For the use only of Registered Medical Practitioners or a Hospital or a Laboratory
Formula re: Contains
Multivitamin Multimineral Capsules
General Statements: All Other Content
Qualitative and Quantitative Composition
(Appropriate overages added)
Pharmaceutical form
Capsules for oral administration.
Formulation re: Other
Clinical particulars
Therapeutic Indications
Becadexamin is indicated for the treatment of vitamins and minerals deficiency states in adults which may be associated with the following conditions:
Dietary restrictions: in conditions such as obesity, cardiovascular diseases, chronic diarrhea or dysentery, etc.
Malnutrition
Infections or recovering from infections
Long term antibiotic use
Old age
Suggested/Recommended/Usage/Directions
Posology and method of administration
Adults and adolescents
Once capsule once daily.
In adolescents dosing regimen should be adjusted according to the individual patient's needs.
Duration of treatment depends on the improvement of the deficiency states.
Precautions re: Children
Children
Becadexamin is not recommended for paediatric use.
Precautions re: All Other
Renal Impairment
Caution should be exercised when using Becadexamin in patients with renal disorders (see section Special Warnings and Special Precautions for Use).
Hepatic Impairment
Caution should be exercised when using Becadexamin in patients with hepatic disorders (see section Special Warnings and Special Precautions for Use).
Contraindications
Becadexamin is contraindicated in:
Hypersensitivity to any of the components,
Treatment with retinoids (see section Interaction with Other Medicaments and Other Forms of Interaction).
Special Warnings and Special Precautions for Use
Concomitant conditions
Caution should be used in case of the following concomitant conditions:
Hepatitis or hepatic disorders,
Kidney disorders,
Intestinal stricture inflammation,
Active duodenal or gastric ulcer,
Diabetes mellitus.
Gastrointestinal symptoms
Patients with ostomies may have altered intestinal transit times.
Cardiac disorders
Becadexamin should be used with caution in the presence of cardiac disease, as it contains vitamin D.
Vision disorders
Cyanocobalamin (vitamin B12) should not be used for Leber's disease or tobacco amblyopia since these optic neuropathies may degenerate further.
Hypercalcaemia
Becadexamin is not recommended for patients with hypercalcaemia or diseases associated with hypercalcaemia such as sarcoidosis and some malignancies, as it contains calcium and vitamin D. It should be given cautiously to these patients.
Effects on the Thyroid
Although iodine is required for the production of thyroid hormones, excessive quantities can cause hyperthyroidism, or even paradoxical goitre and hypothyroidism (see section Undesirable Effects).
Special populations
Patients over the age of 45 years or with nodular goiter are especially susceptible to hyperthyroidism when given iodine supplementation. Reduced doses should therefore be used and supplementation with iodised oil may not be appropriate.
High dose of nicotinamide should be used with caution in patients with peptic ulcer disease, gastritis, liver disease, gall bladder disease, diabetes and gout.
Investigations
As iodine and iodides can affect the thyroid gland, their use may interfere with tests of thyroid function.
Large doses of riboflavin (vitamin B2) result in a bright yellow discoloration of the urine that may interfere with certain laboratory tests.
Ascorbic acid, a strong reducing agent, interferes with laboratory tests involving oxidation and reduction reactions. Falsely-elevated or false-negative test results may be obtained form plasma, faeces, or urine samples depending on such factors as the dose of ascorbic acid and specified method used.
Long-term treatment
Caution is necessary if preparations containing iodine or iodides are taken for long periods.
Long-term use of large doses of pyridoxine (vitamin B6) is associated with the development of severe peripheral neuropathies; the dose at which these occur is not established.
The use of excessive amounts of vitamin A substances over long periods can lead to toxicity (see section Overdose).
Risk of overdosage
Other medicinal product containing vitamin A should not be used while taking Becadexamin as it may cause overdose symptoms (see sections Interaction with Other Medicaments and Other Forms of Interaction; Overdose).
Overdose symptoms may occur as a result of prolonged (several weeks or months) administration of doses starting from 10 000 IU daily, in patients with liver or kidney impairment, low body weight, hypoproteinemia and alcohol abuse (see section Overdose).
