NICOTINE

Posology Adults and children over 12 years of age Nicotine Mouth Spray should be sprayed between the cheek and the teeth. The spray nozzle should be turned to the side and thereafter the mouth spray directed between the cheek and the teeth.

Alternate between the left and right cheek. Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings emerge. If after the first spray cravings are not controlled within a few minutes, a second spray should be used.

If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. Most smokers will require 1-2 sprays every 30 minutes to 1 hour. You may use up to 4 sprays per hour. Do not exceed 2 sprays per dosing episode and 64 sprays (4 sprays per hour over 16 hours) in any 24-hour period.

Nicotine Mouth Spray should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smoking cessation Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Nicotine Mouth Spray and as soon as they are able, reduce the number of sprays used until they have stopped completely.

Smoking reduction Smokers aiming to reduce cigarettes should use the mouth spray, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready smokers should aim to quit smoking completely.

When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking but are having difficulty discontinuing their mouth spray are recommended to contact their pharmacist or doctor for advice.

Method of administration The patient should not eat or drink while using the mouth spray. Care should be taken not to spray the eyes whilst administering the mouth spray. Do not inhale while spraying to avoid getting spray down your throat.

For the best results, do not swallow for a few seconds after spraying. When the spray is used for the first time, the spray pump must be primed. The spray nozzle should be pointed safely away from the user, any adults, children or pets nearby.

The pump should be sprayed 5 times in the air until a fine spray appears. If the spray is not used for 7 days, this priming procedure will need to be repeated.

Nicotine Mouth Spray may cause adverse reactions similar to those associated with nicotine administered by other means, including smoking, and are dose dependent. Most of the undesirable effects reported by the patient usually occur during the first 2-3 weeks after treatment start, and are similar to those seen with other orally delivered forms.

These can include the following: dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, restlessness or impatience; decreased heart rate; and increased appetite or weight gain.

Increased frequency of aphthous ulcer, cough and nasophyringitis may occur after abstinence from smoking. The causality is unclear. During the first few days of treatment irritation to the mouth and throat may be experienced and hiccups are particularly common.

Tolerance is normal with continued use. In addition to this, other cessation associated symptoms were seen in those using a mouth spray: dizziness, presyncopal symptoms, constipation, and gingival bleeding. Nicotine craving, which is recognised as a clinically relevant symptom, is an important element in nicotine withdrawal after smoking cessation.

Reported adverse events associated with nicotine mouth sprays 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), not known (cannot be estimated from the available data).

BODY SYSTEM UNDESIRABLE EFFECTS Nervous system disorders:

Very common Dysgeusia, headache Common Dizziness Uncommon Paraesthesia Eye disorders: Uncommon Lacrimation increase Not known Vision blurred Cardiac disorders: Uncommon Palpitations Not known Atrial fibrillation Vascular disorders: Uncommon Flushing Respiratory, thoracic and mediastinal disorders: Very common Hiccups Uncommon Rhinorrhoea, dyspnoea, bronchospasm, sneezing, nasal congestion Skin and subcutaneous tissue disorders: Uncommon Dry skin, hyperhydrosis, rash, urticaria, pruritus Gastrointestinal disorders: Very common Nausea and dyspepsia Common Vomiting, flatulence, abdominal pain, diarrhoea Uncommon Gingivitis, glossitis Immune system disorders: Uncommon Hypersensitivity Musculoskeletal, connective tissue and bone disorders: Uncommon Musculoskeletal pain General disorders and administration site conditions: Very common Oral soft tissue pain and paraesthesia, stomatitis, salivary hypersecretion, burning lips, dry mouth and/or throat Common Throat tightness, fatigue, chest pain and discomfort and toothache Uncommon Oral mucosal exfoliation, dysphonia 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The risks associated with the use of Nicotine Replacement Therapy (Nicotine replacement Therapy) 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 nonpharmacological interventions.

If this fails, Nicotine Mouth Spray 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 dose should be reduced or discontinued.

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 closely monitor their blood glucose levels while using this product.

Allergic reactions:

Susceptibility to angioedema and urticaria. 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. • GI disease: Swallowing of nicotine may exacerbate symptoms in persons suffering from active oesophagitis, oral or pharyngeal inflammation, gastritis, gastric ulcer or peptic ulcer and oral NRT preparations should be used with caution in these conditions.

Ulcerative stomatitis has been reported. • Seizures: Potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anticonvulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine.

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.

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.

Ethanol content:

This medicinal product contains a small amount of ethanol (alcohol), less than 100mg per spray.

1. Nicotine Mouth Spray is contraindicated in children under 12 years and in non-smokers.