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Forest Laboratories UK Limited

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL
Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
WWW: http://www.forestlabs.com
Medical Information e-mail: medinfo@forest-labs.co.uk

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Summary of Product Characteristics last updated on the eMC: 22/03/2010
SPC Effico Tonic


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1. NAME OF THE MEDICINAL PRODUCT

EFFICO TONIC


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml oral liquid contains:

Vitamin B1 (Thiamine Hydrochloride)

0.18mg

Nicotinamide

2.10mg

Caffeine

20.20mg


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3. PHARMACEUTICAL FORM

Clear colourless to pale straw coloured slightly viscous liquid


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4. CLINICAL PARTICULARS

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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 B1.


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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


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4.3 Contraindications

Use in patients with known hypersensitivity to the product.


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4.4 Special warnings and precautions for use

None stated


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4.5 Interaction with other medicinal products and other forms of interaction

None stated


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4.6 Pregnancy and lactation

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


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4.7 Effects on ability to drive and use machines

None stated


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4.8 Undesirable effects

None stated


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4.9 Overdose

None stated


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5. PHARMACOLOGICAL PROPERTIES

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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.


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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.


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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.


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6. PHARMACEUTICAL PARTICULARS

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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


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6.2 Incompatibilities

None stated


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6.3 Shelf life

Clear colourless or amber glass – 3 years

Clear colourless polyethene terephthalate (PET) or orange coloured PET – 2 years


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6.4 Special precautions for storage

Store away from direct sunlight below 25°C


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6.5 Nature and contents of container

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


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6.6 Special precautions for disposal and other handling

None stated


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7. MARKETING AUTHORISATION HOLDER

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent DA2 6SL.


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8. MARKETING AUTHORISATION NUMBER(S)

PL 0108/5013


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24th November 1988 / 24 November 2003


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10. DATE OF REVISION OF THE TEXT

March 2010


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11. Legal Category

GSL



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/6380/SPC/


Active Ingredients/Generics

 
   caffeine
   nicotinamide
   thiamine