NAME OF THE MEDICINAL PRODUCT

Galpharm Nicotine Replace 2 mg Gum Superdrug Nicotine Replacement 2mg Gum Asda Nicotine Replace 2mg Gum

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chewing Gum containing 2 mg Nicotine (as 13.2 mg Nicotine Resinate)

Excipient(s) with known effect:

1 piece of 2 mg Chewing Gum contains:

Maltitol (E965) 229.5mg Sucralose 1.2mg

Butylated hydroxytoluene (E321) 0.45 mg For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Medicated chewing gum

White/off-white Rectangular shaped coated chewing gum, approximately 19x12mm

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Nicotine 2 mg Gum is indicated for the relief and/or prevention of nicotine withdrawal symptoms including cravings associated with smoking cessation. It is 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.

Nicotine 2 mg Gum is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology and method of administration

Adults and Children over 12 years of age

Nicotine 2 mg Gum should be chewed slowly according to the instructions.

The strength of gum to be used will depend on the smoking habits of the individual. In general, Nicotine 2 mg Gum is suitable for smokers who smoke less than 20 cigarettes a day, and Nicotine 4 mg Gum is suitable for smokers who smoke more than 20 cigarettes a day.

Nicotine 2 mg Gum should be used whenever the individual feels the urge to smoke or to prevent cravings in situations where these are likely to occur.

Smokers who are willing to or able to stop smoking immediately should initially replace all their cigarettes with the Gum. When they feel able to, the number of gums used should be reduced until they have stopped use completely.

Smokers who are aiming to reduce the number of cigarettes smoked should use Nicotine 2 mg Gum, when required, between smoking episodes to prolong smoke-free intervals. The intention should be to reduce smoking as much as possible.

As soon as they are ready smokers should aim to quit smoking completely.

Maximum daily dose: 15 pieces per day.

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 Nicotine 2 mg Gum are recommended to contact their pharmacist or doctor for advice.

For those using the 4 mg gum, switching to the 2 mg gum may be helpful when stopping treatment or reducing the number of gums used each day.

The chewing gums should be used whenever there is an urge to smoke according to the chewing technique described on the pack. The gum will be exhausted after about 30 minutes of use as described. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

4.3 Contraindications

Nicotine 2 mg Gum is contraindicated in:

•    hypersensitivity to nicotine or any component of the chewing gum.

•    children under the age of 12 years.

4.4 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.

Underlying cardiovascular disease: In stable cardiovascular disease Nicotine 2 mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with nonpharmacological interventions. If this fails, Nicotine 2 mg Gum 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 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: Nicotine 2 mg Gum should be used 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. Nicotine gum should be disposed of with care.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicotine 2 mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Excipients: Nicotine 2 mg Gum also contains butylated hydroxy toluene (E321); this may cause irritation to the mucous membranes and local skin reactions (e.g contact dermatitis).

The gum contains maltitol and sucralose. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicotine 2 mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.

4.5 Interaction with other medicinal products and other forms of interaction

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 i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Fertility, pregnancy and lactation

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. 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 used as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable Nicotine 2 mg Gum 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 foetus would not normally be exposed to 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.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

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.

Nicotine 2 mg Gum 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 2 mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.

Excessive consumption of Nicotine 2 mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.

Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.

Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4 mg nicotine gum is used; slower chewing and the use of the 2 mg nicotine gum (if necessary more frequently) will usually overcome this problem.

The chewing gum may stick to, and may in rare cases damage dentures.

Reported adverse events associated with Nicotine 2 mg and 4 mg Gum include:

Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000 including isolated reports) and not known (cannot be estimated from available data).

Nervous System Disorders Very Common: Headache Common: Dizziness

Cardiac Disorders

Uncommon: Palpitations

Very rare: Reversible atrial fibrillation

Gastrointestinal disorders:

Very common: Gastrointestinal discomfort, hiccups, nausea

Common: Vomiting

Skin and subcutaneous tissue disorders Uncommon: Erythema, urticarial

General disorders and administration site conditions Very Common: Sore mouth or throat, jaw-muscle ache Rare: Allergic reactions including angioedema

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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastrointestinal absorption of nicotine.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in nicotine dependence, ATC code: N07BA01

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicotine 2 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.

5.2 Pharmacokinetic properties

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 - 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.

5.3 Preclinical safety data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Gum Base (containing butylated hydroxytoluene [E321])

Calcium Carbonate

Xylitol

Sodium Carbonate Anhydrous

Sodium Hydrogen Carbonate

Acesulfame Potassium

Sucralose

Peppermint

Coolmix

L-Menthol

Talc

Maltitol (E965)

Titanium Dioxide Maltitol liquid Carnauba wax

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months

6.4 Special precautions for storage

Do not store above 25°C.

Keep blister in outer carton to protect from light.

6.5 Nature and contents of container

Packs containing 10, 12, 20, 24, 30, 36, 48, 50, 80, 96 and 108 pieces of chewing gum.

The chewing gums are packed in blisters with 10 or 12 pieces of chewing gum per blister.

The blister pack is made of PVC/PVdC thermoformed blister cards, sealed with aluminium foil.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited

Wrafton

Braunton

Devon

EX33 2DL

8    MARKETING AUTHORISATION NUMBER(S)

PL 12063/0133

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

11/12/2015

10    DATE OF REVISION OF THE TEXT

05/04/2016