Nicorette Cools 4mg Lozenge
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
 NICORETTE LOZENGES 4MG 80_1637769362.jpeg)
Updated on 14 March 2024
File name
ie-leaflet-mock-up-nic-cools-2mg4mg-2436.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 14 March 2024
File name
ie-spc-v13-nic-cools-loz-4mg-2436.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 24 January 2024
File name
ie-pl-nic-cools-2mg4mg-2497.pdf
Reasons for updating
- Change to name of medicinal product
Updated on 03 January 2024
File name
ie-leaflet-nicorette-cools-2mg-4mg-lozenge-2506.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 January 2024
File name
ie-spc-v12-nic-cools-4mg-2506.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 14 August 2023
File name
ie-pl-nic-cools-2mg4mg-2266.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 August 2023
File name
ie-spc-v11-nic-cools-loz-4mg-2266.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 04 March 2023
File name
ie-pl-proposed-clean-nicorette-cools-2327.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 04 March 2023
File name
ie-spc v10-nicorette-cools-4mg-2327.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 25 February 2023
File name
ie-spc v9-nicorette-cools-4mg-2267.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 25 February 2023
File name
ie-pl-nicorette-cools-2267.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 05 July 2022
File name
ie-mockup-pl-clean-bv2247.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 05 July 2022
File name
ie-spc-clean-pa-330-37-12-bv2247.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 04 December 2019
File name
nicorette-cools-4mg-spc-clean-bv1905.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 04 December 2019
File name
ie-pl-cools-2mg4mg.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 17 June 2019
File name
1683spc.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through general sale
Updated on 10 May 2018
File name
1683spc.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Supply through general sale
Updated on 06 April 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 06 April 2018
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Renewal of the licence- national approval
Updated on 06 April 2018
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Free text change information supplied by the pharmaceutical company
Renewal of the licence- national approval
Updated on 08 January 2018
File name
PIL_15492_603.pdf
Reasons for updating
- New PIL for new product
Updated on 27 February 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 27 February 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 4 mg nicotine (as nicotine resinate).
For
athe full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Compressed
Lozenge lozenge (lozenge)
An oval, white to off-white
tabletlozenge imprinted with an "n" on one side and "2" on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic
Iindications
Nicorette Cools 4 mg Lozenges are to be used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms and cravings in smokers 18 years and above. Permanent cessation of tobacco use is the eventual objective.
Nicorette Cools 2 mg Lozenges should preferably be used in conjunction with a behavioural support programme.
Use of Nicorette Cools 4 mg Lozenge in smokers 12 – 17 years inclusive is at the discretion of a doctor: See section 4.2.
4.2 Posology and
Mmethod of Aadministration
Posology
Selecting the strength of lozenge to be used will depend on the smoking habits of the individual.
Adults
Nicorette Cools 4 mg Lozenges 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 or those who smoke fewer than 20 cigarettes per day.
Lozenges should not be used for more than 9 months. If users still feel the need for treatment, a
physicianhealthcare professional should be consulted.
Behavioural therapy advice and support will normally improve the success rate.
Paediatric population
Children and adolescents
Nicorette Cools 4 mg Lozenges should only be used by adolescents (12-17 years inclusive) with advice from a doctor. Nicorette Cools Lozenges are not recommended for use in children below the age of 12.
The safety and efficacy of Nicorette Cools 4 mg Lozenges in children and adolescents has not been investigated.
Method of administration
Oromucosal use.
One 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 16-19 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 lower 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 for up to15 minutes before the lozenge is used.
Abrupt cessation of smoking:
The patient should make every effort to stop smoking completely during treatment with Nicorette Cools Lozenges.
The lozenges should be used whenever there is an urge to smoke.
Sufficient lozenges should be used each day and most smokers usually require 8 to 12, not to exceed 15 lozenges.
The duration of treatment is individual, but up to six weeks treatment is recommended to break the habit of smoking. The nicotine dose should then be gradually reduced, by decreasing the total number of lozenges used per day. The treatment should be stopped, when the daily consumption is down to 1-2 lozenges.
