Abidec Multivitamin Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Abidec Multivitamin Drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Abidec Multivitamin Drops contains 1333IU retinol (as vitamin A palmitate), 400IU ergocalciferol solution, 0.4mg thiamine hydrochloride, 0.8mg riboflavine, 0.8mg pyridoxine hydrochloride, 8mg nicotinamide, and 40mg ascorbic acid in each 0.6ml dose.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
A yellow to orange brown oral drops, solution which darkens upon storage, with some cloudiness.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Abidec Multivitamin Drops is indicated for the prevention of vitamin deficiencies and for the maintenance of normal growth and health during the early years of infancy and childhood; multivitamin supplement.
4.2. Posology and method of administration
Adults and children over 12 years:
Not appropriate.
Children aged 1 to 12 years:
Oral. One 0.6ml dose taken daily.
Maximum daily dose : 0.6ml
Children under 1 year:
Oral. One 0.3ml dose taken daily.
Maximum daily dose : 0.3 ml
The Elderly:
Not appropriate.
Hepatic/renal dysfunction
Normal dosage is appropriate.
4.3 Contraindications
Abidec Multivitamin Drops is contraindicated in individuals with known hypersensitivity to the product or any of its components including peanut oil.
Abidec Multivitamin Drops contains Arachis oil (peanut oil) and should not be taken by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Abidec Multivitamin Drops.
4.4 Special warnings and precautions for use
When prescribing Abidec Multivitamin Drops, as with all multi-vitamin preparations, allowance should be made for vitamins obtained from other sources.
While children are taking Abidec Multivitamin Drops no other vitamin supplement containing vitamins A and D should be taken unless under medical supervision.
This multivitamin supplement should not be given to babies who are receiving more than 500mls of formula milk per day to avoid exceeding the safe upper limit of Vitamin A.
Excessive dosage of vitamin A and D may lead to hypervitaminoses. Due allowance should always be made for intake of these vitamins from other sources.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
None.
Pregnancy and lactation
4.6.
Not indicated.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Vitamin A palmitate
Adverse effects are extremely rare at daily doses of less than 9mg (16363.6iu). Ergocalciferol (Vitamin D2)
The only known adverse effects of vitamin D occur when excessive doses are taken. Adverse effects are not anticipated at the quantity present in Abidec Multivitamin Drops.
Ascorbic Acid (C), Nicotinamide, Pyridoxine (B6), Riboflavin (B2) & Thiamine (B1)
These water soluble vitamins are generally non toxic compounds with a wide margin of safety, the excess amounts being rapidly excreted in the urine. Adverse effects are not anticipated at the quantities present in Abidec Multivitamin Drops.
4.9. Overdose
Symptoms and sign
Abidec Multivitamin Drops contains levels of vitamins which present little risk in overdose.
Vitamin A palmitate
Acute administration of high doses of vitamin A can cause headache, nausea, vomiting and irritability. In infants acute toxicity can lead to transient hydrocephalus. All these effects disappear within 24 hours of taking retinol.
Ergocalciferol (Vitamin D2)
Excessive doses of vitamin D, 60 000 units per day, can result in hypercalcaemia and hypercalciuria. Adverse effects of hypercalcaemia may include muscle weakness, apathy, headache, anorexia, nausea and vomiting, hypertension and cardiac arrhythmias.
Thiamine hydrochloride (Vitamin B1)
When taken orally, thiamine is non-toxic. If large doses are ingested they are not stored by the body but excreted unchanged by the kidneys.
Riboflavin (Vitamin B2)
Riboflavin has been found to be practically non-toxic.
Pyridoxine hydrochloride (Vitamin B6)
Acute doses less than 500mg per day appear to be safe. Excessive doses may lower serum folate concentrations. Sensory neuropathy has been described with chronic dosing of 200 mg daily.
Nicotinamide
A single large overdose of nicotinamide is unlikely to have serious ill effects, though transient abnormalities of liver function might occur.
Ascorbic acid (Vitamin C)
Ascorbic acid is not stored to a great extent by the body, any excess amounts are eliminated in the urine. Ascorbic acid is thought to become toxic at chronic doses in excess of 6 g.
Treatment
Treatment should be supportive and symptomatic.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Vitamin A palmitate
Vitamin A plays an essential role in the function of the retina, the growth and function of epithelial tissue, bone growth, reproduction and embryonic development.
Ergocalciferol (Vitamin D2)
Vitamin D is a regulator of both calcium and phosphate homeostasis. Thiamine hydrochloride (Vitamin B1)
Vitamin B1 is essential for proper carbohydrate metabolism and plays an essential role in the decarboxylation of alpha keto acids.
Riboflavin (Vitamin B2)
Riboflavin is essential for the utilisation of energy from food. It is a component of co-enzymes which play an essential role in oxidative/ reductive metabolic reactions. Riboflavin is also necessary for the functioning of pyridoxine and nicotinic acid.
Pyridoxine hydrochloride (Vitamin B6)
Vitamin B6 is a constituent of the co-enzymes, pyridoxal pyrophosphate and pyridoxamine phosphate, both of which play an important role in protein metabolism.
Nicotinamide
Nicotinamide is an essential component of co-enzymes responsible for proper tissue respiration.
