long periods. High Zinc consumption may promote Copper deficiency due to the antagonistic relationship of these two minerals. No cases of Folic Acid overdosages has been reported.

Storage Conditions

Store at a cool & dry place, protected from light & moisture. Keep out of reach of children.l