Use a lozenge whenever there is an urge to smoke to maintain complete abstinence from smoking. In the event of sudden cravings any spare lozenges should be retained and used whenever there is a craving or an urge to smoke.
Gradual cessation through progressive reduction in smoking:
For smokers who are unwilling or unable to quit abruptly.
Use a lozenge between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much possible.
The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.
If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.
Reduced tobacco consumption should lead to complete cessation of smoking. A quit attempt should be made as soon as the smoker feels ready, but not later than 6 months after start of treatment. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then the schedule for "abrupt cessation" as given above should be started.
If the attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.
Paediatric population
Nicorette Cools 4 mg Lozenges should only be used by adolescents (12-17 years inclusive) with advice from a healthcare professional. Nicorette Cools Lozenges are not recommended for use in children below the age of 12.
The safety and efficacy of Nicorette Cools 4 mg Lozenges in children and adolescents has not been investigated.
Method of administration
Oromucosal use.
One 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 16-19 minutes). The lozenge should not be chewed or swallowed whole.
Users should not eat or drink while a lozenge is in the mouth.
4.3 Contraindications
Hypersensitivity to nicotine or to any of the excipients of the lozengelisted in section 6.1.
Children under the age of 12 years.
Those who have never smoked.
4.4 Special
Wwarnings and Special Pprecautions for Uuse
The benefits of quitting smoking usually outweigh any risk associated with correctly administered nicotine replacement therapy (NRT).
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, uncontrolled hypertension, recent cerebrovascular accident and/or who suffer with uncontrolled hypertension and/or who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette Cools 2 mg Lozenge may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision.
Stable cardiovascular diseases such as hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, and heart failure.
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 released 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: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions.
Paediatric population
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, see section 4.9 Overdose.
Stopping Smoking:
Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolized by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in a 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, tacrine, clozapine and ropinirole. Drugs recognized as of potential clinical significance are tabulated in section 4.5.
Transferred dependence:
Transferred dependence is unusual and is both less harmful and easier to break than smoking dependence.
4.5 Interactions with
Oother Mmedicinal Pproducts and Oother Fforms of Iinteraction
No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increased pain response (angina-pectoris type chest pain) provoked by adenosine administration.
See section 4.4 for more information on altered metabolism of certain drugs when stopping smoking.
Smoking cessation, with or without nicotine substitutes, may alter the response to concomitant medication in ex-smokers. The dose of these drugs may need to be adjusted, and for medicinal products with a narrow therapeutic margin, such as theophylline, smoking cessation should be accompanied by close clinical and even laboratory monitoring and the patient should be informed about the risks of overdose.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.6 Fertility,
Ppregnancy and Llactation
Women of childbearing potential/ contraception in males and females
In contrast to the well known adverse effects of tobacco smoking on human conception and pregnancy, the effects of therapeutic nicotine treatment are unknown. Thus, whilst to date no specific advice regarding the need for female contraception has been found to be necessary, the most prudent state for women intending to become pregnant is to be both non-smoking, and not using NRT.
Whilst smoking may have adverse effects on male fertility, no evidence exists that particular contraceptive measures are required during NRT treatment by males.
Pregnancy
Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.
Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. Therefore the pregnant smoker should always be advised to stop smoking completely without use of nicotine replacement therapy. The risk of continued smoking may pose greater hazard to the foetus as compared with the use of nicotine replacement products in a supervised smoking cessation programme. Use of Nicorette Cools Lozenge by the pregnant smoker should only be initiated after advice from a healthcare professional. The harmful effects of tobacco smoking on the health of the mother and foetus or child have been clearly demonstrated. These include low birth weight, increased risk of miscarriage, and increased perinatal mortality. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby, and the earlier abstinence is achieved the better. Nicotine passes into the foetus and may cause dose-dependent changes in placental/foetal circulation and breathing movements. Pregnant women or those wishing to conceive should be advised to stop smoking without the use of Nicorette Cools Lozenge nicotine replacement therapy. Use of Nicorette Cools Lozenge by the pregnant highly dependent smoker should only be under the guidance of a doctor, following their assessment of the risk/benefit ratio. The decision to use NRT should be made as early on in the pregnancy as possible. The aim should be to use NRT for only 2-3 months.
Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the woman is suffering from nausea during pregnancy.
Breast-feedingLactation
Nicotine passes freely into breast milk in quantities which may affect the child, even at therapeutic doses
., The Nicorette Cools Lozenges should therefore be avoided during breast-feeding.
Should smoking cessation not be achieved, use of the Nicorette Cools Lozenges by breast feeding smokers, therefore patients should ideally be advised to stop smoking without using nicotine replacement therapy. If this does not prove possible, use of the Nicorette Cools Lozenges to assist breastfeeding women in a quit attempt should only be initiated after advice from a health care professional. Where nicotine replacement therapy is used whilst breast-feeding, the Nicorette Cools Lozenges should be taken just after breast-feeding and not during the two hours before breast-feeding. should only be on the recommendation of a doctor following a risk/benefit assessment. To minimize the nicotine content of the breast milk when nicotine replacement therapy is used , women
should try to breastfeed just before they take the product and leave as long a time as is possible (2 hours is suggested) between taking a lozenge and the next feed.
Nicotine & fF
ertility
Smoking increases the risk for infertility in women and men. In vitro studies have shown that nicotine can adversely affect human sperm quality. In rats, impaired sperm quality and reduced fertility have been shown. In females tobacco smoking delays time to conception, decreases in-vitro fertilization success rates, and significantly increases the risk of infertility.
In males tobacco smoking reduces sperm production, increases oxidative stress, and DNA damage. Spermatozoa from smokers have reduced fertilizing capacity.
The specific contribution of nicotine to these effects in humans is unknown.
4.7 Effects on
Aability to Ddrive and Uuse Mmachines
Nicorette Cools 2 mg Lozenge has no or negligible influence on the ability to drive and use machines. However, nicotine replacement users should be aware that cessation of smoking may cause changes in behaviour.
4.8 Undesirable
Eeffects
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.
The Nicorette Cools Lozenge may cause adverse reactions similar to those associated with nicotine given by other means. NRT can cause adverse reactions similar to those associatated with nicotine administered in other ways, including smoking. These may be attributed to the pharmacological effect of nicotine, some of which are dose dependent. At recommended doses Nicorette Cools 2 mg Lozenges have not been found to cause any serious adverse effects. Excessive consumption of Nicorette Cools 2 mg Lozenges by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.
Certain symptoms which have been reported such as depression, , irritability, anxiety, increased appetite 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, sleep disturbance, increased coughing or a cold.
Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent.
Irritation in the mouth and throat may be experienced, however most subjects adapt to this with ongoing use.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of Nicorette Cools Lozenge.
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.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
very common
(1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000, <1/1,000), or very rare (<1/10,000).,not known (cannot be estimated from the available data).
Immune System Disorders
Very rare:hypersensitivity (including allergic and anaphylactic reactions), angioedema
Psychiatric disorders
Common: irritability, anxiety, sleep disorders incl. abnormal dreams
Uncommon: nervousness, depression
Nervous system disorders:
Common: dizziness, headaches
Cardiac Disorders:
Uncommon: palpitations, heart rate increased
Rare: atrial arrhythmia
Respiratory, thoracic and mediastinal disorders:
Common: cough, sore throat
Gastrointestinal disorders:
Very common: nausea, mouth/throat and tongue irritation
Common: vomiting, diarrhoea, gastrointestinal discomfort and/or pain, flatulence, hiccups, heartburn, dyspepsia
Skin and Subcutaneous Tissue Disorders:
Uncommon: rash, erythema, urticaria
General Disorders and Administration Site Conditions:
|
Uncommon: fatigue, malaise, chest pain
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
|
|
Rare
|
Atrial fibrillation
|
|
Vascular disorders
|
|
|
Uncommon
|
Flushing, hypertension
|
|
Respiratory, thoracic and mediastinal disorders
|
|
|
Very common
|
Cough, hiccups, throat irritation
|
|
Uncommon
|
Bronchospasm, dysphonia, dyspnoea, nasal congestion, oropharyngeal pain, sneezing, throat tightness
|
|
Gastrointestinal disorders
|
|
|
Very common
|
Nausea, mouth/throat and tongue irritation
|
|
Common
|
Abdominal pain, dry mouth, diarrhoea, dyspepsia, flatulence, salivary hypersecretion, stomatitis, vomiting, heartburn
|
|
Uncommon
|
Eructation, glossitis, oral mucosal blistering and exfoliation, paresthesia oral,
|
|
Rare
|
Dysphagia, hypoaesthesia oral, retching
|
|
Not known
|
Dry throat, gastrointestinal discomfort, lip pain
|
|
Skin and subcutaneous tissue disorders
|
|
|
Uncommon
|
Hyperhidrosis, pruritus, rash, urticaria, 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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
4.9 Overdose
The acute minimum lethal oral dose of nicotine in man is believed to be 40 to 60 mg.
