SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Effico Tonic

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml oral liquid contains:

Vitamin Bj (Thiamine Hydrochloride)

Nicotinamide Caffeine

3    PHARMACEUTICAL FORM

Oral solution

Clear, colourless/ light straw coloured, slightly viscous liquid

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A gentle pick-me-up and appetite promoter to combat the depressing effects that occur when tired, listless, run down, after a weakening illness or hospitalisation and due to too little nicotinamide and Bj.

4.2    Posology and method of administration

Adults and elderly:

10ml immediately before meals, three times a day.

Children (over 6 years):

2.5 to 5 ml taken as for adults.

Method of administration - oral use.

Contraindications

Use in patients with known hypersensitivity to the product.

4.4    Special warnings and precautions for use

None stated.

4.5    Interactions with other medicinal products and other forms of interaction

None stated.

4.6    Pregnancy and lactation

Contra-indicated in pregnancy and lactation unless considered essential by the physician.

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

None stated.

5.1    Pharmacodynamic properties

Caffeine is a mild CNS stimulant and its inclusion in the formulation helps counteract symptoms of tiredness and listlessness after a weakening illness or hospitalisation.

Thiamine and nicotinamide are present as vitamin supplements. Deficiencies of these two vitamins produce symptoms including fatigue and lethargy with anorexia or loss of appetite.

5.2    Pharmacokinetic properties

Nicotinamide is readily absorbed from the gastrointestinal tract. It has a short half-life and after low doses, the principle metabolites are the N-methyl, 2-and 4- pyridone derivatives.

Thiamine is absorbed from the gastrointestinal tract and widely distributed to most body tissues. It is not stored in the body and amounts in excess of the body's requirements are excreted in the urine as unchanged thiamine or as metabolites.

Caffeine is absorbed readily after oral administration. The average half-life is reported to be 3.5 hours. Peak plasma concentrations of 1.5 to 1.8 mg/litre have been measured after a 100mg oral dose.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol 96% Sodium benzoate Citric acid

Concentrated hydrochloric acid Sucrose

Compound gentian infusion H & R summer fruit flavour 288234 Purified water

6.2    Incompatibilities

None stated.

6.3    Shelf life

Clear, colourless glass bottles - 3 years.

Clear, colourless polyethene terephthalate (PET) bottles - 2 years.

6.4    Special precautions for storage

Store away from direct sunlight below 25 °C.

6.5    Nature and contents of container

Clear colourless glass bottle, clear colourless polyethene terephthalate (PET) bottle or orange coloured PET bottle with food grade polypropylene tamper-evident caps pigmented with titanium dioxide and containing    300ml or 500ml.

6.6    Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION    HOLDER

Forest Laboratories UK Limited,

Whiddon Valley,

Barnstaple,

North Devon,

EX32 8NS,

United Kingdom.

8. MARKETING AUTHORISATION NUMBER

PL 00108/5013R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24^th November 1988 / 24^th November 2003

10 DATE OF REVISION OF THE TEXT

20/11/2015