INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
VI-DAYLIN® DROPS

SCHEDULING STATUS
S0

PROPRIETARY NAME
(and dosage form)

VI-DAYLIN^® DROPS

COMPOSITION
Each 0,6 mL contains:

Vitamin A	5 000 IU
Vitamin D (Viosterol)	400 IU
Vitamin B1 (thiamine hydrochloride)	1,5 mg
Vitamin B2 (riboflavine)	1,2 mg
Vitamin B6 (pyridoxine hydrochloride)	0,5 mg
Nicotinamide	10 mg
Vitamin C (ascorbic acid)	50 mg

Preserved with :

Methylparaben	0,05% m/v
Benzoic acid	0,10% m/v

PHARMACOLOGICAL CLASSIFICATION
A.22.1.1 Vitamins for paediatric use

PHARMACOLOGICAL ACTION
VI-DAYLIN^®Drops provide vitamins for infants.

INDICATIONS
VI-DAYLIN^®Drops are intended for use as a dietary supplement.

CONTRA-INDICATIONS
VI-DAYLIN^®Drops are contra-indicated in patients hypersensitive to any of the ingredients. Not intended for patients where specific vitamin deficiency exists.

WARNINGS
Keep this product out of the reach of children. In cases of accidental overdose, call a doctor or seek medical advice immediately.

Women who are, or might become pregnant should avoid taking daily supplements containing more than 5000 iu vitamin A, without consulting a medical practitioner. The safe dosage may be exceeded when medicines and/or health products containing vitamin A are taken together with a high dietary intake of vitamin A.

DOSAGE AND DIRECTIONS FOR USE
VI-DAYLIN^®Drops will not curdle milk and may be added to infants' feeds or may he mixed with cereal or fruit juice, or may be taken as is.
Daily dosage for babies 1 - 12 months:
0,6 mL orally or as directed by the doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects
Allergic reactions, including rash, pruritus, and anaphylaxis have been reported with vitamin use.
Components of these products have been associated with gastrointestinal effects such as heartburn, eructation, abdominal pain and cramps, diarrhoea, constipation, vomiting, nausea and anorexia.
Deterioration of acneiform vulgaris, or eruption of acneiform exanthema, has been noted with several components.
Bright yellow urine discoloration has been reported with riboflavine usage.
Long term administration of Vitamin A >10 000 IU daily may cause chronic hypervitaminosis A. Symptoms of chronic intoxication are as follows: headache, vertigo, hyperkeratosis, changes in skin and mucous membranes, tenderness and pain in the bone and joints, fever, increased serum cholesterol and serum triglyceride concentration, intracranial hypertension, fatigue, hypercalcaemia, hyperglycaemia, increased alkaline phosphatase, hypoproteinamia, hypoprothrombinaemia, low serum ascorbic acid, decreased protein content of the cerebrospinal fluid, elevated urinary hydroxyproline and hypercalciuria, polyuria, increased frequency of micturition, urinary incontinence, enuresis and acute renal failure due to tubular necrosis, papilledema, dryness, haemorrhages and fissures of the lips, yellow to yellow-orange discolouration of the skin, decreased tolerance to sunlight; changes in pigmentation, hair loss and brittle nails, spider angiomas and oedema.
Prolonged moderate intake of Vitamin A (20 000 IU per day), when taken over prolonged periods of time can cause significant hepatic injury, including cirrhosis. Total cumulative dose may be a critical factor.
Characteristic features of chronic Vitamin D intoxication include hypercalcemia and deposition of calcium salts in various tissues. Occasionally, mental disturbances, cerebella ataxia, peripheral facial paresis, apathy, and lack of interest have been reported.
Precautions
Caution should he used in patients with chronic liver disease and in patients with hyperlipidemia.
Vitamin D should be used with caution in patients with hypercalcaemia.
Increased sensitivity to Vitamin D is observed in patients with renal impairment and having an abnormal calcium/phosphorus ratio.
Drug interactions
The effects of Vitamin D may be reduced in patients taking barbiturates or anti-convulsants due to accelerated metabolism of Vitamin D.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
High doses of individual components of this 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.
High doses of Vitamin A can lead to haemolysis, anaemia, neutropenia, leukocytosis, thrombocytopenia, aplastic anaemia, increased sedimentation rate, and accelerated reabsorption of trabecular and cortical bone.
Initial symptoms of Vitamin D overdose are usually comprised of weakness, lassitude, headache, nausea, vomiting and diarrhoea. Renal function can be impaired at an early stage with polyuria, polydipsia, nocturia, decreased urinary concentrating ability and proteinuria.
If symptoms of overdosage arise, discontinue use of the medicine. Treatment is symptomatic and supportive.

IDENTIFICATION
VI-DAYLIN^®Drops is a yellow liquid with a characteristic citrus odour and flavour.

PRESENTATION
VI-DAYLIN^®Drops are supplied in 25 mL amber glass bottles, with calibrated dropper to allow for the measuring of exact dosage.

STORAGE INSTRUCTIONS
Store in a cool (below 25°C) place. Protect from light. Keep out of reach of children.

REFERENCE/REGISTRATION NUMBERS
H2088 (Act 101/1965)

BOTSWANA ONLY
Scheduling Status:
Conditions of Registration: To be allocated by the Botswana Ministry of Health
Registration Number: To be allocated by the Botswana Ministry of Health
Date of Publication: To be allocated by the Botswana Ministry of Health

NAME AND BUSINESS ADDRESS OF APPLICANT
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue,
Bryanston Ext 77
Private Bag X69
Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT
March 1975

16015-07/2004
Highland Print

Updated on this site: November 2005
Source: Hospital Pharmacy
SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005