When used as directed symptoms of overdose with nicotine may occur in patients with low pre-treatment nicotine intake or if other sources of nicotine are used concomitantly.
Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in
small children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Symptoms of overdose are those of acute nicotine poisoning and include nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, disturbed hearing and marked weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.
Management of overdose:
Administration of nicotine must be stopped immediately and the patient should be treated symptomatically. If excessive amount of nicotine is swallowed, activated Activated charcoal reduces the gastrointestinal absorption of nicotine.
5.2 Pharmacokinetic Properties
Absorption
Nicorette Cools 4 mg 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 Nicorette Cools 4 mg Lozenge is typically achieved in 16-19 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. The peak plasma concentration of nicotine achieved after a single dose is approximately 5 ng/ml for a Nicorette Cools 2 mg Lozenge. Ingestion of Nicorette Cools 2 mg 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.
Biotransformation
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.
[...]6.3 Shelf Life
Polypropylene container:
3 years.
Blister: 2 years.
6.6 Instructions for Use and Handling and Disposal
Any unused
medicinal product or waste material should be disposed of in accordance with local requirements.
10. DATE OF REVISION OF THE TEXT
July 2014February 2017
Updated on 27 February 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 4 mg nicotine (as nicotine resinate).
For
athe full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Compressed
Lozenge lozenge (lozenge)
An oval, white to off-white
tabletlozenge imprinted with an "n" on one side and "2" on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic
Iindications
Nicorette Cools 4 mg Lozenges are to be used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms and cravings in smokers 18 years and above. Permanent cessation of tobacco use is the eventual objective.
Nicorette Cools 2 mg Lozenges should preferably be used in conjunction with a behavioural support programme.
Use of Nicorette Cools 4 mg Lozenge in smokers 12 – 17 years inclusive is at the discretion of a doctor: See section 4.2.
4.2 Posology and
Mmethod of Aadministration
Posology
Selecting the strength of lozenge to be used will depend on the smoking habits of the individual.
Adults
Nicorette Cools 4 mg Lozenges 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 or those who smoke fewer than 20 cigarettes per day.
Lozenges should not be used for more than 9 months. If users still feel the need for treatment, a
physicianhealthcare professional should be consulted.
Behavioural therapy advice and support will normally improve the success rate.
Paediatric population
Children and adolescents
Nicorette Cools 4 mg Lozenges should only be used by adolescents (12-17 years inclusive) with advice from a doctor. Nicorette Cools Lozenges are not recommended for use in children below the age of 12.
The safety and efficacy of Nicorette Cools 4 mg Lozenges in children and adolescents has not been investigated.
Method of administration
Oromucosal use.
One 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 16-19 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 lower 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 for up to15 minutes before the lozenge is used.
Abrupt cessation of smoking:
The patient should make every effort to stop smoking completely during treatment with Nicorette Cools Lozenges.
The lozenges should be used whenever there is an urge to smoke.
