Land: Malta
Språk: engelsk
Kilde: Medicines Authority
NICOTINE
McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
N07BA01
NICOTINE 15 mg
TRANSDERMAL PATCH
NICOTINE 15 mg
OTC
OTHER NERVOUS SYSTEM DRUGS
Withdrawn
2006-08-30
355 black xxx Nicorette Patch 2007-11-20/LKL-c 618693 Häfte/Booklet 618687 England/GB 80 x 70 mm -- 36 pages Registration Department Marketing Department We hereby confirm that we have examined and approved the following: We hereby confirm that we have examined and approved the following: Text Spelling Codes Name + address (licence holder) Licence No.: (market authorisation No.) Inline printing during production Country specific symbols/text e.g legal Exp. date: Design Date / signature Date / signature LABELING APPROVAL BY SIGNING THE ATTACHED ARTWORK THE MARKET CONFIRM THAT THIS DOCUMENT HAS BEEN CHECKED COMPLETELY, I.E. THE CORRECTNESS OF ALL ASPECTS (TEXT, DOSAGE VALUES, SPELLING, FONT SIZE ETC.) IS CERTIFIED. IN CASE OF ALTERATIONS THE CONCERNED PARTS MUST BE MARKED CLEARLY. THE MARKET APPROVAL OF THIS DOCUMENT AUTHORIZES THE PLANT TO PRINT THE CONTENT FOR THIS PROOF. THE MARKET TAKES FULL RESPONSIBILITY FOR CORRECTNESS OF THIS PRINT PROOF. 618693c_info.pdf 07-11-20 06.56.40 PATCH NICOTINE TRANSDERMAL PATCH 06-0810 PERSONALISED SUPPORT PROGRAMME ENROL ON THE INTERNET OR CALL NOW ON 0800 244 838. WITH 618693 618693c.qxd 07-11-20 06.59 Sida 1 A GUIDE FOR USERS WHAT YOU SHOULD KNOW ABOUT NICORETTE ® NICORETTE ® NICORETTE ® 15 MG PATCH 10 MG PATCH 5 MG PATCH Step 1 Step 2 Step 3 PLEASE READ THIS LEAFLET CAREFULLY before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ASK YOUR DOCTOR, NURSE OR PHARMACIST. IN THIS LEAFLET 1 WHAT THIS MEDICINE IS FOR _PAGE 4_ 2 BEFORE USING THIS MEDICINE _PAGE 6_ 3 ■ DO NOT USE NICORETTE PATCH _PAGE 6_ ■ TALK TO YOUR DOCTOR, NURSE OR PHARMACIST _PAGE 6_ ■ IF YOU ARE PREGNANT OR BREAST-FEEDING _PAGE 7_ 3 HOW AND WHEN TO USE THIS MEDICINE _PAGE 9_ ■ HOW TO USE NICORETTE PATCH _PAGE 9 _ ■ WHEN TO USE NICORETTE PATCH _PAGE 11_ ■ HOW TO S Les hele dokumentet
Version No:5, Approved copy SNAS BV 1456 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette 15mg Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nicotine, 15mg released over 16 hours use. Each patch is 30 sq.cm, containing nicotine 0.83mg/sq.cm. For excipients see section 6.1 3 PHARMACEUTICAL FORM Transdermal Patch 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorette Patch is indicated for the relief of nicotine withdrawal symptoms as an aid to smoking cessation in adults and children over 12 years of age. It is also indicated in pregnant and lactating women (see section 4.6). If possible, Nicorette Patch should be used in conjunction with a behavioural support programme. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The patient should make every effort to stop smoking completely during treatment with Nicorette Patch. Behavioural therapy, advice and support will normally improve the success rate. Nicorette Patch should be applied to clean, dry intact areas of hairless skin, for example on the hip, upper arm, or chest. These areas should be varied each day and the same site should not be used on consecutive days. There is no clinically significant difference in bioavailability of nicotine when the patch is applied to either the hip, upper arm or chest. _ADULTS (OVER 18 YEARS OF AGE)_ The daily dose is one patch delivering 15mg, 10mg or 5mg nicotine as appropriate, with application limited to 16 hours in a 24 hour period in each case. Daily treatment commences with one 15mg (30cm 2 ) patch, applied on waking (usually in the morning) and removed 16 hours later (usually at bedtime). After removal, used patches should be disposed of carefully (see warnings). Treatment should continue at this dose for an initial Les hele dokumentet