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IBERET-FOLIC 500 Multivitamins / Iron Film-Coated Tablet 1's

NONRXDRUG-DRP-6991-1pc
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Description

Indications/Uses

Anti-anemic.
Iberet-Folic 500 is indicated in non-pregnant adults for the 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 and may be taken on an empty stomach.
Adults: For the treatment of iron deficiency where there is an associated deficient intake or increase need for the B-complex vitamins, the recommended dose is one tablet daily.
Pregnant Adults: For the prevnetion and treatment of iron deficiency where there is a concomitant deficient intake or increased need for the B-complex vitamins including folic acid, the recommended dose is one tablet daily.
Do not chew or crush tablet, swallow whole.
Missed dose: No information available.
 

Overdosage

Taken more than recommended dose: Acute overdosage of iron may cause nausea and vomiting and, in severe cases, hepatic necrosis, cardiovascular collapse, and death. The lethal dose of orally ingested elemental iron is estimated to be 180 to 300 mg/kg of body weight. However, a dose of elemental iron as low as 30 mg/kg may be toxic in some individuals and ingestion of doses as low as 60 mg/kg have resulted in death.
Toxicity that occurs with an acute iron overdosage results from a combination of the corrosive effects on the gastrointestinal mucosa and the metabolic and hemodynamic effects caused by the presence of excessive elemental iron.
The signs and symptoms of acute iron poisoning may occur within 10 to 60 minutes or be delayed for several hours. Initial clinical manifestations may encompass acute gastrointestinal irritation, including epigastric pain, nausea, vomiting, diarrhea of green and subsequently tarry stools, melena, and hematemesis which may be associated with drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma. Hepatic necrosis and hepatic failure may develop. Because of potential toxic effects of overdosage, immediate medical attention is warranted.
Iron poisoning should be treated by emptying the stomach via ipecac-induced vomiting or preferably by gastric lavage with a large bore tube. If the patient has experienced multiple episodes of vomiting, especially if the vomitus contains blood, ipecac syrup should not be administered.
Vomitus should be examined for returned Gradumet tablets. If sufficient tablets are not returned, the possibility of whole gut lavage with 0.9% sodium chloride solution plus a saline cathartic should be considered. Surgical removal of iron tablets, which are visible in abdominal radiographs, may be required if other means of removing the drug are unsuccessful.
The best method of assessing the severity of an iron ingestion is to measure the serum iron and total iron binding capacity (TIBC). If the serum iron level is greater than TIBC, the potential for systemic toxicity exists. Serum iron and total iron-binding capacity levels may be used as guidelines for use of deferoxamine, an agent used to chelate elemental iron.
Chelation therapy with deferoxamine should be considered when the following conditions exists.
1. potentially lethal dose (180 to 300 mg/kg or more) of elemental iron has been ingested.
2. Serum concentrations are greater than 400 to 500 μg/dL.
3. Serum iron concentrations exceed total iron binding capacity; and/or.
4. Patients have severe symptoms of iron intoxication such a coma, shock or seizure.
Hemodialysis is of little value in the treatment of iron intoxication.
Supportive treatment, including suction and maintenance of airway; correction of acidosis and control of shock and dehydration with intravenous fluids or blood, oxygen and vasopressors, should be administered as required.
High doses of individual components of the product have been associated with eczematous and exanthematous skin lesions, fatigue and insomnia.
In higher niacinamide doses, liver damage, gout and ulcer formation have been noted.
In high doses of pyridoxine, peripheral sensory neuropathy and vesicular skin lesions have been reported.
Hemolysis has been reported at high doses of ascorbic acid, especially in patients with glucose-6-phosphatase dehydrogenase deficiency.
 

Administration

Should be taken on an empty stomach: Best taken between meals. May be taken w/ meals to reduce GI discomfort. Swallow whole, do not chew/crush tab.
 

Contraindications

Iberet-Folic 500 is contraindicated in individuals known to be hypersensitive to any of its components.
Iberet-Folic 500 is contrainidcated in patients with thalassemia, sideroblastic anemia, hemochromatosis and hemochromatosis and hemosiderosis.
Iberet-Folic 500 should not be used in pediatric patients.
Iberet-Folic 500 is contraindicated in the rare instance of hypersensitivity to folic acid.
 

