NIQUITIN Transdermal patch Ref.[27687] Active ingredients: Nicotine

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 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. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the nicotine patch dose should be reduced or discontinued.

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 diabetics 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 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.
• Cardiovascular disease: The pre-cessation regimen should not be used in people with known cardiovascular disease without evaluation of the risk/benefit by a healthcare professional.

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 with care.

Patches should be kept out of the sight and reach of children.

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 is potentially a dermal irritant and can cause contact sensitisation. Care should be taken during handling and in particular contact with theeyes and nose avoided. After handling, wash hands with water alone as soap may increase nicotine absorption.

Users who initiate quitting with pre-cessation NRT and experience exaggerated effects as listed in ‘overdose’ (see section 4.9) should discontinue smoking and if the symptoms persist remove the patch. If symptoms improve after smoking cessation, the user may resume using the patch.

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.

Healthcare professionals are reminded that smoking cessation itself may require the adjustment of some drug therapy.

Pregnancy

Smoking during pregnancy is associated with risks as intra-uterine growth retardation, premature birth or stillbirth. 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. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be recommended by a healthcare professional to assist a quit attempt.

The risk of using NRT to the foetus 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 foetus affecting breathing movements and has a dose dependent effect on placental/foetal 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 at night before going to bed when the foetus would not normally be exposed to nicotine.

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.

Ideally smoking cessation during lactation should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended by healthcare professional to assist a quit attempt.

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 made as long as possible. Women should try to breastfeed just before they take the product.

Fertility

Effects of nicotine on male reproductive tissues have been observed in rats (see section 5.3), however the clinical significance is unknown.

NiQuitin Patches have no or negligible influence on the ability to drive and use machines. However, users of nicotine replacement products should be aware that smoking cessation can cause behavioural changes.

NRT may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking. These may be attributable to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses, NiQuitin patches have not been found to cause any serious adverse effects. Excessive use of NiQuitin patches by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, sleep disturbance, coughing or influenza-like illness. Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration and insomnia may be related to withdrawal symptoms associated with smoking cessation.

Application site reactions are the most frequent adverse reaction associated with NiQuitin. NiQuitin can cause other adverse reactions related to the pharmacological effect of nicotine or withdrawal effects related to smoking.

The following undesirable effects have been reported in clinical trials or spontaneously post-marketing.

Certain symptoms which have been reported such as depression, irritability, nervousness, restlessness, mood lability, anxiety, drowsiness, impaired concentration, insomnia and sleep disturbances may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from asthenia, headache, dizziness, coughing or influenza-like illness.

Immune System Disorders

Uncommon>1/1000; <1/100: hypersensitivity NOS*

Very rare <1/10000: anaphylactic reactions

Psychiatric disorders

Very common >1/10: sleep disorders including abnormal dreams and insomnia

Common >1/100; <1/10: nervousness

Nervous system disorders

Very Common >1/10: headache, dizziness

Common >1/100; <1/10: tremor

Not known: seizures

Cardiac disorders

Common >1/100; <1/10: palpitations

Uncommon >1/1000; <1/100: tachycardia NOS

Respiratory, Thoracic and Mediastinal Disorders

Common >1/100; <1/10: dyspnoea, pharyngitis, cough

Gastrointestinal Disorders

Very Common >1/10: nausea, vomiting

Common >1/100; <1/10: dyspepsia, abdominal pain upper, diarrhea NOS, dry mouth, constipation

Skin and Subcutaneous Tissue Disorders

Common >1/100; <1/10: sweating increased

Very rare >1/100000; <1/10000: dermatitis allergic*, dermatitis contact*, photosensitivity

Musculoskeletal and Connective Tissue Disorders

Common >1/100; <1/10: arthralgia, myalgia

General 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, fatigue

Uncommon >1/1000; <1/100: malaise, influenza-like illness

^* see below

Application 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.