1. Name Of The Medicinal Product
EFFICO TONIC
2. Qualitative And Quantitative Composition
Each 5ml oral liquid contains:
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3. Pharmaceutical Form
Clear colourless to pale 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 B1.
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
4.3 Contraindications
Use in patients with known hypersensitivity to the product.
4.4 Special Warnings And Precautions For Use
None stated
4.5 Interaction 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
4.9 Overdose
None stated
5. Pharmacological Properties
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 or amber glass – 3 years
Clear colourless polyethene terephthalate (PET) or orange coloured PET – 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 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.
6.6 Special Precautions For Disposal And Other Handling
None stated
7. Marketing Authorisation Holder
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8. Marketing Authorisation Number(S)
PL 0108/5013
9. Date Of First Authorisation/Renewal Of The Authorisation
24th November 1988 / 24 November 2003
10. Date Of Revision Of The Text
March 2010
11. Legal Category
GSL
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