Sufficient lozenges should be used each day and most smokers usually require 8 to 12, not to exceed 15 lozenges.
The duration of treatment is individual, but up to six weeks treatment is recommended to break the habit of smoking. The nicotine dose should then be gradually reduced, by decreasing the total number of lozenges used per day. The treatment should be stopped, when the daily consumption is down to 1-2 lozenges.
Use a lozenge whenever there is an urge to smoke to maintain complete abstinence from smoking. In the event of sudden cravings any spare lozenges should be retained and used whenever there is a craving or an urge to smoke.
Gradual cessation through progressive reduction in smoking:
For smokers who are unwilling or unable to quit abruptly.
Use a lozenge between smoking episodes to manage the urge to smoke, to prolong smoke-free intervals and with the intention to reduce smoking as much possible.
The number of lozenges a day is variable and depends on the patients needs. Nonetheless it should not exceed 15 lozenges per day.
If a reduction in number of cigarettes per day has not been achieved after 6 weeks, professional advice should be sought.
Reduced tobacco consumption should lead to complete cessation of smoking. A quit attempt should be made as soon as the smoker feels ready, but not later than 6 months after start of treatment. When the number of cigarettes has been reduced to a level from which the user feels able to quit completely, then the schedule for "abrupt cessation" as given above should be started.
If the attempt to stop smoking completely has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.
Paediatric population
Nicorette Cools 4 mg Lozenges should only be used by adolescents (12-17 years inclusive) with advice from a healthcare professional. Nicorette Cools Lozenges are not recommended for use in children below the age of 12.
The safety and efficacy of Nicorette Cools 4 mg Lozenges in children and adolescents has not been investigated.
Method of administration
Oromucosal use.
One 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 16-19 minutes). The lozenge should not be chewed or swallowed whole.
Users should not eat or drink while a lozenge is in the mouth.
4.3 Contraindications
Hypersensitivity to nicotine or to any of the excipients of the lozengelisted in section 6.1.
Children under the age of 12 years.
Those who have never smoked.
4.4 Special
Wwarnings and Special Pprecautions for Uuse
The benefits of quitting smoking usually outweigh any risk associated with correctly administered nicotine replacement therapy (NRT).
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, uncontrolled hypertension, recent cerebrovascular accident and/or who suffer with uncontrolled hypertension and/or who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, Nicorette Cools 2 mg Lozenge may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision.
Stable cardiovascular diseases such as hypertension, stable angina pectoris, cerebrovascular disease, occlusive peripheral arterial disease, and heart failure.
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 released 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: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastric or peptic ulcers and oral NRT preparations should be used with caution in these conditions.
Paediatric population
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, see section 4.9 Overdose.
Stopping Smoking:
Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolized by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in a 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, tacrine, clozapine and ropinirole. Drugs recognized as of potential clinical significance are tabulated in section 4.5.
Transferred dependence:
Transferred dependence is unusual and is both less harmful and easier to break than smoking dependence.
4.5 Interactions with
Oother Mmedicinal Pproducts and Oother Fforms of Iinteraction
No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increased pain response (angina-pectoris type chest pain) provoked by adenosine administration.
See section 4.4 for more information on altered metabolism of certain drugs when stopping smoking.
Smoking cessation, with or without nicotine substitutes, may alter the response to concomitant medication in ex-smokers. The dose of these drugs may need to be adjusted, and for medicinal products with a narrow therapeutic margin, such as theophylline, smoking cessation should be accompanied by close clinical and even laboratory monitoring and the patient should be informed about the risks of overdose.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.6 Fertility,
Ppregnancy and Llactation
Women of childbearing potential/ contraception in males and females
In contrast to the well known adverse effects of tobacco smoking on human conception and pregnancy, the effects of therapeutic nicotine treatment are unknown. Thus, whilst to date no specific advice regarding the need for female contraception has been found to be necessary, the most prudent state for women intending to become pregnant is to be both non-smoking, and not using NRT.
Whilst smoking may have adverse effects on male fertility, no evidence exists that particular contraceptive measures are required during NRT treatment by males.