Ascorbic acid (Vitamin C)
Ascorbic acid is a water soluble vitamin and a powerful antioxidant. It is a cofactor in numerous biological processes, such as the metabolism of folic acid, amino acid oxidation and the absorption and transport of iron. It is also required for the formation, maintenance and repair of intercellular cement material. Ascorbic acid is important in the defence against infection, the normal functioning of T-lymphocytes and for the effective phagocytic activity of leucocytes. It also protects cells against oxidation damage to essential molecules.
5.2. Pharmacokinetic properties
Absorption
Vitamins A, B1, B2, B6, C, D2 and nicotinamide are well absorbed from the gastro-intestinal tract.
Distribution
The vitamins present in Abidec Multivitamin Drops are widely distributed to all tissues in the body.
Metabolism and elimination
Vitamin A palmitate
Vitamin A palmitate is hydrolysed in the intestinal lumen to retinol which is then absorbed. Retinol circulates in the blood bound to retinol binding protein which protects it from glomerular filtration. The complex circulates to target tissues where the vitamin is released, permeates the cell and binds intracellularly to cellular retinol binding protein. Of the absorbed retinol 20 -50 % is either conjugated or oxidised to various products and excreted over a matter of days in the urine and faeces, while the remainder is stored. This stored retinol is gradually metabolised by the liver and peripheral tissues.
Ergocalciferol (Vitamin D2)
Vitamin D circulates in the blood associated with vitamin D binding protein. It is stored in fat deposits. Ergocalciferol is hydroxylated in the liver and gut to 25-hydroxy colecalciferol which is then further metabolised in the kidney to the active form 1,25-dihydroxycolecalciferol and other hydroxylated metabolites. Ergocalciferol and it’s metabolites are excreted largely in bile with eventual elimination in the faeces, with only small amounts of some of the metabolites appearing in the urine.
Thiamine hydrochloride (Vitamin Bi)
Thiamine has a plasma half life of 24 hours and is not stored to any great extent in the body. Excess ingested thiamine is excreted in the urine as either the free vitamin or as the metabolite, pyrimidine.
Riboflavin (Vitamin B2)
Following absorption riboflavin is converted into the co-enzymes: flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD). Riboflavin is not stored in body tissues to any great extent and amounts in excess of the body’s requirements are excreted in the urine largely unchanged.
Pyridoxine hydrochloride (Vitamin B6)
The half life of pyridoxine ranges from 15 - 20 days. Once absorbed vitamin B6 is converted to it’s active co-enzyme form pyridoxal 5-phosphate. Muscle is the major storage site for pyridoxal 5-phosphate. It is degraded in the liver to 4-pyridoxic acid which is eliminated by the kidneys.
Nicotinamide
Nicotinamide is readily taken up into tissues and utilised for the synthesis of the co-enzyme forms nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP). Nicotinamide is degraded in the liver and other organs to a number of products that are excreted in the urine, the major metabolites being n-methyl-2-pyridone-5-carboxamide and n-methylnicotinamide.
Ascorbic acid (Vitamin C)
Ascorbic acid reaches a maximum plasma concentration 4 hours following oral administration after which there is rapid urinary excretion. Following oral administration 60 % of the dose is excreted in 24 hours either as ascorbic acid or its metabolite dihydroascorbic acid.
Pharmacokinetics in Renal Impairment
There have been no specific studies of Abidec Multivitamin Drops in renal impairment.
Pharmacokinetics in the Elderly
Not appropriate.
5.3. Preclinical safety data
Mutagenicity
There is insufficient information to determine the mutagenic potential of the active ingredients. However very large doses of vitamin C are claimed to be mutagenic.
Carcinogenicity
There is insufficient information to determine the carcinogenic potential of the active ingredients.
Teratogenicity
High doses of vitamin D are known to be teratogenic in experimental animals, but direct evidence for this is lacking in humans. The teratogenicity of vitamin A in animals is well known, both high and low levels of the vitamin result in defects. But the significance of this for humans is in dispute. Synthetic versions of vitamin A (Isotretinoin and Etretinate) have been shown to be powerful teratogens. There is insufficient information to determine the teratogenic potential of the other active ingredients.
Fertility
Not appropriate.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Sodium hydroxide Sugar (mineral water grade)
Refined peanut oil (a carrier for Vitamin A palmitate) Polysorbate 60 Purified water Nitrogen, Oxygen free
6.2. Incompatibilities
None known.
6.3. Shelf life
18 months after manufacture. Once opened use within 4 weeks.
6.4. Special precautions for storage
Do not store above 25°C. Keep bottle in outer carton.
6.5 Nature and contents of container
Abidec Multivitamin Drops are presented in an amber Type III glass bottle, with Tamper-evident Polypropylene cap or ROPP aluminium cap containing a PET/ Aluminium/ Polyethylene/ Expanded Polyethylene laminated wad.
One or two 25 ml bottles are enclosed in a printed cardboard carton with one polyethylene / polystyrene syringe graduated at 0.3 ml and 0.6 ml. Alternatively, two cartons containing a 25 ml bottle and polyethylene / polystyrene syringe may be shrink wrapped to provide a pack size of 50 ml.
6.6. Instruction for use, handling and disposal
None applicable.
7. MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 02855/0015
9 Date of the first authorisation or renewal
11/10/2005
10 DATE OF REVISION OF THE TEXT
29/10/2014