NICOTINE

45mg Inhaler is for oral inhalation use only. 45mg Inhaler should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Inhaler and as soon as they are able, reduce the number of charges used until they have stopped completely.

Smokers aiming to reduce cigarettes should use the Inhaler, 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.

Maximum daily dose: 2 packs 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 Inhaler are recommended to contact their pharmacist or doctor for advice.

Each pack lasts for 20 charges. Each charge apart from the first one (see Section 2) provides a comparable number of inhalations to a conventional cigarette, although frequency, puffing/inhalation time and technique vary between individuals.

3). 45mg Inhaler stick: • Tear away the strip on the pack and remove the cellophane outer wrap completely. • Peel away the foil strip at the bottom of the pack. 45mg Inhaler stick. • Hold the pack upright and away from you. • Insert the arrowed end of the stick into the base of the pack and push firmly for five seconds to charge.

45mg Inhaler stick, you need to repeat this charging step and shake well before use. 45mg Inhaler for more than two days, repeat this charging step. • You should only fill the stick before you intend to use it. If spray comes into contact with skin or eyes, rinse gently with water.

45mg Inhaler stick: • Inhale through the filter end of the stick as you would with a cigarette ensuring you don’t cover the air inlet holes at the filter end of the stick. • On average each charge apart from the first one provides a comparable number of puffs to a conventional cigarette.

• The stick is empty when you no longer feel the flavoured spray in your mouth. 45mg Inhaler stick back in the pack when not in use. 45mg Inhaler stick is designed so that proper inhalation does not usually produce a visible vapour exhale.

Effects of smoking Cessation 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. 45 mg Inhaler 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, nicotine has not been found to cause any serious adverse effects. Excessive use of nicotine by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Most of the undesirable effects reported by the patient occur during the first weeks after starting treatment. About 40% of users experience mild local reactions such as cough and irritation in the mouth and throat. Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of this product.

The adverse reactions below are listed by system organ class (SOC).

Frequencies are defined in accordance with current guidance, as:

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.

Reported adverse events associated with inhaled nicotine include:

System Organ Class Incidence Reported Adverse Event Immune System Disorders Common Not known Hypersensitivitya Anaphylactic reactiona Psychiatric disorders Uncommon Abnormal dreamsc Nervous System Disorders Very Common Common Common Common Common Headachea# Burning sensationb Dizziness Dysgeusia Paraesthesiaa Eye Disorders Not known Not known Blurred Vision Lacrimation increased Cardiac Disorders Uncommon Uncommon Very Rare Palpitationsa Tachycardiaa Reversible atrial fibrillation Vascular Disorders Uncommon Uncommon Flushinga Hypertensiona Respiratory, Thoracic and Mediastinal Disorders Very Common Very Common Common Uncommon Uncommon Uncommon Uncommon Uncommon Cough* Throat irritation Nasal Congestion Bronchospasm Dysphonia Dyspnoeaa Sneezing Throat tightness Gastrointestinal Disorders Very Common Very Common Very Common Common Common Common Nauseaa Stomatitis Hiccups Abdominal pain Diarrhoea** Dry mouth Common Common Common Common Uncommon Uncommon Uncommon Uncommon Rare Rare Rare Not known Not known Not known Dyspepsia Flatulence Salivary hypersecretion Vomitinga Eructation Glossitis Oral mucosal blistering and exfoliation Paraesthesia oral** Dysphagia Hypoaesthesia oral** Retching Dry throat Gastrointestinal discomforta Lip pain Skin and Subcutaneous Tissue Disorders Uncommon Uncommon Uncommon Uncommon Not known Not known Hyperhidrosisa Pruritusa Rasha Urticariaa Angioedemaa Erythemaa General Disorders and Administration Site Conditions Common Uncommon Uncommon Uncommon Fatiguea Astheniaa Chest discomfort and paina Malaisea a Systemic effects; b At the application site c Identified if formulation was used at night *Higher frequency observed in clinical studies with inhaler formulation.

Any risks that may be associated with the use of nicotine are substantially outweighed by the well-established dangers of continued smoking. 45 mg Inhaler presents a lesser hazard than continuing to smoke. However, dependent smokers currently hospitalised as a result of myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable and/or who have uncontrolled hypertension should be encouraged to stop smoking with non- pharmacological interventions.

45 mg Inhaler 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 nicotine replacement therapy (NRT) is initiated, as catecholamines released by nicotine can affect carbohydrate metabolism.

GI disease:

Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal or 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.

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.

45mg Inhaler. 45mg Inhaler is contraindicated in children and adolescents under the age of 18 years.