Pregnancy
Smoking during pregnancy is associated with risks such as intra-uterine growth retardation, premature birth or stillbirth. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby. The earlier abstinence is achieved the better.
Nicotine passes to the foetus and affects its breathing movements and circulation. The effect on the circulation is dose-dependent. Therefore the pregnant smoker should always be advised to stop smoking completely without use of nicotine replacement therapy. The risk of continued smoking may pose greater hazard to the foetus as compared with the use of nicotine replacement products in a supervised smoking cessation programme. Use of Nicorette Cools Lozenge by the pregnant smoker should only be initiated after advice from a healthcare professional. The harmful effects of tobacco smoking on the health of the mother and foetus or child have been clearly demonstrated. These include low birth weight, increased risk of miscarriage, and increased perinatal mortality. Stopping smoking is the single most effective intervention for improving the health of both pregnant smoker and her baby, and the earlier abstinence is achieved the better. Nicotine passes into the foetus and may cause dose-dependent changes in placental/foetal circulation and breathing movements. Pregnant women or those wishing to conceive should be advised to stop smoking without the use of Nicorette Cools Lozenge nicotine replacement therapy. Use of Nicorette Cools Lozenge by the pregnant highly dependent smoker should only be under the guidance of a doctor, following their assessment of the risk/benefit ratio. The decision to use NRT should be made as early on in the pregnancy as possible. The aim should be to use NRT for only 2-3 months.
Intermittent dosing products may be preferable as these usually provide a lower daily dose of nicotine than patches. However, patches may be preferred if the woman is suffering from nausea during pregnancy.
Breast-feedingLactation
Nicotine passes freely into breast milk in quantities which may affect the child, even at therapeutic doses
., The Nicorette Cools Lozenges should therefore be avoided during breast-feeding.
Should smoking cessation not be achieved, use of the Nicorette Cools Lozenges by breast feeding smokers, therefore patients should ideally be advised to stop smoking without using nicotine replacement therapy. If this does not prove possible, use of the Nicorette Cools Lozenges to assist breastfeeding women in a quit attempt should only be initiated after advice from a health care professional. Where nicotine replacement therapy is used whilst breast-feeding, the Nicorette Cools Lozenges should be taken just after breast-feeding and not during the two hours before breast-feeding. should only be on the recommendation of a doctor following a risk/benefit assessment. To minimize the nicotine content of the breast milk when nicotine replacement therapy is used , women
should try to breastfeed just before they take the product and leave as long a time as is possible (2 hours is suggested) between taking a lozenge and the next feed.
Nicotine & fF
ertility
Smoking increases the risk for infertility in women and men. In vitro studies have shown that nicotine can adversely affect human sperm quality. In rats, impaired sperm quality and reduced fertility have been shown. In females tobacco smoking delays time to conception, decreases in-vitro fertilization success rates, and significantly increases the risk of infertility.
In males tobacco smoking reduces sperm production, increases oxidative stress, and DNA damage. Spermatozoa from smokers have reduced fertilizing capacity.
The specific contribution of nicotine to these effects in humans is unknown.
4.7 Effects on
Aability to Ddrive and Uuse Mmachines
Nicorette Cools 2 mg Lozenge has no or negligible influence on the ability to drive and use machines. However, nicotine replacement users should be aware that cessation of smoking may cause changes in behaviour.
4.8 Undesirable
Eeffects
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.
The Nicorette Cools Lozenge may cause adverse reactions similar to those associated with nicotine given by other means. NRT can cause adverse reactions similar to those associatated with nicotine administered in other ways, including smoking. These may be attributed to the pharmacological effect of nicotine, some of which are dose dependent. At recommended doses Nicorette Cools 2 mg Lozenges have not been found to cause any serious adverse effects. Excessive consumption of Nicorette Cools 2 mg Lozenges by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.
Certain symptoms which have been reported such as depression, , irritability, anxiety, increased appetite 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, sleep disturbance, increased coughing or a cold.
Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent.
Irritation in the mouth and throat may be experienced, however most subjects adapt to this with ongoing use.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of Nicorette Cools Lozenge.
