For the use only of Registered Medical Practitioners or a Hospital or a Laboratory

BECADEXAMIN

1. GENERIC NAME

Multivitamin Multimineral Capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Soft Gelatin capsule contains:

Vitamin A 5000 IU (as Vitamin A Concentrate Oil IP)
Vitamin D3 (Cholecalciferol IP) 400 IU
Vitamin E (Tocopheryl Acetate IP) 15 mg
Vitamin B1 IP 5 mg
Vitamin B2 IP 5 mg
Nicotinamide IP 45 mg
D-Panthenol IP 5 mg
Vitamin B6 IP 2 mg
Vitamin C IP 75 mg
Folic Acid IP 1000 mcg
Vitamin B12 IP 5 mcg
Dibasic Calcium Phosphate IP 70 mg
Copper Sulfate Pentahydrate BP 0.1 mg
Manganese Sulfate Monohydrate BP 0.01 mg
Zinc Sulphate Monohydrate IP 28.7 mg (equivalent to 10.4 mg of elemental Zinc)
Potassium Iodide IP 0.025 mg
Light Magnesium Oxide IP 0.15 mg
(Appropriate overages added)
Excipients q.s.
Approved colours used in empty gelatin capsule shell

3. DOSAGE FORM AND STRENGTH

Capsules for oral administration.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

BECADEXAMIN is indicated for the treatment of vitamins and minerals deficiency states
in adults which may be associated with the following conditions:

1
 • Dietary restrictions: in conditions such as obesity, cardiovascular diseases, chronic
diarrhoea or dysentery, etc.
• Malnutrition
• Infections or recovering from infections
• Long term antibiotic use
• Old age

4.2 Posology and Method of Administration

Adults and adolescents

One 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.

Children

BECADEXAMIN is not recommended for paediatric use.

Elderly

There are no relevant data available.

Renal Impairment

Caution should be exercised when using BECADEXAMIN in patients with renal disorders
(see 4.4 Special Warnings and Precautions for Use).

Hepatic Impairment

Caution should be exercised when using BECADEXAMIN in patients with hepatic

disorders (see 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

BECADEXAMIN is contraindicated in:

• Hypersensitivity to any of the components,
• Treatment with retinoids (see 4.5 Drug Interaction)

2
4.4 Special Warnings and 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 4.8
Undesirable Effects)

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
from plasma, faeces, or urine samples depending on such factors as the dose of ascorbic
acid and specific method used.

3
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 4.9 Overdose).

Risk of overdosage
Other medicinal product containing vitamin A should not be used while taking
BECADEXAMIN as it may cause overdose symptoms (see 4.5 Drug Interaction; 4.9
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 4.9 Overdose).

Other medicinal product containing vitamin E should not be used while taking this product
as it may cause overdose symptoms (see 4.9 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.

4.5 Drug 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.

4
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
Zinc supplements also reduce the absorption of fluoroquinolones.

Tetracycline antibiotics, other than doxycycline also decrease 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.

Calcium salts reduce the absorption of some fluoroquinolones, and tetracyclines therefore,
doses should be separated by at least 3 hours.

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
bisphosphonates, therefore doses should be separated by at least 3 hours.

Folic acid antagonists

Folate deficiency states may be produced by drugs such as antiepileptics, oral
contraceptives, antituberculous drugs, alcohol, glucarpidase, and 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 and orlistat

Cholestyramine, colestipol and mineral oils used orally may reduce the absorption of
vitamin A and vitamin E.

5
Orlistat may interfere with the absorption of 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 4.4
Special Warnings and Precautions for Use; 4.9 Overdose). Thus, the use of
BECADEXAMIN is contraindicated during the treatment with retinoids (see 4.3
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 ethinylestradiol or levonorgestrel.

Levodopa
BECADEXAMIN 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 vitamin 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.

6
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.

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.

7
Prolonged use of high doses of zinc supplements, leads to copper deficiency with
associated sideroblastic anaemia and neutropenia.

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.

Other
Absorption of vitamin B12 from the gastrointestinal tract may be reduced by aminosalicylic
acid, histamine H2-antagonists, and colchicine. Aluminium, and magnesium salts may
decrease the absorption of fluoride.

