Land: Malta
Taal: Engels
Bron: Malta Medicines Authority
CAFFEINE, NICOTINAMIDE, THIAMINE HYDROCHLORIDE
Forest Laboratories UK Limited Whiddon Valley, Barnstaple North Devon, EX32 8NS, United Kingdom
A13A
CAFFEINE 20.2 mg/5ml NICOTINAMIDE 2.1 mg/5ml THIAMINE HYDROCHLORIDE 0.18 mg/5ml
ORAL LIQUID
CAFFEINE 20.2 mg/5ml NICOTINAMIDE 2.1 mg/5ml THIAMINE HYDROCHLORIDE 0.18 mg/5ml
OTC
TONICS
Withdrawn
2007-06-12
32000963 BRAILLE READS: e f f i c o t o n i c BRAILLE SPECIFICATION: MARBURG MEDIUM 100% 95% 50% 5% Product Name Market Component No. of Colours Profile Dimensions Point of Sale Code Pharmacode Production Site No. Packaging Supplier Originated on Originated by Originated at Proof Status Amended by Date Completed TEXT SIZES Smallest Text 5pt Line Spacing 5pt FONTS USED Rotis Semi Sans Effico Tonic 300ml UK Label 4 As base-on A/W 75 x 185mm 5014398002367 N/A 32000963 William Ranson 01/09/2010 Operator 004 ARK P1 / M1 -- 00/00/2010 Forest Version 2 - November 2009 ARK PHARMA GRAPHICS LTD Crown House Business Centre, Home Gardens, Dartford, Kent, DA1 1DZ. Tel +44(0)1322 424656 FOREST JOB NO.: 32000963 BAR PRINTS 100MM @ 100% ARTWORK APPROVAL SIGNATURE BOX PROOFREADER SITE PACKAGING FOREST REGULATORY FOREST MARKET AFFILIATE FOREST APPROVAL FOREST LABORATORIES Cutterguide + Braille TOP PLY FACE: CYAN MAGENTA YELLOW BLACK VARN TOP PLY REVERSE: BLACK MAGENTA CARRIER FACE: BLACK MAGENTA VARN REL VARN 100% 95% 50% 5% Product Name Market Component No. of Colours Profile Dimensions Point of Sale Code Pharmacode Production Site No. Packaging Supplier Originated on Originated by Originated at Proof Status Amended by Date Completed TEXT SIZES Smallest Text 5pt Line Spacing 5pt FONTS USED Rotis Semi Sans Effico Tonic 300ml UK Label 4 As base-on A/W 75 x 185mm 5014398002367 N/A 32000963 William Ranson 01/09/2010 Operator 004 ARK P1 / M1 -- 00/00/2010 Forest Version 2 - November 2009 ARK PHARMA GRAPHICS LTD Crown House Business Centre, Home Gardens, Dartford, Kent, DA1 1DZ. Tel +44(0)1322 424656 FOREST JOB NO.: 32000963 BAR PRINTS 100MM @ 100% ARTWORK APPROVAL SIGNATURE BOX PROOFREADER SITE PACKAGING FOREST REGULATORY FOREST MARKET AFFILIATE FOREST APPROVAL FOREST LABORATORIES Cutterguide + Braille TOP PLY FACE: CYAN MAGENTA YELLOW BLACK Lees het volledige document
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT EFFICO TONIC 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml oral liquid contains: Vitamin B 1 (Thiamine Hydrochloride) 0.18mg Nicotinamide 2.10mg Caffeine 20.20mg 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 B 1 . 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 CONTRA-INDICATIONS Use in patients with known hypersensitivity to the product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE None stated 4.5 INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION None stated 4.6 PREGNANCY AND LACTATION Contra-indicated in pregnancy and lactation unless considered essential by the physician. Page 2 of 3 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 Lees het volledige document