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1. Niquitin Mint 2,5 Mg Munsönderfallande Film
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Document: NiQuitin Mint lozenge ENG SmPC change

• NiQuitin Mint lozenge SmPC
• NiQuitin Mint lozenge ENG SmPC

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summary of the product characteristics

NiQuitin Mint 2 mg lozenge

NiQuitin Mint 4 mg lozenge

Each lozenge contains 2 mg or 4 mg nicotine (as nicotine resinate).

Excipients with known effect (per lozenge):

Aspartame (E951) 6 mg

Mannitol (E421) 1036 mg in the 2 mg lozenge, 1027 mg in the 4 mg lozenge

Sodium 17 mg

Mint flavour (contains lactose (2,9 mg) and soya protein (8,8 mg)) 61,2 mg

For the full list of excipients, see section 6.1

Lozenge

2 mg: White, round lozenge with convex surfaces, debossed NL2S on one side.

4 mg: White, round lozenge with convex surfaces, debossed NL4S on one side.

NiQuitin Mint is indicated for the relief of withdrawal symptoms associated with smoking cessation. If possible, when stopping smoking, NiQuitin Mint should be used in conjunction with a behavioural support programme.

Adults (including the elderly):

NiQuitin Mint Lozenges 2 mg are suitable for smokers with low nicotine dependency e.g. those smoking their first cigarette of the day more than 30 minutes after waking up.

NiQuitin Mint Lozenges 4 mg are suitable for smokers with high nicotine dependency e.g. those smoking their first cigarette of the day within 30 minutes of waking up.

Users should stop smoking completely during treatment with NiQuitin Mint Lozenges.

Users should follow the schedule of treatment below:

Step 1 Weeks 1 to 6	Step 2 Weeks 7 to 9	Step 3 Weeks 10 to 12	To help stay smoke free over the next 12 weeks: use 1-2 lozenges per day only on occasions when strongly tempted to smoke
Initial treatment period	Step down treatment period	Step down treatment period
1 lozenge every 1 to 2 hours	1 lozenge every 2 to 4 hours	1 lozenge every 4 to 8 hours

During weeks 1 to 6 it is recommended that users take a minimum of 9 lozenges per day.

Users should not exceed 15 lozenges per day.

Lozenges should not be used for more than 24 weeks (6 months). If users still feel the need for treatment, a physician should be consulted.

Paediatric populationNiQuitin Mint is not recommended for use in children below 12 years of age due to lack of data on safety and efficacy.

NiQuitin Mint Lozenges should only be used in adolescents (12-17 years) with advice from a doctor.

Method of administrationOne lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other, and repeated, until the lozenge is completely dissolved (approximately 20 – 30 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth. Liquids which lowers the pH in the mouth such as coffee, juice and soft drinks, can decrease the absorption of nicotine in the mouth. To obtain maximum absorption of nicotine these liquids should be avoided in up to 15 minutes before the lozenge is used.

NiQuitin Mint Lozenges are contraindicated in:

• those with hypersensitivity to the active substance or any of the excipients listed in section 6.1;

• people with hypersensitivity to peanut or soya;

• children below the age of 12 years and non-smokers;

• those with phenylketonuria;

• those with unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmias;

• those who have recently suffered myocardial infarction or cerebrovascular accident.

NiQuitin Mint should only be used after advice from a doctor in subjects with

• uncontrolled hypertension;

• active peptic ulcers, or severe renal or hepatic impairment;

• pheochromocytoma, hyperthyroidism or insulin-dependent diabetes;

• cardiovascular disease (e.g. stable angina pectoris, heart failure, cerebrovascular disease, vasospastic diseases, severe peripheral vascular disease).

Swallowing nicotine may exacerbate symptoms in persons suffering from active oesophagitis, oral or pharyngeal inflammation or gastritis.

Seizures: Use with caution in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine.

NiQuitin Mint Lozenges are sugar free, but do contain aspartame which metabolises to phenylalanine, which is of relevance for those with phenylketonuria.

Sodium content: Each NiQuitin Mint Lozenge contains 17mg of sodium. People on a low sodium diet should take this into account.

Lactose content: Consumers with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take NiQuitin Mint Lozenge.

Mannitol content: May have a mild laxative effect.

