- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Adults 18 years and over
Abrupt cessation of smoking:During a quit attempt every effort should be made to stop smoking with NiQuitin patches.NiQuitin therapy should usually begin with NiQuitin 21 mg and be reduced according to the following dosing schedule:-
|Step 1 NiQuitin 21 mg||First 6 weeks|
|Step 2 NiQuitin 14 mg||Next 2 weeks|
|Step 3 NiQuitin 7 mg||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 is not recommended for use in children under 12 years of age.
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.
Very rare <1/10000: anaphylactic reactionsPsychiatricVery common >1/10: sleep disorders including abnormal dreams and insomnia
Common >1/100; <1/10: nervousnessNervous system disorders
Very Common >1/10: headache, dizzinessCommon >1/100; <1/10: tremor
Not known: seizuresCardiac disordersCommon >1/100; <1/10: palpitations
Uncommon >1/1000; <1/100: tachycardia NOSRespiratory, Thoracic and Mediastinal DisordersCommon >1/100; <1/10: dyspnoea, pharyngitis, coughGastrointestinal DisordersVery Common >1/10: nausea, vomitingCommon >1/100; <1/10: dyspepsia, abdominal pain upper, diarrhea NOS, dry mouth, constipationSkin and Subcutaneous Tissue DisordersCommon >1/100; <1/10: sweating increasedVery rare > 1/100000; <1/10000: dermatitis allergic*, dermatitis contact*, photosensitivityMusculoskeletal and Connective Tissue Disorders
Common >1/100; <1/10: arthralgia, myalgiaGeneral Disorders and Administration Site Conditions
Very Common >1/10: application site reactions NOS*Common >1/100; <1/10: chest pain, pain in limb, pain NOS, asthenia, fatigueUncommon >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 generalized 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.
ManagementOverdose 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 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 (worn for 24 hours), dose-dependent steady state plasma nicotine concentrations are achieved following the second NiQuitin application and are maintained throughout the day. These steady state maximum concentrations are approximately 30% higher than those following a single application of NiQuitin.Plasma concentrations of nicotine are proportional to dose for the three dosage forms of NiQuitin. The mean plasma steady state concentrations of nicotine are approximately 17ng/ml for the 21mg/day patch, 12ng/ml for the 14mg /day patch and 6ng/ml for the 7mg/day patch. For comparison, half-hourly smoking of cigarettes produces average plasma concentrations of approximately 44ng/ml.The pronounced early peak in nicotine blood levels seen with inhalation of cigarette smoke is not observed with NiQuitin.
DistributionFollowing removal of NiQuitin, 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 is removed most non-smoking patients will have non-detectable nicotine concentrations in 10 to 12 hours.A dose of radiolabelled 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 2.5l/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 NiQuitin. Obese men using NiQuitin 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/Aluminium/Polyethylene Terephthalate/ Ethylene vinyl acetate|
|Rate Controlling Membrane:||Polyethylene Film|
|Contact Adhesive and Protective Layer:||Polyisobutylene Adhesive Laminate|
|Printing Ink:||FGN-7214 NT20 Brown 465 (Ink)|
Omega Pharma Ltd
Omega Pharma Ltd, 1st Floor, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK
+44 (0)203 598 9603
+44 (0)1748 828 860