COMPOSITION
Each hard gelatin capsule contains:
| Ingredient | Strength |
|---|---|
| Iron (III) Hydroxide Polymaltose Complex E.q. to Elemental Iron | 100 mg |
| Folic Acid BP | 1.5 mg |
| Vitamin B12 BP | 15 mcg |
| Zinc Sulphate Monohydrate BP | 61.8 mg |
| E.q. to Elemental Zinc | 22.5 mg |
Approved colour used in empty capsule shell.
Appropriate overages of vitamins are added to compensate for loss on storage.
Excipients
Dibasic calcium phosphate
Microcrystalline cellulose
Magnesium stearate
Colloidal Anhydrous silica
Purified Talc
INDICATIONS
Iron deficiency anaemias due to chronic blood loss.
Hook-worm infestation.
Inadequate intake of iron etc.
Other dimorphic Anaemias.
Lack of appetite, rundown conditions; these are common symptoms of Anaemias which might occur initially.
IRON (III) HYDROXIDE POLYMALTOSE
MECHANISM OF ACTION
The absorption of ferric iron from Iron (III) Hydroxide Polymaltose is controlled by a feedback mechanism, when Iron (III) Hydroxide Polymaltose comes in contact with the iron binding sides at the mucosal surface, a physiological exchange is assumed to occur.
Iron (III) Hydroxide Polymaltose releases the required amount of ferric iron, which is actively transported into the mucosal cell by a carrier protein and from there released for binding to ferritin or transferritin.
Bioavailability
Iron (III) Hydroxide Polymaltose Complex and ferrous sulphate have been demonstrated to have equivalent bioavailability in infants.
Absorption of Iron (III) Hydroxide Polymaltose complex is not affected by food or milk, enabling administration without consideration of the timing of feed.
Also, to date there are no reports of any interaction with foods or medicines.
FOLIC ACID
PHARMACOLOGICAL ACTIONS
The primary use of folic acid in treating deficiency states that arise from inadequate levels of the vitamin.
Folate deficiency may be caused by:
Increased demand (For example, pregnancy and lactation)
Poor absorption caused by pathology of the small intestine
Alcoholism
Treatment with drugs that are dihydrofolate reductase inhibitors
A primary result of folic acid deficiency is megaloblastic Anaemia, Caused by diminished synthesis of purines and pyrimidines.
This leads to an inability of erythropoetic tissue to make DNA and proliferate.
THERAPEUTIC USES
Folic acid supplementation to prevent folic acid deficiency should be considered in high risk patients, including:
Pregnant women
Alcoholism
Patients with haemaolytic anaemis
Liver disease
Certain skin disease
Patients on renal dialysis
CYANOCOBALAMIN (VITAMIN B12)
Various organic groups may be covalently bound to the cobalt atoms, forming different cobalamines.
Cyanocobalamin and hydroxocobalamin and other cobalamin found in food sources are converted to the active forms like deoxyadenosylcobalamin and methyl cobalamin.
PHARMACOLOGICAL ACTIONS
The most characteristic clinical manifestation of vitamin B12 deficiency is megaloblastic anaemia.
Vitamin B12 deficiency also causes a neurologic syndrome that usually begins with paresthesia and weakness in peripheral nerves and spasticity, ataxia and other central nervous system dysfunctions.
The most common cause of vitamin B12 deficiency are:
Partial or total gastrectomy
Diseases that affect the distal ileum, such as malabsorption syndromes
Inflammatory bowel diseases
ZINC
Zinc has been identified as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase.
Zinc facilitates wound healing; helps maintain normal growth rates, normal skin hydration and senses of taste and smell.
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients
Symptoms of iron intolerance
POSSIBLE DRUG AND FOOD INTERACTIONS
Iron salts and tetracycline absorption is diminished if taken concomitantly by mouth.
Iron salts should be administered 3 hours before or 2 hours after the tetracycline.
Concomitant ingestion of antacids and tea will also decrease the absorption of iron salts.
Iron salts may reduce the effects of penicillamine.
SIDE EFFECTS
Some Patients affected with pernicious anaemia may not respond to orally administerd Cyanocobalamin with intrinsic factor Concentrate and there is no known way to predict which patients will respond or which patients may cease to respond.
Periodic examinations and laboratory studies of pernicious anaemia patients are essential and recommended.
Folic acid may obscure pernicious anaemia in that the peripheral blood picture may revert to normal while neurological manifestations may remain progressive.
BIOGLOBIN Capsules should not be relied on to correct the serious folic acid deficiency characterizing sprue or the malabsorption syndrome. In these conditions therapeutic amounts of folic acid should be administered.
Excessive doses of iron preparation may lead to toxicity in children.
Adverse effects of iron administered in therapeutic doses may include:
Gastro-intestinal discomfort
Diarrhea
Vomiting
Constipation
Side-effects may be reduced by taking the medication with or immediately after food.
As a result of iron therapy stools may become darkened or black in colour.
Symptoms, which may not appear for several hours, include:
Epigastic pain
Diarrhea
Vomiting
Haematemesis
Circulatory failure may follow if the diarrhea and haemorrhage are severe.
Hours or days later, after apparent recovery, metabolic acidosis, convulsions and coma may occur.
If the patients survive, symptoms of acute liver necrosis may develop and may lead to death due to hepatic coma.
SYMPTOMS AND TREATMENT OF OVERDOSE
Symptoms of overdosage can be any of those described under "Side-effects and Special Precautions" above.
If any symptoms of intolerance occur, the drug should be temporary or permanently discontinued.
In acute poisoning desferrioxamine should be administered under the direction of a physician but preferably should not be administered during the 1st trimester of pregnancy.
Alternatively, and preferably in the treatment during pregnancy and lactation, empty the stomach by inducing emesis using a 1 to 5% solution of sodium bicarbonate lavage.
Fluid loss should be replaced by the I.V. administration of compound sodium lactate injection or NaCl and dextrose injection.
A m the considered toxic in children. Speed is essential here to block the absorption of iron.
DOSAGE AND ADMINISTRATION
Adults and Children (Above 12 years):
1 - 2 capsules daily, or as directed by the physician.
WARNING AND PRECAUTIONS
Prolong administration in excess of the recommended dose as prescribed by the physician (one capsule per day) may result in iron overload.
Iron overloading and toxicity may occur in patients receiving both oral and parenteral administration of iron.
Care should be taken when given to patients with anemias not produced by iron deficiency unless iron deficiency is also present.
Care should be taken when given to patients with iron-storage or iron-absorption disease; haemoglobinopathies or existing gastro-intestinal disease.
PREGNANCY AND LACTATION
Iron containing products, if required, should be used during pregnancy after the first thirteen weeks.
STORAGE
Store below 30°C.
Protect from Sunlight.
KEEP OUT OF REACH OF CHILDREN.
PRESENTATION
3 × 10 Capsules Blister Pack.
SHELF LIFE
24 months
DATE OF PUBLICATION OF THIS PACKAGE INSERT
April - 2024
DATE OF REVIEW OF THIS PACKAGE INSERT
2 years.
Manufactured for
PHARMATRUST LTD.
Accra - Ghana
INGH077-00