Other medicinal product containing vitamin E should not be used while taking this product as it may cause overdose symptoms (see section Overdose).
Treatment preparation and monitoring
Becadexamin should, if possible, not be given to patients with suspected vitamin B12 deficiency without first confirming the diagnosis.
Plasma phosphate concentrations should be controlled during vitamin D therapy to reduce the risk of ectopic calcification.
Tolerance
Tolerance may be induced with prolonged use of large doses of vitamin C, resulting in symptoms of deficiency when intake is reduced to normal.
Precautions re: Pregnant or Nursing or Prescription Medications
Interaction with Other Medicaments and Other Forms of Interaction
Diuretics
As Becadexamin contains calcium and vitamin D, hypercalcaemia may occur when it is given with thiazide diuretics.
Thiazide diuretics decrease urinary excretion of calcium. Plasma-calcium concentrations should be monitored in patients receiving the drugs together.
Corticosteroids
Corticosteroids reduce calcium absorption.
Corticosteroids may counteract the effect of vitamin D.
Cardiac glycosides
Calcium enhances the effects of digitalis glycosides on the heart and may precipitate digitalis intoxication.
Antibiotics
Tetracycline antibiotics, other than doxycycline also decreases zinc absorption, they should therefore be administered 2 hours before or 3 hours after the administration of Becadexamin, in those cases where concomitant use is necessary.
Penicillamine (a chelating agent) may reduce the absorption of zinc.
Penicillamine and antituberculous drugs (such as isoniazid) may increase the requirements for folic acid and pyridoxine (vitamin B6).
Neomycin used orally may reduce the absorption of vitamin A, vitamin B12 and vitamin E.
Rifampicin and isoniazid may reduce the effectiveness of vitamin D.
Bisphosphonates
As Becadexamin contains calcium and magnesium salts, it reduces the absorption of bisphosphates, therefore doses should be separated by at least 3 hours.
Folic acid antagonists
Folate deficiency states may be produced by folic acid antagonists such as methotrexate, pyrimethamine, triamterene, trimethoprim and sulfonamides.
Amiodarone
The effects of iodine and iodides on the thyroid may be altered by other compounds including amiodarone.
Cholestyramine, colestipol and mineral oils
Cholestyramine, colestipol and mineral oils used orally may reduce the absorption of vitamin A and vitamin E.
Retinoids
Combined treatment with retinoids (isotretinoin, etretinate, bexarotene) and vitamin A in doses exceeding 4000-5000 IU daily may induce vitamin A overdose symptoms (see sections Special Warnings and Special Precautions for Use; Overdose). Thus, the use of Becadexamin is contraindicated during the treatment with retinoids (see section Contraindications).
Oral contraceptives
Oral contraceptives may increase vitamin A plasma concentration.
Serum concentration of vitamin B6, vitamin B12 and folic acid may be decreased by use of oral contraceptives.
Large supplements of vitamin C have been reported to increase serum ethinylestradiol concentrations in women taking oral contraceptives, but a further study showed no effect on either ethinylestradion or levonorgestrel.
Levodopa
Becedexamin contains vitamin B6 which reduces the effects of levodopa, but this does not occur if a dopa decarboxylase inhibitor is also given.
Altretamine
Becadexamin contains B6 which reduces the activity of altretamine.
Lithium
The effects of iodine and iodides on the thyroid may be altered by other compounds including lithium.
Antiepileptics
Vitamin B6 and folic acid has been reported to decrease serum concentrations of phenobarbital and phenytoin.
Some antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin, and primidone) may increase vitamin D requirements.
Antiepileptics may produce folate deficiency states.
Replacement therapy with folinic acid or folic acid may become necessary during antiepileptic therapy in order to prevent development of megaloblastic anaemia.
Concomitant nicotinamide and carbamazepine may decrease carbamazepine clearance.
Hydralazine
Hydralazine may increase the requirements for pyridoxine.
Omeprazole
Omeprazole has been reported to impair the bioavailability of vitamin B12 and dietary vitamin C.