Smoking cessation, with or without nicotine substitutes, may alter the response to concomitant medication in ex-smokers. The following drugs may require adjustment in dose at cessation of smoking:

May require a decrease in dose at cessation of smoking	Possible mechanism of action
Caffeine, theophylline, imipramine, pentazocine, phenacetin, phenylbutazone, tacrine, clomipramine.	Reduced induction of CYP1A2
Insulin	Increase in sub-cutaneous insulin absorption
Adrenergic antagonists e.g. prazosin, propranolol.	Decreases circulating catecholamines
May require an increase in dose at cessation of smoking	Possible mechanism of action
Adrenergic agonists e.g. isoprenaline, salbutamol	Decreases in circulating catecholamines

Fertility

Effects on human fertility have not been established. Animal studies on fertility are considered to have limited relevance to the clinical use of transdermal nicotine, since the overall dose and routes of exposure cannot be directly correlated to the controlled use of a transdermal nicotine replacement therapy [refer 5.3 Preclinical Safety Data]. ¨

Pregnancy

Nicotine passes into the foetus and affects the breathing pattern and circulation of the foetus. The effect on the circulation of the foetus is dose-dependent. Pregnant smokers should therefore always be recommended to stop smoking without nicotine replacement therapy. The risk of continuous smoking may pose a greater risk for the foetus than the use of nicotine replacement therapy and medical assessment of the risk/benefit ratio of the use of NiQuitin Mint should be made. NiQuitin Mint lozenge should not be used except by pregnant women with high nicotine dependence on doctors advice.

Breastfeeding Nicotine passes freely into breast milk in quantities that may affect the child even with therapeutic doses. NiQuitin Mint Lozenges should therefore be avoided during breastfeeding.

Should smoking cessation not be achieved, use of NiQuitin Mint Lozenges by breastfeeding mothers should only be initiated after advice from a healthcare professional.

NiQuitin Mint has no or negligible influence on the ability to drive and use machines.

NiQuitin Mint Lozenges can cause adverse reactions similar to those associated with nicotine administered in other ways. These may be attributed to the pharmacological effects of nicotine, which are dose dependent.

Immune system disorders:

Rare (³1/10,000 to <1/1,000): Hypersensitivity

Very rare (<1/10000): Anaphylactic reactions

Nervous system disorders:

Very common (≥1/10): Dizziness

Common (≥1/100, <1/10): Headache and Tremor.

Cardiac disorders:

Uncommon (≥1/1000, <1/100): Palpitations and Tachycardia.

Respiratory, thoracic and medistinal disorders:

Common (≥1/100, <1/10): Pharyngitis, cough, pharyngolaryngeal pain and Dyspnoea.

.

Gastrointestinal disorders:

Very common (≥1/10): Nausea and Vomiting .

Common (≥1/100, <1/10):, dyspepsia, abdominal pain upper, diarrhoea, dry mouth, constipation, hiccups, stomatitis, flatulence and oral discomfort.

Uncommon (≥1/1000, <1/100): Dysphagia

General disorders and adminnstration site conditions:

Common (≥1/100, <1/10): Asthenia, Fatigue, Malaise and Influenza type illness

Psychiatric disorders:

Very common (≥1/10): Insomnia

Common (≥1/100, </10):Nervousness..

Certain symptoms which have been reported such as depression, irritability, anxiety and insomnia may be related to withdrawal symptoms associated with smoking cessation. Subjects quitting smoking by any means could expect to suffer from headache, dizziness, increased coughing or a cold.

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 national reporting system listed in Appendix V

Even small quantities of nicotine may be dangerous in children. If poisoning is suspected in a child, a doctor must be consulted immediately.

Overdose with NiQuitin Mint Lozenges may occur if too many lozenges are ingested.

Signs and symptoms of an overdose would be expected to be the same as those of acute nicotine poisoning, including pallor, cold sweat, nausea, salivation, vomiting, abdominal pain, diarrhoea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion and weakness.

Prostration, hypotension, respiratory failure and convulsions may ensue with large overdoses. Lethal doses produce convulsions quickly and death follows as a result of peripheral and central respiratory paralysis or, less frequently, cardiac failure.

Treatment of overdose:

In the event of overdosage, vomiting should be induced with syrup of ipecac or gastric lavage carried out (wide bore tube). A suspension of activated charcoal should then be passed through the tube and left in the stomach. Artificial respiration with oxygen should be instituted if needed and continued for as long as necessary. Other therapy, including treatment of shock, is purely symptomatic.

Pharmacotherapeutic group: Drugs used in nicotine dependence

ATC Code: N07BA01

Nicotine, the main alkaloid in tobacco products and a naturally occurring autonomic substance, is an agonist at nicotine receptors in the peripheral and central nervous system and has pronounced CNS and cardiovascular effects. When consumed in tobacco products, it has been shown to be addictive and upon cessation craving and withdrawal symptoms occur. These craving and withdrawal symptoms include urge to smoke, depressed mood, insomnia, irritability, frustration or anger, anxiety, difficulty in concentrating, restlessness and increased appetite or weight gain. The lozenges replace some of the nicotine provided by tobacco and help reduce the severity of these nicotine craving and withdrawal symptoms.

