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NICOTINELL RAPID RELIEF is a brand name for Nicotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicine is to be used for the treatment of tobacco or electronic cigarettes dependence in adults by relief of nicotine withdrawal symptoms, including cravings, during a quit attempt or to cut down smoking or vaping before stopping completely. Permanent cessation of tobacco or electronic cigarettes use is the…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Behavioural therapy advice and support will normally improve the success rate. Adults and Elderly Up to 4 sprays per hour may be used. Do not exceed 2 sprays per dosing episode and do not exceed 64 sprays (4 sprays per hour, over 16 hours) in any 24-hour period.
Abrupt Smoking or Vaping Cessation For smokers or vapers willing and ready to stop smoking or vaping immediately. Subjects should stop smoking or vaping completely during the course of treatment with this medicine. The following chart lists the recommended usage schedule for the oromucosal spray during full treatment (Step I) and during tapering (Step II and Step III).
Step I:
Weeks 1-6 Use 1 or 2 sprays when cigarettes/e-cigarettes normally would have been smoked/vaped or if cravings emerge. If after a single 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/vapers will require 1-2 sprays every 30 minutes to 1 hour.
Step II:
Weeks 7-9 Start reducing the number of sprays per day. By the end of week 9 subjects should be using HALF the average number of sprays per day that was used in Step I.
Step III:
Weeks 10-12 Continue reducing the number of sprays per day so that subjects are not using more than 4 sprays per day during week 12. When subjects have reduced to 2-4 sprays per day, oromucosal spray use should be discontinued.
Example:
If an average of 15 cigarettes/e-cigarettes per day are usually smoked, 1-2 sprays should be used at least 15 times during the day. To help stay smoke/vape free after Step III, subjects may continue to use the oromucosal spray in situations when they are strongly tempted to smoke/vape.
One spray may be used in situations where there is an urge to smoke/vape, with a second spray if one spray does not help within a few minutes. No more than four sprays per day should be used during this period. Gradual cessation through progressive reduction in smoking or vaping For smokers or vapers who are not willing or ready to quit abruptly.
Effects of smoking cessation Regardless of the means used, a variety of symptoms are known to be associated with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, and restlessness or impatience.
There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or apthous ulceration, or nasopharyngitis. In addition, and of clinical significance, nicotine cravings may result in profound urges to smoke.
Effects of vaping Cessation The nicotine withdrawal effects of vaping cessation have not been established, however it is anticipated that many of the effects relating to nicotine withdrawal will be the same as those seen with tobacco smoking cessation.
Adverse Drug Reactions This medicinal product may cause adverse reactions similar to those associated with nicotine given by other means and these are mainly dose-dependent. Allergic reactions such as angioedema, urticaria or anaphylaxis may occur in susceptible individuals.
Local adverse effects of administration are similar to those seen with other orally delivered forms. During the first few days of treatment irritation in the mouth and throat may be experienced, and hiccups are particularly common. Tolerance is normal with continued use.
Daily collection of data from trial subjects demonstrated that very commonly occurring adverse events were reported with onset in the first 2-3 weeks of use of the oromucosal spray and declined thereafter. Adverse reactions with oromucosal nicotine formulations identified from clinical trials and during post-marketing experience are presented below.
The frequency category has been estimated from clinical trials for the adverse reactions identified during post-marketing experience. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from the available data).
This medicinal product should not be used by non-smokers/non-vapers. The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT). The risks of continued vaping are not yet established.
A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions: • Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, recent cerebrovascular accident and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking/vaping with non- pharmacological interventions (such as counselling).
If this fails, the oromucosal spray may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision. The risks of continued vaping are not yet established. • Diabetes Mellitus.
Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when smoking is stopped and NRT is initiated as reduction in nicotine induced catecholamine release can affect carbohydrate metabolism.
• Allergic reactions: Susceptibility to angioedema and urticaria. • 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. • Gastrointestinal Disease: Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and NRT preparations should be used with caution in these conditions.