Anticoagulants
As Becadexamin contains vitamin E, caution should be used during concomitant administration of anticoagulants (dicoumarol, warfarin, indanediones) due to the risk of their efficacy reduction, hypoprothrombinaemia and bleeding. During prolonged administration of vitamin E, the prothrombin time should be monitored on a regular basis.
Cyclosporine
Vitamin E may increase the absorption of cyclosporine.
Precautions re: All Other
Calcium, vitamin D
There is an increased risk of hypercalcaemia if vitamin D is given with calcium. Vitamin D increases the gastrointestinal absorption of calcium. Plasma-calcium concentrations should be monitored in such situations.
Fluoride
As Becadexamin contains calcium, it reduces the absorption of fluoride; therefore doses should be separated by at least 3 hours.
Phosphates
As Becadexamin contains vitamin D, there is an increased risk of hypercalcaemia if it is given with phosphate. Plasma-calcium concentrations should be monitored in such situations.
Phosphorus-containing preparations may reduce the absorption of zinc.
Iron supplements
The absorption of zinc may be reduced by additionally taken iron supplements.
Calcium in Becadexamin may reduce iron absorption when administered concomitantly with iron supplements. Oral iron preparations should not therefore be taken within 1 hour before or 2 hours after taking Becadexamin.
Zinc supplements
Additionally taken zinc supplements reduce the absorption of copper.
Vitamin C
As Becadexamin contains vitamin C, it may increase the absorption of iron in iron-deficiency states.
Alcohol
Alcohol enhances the toxic effect of vitamin A and may produce folate deficiency states.
Precautions re: Pregnant or Nursing or Prescription Medications
Pregnancy
Becadexamin should be used by pregnant women only after consultation with a physician.
Lactation
Becadexamin should be used by lactating women only after consultation with a physician.
Precautions re: All Other
Undesirable effects
Multivitamins are generally well tolerated when used within the recommended dose. The following adverse events have been reported with use of ingredients of Becadexamin.
The frequency of most of these events cannot be estimated from the available data.
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency.
Frequencies are defined as:
Very common greater than or equal to 1/10
Common greater than or equal to 1/100 to less than 1/10
Uncommon greater than or equal to 1/1000 to less than 1/100
Rare greater than or equal to 1/10000 to less than 1/1000
Very rare less than 1/10000
Not known (cannot be estimated from the available data).
Immune system disorders
Not Known: Hypersensitivity reactions (see Skin and subcutaneous tissue disorders), anaphylactic reaction
Gastrointestinal disorders
Not Known: Abdominal pain, nausea, vomiting, diarrhea, constipation, gastrointestinal disturbances, black faeces.
Psychiatric disorders
Not Known: Sleep disturbances.
Nervous system disorders
Not Known: Headache, dizziness.
Skin and subcutaneous tissue disorders
Not Known: Rash
Metabolic disorders
Very Rare: Diabetogenic effects
Overdose
Overdose of Becadexamin can lead to the following symptoms and signs.
Symptoms and signs
Symptoms include: gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, constipation, taste disturbances, thirst), cardiac arrhythmias (tachycardia, bradycardia), hypotension, cardiac arrest, renal impairment, polyuria, nocturia, muscle weakness, headache, drowsiness, dizziness/vertigo, irritability, sweating, lassitude, somnolence, confusion, shock, coma, thirst, elevations in liver tests and liver damage, including jaundice and parenchymal liver cell injury.
Treatment
The treatment consists of its withdrawal and symptomatic treatment, if necessary.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
GSK Becadexamin | Supplement DB
Formula re: Contains
Pharmacological Properties
Pharmacodynamic Properties
Pharmacotherapeutic group: Multivitamins and other minerals, including combinations, ATC Code A11AA03.
Mechanism of action and Pharmacodynamic Effects
Becadexamin contains active substances with synergistic, therapeutic actions, necessary for maintenance and/or improvement of functional activities of the body.
Vitamins, their precursors, minerals and trace elements are included to treat deficiencies. Many of those act as co-factors for various metabolic functions.
