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NICORETTE QUICKMIST SPEARMINT is a brand name for Nicotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This product relieves and/or prevents craving and nicotine withdrawal symptoms in nicotine dependence, such as those arising from the use of tobacco or electronic cigarettes. It is indicated to aid quitting or reduction prior to quitting, to assist those who are unwilling or unable to use such products, and as a safer…
Verbatim from this product's MHRA label. Tap a section to expand.
The patient should make every effort to stop smoking or vaping completely during treatment with this product. Behavioural therapy, advice and support will normally improve the success rate. Directions for use For those using this product for the first time or those who have not used the spray for 2 days, they must first prime the spray pump.
Priming 1. Point the spray safely away from you and any other adults, children or pets that are near you. 2. Press the top of the QuickMist with your index finger 3 times until a fine spray appears. Note: priming reduces the number of sprays you may get from this product.
After priming, point the spray nozzle as close to the open mouth as possible. Press the top of the dispenser and release one spray into your mouth, avoiding the lips. Do not inhale while spraying to avoid getting spray down your throat.
For best results, do not swallow for a few seconds after spraying. The patient should not eat or drink when administering the oromucosal spray. Care should be taken not to spray the eyes whilst administering the mouth spray. Adults and Children over 12 years of age Use 1 or 2 sprays when you would normally have smoked or vaped 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. Each mouthspray contains at least 150 sprays. This product should be used whenever the urge to smoke or vape is felt or to prevent cravings in situations where these are likely to occur.
Patients willing or able to stop smoking/vaping immediately should initially replace all their cigarettes/e-cigarettes with this product and as soon as they are able, reduce the number of sprays used until they have stopped completely.
Patients aiming to reduce cigarettes/e-cigarettes should use the Mouthspray, between smoking/vaping episodes, as needed, to prolong smoke/vape-free intervals and to reduce their use as much as possible. As soon as they are ready patients should aim to quit smoking/vaping completely.
Effects of smoking Cessation Some symptoms may be related to nicotine withdrawal associated with stopping smoking. 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.
These have been observed in those using the mouthspray. Increased frequency of aphthous ulcer, cough and nasopharyngitis may occur after abstinence from smoking. The causality is unclear. In addition to this, other cessation-associated symptoms were seen in those using the 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. 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 product may cause adverse reactions similar to those associated with nicotine given by other means, including smoking and vaping, and these are mainly dose-dependent. Most adverse events reported with this product occur during the early phase of treatment and are similar to those seen with other orally delivered forms.
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. 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 spray, and declined thereafter.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of this product. The adverse reactions observed in patients treated with oral nicotine formulations during clinical trials and post-marketing experience are listed below by System Organ Class (SOC).
Any risks that may be associated with NRT are substantially outweighed by the well-established dangers of continued smoking. 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: Underlying cardiovascular disease: In stable cardiovascular disease this product 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 cerebrovascular accident and who are considered to be haemodynamically unstable and/or who have uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions.
If this fails, this product may be considered, but as data on safety in this patient group are limited, initiation should only be under 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 quitting, and NRT is initiated as reductions in nicotine induced catecholamines released by nicotine can affect carbohydrate metabolism.
GI disease:
Nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and NRT preparations should be used with caution in these conditions.
Seizures:
Potential risks and benefits of nicotine should be carefully evaluated before use in subjects with a history of epilepsy as cases of convulsions have been reported in association with nicotine.
Renal or hepatic impairment:
1. This product is contraindicated in children under 12 years.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking/vaping but are having difficulty discontinuing their Mouthspray are recommended to contact their pharmacist or doctor for advice.
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). Body System Incidence Reported Adverse Event (Preferred Term) Immune System Disorders Common Not known Hypersensitivitya Anaphylactic reactiona Psychiatric disorders Uncommon Abnormal dreams* Nervous System Disorders Very common Common Common Common Common Not known Headachea# Burning sensationc Dizziness Dysgeusia Paraesthesiaa Seizures Eye Disorders Not known Not known Blurred Vision Lacrimation increased Cardiac Disorders Uncommon Uncommon Not known Palpitationsa Tachycardiaa Atrial fibrillation Vascular Disorders Uncommon Uncommon Flushinga Hypertensiona Respiratory, Thoracic and Mediastinal Disorders Common Very common Very common Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Cough** Hiccups**** Throat irritation ** Bronchospasm Dysphonia Dyspnoeaa Nasal congestion Oropharyngeal pain Rhinorrhoea Sneezing Throat tightness Gastrointestinal Disorders Very common Common Common Common Common Common Common Common Common Common Uncommon Nauseaa Abdominal pain Diarrhoea*** Dry mouth Dyspepsia Flatulence Salivary hypersecretion Stomatitis Toothache Vomitinga Eructation Uncommon Uncommon Uncommon Uncommon Rare Rare Rare Not known Not known Not known Gingivitis Glossitis Oral mucosal blistering and exfoliation Paraesthesia oral*** Dysphagia Hypoaesthesia oral*** Retching Dry throat Gastrointestinal discomforta Lip pain Musculoskeletal and connective tissue disorders Uncommon Uncommon Not known Pain in jawb Musculoskeletal pain Muscle tightnessb Skin and Subcutaneous Tissue Disorders Uncommon Uncommon Uncommon Uncommon Uncommon Not known Not known Dry skin Hyperhidrosisa Pruritusa Rasha Urticaria** Angioedemaa Erythemaa General disorders and administration site conditions: Common Uncommon Uncommon Uncommon Fatiguea Astheniaa Chest discomfort and paina Malaise a Systemic effects; b Tightness of jaw and pain in jaw with nicotine gum formulation c At the application site *Identified only for formulations applied during the night **Higher frequency observed in clinical studies with inhaler formulation.
***Reported the same or less frequently than placebo **** Higher frequency observed in clinical studies with mouth spray formulation # Although the frequency in the active group is less than that of the placebo group, the frequency in the specific formulation in which the PT was identified as a systemic ADR was greater in the active group than the placebo group.
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
This product 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 children:
Doses of nicotine tolerated by adult and adolescent smokers or vapers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children.
9 Overdose.
Phaeochromocytoma and uncontrolled hyperthyroidism:
As nicotine causes release of catecholamines, this product 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.
g. theophylline, clozapine and ropinirole.
Excipients:
The mouthspray contains about 7 mg of alcohol (ethanol) in each spray which is equivalent to 97 mg/ml. The amount in one spray of this medicine is equivalent to less than 2 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains about 12 mg propylene glycol in each spray which is equivalent to 157 mg/mL. g. contact dermatitis), or irritation to the eyes and mucous membranes. e. is essentially ‘sodium- free’. Care should be taken not to spray the eyes whilst administering the spray.