| Section 4.1
Nicotinell patches relieve and/or prevent cravings and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.
Nicotinell patches are indicated in pregnant and lactating women making a quit attempt.
Nicotinell patches should preferably be used in conjunction with a behavioural support programme.
Replaces:
Relief of nicotine withdrawal symptoms as an aid to smoking cessation.
Concurrent counselling/behavioural support is recommended as it is likely to increase the chances of a successful quit attempt
Route of administration: transdermal.
Section 4.2
Deletion of:
Those who use nicotine replacement therapy beyond 9 months are recommended to seek additional help and advice from a healthcare professional.
Section 4.6
Pregnancy
Stopping 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 fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but Nicotinell patches 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 fetus would not normally be exposed to nicotine.
Replaces:
Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or still birth. 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 nicotine replacement therapy. For women unable to quit on their own, nicotine replacement therapy may be recommended to assist a quit attempt. The risk of using nicotine replacement therapy to the foetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentrations and no additional exposure to polycyclic hydrocarbons and carbon monoxide.
As nicotine passes to the foetus affecting breathing movements and has a dose-dependent effect on the placental/foetal circulation, the decision to use nicotine replacement therapy should be made on a risk-benefit assessment as early on in pregnancy as possible with the aim of discontinuing use after 2-3 months.
Intermittent dose 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 to avoid exposure overnight, when the foetus would not normally be subjected to smoke-derived nicotine).
Lactation
The 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.
Replaces:
Nicotine from smoke and nicotine replacement therapy is found in breast milk. However the amounts 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 products, compared to patches, may minimize the amount of nicotine in the breast milk as the time between administrations of nicotine replacement therapy and feeding can be more easily prolonged.
Section 10
Date change from 22 December 2009 to 8 December 2010
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