Metatone Tonic

1. Name Of The Medicinal Product

Metatone

2. Qualitative And Quantitative Composition

METATONE contains Vitamin B1 (Thiamine hydrochloride Ph Eur) 500 micrograms, Calcium glycerophosphate Ph Eur 45.6 mg, Potassium glycerophosphate 45.6 mg, Sodium glycerophosphate 22.8 mg and Manganese glycerophosphate NFX 697 micrograms in each 5 ml.

3. Pharmaceutical Form

A clear red liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

METATONE is indicated in the management of convalescence and debility.

4.2 Posology And Method Of Administration

Adults and children 12 years and over:

Oral. One or two 5 ml spoonfuls, preferably diluted, two or three times daily before meals.

Maximum daily dose: 30 ml

Children aged 6 years and over:

Oral. One 5 ml spoonful, preferably diluted, two or three times daily before meals.

Maximum daily dose: 15 ml

Children under 6 years

Metatone is not suitable for administration to children under six years of age, except under the advice of a physician.

The Elderly:

Normal adult dosage is appropriate.

4.3 Contraindications

METATONE is contraindicated in individuals with known hypersensitivity to the product or any of its components.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No known contraindications.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

No specific measures are advised. Treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Vitamin B₁

Vitamin B₁ is essential for proper carbohydrate metabolism and plays an essential role in the decarboxylation of alpha keto acids. Vitamin B₁ deficiency may lead to the clinical condition known as Beri-Beri.

Glycerophosphates

Glycerophosphates were introduced on the grounds that lecithin contains phosphorus in the form of the glycerophosphate radical and that glycerophosphates would therefore be a source of phosphorus that would be more easily assimilated by the tissues, particularly by the brain. Phosphorus is essential for most metabolic processes. As calcium phosphate, phosphorus is a major constituent of bones and teeth. In addition phosphates are a major constituent of all oils and as adenosine phosphates, play an essential role in energy liberation and utilisation.

Calcium

Calcium is a major component of bones and teeth and is necessary for the clotting of blood, the integrity of many cells, especially those of the neuromuscular system and for cardiac function. The consequence of decreased calcium levels in its extreme includes convulsions, tetany, behavour and personality disorders, mental growth retardation and bone deformities, the most common being rickets in children and osteomalacia in adults.

Manganese

Manganese is required for the synthesis of the mucopolysaccharides of cartilage, glucose utilisation, steroid biosynthesis and for the activity of pyruvate carboxylase.

Sodium and Potassium

Sodium is present as the sodium ion in all body fluids and in particular in extracellular fluids, whilst potassium as the potassium ion is largely present intracellulary. Together, sodium and potassium control many cellular events, with a critical role in maintaining fluid balance and in muscle and nerve activity.

5.2 Pharmacokinetic Properties

Vitamin B₁

Vitamin B₁ is well absorbed in the gastro-intestinal tract. An active transport process is involved. After absorption, Vitamin B₁ is widely distributed to all tissues and appears in the foetal circulation during pregnancy; active transfer is involved. Vitamin B₁ appears in breast milk at concentrations which are dependent on the maternal serum levels.

Vitamin B₁ is not stored to an appreciable extent, and excess is excreted, unchanged, together with the products of hepatic metabolism, in the urine.

Calcium

In the digestive tract, the total quantity of calcium available for absorption is augmented by the calcium in intestinal secretions. Calcium is incompletely absorbed from the gut and normally, depending on the intake, 70 - 80% of calcium from the diet is excreted in the faeces.

Manganese

Little information is available on the pharmacokinetics of manganese, however, presumably, sufficient of this trace element is absorbed from the G.I. tract to maintain health in normal individuals.

Sodium and Potassium

Dietary sodium and potassium are readily absorbed and excessive amounts are excreted mainly via the kidneys.

5.3 Preclinical Safety Data

There is insufficient information available to determine whether some of the active ingredients have mutagenic, carcinogenic, teratogenic potential, or the potential to impair fertility.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose

Phosphoric acid (66.3%)

Glucose syrup (41° Baume)

Sodium citrate

Ethanol 96%

Amaranth (E123)

Caramel T12

Mixed oils (composed of Bitter orange oil, Orange oil, Nutmeg oil, Clove oil, Cassia oil, Anethole, Caraway oil.)

Water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

When diluted with water this product should be used within 14 days.

Store below 25°C.

6.5 Nature And Contents Of Container

300 ml or 500 ml amber glass bottle with ROPP cap or with ROPP cap contained in a cardboard carton.

300 ml or 500 ml amber glass bottle with 3 piece plastic child resistant, tamper evident closure fitted with a polyester faced wad or with a 3 piece plastic child resistant, tamper evident closure fitted with a polyester faced wad contained in cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

None applicable.

7. Marketing Authorisation Holder

Chefaro UK Ltd,

4^th Floor, Hamilton House,

Mabledon Place, Bloomsbury,

LONDON, WC1H 9BB

United Kingdom

8. Marketing Authorisation Number(S)

PL 02855/0017

9. Date Of First Authorisation/Renewal Of The Authorisation

30th November 2004

10. Date Of Revision Of The Text

14^th November 2010