4.6 Use in 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.

Pregnancy and Lactation

Fertility
There are no relevant data available.

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.

4.7 Effects on Ability to Drive and Use Machines

There are no clinical data proving that BECADEXAMIN may have an influence on the
ability to drive or use machines.

8
4.8 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 ≥1/10
Common ≥1/100 to <1/10
Uncommon ≥1/1000 to <1/100
Rare ≥1/10000 to <1/1000
Very rare <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, diarrhoea, 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, dermatitis acneiform and dermatitis bullous

Metabolic disorders

Very Rare: Diabetogenic effects

4.9 Overdose

9
Overdose of BECADEXAMIN can lead to the following symptoms and signs.

Symptoms and signs

Symptoms include: gastrointestinal disturbances (abdominal pain, nausea, vomiting,

diarrhoea, 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.

5. PHARMACOLOGICAL PROPERTIES

5.1 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 defence 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.

10
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 of 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 in the body and therefore, can be considered a provitamin
form of panothenic 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

11
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
It is 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.

5.2 Pharmacodynamic Properties

Pharmacotherapeutic group: Multivitamins and other minerals, including combinations,

ATC Code A11AA03.

5.3 Pharmacokinetic Properties

There are no relevant data available.

5.4 Clinical Studies

There are no relevant data available.

6. NONCLINICAL PROPERTIES

There are no relevant data available.

7. DESCRITPTION

Capsules for oral administration.

12
Each Soft Gelatin capsule contains:
Vitamin A 5000 IU (as Vitamin A Concentrate Oil IP)
Vitamin D3 (Cholecalciferol IP) 400 IU
Vitamin E (Tocopheryl Acetate IP) 15 mg
Vitamin B1 IP 5 mg
Vitamin B2 IP 5 mg
Nicotinamide IP 45 mg
D-Panthenol IP 5 mg
Vitamin B6 IP 2 mg
Vitamin C IP 75 mg
Folic Acid IP 1000 mcg
Vitamin B12 IP 5 mcg
Dibasic Calcium Phosphate IP 70 mg
Copper Sulfate Pentahydrate BP 0.1 mg
Manganese Sulfate Monohydrate BP 0.01 mg
Zinc Sulphate Monohydrate IP 28.7 mg (equivalent to 10.4 mg of elemental Zinc)
Potassium Iodide IP 0.025 mg
Light Magnesium Oxide IP 0.15 mg

(Appropriate overages added)

Excipients q.s.

Approved colours used in empty gelatin capsule shell

8. PHARMACEUTICAL PARTICULARS

List of Excipients
Lecithin soyabean, partially hydrogenated vegetable oil, yellow beeswax, arachis oil,
purified water.

Capsule shell contains sunset yellow FCF, brilliant blue FCF, erythrosine, ponceau 4R,
titanium dioxide.

8.1 Incompatibilities

There are no relevant data available.

8.2 Shelf Life

The expiry date is indicated on the label and packaging.

8.3 Packaging Information

13
Capsules in an amber glass bottle.

8.4 Storage and Handling Information

Store at temperature not exceeding 300 C protected from direct sunlight.

Keep out of reach of children.

There are no special requirements for use and handling of this product.

9. PATIENT COUNSELLING INFORMATION

Registered Medical Practitioners may counsel their patients about the special warnings and
precautions for use, drug interactions, undesirable effects, and any relevant contra-
indications of BECADEXAMIN. Patients may also be informed about posology, method of
administration and storage/handling information as applicable.

10. DETAILS OF MANUFACTURER

The Manufacturing Site details are mentioned on the label and packaging.

For further information please contact:

GlaxoSmithKline Pharmaceuticals Limited.
Registered Office
Dr. Annie Besant Road, Worli,
Mumbai 400 030, India.

11. DETAILS OF PERMISSION OR LICENCE NUMBER WITH DATE

Manufacturing License number is indicated on the label and packaging.

12. DATE OF REVISION

24-Apr-2020

Version BEC/PI/IN/2020/01

Trade marks are owned by or licensed to the GSK group of companies

Adapted from:
• Theragran M NCDS version 05 dated 21 January 2020
• PDR for Nutritional Supplements. 2nd edition.
• COBADEX Z Prescribing Information (India).

14