Boehringer Ingelheim Ltd Consumer Healthcare

Pharmaton Kiddi, Oral Solution

Each 7.5 ml of contains:

Each 7.5 ml contains 8.96 mg of sodium (corresponding to 0.390 mmol) and 0.141 mg of ethanol.

For a full list of excipients, see section 6.1.

Oral solution

A viscous, clear to slightly opalescent, orange solution with an orange odour and taste.

As a supplement for persons requiring a dietary adjunct in for example, convalescence, loss of appetite and in the correction of specific vitamin deficiencies.

The recommended doses are:

Children 1 to 5 years: 7.5 ml daily

Children over 5 years and adults: 15 ml per day

Pharmaton Kiddi should be taken ½ to 1 hour before meals, ideally before breakfast or lunch.

Pharmaton Kiddi may be diluted with water or mixed with food.

Pharmaton Kiddi may show a natural turbidity which is due to the fruit concentrate. This does not impair its efficacy. Shake well before use.

Pharmaton Kiddi should not be taken:

• in cases of existing disorders of calcium metabolism, such as hypercalcaemia and hypercalciuria

• in cases of hypersensitivity to any of the ingredients in the product

• in cases of renal insufficiency

• concomitantly with other products containing vitamin D

• in cases of hypervitaminosis of vitamin D

Allowances for vitamin D from other sources should be made, as excessive amounts of vitamin D may be harmful.

Pharmaton Kiddi should not be taken over a prolonged period in a dosage exceeding the recommended one.

Prolonged excessive ingestion of vitamin D can lead to hypervitaminosis states, which may occur if foods high in this vitamin, (for example liver), are ingested in association with the recommended doses of this product.

Pharmaton Kiddi contains 2.52 g of sorbitol per maximum recommended daily dose of 15 ml. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

At the recommended dosage, no interactions with other drugs have been reported.

No controlled studies in either animals or humans using Pharmaton Kiddi at the recommended doses in pregnant or lactating women are available.

Vitamin D given during the last trimester of pregnancy may cause hypercalcaemia in infants.

It is advised that if possible women receiving vitamin D do not breastfeed their infants as this may lead to the development of hypercalcaemia in the infant.

No effects on ability to drive and use machines are known.

At the product's recommended dosage no significant side-effects have been reported.

Overdosage of Pharmaton Kiddi may result in toxicity. This is a result of the toxicity of the liposoluble vitamin D and the water-soluble vitamin B6. Prolonged daily intake of an overdosage (50 ml or more) of Pharmaton Kiddi may result in toxicity from the lipid-soluble vitamin D and the water-soluble Vitamin B6.

Such overdosage may cause symptoms of vitamin D overdose such as vomiting, headache and diarrhoea and may also induce hypercalcaemia resulting in constipation. Such overdose of vitamin B6 may cause peripheral neuropathy resulting in neurological symptoms such as hyperaesthesia, paraesthesia and muscle weakness.

An unbalanced or deficient diet may not provide all the necessary vitamins and minerals which children require. In situations where there is increased demand or inadequate diet, vitamins and minerals correct and prevent impairment of cell metabolism. Insufficient supply of essential substances which the body is unable to synthesise itself, may cause debility, tiredness, a decrease in vitality, reduced resistance and delayed recovery from illness.

Lysine is an essential amino acid which improves growth and liver function and helps make new protein and bone. In countries in which cereals and potatoes are the main foods, the body can get too little lysine. Cooking, baking and deep-freezing can lead to loss of lysine from foods. Lysine deficiency leads to a reduction in protein synthesis and a decrease in enzymatic activity in the liver and pancreas. Loss of appetite can be a sign of lysine deficiency. In children, lysine is the amino acid most often inadequately supplied.

The action of lysine is supplemented by the B-complex vitamins which are necessary for normal metabolic functions including metabolism of protein, fat and carbohydrate.

Calcium and phosphorus are essential for the formation of bone mass.

Vitamin D is required for the absorption and utilisation of calcium and phosphorus and therefore contributes to the development and maintenance of healthy bones and teeth and the functioning of the muscles and nerves.

There are no data available on the pharmacokinetics of Pharmaton Kiddi.

Sorbitol (E420)

Carmellose sodium

Orange essence

Polysorbate 80

Polysorbate 20

Saccharin sodium

Potassium sorbate (E202)

Sodium benzoate (E211)

Citric acid monohydrate

Disodium edetate

Ascorbic acid

Ethanol

Purified water

Not applicable

2 years

Do not store above 25°C

Keep the bottle tightly closed

100 ml & 200 ml brown glass bottles sealed with aluminium ROPP caps. The bottles are further packaged into cardboard cartons. The final packaging contains a plastic measuring cup.

Not all pack sizes may be marketed.

No special requirements

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

PA 7/61/1

6 April 2001 / 6^th April 2006

July 2006