GSL: General Sales Licence
This information is intended for use by health professionals
NiQuitin Clear patches should be applied once a day, at the same time each day and preferably soon after waking, to a different non-hairy, clean, dry skin site and worn continuously for 24 hours. The NiQuitin Clear patch should be applied promptly on removal from its protective sachet. It should be pressed firmly on the skin with the palm of hand for 10 seconds. Areas where the skin creases should be avoided.
Avoid applying to any skin which is broken, red or irritated. After 24 hours the used patch should be removed and a new patch applied to a fresh skin site. The patch should not be left on for longer than 24 hours. Skin sites should not be reused for at least seven days. Only one patch should be worn at a time.
The patch should be kept sealed in its protective sachet until ready to use. The user should wash hands with water after handling the patch, and avoid contact with eyes and nose.
Patches may be removed before going to bed if desired. However, use for 24 hours is recommended to optimise the effect against morning cravings.
Water will not harm the nicotine transdermal patch, if it has been applied properly. The user can bathe, swim or shower for short periods while wearing the nicotine transdermal patch.Concurrent behavioural support is recommended, as such programmes have been shown to be beneficial for smoking cessation.Adults (18 years and over)Abrupt cessation of smoking:During a quit attempt every effort should be made to stop smoking with NiQuitin Clear.NiQuitin Clear therapy should usually begin with NiQuitin Clear 21 mg Patch and be reduced according to the following dosing schedule:-
|Step 1||NiQuitin Clear 21 mg Patch||First 6 weeks|
|Step 2||NiQuitin Clear 14 mg Patch||Next 2 weeks|
|Step 3||NiQuitin Clear 7 mg Patch||Last 2 weeks|
Gradual Cessation:For smokers who are unwilling or unable to quit abruptly.The 21 mg patch can be used daily for 2-4 weeks while the user continues to smoke as needed. At the end of the 2-4 weeks the user should quit completely and continue using Step 1 21 mg patch for 6 weeks daily without smoking. Thereafter following the Step 2 and 3 directions for abrupt cessation above. Should the patient feel able to quit completely before their designated quit date they can do so.
Reduction in smoking:For smokers who wish to cut down with no immediate plans to quit.A patch can be used while the user continues to smoke as needed. The user should reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Temporary AbstinenceApply a patch to control troublesome withdrawal symptoms including craving during the period when smoking is being avoided. Users should be encouraged to stop smoking completely as soon as possible.If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Adolescents and childrenAdolescents (12 to 17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are not ready or not able to stop smoking abruptly, advice from a healthcare professional should be sought.Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Clear is not recommended for use in children under 12 years of age.
Nicotine replacement therapy may exacerbate symptoms in persons suffering from active oesophagitis, oral and pharyngeal inflammation, gastritis, gastric ulcer or peptic ulcer.Diabetes: Blood glucose levels may be more variable when stopping smoking, with or without NRT as catecholamines released by nicotine can affect carbohydrate metabolism so it is important for diabetic to monitor their blood glucose levels more closely than usual while using this product.Allergic reactions: Susceptibility to angioedema and urticaria.Atopic or eczematous dermatitis (due to localised patch sensitivity): In the case of severe or persistent local reactions at the site of application (e.g. severe erythema, pruritus or oedema) or a generalised skin reaction (e.g. urticaria, hives or generalised skin rashes), users should be instructed to discontinue use of NiQuitin Clear and contact their physician.Contact sensitisation: Patients with contact sensitisation should be cautioned that a serious reaction could occur from exposure to other nicotine-containing products or smoking.A risk benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:• Renal and hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.• Phaeochromocytoma and uncontrolled hyperthyroidism: Use with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma as nicotine causes release of catecholamines.• Seizures: Potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine.Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. The patches should be folded in half with the adhesive side innermost and disposed of with care.Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.Safety on handling: NiQuitin Clear is potentially a dermal irritant and can cause contact sensitisation. Care should be taken during handling and in particular contact with the eyes and nose avoided. After handling, wash hands with water alone as soap may increase nicotine absorption.
PregnancyStopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.
LactationThe relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.
