1. Name Of The Medicinal Product
Nicorette 10mg Patch or Boots NicAssist 10 mg Patch
2. Qualitative And Quantitative Composition
Nicotine, 10mg released over 16 hours use. Each patch is 20 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 (30cm2) 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 period of 8 weeks. Patients who have successfully abstained from smoking during this 8 week period should be supported through a further 4 week weaning period, using the lower strength patches. Downward titration of dose is achieved by applying one 10mg (20cm2) patch daily for 2 weeks followed by one 5mg (10cm2) patch daily for a further 2 weeks.
Adults who use NRT beyond 9 months are recommended to seek additional help and advice from a healthcare professional.
Adolescents (12 to 18 years)
The dose and method of use are as for adults however as data are limited in this age group, the recommended treatment duration is 12 weeks. If longer treatment is required, advice from a healthcare professional should be sought.
4.3 Contraindications
Nicorette Patches should not be administered to patients with known hypersensitivity to nicotine or any component of the patch.
4.4 Special Warnings And Precautions For Use
Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.
Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Patch presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Patch may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.
Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.
Renal or hepatic impairment: Nicorette Patch should be used 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.
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. After removal, the patch should be folded in half, adhesive side innermost, and placed inside the opened sachet, or in a piece of aluminium foil. The used patch should then be disposed of carefully, away from the reach of children or animals.
Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Patch should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.
Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.
Generalised dermatological disorders :Patients with chronic generalised dermatological disorders such as psoriasis, chronic dermatitis or urticaria should not use Nicorette Patch.
Erythema may occur. If it is severe or persistent, treatment should be discontinued.
Minor skin reactions are seen at the patch application site in a proportion of patients when commencing treatment (see also section 4.8). If skin reactions become more severe or more generalized, patients should be advised to discontinue use of patches and seek further medical help regarding nicotine replacement therapy.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.
4.6 Pregnancy And Lactation
Pregnancy
NRT is not contraindicated in pregnancy. The decision to use NRT should be made on a risk-benefit assessment as early on in the pregnancy as possible with the aim of discontinuing use as soon as possible.
Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.
Ideally smoking cessation during pregnancy should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended to assist a quit attempt.
Nicotine passes to the fetus affecting breathing movements and has a dose-dependent effect on placental/fetal circulation. However the risk of using NRT to the fetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.
Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the women is suffering from nausea during pregnancy. If patches are used they should be removed before going to bed.
Lactation
NRT is not contraindicated in lactation. Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.
Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be more easily prolonged.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.
Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.
Nicorette Patch may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Patch has not been found to cause any serious adverse effects. Excessive use of Nicorette Patch by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.
About 20% of Nicorette patch users experience mild local skin reactions, during the first weeks of treatment. In some patients the skin reactions may become more severe eg skin blistering or a burning sensation or may be more generalized (see section 4.4).
Reported adverse events associated with Nicorette 5mg, 10mg and 15mg patch include:
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
*Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.
4.9 Overdose
Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.
Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Nicotine has no therapeutic uses except as replacement therapy for the relief of abstinence symptoms in nicotine-dependent smokers.
Owing to its many actions, the overall effects of nicotine are complex. A wide variety of stimulant and depressant effects are observed that involve the central and peripheral nervous, cardiovascular, endocrine, gastro-intestinal and skeletal motor systems. Nicotine acts on specific binding sites or receptors throughout the nervous system.
5.2 Pharmacokinetic Properties
Taking into account the residual concentration of nicotine in the transdermal system, the nicotine released from the system is efficiently absorbed: a bioavailability of between 80-100% has been reported. There is no clinically significant difference in bioavailability of nicotine when the patch is applied to either the hip, upper arm or chest.
Steady state concentrations of plasma nicotine in volunteers were examined during a study period of six days. Although nicotine was detectable 24 hours after the first dose, the data did not indicate any accumulation.
Tmax of nicotine after application of a 30cm2 nicotine transdermal system has been shown to vary between 6 ± 2 and 9 ± 3 hours: Cmax has been shown to vary between 13 ± 3 and 16 ± 5 ng/ml. No differences in these pharmacokinetic parameters have been observed between males and females.
All Nicorette Patches are labelled by the average amount of nicotine absorbed by the patient over 16 hours.
5.3 Preclinical Safety Data
Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.
There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Medium molecular weight polyisobutylene
Low molecular weight polyisobutylene
Polybutylene
Polyester non- woven
Backing film
Siliconised polyester release liner
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store at above 30oC.
6.5 Nature And Contents Of Container
Heat sealed multilaminate pouch containing one patch. Cartons of 1, 2, 3, 7*, 14 and 28 pouches (*pack presently marketed).
6.6 Special Precautions For Disposal And Other Handling
Cut open the pouch with scissors along the line, as indicated. A clean, dry intact area of skin is selected which is hairless, such as the hip, upper arm or chest. The transparent plastic backing is peeled away and the patch pressed carefully onto the skin. The fingers should be rubbed firmly round the edge to ensure that the patch sticks properly. The patch will normally resist bathing, showering, or swimming, but if it does come off it should be replaced with a new one. Use of skin oils or talc can prevent proper adhesion of the patch.
It is intended that the patch is worn through the waking hours (approximately 16 hours) being applied on waking and removed at bedtime. Nicotine residues in the used patches may present a hazard to children and pets, thus used patches should be folded, sticky sides together, put back in an empty pouch and placed in household rubbish.
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK
8. Marketing Authorisation Number(S)
PL 15513/0176
9. Date Of First Authorisation/Renewal Of The Authorisation
22 January 2008
10. Date Of Revision Of The Text
20 April 2010
No comments:
Post a Comment