NiQuitin Clear is indicated for the relief of nicotine withdrawal symptoms including cravings as an aid to smoking cessation.  If possible, when stopping smoking, NiQuitin Clear should be used in conjunction with a behavioural support programme.


The patches should be used as directed below.  Prior to initiation of therapy users should be committed to stopping smoking.  During a quit attempt, every effort should be made to stop smoking during treatment with NiQuitin Clear.  Concurrent behavioural support is recommended, as such programmes have been shown to be beneficial for smoking cessation.

Adults (18 years and over)

NiQuitin Clear patches should be applied once a day, at the same time each day and preferably soon after waking, to a 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.

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.

Patches may be removed before going to bed if desired.  However use for 24 hours is recommended to optimise the effect against morning cravings.

NiQuitin Clear therapy should usually begin with NiQuitin Clear 21 mg and be reduced according to the following dosing schedule:-

Dose
Duration

Step 1
NiQuitin Clear 21 mg
First 6 weeks

Step 2
NiQuitin Clear 14 mg
Next 2 weeks

Step 3
NiQuitin Clear 7 mg
Last 2 weeks


Light smokers (e.g.  those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin Clear 7 mg for the final 2 weeks.

Patients on NiQuitin Clear 21 mg who experience excessive side-effects (please refer to precautions), which do not resolve within a few days, should change to NiQuitin Clear 14mg.  This strength should then be continued for the remainder of the 6 week course before stepping down to NiQuitin Clear 7mg for two weeks.  If the symptoms persist the patient should be advised to seek the advice of a healthcare professional.

For optimum results, the 10 week treatment course (8 weeks for light smokers or patients who have reduced strength as above), should be completed in full.  Treatment with NiQuitin Clear patch may be continued beyond 10 weeks if you need it to stay cigarette free, however those who use the patches beyond 9 months are recommended to seek additional help and advice from a healthcare professional.

Further courses may be used at a later time, for NiQuitin Clear patch users who continue or resume smoking.

Adolescents and children

Adolescents (12 to 17 years) should follow the schedule of treatment for adults presented above for steps 1, 2 and 3, but as data are limited, duration of NRT in this age group is restricted to 12 weeks.  If longer treatment is required advice from a healthcare professional should be sought.

NiQuitin Clear is not recommended for use in children under 12 years of age.

Special warnings and precautions for use
The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well established dangers of continued smoking.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions.  If this fails, NiQuitin Clear patches may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.  Once patients are discharged from hospital they can use NRT as normal.

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

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.

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.

Pregnancy and lactation
Pregnancy

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.  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.

However, as nicotine passes to the fetus affecting breathing movements and has a dose dependent effect on placental/fetal circulation, the decision to use NRT should be made as early on in the pregnancy as possible.  The aim should be to use NRT for only 2-3 months.

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 woman is suffering from nausea during pregnancy.  If patches are used they should be removed before going to bed.

Lactation

Nicotine from smoking and NRT is found in breast milk.  However the amount of nicotine the infant is exposed to from NRT 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.