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.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
very common
(1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000, <1/1,000), or very rare (<1/10,000).,not known (cannot be estimated from the available data).
Immune System Disorders
Very rare:hypersensitivity (including allergic and anaphylactic reactions), angioedema
Psychiatric disorders
Common: irritability, anxiety, sleep disorders incl. abnormal dreams
Uncommon: nervousness, depression
Nervous system disorders:
Common: dizziness, headaches
Cardiac Disorders:
Uncommon: palpitations, heart rate increased
Rare: atrial arrhythmia
Respiratory, thoracic and mediastinal disorders:
Common: cough, sore throat
Gastrointestinal disorders:
Very common: nausea, mouth/throat and tongue irritation
Common: vomiting, diarrhoea, gastrointestinal discomfort and/or pain, flatulence, hiccups, heartburn, dyspepsia
Skin and Subcutaneous Tissue Disorders:
Uncommon: rash, erythema, urticaria
General Disorders and Administration Site Conditions:
|
Uncommon: fatigue, malaise, chest pain
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
|
|
Rare
|
Atrial fibrillation
|
|
Vascular disorders
|
|
|
Uncommon
|
Flushing, hypertension
|
|
Respiratory, thoracic and mediastinal disorders
|
|
|
Very common
|
Cough, hiccups, throat irritation
|
|
Uncommon
|
Bronchospasm, dysphonia, dyspnoea, nasal congestion, oropharyngeal pain, sneezing, throat tightness
|
|
Gastrointestinal disorders
|
|
|
Very common
|
Nausea, mouth/throat and tongue irritation
|
|
Common
|
Abdominal pain, dry mouth, diarrhoea, dyspepsia, flatulence, salivary hypersecretion, stomatitis, vomiting, heartburn
|
|
Uncommon
|
Eructation, glossitis, oral mucosal blistering and exfoliation, paresthesia oral,
|
|
Rare
|
Dysphagia, hypoaesthesia oral, retching
|
|
Not known
|
Dry throat, gastrointestinal discomfort, lip pain
|
|
Skin and subcutaneous tissue disorders
|
|
|
Uncommon
|
Hyperhidrosis, pruritus, rash, urticaria, 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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
4.9 Overdose
The acute minimum lethal oral dose of nicotine in man is believed to be 40 to 60 mg.
When used as directed symptoms of overdose with nicotine may occur in patients with low pre-treatment nicotine intake or if other sources of nicotine are used concomitantly.
Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in
small children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Symptoms of overdose are those of acute nicotine poisoning and include nausea, vomiting, increased salivation, abdominal pain, diarrhea, sweating, headache, dizziness, disturbed hearing and marked weakness. At high doses, these symptoms may be followed by hypotension, weak and irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.
Management of overdose:
Administration of nicotine must be stopped immediately and the patient should be treated symptomatically. If excessive amount of nicotine is swallowed, activated Activated charcoal reduces the gastrointestinal absorption of nicotine.
5.2 Pharmacokinetic Properties
Absorption
Nicorette Cools 4 mg 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 Nicorette Cools 4 mg Lozenge is typically achieved in 16-19 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. The peak plasma concentration of nicotine achieved after a single dose is approximately 5 ng/ml for a Nicorette Cools 2 mg Lozenge. Ingestion of Nicorette Cools 2 mg 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.
Biotransformation
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.
[...]6.3 Shelf Life
Polypropylene container:
3 years.
Blister: 2 years.
6.6 Instructions for Use and Handling and Disposal
Any unused
medicinal product or waste material should be disposed of in accordance with local requirements.
10. DATE OF REVISION OF THE TEXT
July 2014February 2017
Updated on 10 July 2014
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 10 July 2014
Reasons for updating
- Change to section 6.3 - Shelf life
Free text change information supplied by the pharmaceutical company
Updated on 16 April 2013
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 16 April 2013
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 11 January 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 11 January 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Updated on 19 September 2012
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 19 September 2012
Reasons for updating
- New SPC for new product