Iberet Folic-500

Iberet Folic-500

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Ferrous sulfate, vitamin C, niacinamide, Calcium pantothenate, vitamin B1, vitamin B2, vitamin B6, vitamin B12, folic acid.
Description
Each filmtab tablet provides: Ferrous Sulfate* 525 mg (equivalent to 105 mg of elemental iron), Vitamin C (Ascorbic Acid) 500 mg, Niacinamide 30 mg, Calcium Pantothenate 10 mg, Vitamin B1 (Thiamine Mononitrate) 6 mg, Vitamin B2 (Riboflavin) 6 mg, Vitamin B6 (Pyridoxine Hydrochloride) 5 mg, Vitamin B12 (Cyanocobalamin) 25 mcg, Folic Acid 800 mcg.
Iberet Folic-500 is an Abbott hematinic containing iron in the Gradumet controlled-release vehicle; vitamin C for enhancement of iron absorption and the B-complex vitamins including Folic Acid. The Iberet Folic 500 Filmtab is for oral use.
*in controlled-release form (Gradumet).
Excipients/Inactive Ingredients: Polyethylene glycol, magnesium stearate, povidone, methacrylic acid & methyl methacrylate, magnesium oxide, FD&C Blue No.1, talc, stearic acid, polyvinil alcohol, titanium dioxide, FD&C Red No.7, lecithin, xanthan gum, FD&C Blue No. 2, hypermellose.
Indications/Uses
Iberet Folic 500 is indicated in non-pregnant adults for treatment of iron deficiency and prevention of concomitant folic acid deficiency where there is an associated deficient intake or increased need for the B-complex vitamins. Iberet Folic 500 is also indicated in pregnancy for the prevention and treatment of iron deficiency where there is a concomitant deficient intake or increased need for the B-complex vitamins (including folic acid).
Dosage/Direction for Use
Iberet Folic 500 is administered orally. Usual adult dose, including pregnant females: One tablet daily, or as directed by a physician. 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.
Overdosage
Signs and Symptoms of Overdose: Close tightly and keep out of reach of children. Contains iron, which can be harmful or fatal to adults and children in large doses. Hepatic necrosis and hepatic failure may develop. In case of accidental overdose, seek professional assistance immediately.
Contraindications
Known sensitivity to any of its ingredients. Repeated blood transfusions or parenteral iron therapy contraindicate concurrent oral iron therapy. Iberet Folic 500 is contraindicated in the rare instance of hypersensitivity to folic acid and in patients with pernicious anaemia.
Special Precautions
Where anaemia exists, its nature should be established and underlying causes determined. Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in mouth, but swallowed whole with water. In older patients and those tending to lead to vitamin B12 depletion, serum B12 levels should be regularly assessed during treatment with Iberet Folic 500. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Side Effects
Post marketing: The following adverse drug reactions have been reported during post-marketing surveillance. The frequency of these reactions is considered not known (cannot be estimated from the available data).
Ferrous sulfate: Immune system disorders: allergic reaction from rash to anaphylaxis.
Gastrointestinal disorders: Injury to mouth and pharynx (throat), mouth ulceration (in cases of incorrect use, when tablets are chewed, suck or left in the mouth), esophageal ulcer (i.e ulcer on the tube that connects the mouth with the stomach), nausea, vomiting, abdominal pain or discomfort hematemesis, blackening of stools, diarrhea, constipation, ileus.
Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects the mouth with the stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways.
The likelihood of gastric intolerance to iron in the controlled-release Gradumet vehicle is remote. If such should occur, the tablet may be taken after a meal.
Vitamin C (Ascorbic Acid): Ascorbic acid is usually well tolerated. However, large doses are reported to cause diarrhea and other gastrointestinal disturbances and are associated with the formation of renal calcium oxalate calculi.
Folic acid: Immune system disorders: Hypersensitization has been reported following both oral and parenteral administration of folic acid.
Drug Interactions
Antacids may decrease iron absorption. Ferrous sulphate may interfere with the absorption of tetracyclines. The antiparkinsonism effects of levodopa may be reversed by pyridoxine. Iron absorption is inhibited by the ingestion of eggs or milk.
Storage
Store below 30°C.
ATC Classification
B03AE02 - iron, multivitamins and folic acid ; Belongs to the class of iron in other combinations. Used in the treatment of anemia.
Presentation/Packing
Filmtab 60's.
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