SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

HEALTHY START Children's Vitamin Drops

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Active ingredients per ml:

Retinol (Vitamin A) 1664 microgram/5000 iu (added as synthetic retinol concentrate, oily form)

Ascorbic acid (Vitamin C) 150 mg (added as sodium ascorbate) Cholecalciferol (Vitamin D3) 50 microgram/2000 iu (added as cholecalciferol concentrate, oily form)

For the full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Oral drops, solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Prophylactic against vitamin deficiency in children up to    5    years of age.

4.2 Posology and method of administration

Route of Administration: Oral

Healthy Start children’s vitamin drops can be given to infants and young children aged between 6 months and 5 years. Bottle-fed infants receiving 500ml or more of formula a day do not need supplementation. Breast-fed infants can start Healthy Start children’s vitamin drops from one month if the mother’s vitamin D status in pregnancy was not adequate

The recommended dose is 5 drops daily (5 drops contain approximately 233 micrograms (or 700 iu) of Vitamin A, 20mg of Vitamin C and 7.5 micrograms (or 300 iu) of Vitamin D.)

No dosage recommendations are made for the elderly or for adults.

Directions for drop wise administration using the dropper device are provided as follows:

1. Shake the bottle.

2.    Unscrew the cap.

3.    Turn the bottle vertically upside-down and tap base with index finger until drop forms.

4.    To avoid overdosing catch drops on spoon before adding to drink or feed.

5.    Screw cap back firmly after use.

4.3 Contraindications

Hypersensitivity to Vitamin A, C or D or any other excipients used in this preparation.

4.4    Special warnings and precautions for use

Babies who are fed infant formula should not be given Healthy Start children’s vitamin drops until they are having less than 500ml of infant formula a day. These products are fortified with vitamins and minerals and there is risk of high intakes if they are consumed together.

Should not be taken if pregnant, trying to become pregnant or breast-feeding (see section 4.6).

Do not exceed the 5 drops daily dosage.

Sustained administration of excessive doses of Vitamin D, particularly when more than one product containing Vitamin D is being received, may result in Vitamin D toxicity; a common finding in Vitamin D toxicity is the development of hypercalcaemia; the first symptoms of hypercalcaemia may include anorexia, nausea and vomiting, followed by polyuria, polydipsia, weakness, nervousness and pruritus; renal function is impaired. Hypercalciuria leading to calcifications in the kidneys may occur.

Medical attention should be sought if sustained administration of excessive doses has occurred, and for appropriate management in the event of suspected Vitamin D toxicity.

Healthy Start children’s vitamin drops should not be taken with other vitamin containing products except under medical supervision.

4.5    Interactions with other Medicaments and other forms of Interaction

None stated

4.6 Pregnancy and Lactation

Use of excessive doses should be avoided in pregnancy especially during the first trimester. High levels of Vitamin A may cause birth defects.

4.7 Effects on Ability to Drive and Use Machines

None stated

4.8 Undesirable effects

None stated.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

4.9 Overdose

There is no specific experience of overdosage with Healthy Start children's vitamin drops.

Refer to Section 4.4 in the case of the sustained administration of excessive dosages. In the event of swallowing the entire contents of the bottle, seek medical attention.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The active constituents can all be viewed as prophylactic dietary supplements to avoid specific deficiencies. They are all extremely well documented in the literature. A brief summary of their pharmacological actions follows:

Vitamin A

Vitamin A has a number of important functions in the body. It plays an essential role in the function of the retina. It is apparently essential for the growth and differentiation of epithelial tissue. It is required for the growth of bone, reproduction and embryo development. It has a stabilising effect on various membranes.

Vitamin D

The physiological role of Vitamin D is best characterised as that of a positive regulator in calcium homeostasis. Phosphate metabolism is affected by the vitamin in a parallel manner to that of calcium. Thus Vitamin D serves to maintain calcium and phosphate ions at concentrations in plasma that are essential for normal neuromuscular activity, mineralisation of bone and other calcium dependent functions.

Vitamin C

Ascorbic acid functions in a number of biochemical reactions, mostly involving oxidation. At tissue level the major role of ascorbic acid is related to the synthesis of intercellular substances including collagen. Scurvy is associated with defective collagen synthesis and since man cannot synthesise ascorbic acid dietary intake is essential to avoid this condition.

5.2    Pharmacokinetic Properties

None stated.

5.3    Preclinical Safety Data

None stated.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Glycerol

Polysorbate 80 Canary Banana Flavour Alpha-tocopherol Medium Chain Triglycerides Purified water

6.2    Incompatibilities

None stated.

6.3    Shelf life

10 months.

6.4    Special precautions for storage

Do not store above 25 °C.

6.5    Nature and contents of container

10 ml amber glass bottle fitted with a dropper device made from polyethylene and a screw cap made from polypropylene.

6.6    Special Precaution for Disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Secretary of State for Health Department of Health Healthy Food Schemes Richmond House Room 164 79 Whitehall London SW1A 2NS

8    MARKETING AUTHORISATION NUMBER(S)

PL 01511/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/11/2005

03/06/2015