Vitamin A
Retinol is an essential nutrient needed in small amounts by humans for the normal functioning of the visual system, growth and development and maintenance of epithelial cellular integrity, immune function and reproduction.
Vitamin D (cholecalciferol)
Vitamin D is required to maintain normal blood levels of calcium and phosphate, which are in turn needed for the normal mineralization of bone, muscle contraction, nerve conduction and general cellular function in all cells of the body.
Vitamin E (tocopherol acetate)
Vitamin E is the major lipid-soluble antioxidant in the cell antioxidant defense system acts and maintains the integrity of the vascular endothelium.
Vitamin B1 (thiamine mononitrate)
Vitamin B1 is an essential co-enzyme in oxidative metabolism of -ketoacids and increases the activity of acetylcholine in nerve endings.
Vitamin B2 (riboflavin)
Vitamin B2 is an essential component in function of certain co-enzymes important for energy production taking part in numerous oxidation and reduction reactions. It has also an important role in maintaining a healthy skin.
Nicotinamide
Nicotinamide is involved in a large number or processes such as production of energy, synthesis of fatty acids, cholesterol, steroids, signal transduction and the maintenance of integrity of genome.
D-Panthenol
D-Panthenol (Dexpanthenol) is the synthetic alcohol form of pantothenic acid. It is converted to pantothenic acid n the body and therefore, can be considered a provitamin form of pantothenic acid. Pantothenic acid is a precursor of co-enzyme A, necessary for energy production, involved in fatty acid metabolism, formation of acetylcholine and improvement of epithelization and wound healing. It is also necessary for folic acid and carbohydrate metabolism.
Vitamin B6 (pyridoxine hydrochloride)
It takes part in formation of some important co-enzymes involved in protein metabolism and HEM biosynthesis. As a coenzyme it functions in metabolism of amino acids, glycogen and sphingoid bases.
Vitamin C (ascorbic acid)
Vitamin C is an electron donor (reducing agent or antioxidant) for 11 enzymes. It has a role in hydroxylation of certain compounds. It helps in maintenance of intracellular skeleton of cartilages, bones and teeth. It is essential in maintenance of capillary wall integrity and regulation of capillary permeability. Vitamin C promotes absorption of soluble non-haem iron.
Folic acid
It is essential for erythropoiesis, maturation of red blood cells and biosynthesis of the DNA.
Vitamin B12 (cyanocobalamin)
It is essential for erythropoiesis, formation of myelin sheet and synthesis of the DNA.
Calcium
It activates certain enzymes. It maintains the normal excitability of the myocardium and nerves and helps in maintenance of capillary wall integrity. It is essential in the structure of bones and teeth, for muscular contraction and many metabolic processes.
Copper
It is essential for synthesis of hemoglobin, formation of bone and myelin, for the activity of certain enzymes, such as cytochrome oxidases (tissue oxidation).
Manganese
Is it a co-factor in many enzyme reactions, which involve phosphorylation and synthesis of cholesterol and fatty acids.
Zinc
Zinc is an essential component of a large number (> 300) of enzymes participating in the synthesis and degradation of carbohydrates, lipids, proteins, and nucleic acids as well as in the metabolism of other micronutrients. Zinc plays a major role in the immune system. It also acts as an antioxidant. It is important for normal growth, wound healing and sexual maturation, for crystallization and release of insulin (the pancreas of diabetic individuals contains only half of the normal quantity of zinc).
Iodine
It has a role in the synthesis of thyroid hormones.
Magnesium
Magnesium functions as a co-factor of many enzymes involved in energy metabolism, protein synthesis, RNA and DNA synthesis, maintenance of the electrical potential of nervous tissues, cell membrane stabilizing action and muscle contraction.
General Statements: All Other Content
Shelf Life
The expiry date is indicated on the label and packaging.
Storage
Special Precautions for Storage
Store at temperature not exceeding 30 degrees C protected from direct sunlight.
Precautions re: Children
Keep out of reach of children.
General Statements: All Other Content
Nature and Specification of Container
Capsules in an amber glass bottle.