1. • Children under the age of 18 years. • Those who have never smoked/vaped.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nicotine in United Kingdom.
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The oromucosal spray is used between periods of smoking/vaping in order to prolong the smoke-free/ vape-free intervals and with the intention to reduce smoking/vaping as much as possible. The patient should be aware that an incorrect use of the spray may enhance adverse effects.
A cigarette/e-cigarette is replaced with one dose (1-2 sprays) and a quit attempt should be made as soon as the smoker/vaper feels ready and no later than 12 weeks after start of treatment. If a reduction in cigarette/e-cigarette consumption has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.
After quitting smoking/ vaping, gradually reduce the number of sprays per day. When subjects have reduced to 2-4 sprays per day, oromucosal spray should be discontinued. Regular use of the oromucosal spray beyond 6 months is not recommended.
Some ex- smokers/vapers may need treatment with the oromucosal spray longer to avoid returning to smoking/vaping. Any remaining oromucosal spray should be retained to be used in the event of sudden cravings.
Paediatric population:
Do not administer this medicinal product to persons under 18 years of age. There is no experience of treating adolescents under the age of 18 with this medicinal product. Method of administration Before the first use, press firmly the top of the dispenser with your index finger 3 times in the air until a fine spray appears (priming).
After priming, point the spray nozzle as close to the open mouth as possible. Press firmly the top of the dispenser and release one spray into the mouth, avoiding the lips. Subjects should not inhale while spraying to avoid getting spray into the respiratory tract.
For best results, do not swallow for a few seconds after spraying. Subjects should not eat or drink when administering the oromucosal spray.
System Organ Class Reported adverse reactions Immune system disorders Common Hypersensitivity Not known Allergic reactions including angioedema and anaphylaxis Psychiatric disorders Uncommon Abnormal dream Nervous system disorders Very common Headache Common Dysgeusia, paraesthesia Eye disorders Not known Blurred vision, lacrimation increased Cardiac disorders Uncommon Palpitations, tachycardia Not known Atrial fibrillation.
Vascular disorders Uncommon Flushing, hypertension Respiratory, thoracic and mediastinal disorders Very common Hiccups, throat irritation Common Cough Uncommon Bronchospasm, rhinorrhoea, dysphonia, dyspnoea, nasal congestion, oropharyngeal pain, sneezing, throat tightness Gastrointestinal disorders Very common Nausea Common Abdominal pain, dry mouth, diarrhoea, dyspepsia, flatulence, salivary hypersecretion, stomatitis, vomiting Uncommon Eructation, gingival bleeding, glossitis, oral mucosal blistering and exfoliation, paraesthesia oral Rare Dysphagia, hypoaesthesia oral, retching Not known Dry throat, gastrointestinal discomfort, lip pain Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis, pruritus, rash, urticaria Not known Erythema General disorders and administration site conditions Common Burning sensation, fatigue Uncommon Asthenia, chest discomfort and pain, malaise 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
Paediatric population Danger in children:
Doses of nicotine tolerated by smokers or vapers can produce severe toxicity in children that may be fatal. 9 Overdose.
Transferred dependence:
Transferred dependence can occur but 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.
g. theophylline, tacrine, clozapine and ropinirole. g. imipramine, olanzapine, clomipramine and fluvoxamine may also increase on cessation of smoking, although data to support this are lacking and the possible clinical significance of this effect for these drugs is unknown.
Limited data indicate that the metabolism of flecainide and pentazocine may also be induced by smoking.
Excipients:
This medicinal product contains 7 mg of ethanol in each spray which is equivalent to 100 mg/ml. 5 ml beer or 1 ml wine. The small amount of alcohol in this medicinal product will not have any noticeable effects. 025% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
43 mg/ml. 26 mg/ml. Benzyl alcohol may cause allergic reactions. Care should be taken not to spray the eyes whilst administering the oromucosal spray.