Six week smoking cessation rates for Nicotine Lozenge 2 mg were 46.0% and 29.7% in active and placebo groups respectively. Rates at six months were 24.2% and 14.4 % in active and placebo groups respectively. Odds ratios, adjusted for centre effects, at six weeks and six months were calculated as 2.10 and 1.96 respectively.

Six week smoking cessation rates for Nicotine Mint Lozenge 4 mg were 48.7% and 20.8% in active and placebo groups respectively. Rates at six months were 23.6% and 10.2 % in active and placebo groups respectively. Odds ratios, adjusted for centre effects, at six weeks and six months were calculated as 3.69 and 2.76 respectively.

Absorption
NiQuitin Mint Lozenges completely dissolve in the oral cavity, and the entire amount of nicotine contained in the lozenge becomes available for buccal absorption or ingestion (swallowing). Complete dissolution of NiQuitin Mint Lozenge is typically achieved in 20-30 minutes. Concurrent consumption of liquids which lower pH in the mouth, such as coffee, juice and carbonated drinks, can drastically reduce the absorption of nicotine.

For the 2 mg lozenge the peak plasma concentration of nicotine achieved after a single dose is approximately 4.4 ng/ml. When dosed every 1.5 hours, the steady state peak and trough concentrations are 12.7 and 9.4 ng/ml respectively.

For the 4 mg lozenge the peak plasma concentration of nicotine achieved after single dose is approximately 10.8 ng/ml. When dosed every 1.5 hours, the steady state peak and trough concentrations are 26.0 and 19.7 ng/ml respectively.

Ingestion of NiQuitin Mint Lozenges not following dosing instructions (chewed, retained in the mouth and swallowed; chewed and immediately swallowed) gives a slower and a somewhat reduced absorption of nicotine.

Distribution

As the plasma protein binding of nicotine is low (4.9% - 20%), the volume of distribution of nicotine is large (2.5 l/kg). The distribution of nicotine to tissue is pH dependent, with the highest concentrations of nicotine found in the brain, stomach, kidney and liver.

Metabolism
Nicotine is extensively metabolized to a number of metabolites, all of which are less active than the parent compound. The metabolism of nicotine primarily occurs in the liver, but also in the lung and kidney. Nicotine is metabolized primarily to cotinine but is also metabolized to nicotine N-oxide. Cotinine has a half-life of 15-20 hours and its blood levels are 10 times higher than for nicotine. Cotinine is further oxidized to trans-3-hydroxycotinine, which is the most abundant metabolite of nicotine in the urine. Both nicotine and cotinine undergo glucuronidation.

Elimination
The elimination half-life of nicotine is approximately 2 hours (range 1 - 4 hours). Total clearance for nicotine ranges from approximately 62 to 89 l/hr. Non-renal clearance for nicotine is estimated to be about 75% of total clearance. Nicotine and its metabolites are excreted almost exclusively in the urine. The renal excretion of unchanged nicotine is highly dependent on urinary pH, with greater excretion occurring at acidic pH.

The general toxicity of nicotine is well documented. Nicotine was not mutagenic or carciogenic in conventional assays. In studies in pregnant animals, at exposure levels resulting in maternal toxicity (in excess of those that will be obtained with the recommended use of NiQuitin Mint), a mild foetal toxicity was seen. Other effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development. Effects on fertility have not been established.

Nicotine has been reported to induce changes to the ovary and uterus of female rats and mice following repeated oral or intraperitoneal administration of doses exceeding those that result from the recommended use of NiQuitin Mint Lozenge. Repeated intraperitoneal or oral administration of nicotine to male rats at doses exceeding those resulting from the recommended use of NiQuitin Mint Lozenge was reported to cause a decrease in testis weight, changes in the epididymis and vas deferens, and a reversible decrease in Sertoli cell numbers with impairment of spermatogenesis.

Mannitol (E421)

Sodium alginate

Xanthan gum

Potassium hydrogen carbonate

Calcium polycarbophil

Sodium carbonate anhydrous

Aspartame (E951)

Magnesium stearate

Mint flavour powder 57581 (contains lactose and soya protein)

Not applicable.

Blister pack: 18 months

Polypropylene container: 2 years

Do not store above 25C. Store in the original package in order to protect from moisture.

Clear or opaque Polyvinyl Chloride/Polyethylene/Polyvinylidene Chloride blisters in packs of 12, 36 and 72 or a Polypropylene tablet container with cap containing 24 lozenges, in packs of 24, 48 och 72. The outer layer of the tablet container and the cap are composed of Polypropylene and a colour, the desiccant lining is composed of Polyethylene Glycol and Molecular Sieve.

Not all pack sizes may be marketed.

No special requirements.

GlaxoSmithKline Consumer Healthcare A/S
Nykær 68

2605 Brøndby

Denmark

2 mg: 17137

4 mg: 17138

2002-11-01/2007-11-01

2015-09-30