Immune System DisordersUncommon >1/1000; <1/100: hypersensitivity NOS* Very rare <1/10000: anaphylactic reactions
PsychiatricVery common >1/10: sleep disorders including abnormal dreams and insomnia Common >1/100; <1/10: nervousness
Nervous system disordersVery Common >1/10: headache, dizziness Common >1/100; <1/10: tremorNot known: seizures
Cardiac DisordersCommon >1/100; <1/10: palpitations Uncommon >1/1000; <1/100: tachycardia NOS
Respiratory, Thoracic and Mediastinal DisordersCommon >1/100; <1/10: dyspnoea, pharyngitis, cough
Gastrointestinal DisordersVery Common >1/10: nausea, vomitingCommon >1/100; <1/10: dyspepsia, abdominal pain upper, diarrhoea NOS, dry mouth, constipation
Skin and Subcutaneous Tissue DisordersCommon >1/100; <1/10: sweating increasedVery rare >1/100000; <1/10000: dermatitis allergic*, dermatitis contact*, photosensitivity
Musculoskeletal and Connective Tissue DisordersCommon >1/100; <1/10: arthralgia, myalgia
General Disorders and Administration Site ConditionsVery common >1/10: application site reactions NOS*Common >1/100; <1/10: chest pain, pain in limb, pain NOS, asthenia, fatigue Uncommon >1/1000; <1/100: malaise, influenza-like illness*see belowApplication site reactions, including transient rash, itching, burning, tingling, numbness, swelling, pain and urticaria are the most frequent undesirable effects of NiQuitin patch. The majority of these topical reactions are minor and resolve quickly following removal of the patch. Pain or sensation of heaviness in the limb or area around which the patch is applied (e.g. chest) may be reported.Hypersensitivity reactions, including contact dermatitis and allergic dermatitis have also been reported. In the case of severe or persistent local reactions at the application site (e.g. severe erythema, pruritus or oedema) or a generalised skin reaction (e.g. urticaria, hives or generalised skin rashes) users should be instructed to discontinue use of NiQuitin and contact their physician.If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the NiQuitin dose should be reduced or discontinued.
SymptomsSigns and symptoms of an overdose from a nicotine patch would be expected to be the same as those of acute nicotine poisoning, including pallor, cold sweat, salivation, nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion and weakness. Prostration, hypotension, respiratory failure, rapid or weak or irregular pulse, circulatory collapse and convulsions (including terminal convulsions) may ensue with large overdoses.
Overdose from Topical ExposureThe nicotine patch(es) should be removed immediately in the event of an overdose or if the patient shows signs of overdosage. The user should seek medical attention immediately. The skin surface may be flushed with water and dried. No soap should be used since it may increase nicotine absorption. Nicotine will continue to be delivered into the bloodstream for several hours after removal of the system because of a depot of nicotine in the skin.
Overdose from IngestionAll nicotine intake should stop immediately. The patient should seek medical attention immediately and be treated symptomatically.Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastrointestinal absorption of nicotine.
AbsorptionFollowing transdermal application, the skin rapidly absorbs nicotine released initially from the patch adhesive. The plasma concentrations of nicotine reach a plateau within 2-4 hours after initial application of NiQuitin Clear with relatively constant plasma concentrations persisting for 24 hours or until the patch is removed.Approximately 68% of the nicotine released from the patch enters systemic circulation and the remainder of the released nicotine is lost via vaporisation from the edge of the patch.With continuous daily application of NiQuitin Clear (worn for 24 hours), dose- dependent steady state plasma nicotine concentrations are achieved following the second NiQuitin Clear application and are maintained throughout the day. These steady state maximum concentrations are approximately 30% higher than those following a single application of NiQuitin Clear.Plasma concentrations of nicotine are proportional to dose for the three dosage forms of NiQuitin Clear. The mean plasma steady state concentrations of nicotine are approximately 17 ng/ml for the 21 mg/day patch, 12 ng/ml for the 14 mg /day patch and 6 ng/ml for the 7 mg/day patch. For comparison, half-hourly smoking of cigarettes produces average plasma concentrations of approximately 44 ng/ml.The pronounced early peak in nicotine blood levels seen with inhalation of cigarette smoke is not observed with NiQuitin Clear.
DistributionFollowing removal of NiQuitin Clear, plasma nicotine concentrations decline with an apparent mean half-life of 3 hours, compared with 2 hours for IV administration due to continued absorption of nicotine from the skin depot. If NiQuitin Clear is removed most non-smoking patients will have non-detectable nicotine concentrations in 10 to 12 hours.A dose of radio-labelled nicotine given intravenously showed a distribution of radioactivity corresponding to the blood supply with no organ selectively taking up nicotine. The volume of distribution of nicotine is approximately 2.5 l/kg.
MetabolismThe major elimination organ is the liver and average plasma clearance is about 1.2 l/min; the kidney and the lung also metabolise nicotine. More than 20 metabolites of nicotine have been identified, all of which are believed to be pharmacologically inactive. The principal metabolites are cotinine and trans-3-hydroxycotinine. Steady state plasma cotinine concentrations exceed nicotine by 10-fold. The half-life of nicotine ranges from 1 to 2 hours and cotinine's between 15 and 20 hours.
ExcretionBoth nicotine and its metabolites are excreted through the kidneys and about 10% of nicotine is excreted unchanged in the urine. As much as 30% may be excreted in the urine with maximum flow rates and extreme urine acidification (pH≤5).There were no differences in nicotine kinetics between men and women using nicotine patches. Obese men using nicotine patch had significantly lower AUC and Cmax values compared with normal weight men. Linear regression of AUC vs total body weight showed the expected inverse relationship (AUC decreases as weight increases). Nicotine kinetics were similar for all sites of application on the upper body and upper outer arm.
|Drug Reservoir:||Ethylene Vinyl Acetate Copolymer|
|Occlusive Backing:||Polyethylene Terephthalate/ Ethylene vinyl acetate|
|Rate Controlling Membrane:||Polyethylene Film|
|Contact Adhesive and Protective Layer:||Polyisobutylene Adhesive Laminate|
|Printing Ink:||White ink|