Special Precautions

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. In case of accidental overdose, call a doctor or seek a medical advice immediately.
Iron therapy could induce relapse of erythropoietic protoporphyria. Iron overload has been suggested as being involved in the pathogenesis of porphyria cutanea tarda.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
Where anemia exists, its nature should be established and underlying causes determined.
Iberet-Folic 500 contains increased amounts (see Description) of folic acid per tablet. Folic acid especially in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. Concomitant parenteral therapy with Vitamin B12 may be necessary in patients with deficiency of vitamin B12. Pernicious anemia is rare in women of childbearing age, and the likelihood of its occurrence alone with pregnancy is reduced by impairment of fertility associated with vitamin B12 deficiency.
Caution should be exercised when dosing ascorbic acid in patients with chronic renal failure and in patients receiving acetylsalicylic acid.
Like other oral iron preparations, Iberate-Folic 500 should be stored out of the reach of children to guard against accidental iron poisoning. (See as follows.)
Laboratory tests: In older patients and those with conditions tending to lead to vitamin B12, depletion, serum B12 levels should be regularly assessed during treatment with Iberet-Folic 500.
False occult blood tests possible.
 

Use In Pregnancy & Lactation

Pregnancy: Studies in pregnant women have not shown that Iberet-Folic 500 increases the risk of fetal abnormalities if administered during pregnancy. If this drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out of the possibility of harm, however, Iberet-Folic 500 should be used during pregnancy only if clearly needed.
Lactation: Folic acid, ascorbic acid, and B-complex vitamins are excreted in breast milk.
 

Adverse Reactions

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. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Allergic reactions, included rash, pruritus, and anaphylaxis have been reported with vitamin use.
Components of products have been associated with gastrointestinal effects such as heartburn, eructation, abdominal pain and cramps, diarrhea, vomiting, nausea and anorexia.
Hepatic dysfunction with abnormal liver function tests, including hyperbilirubinemia, has been noted.
Deterioration of acneiform vulgaris, or eruption of acneiform exanthema, has been noted with several components.
Bright yellow urine discoloration has been reported with riboflavin usage.
Niacinamide has strong vasodilator effects, most often characterized by flushing, dizziness or faintness.
Peripheral sensory neuropathies have been noted with usage of pyridoxine.
Stone formation, crystalluria and oxalosis, with ascorbic acid usage, have been reported in the literature.
Black discoloration of the stool has been reported with iron usage.
Isolated cases of injury to mouth and pharynx, esophageal ulcer, hematemesis and ileus have been reported.
 

Drug Interactions

Absorption of iron inhibited by magnesium trisilicate, antacids or cholestyramine. With concomitant use of alcohol, toxic delirium and lactic acidosis have been noted.
Ferrous sulfate may interfere with the absorption of tetracyclines. Therefore, these drugs should be given two to three hours apart.
Concomitant use of niacin and nicotine has been reported to cause increased flushing and dizziness.
Since pyridoxine is noted to have effects on dopamine, drug interactions are possible. A drug interaction with levodopa is noted, but can be avoided if levodopa is given in combination with decarboxylase inhibitor.
Prothrombin times are decreased when ascorbic acid is used concomitantly with anticoagulants.
Concurrent administration of oral iron preparations may interfere with the oral absorption of some quinolone anti-infective agents (e.g. ciprofloxacin, norfloxacin, ofloxacin) resulting in decreased serum and urine concentrations of the quinolones. Therefore, oral iron preparations should not be ingested with or within two hours of a dose of an oral quinolone.
Drug-Food Interactions: Eggs inhibit iron absorption. Coffee and tea consumed with a meal or one hour after a meal may significantly inhibit the absorption of dietary iron. Its clinical significance has not been determined. Oral iron preparations should not be taken within one hour or two hours after ingestion of the previously mentioned.
 

Storage

Store at temperatures not exceeding 30°C.
 

MedsGo Class

Vitamins & Minerals (Pre & Post Natal) / Antianemics

Features

Brand
Iberet-Folic 500
Full Details
Drug Ingredients
  • Ascorbic Acid
  • Calcium Pantothenate
  • Iron
  • Multivitamins
  • Vit. B1
  • Vit. B12
  • Vit. B2
  • Vit. B3
  • Vit. B6
  • Vit. B9 (Folic Acid)
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Multivitamins / Iron
Dosage Form
Film-Coated Tablet
Registration Number
DRP-6991-100
Drug Classification
Over-The-Counter (OTC)
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  CODE Drug Packaging Availability Price  
IBERET-FOLIC 500 Multivitamins / Iron Film-Coated Tablet 1's, Drug Packaging: Film-Coated Tablet 1's
NONRXDRUG-DRP-6991-1pc
Film-Coated Tablet 1's
In stock
3250
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