NiQuitin Minis Mint 4 mg Lozenges – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

NiQuitin Minis Mint 4 mg Lozenges

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

For a full list of excipients, see section 6.1.

Excipient with known effect:

Each lozenge contains 4 mg sodium

3 PHARMACEUTICAL FORM

Compressed Lozenge

White to off white biconvex oval lozenge. “NIC4” is debossed onto one face.

Dimensions of approximately 10 mm length × 5 mm width

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

NiQuitin Minis 4 mg Lozenges Nicotine Replacement Therapy (NRT) reduces craving and withdrawal symptoms in people with nicotine dependence from smoking tobacco, or from the inhalation of nicotine-containing vapour (vaping/e-cigarettes), and heat-not-burn tobacco/heated tobacco products.

NiQuitin Minis 4 mg Lozenges are indicated to assist in abrupt quitting and gradual cessation of smoking and vaping e-cigarettes and heat-not-burn tobacco/heated tobacco prior to quitting, and to allow temporary abstinence, e.g. when use of these products is not allowed. NiQuitin Minis can also be used to reduce consumption of cigarettes, vapes/e-cigarettes and heat-not-burn tobacco/heated tobacco in those with no immediate plans to quit.

NiQuitin patches and oral forms of NRT may be used in combination where appropriate. If possible, NRT should be used in conjunction with a behavioural support programme to improve the success rate for quitting nicotine.

NiQuitin Minis 4 mg Lozenges are indicated in pregnant and lactating women making a quit attempt.

4.2 Posology and method of administration

Posology:

Users should make every effort to stop smoking or vaping (e-cigarettes/heat-not-burn tobacco/heated tobacco) completely during treatment with NiQuitin Minis Mint.

The strength of lozenge to be used will depend on the smoking or vaping habits of the individual.

NiQuitin Minis Mint 4 mg Lozenges are suitable for smokers who smoke more than 20 cigarettes a day and vapers using liquid strengths > 12 mg/ml (1.2%). Behavioural therapy advice and support will normally improve the success rate.

Adults (18 year and over)

Abrupt cessation of smoking or vaping (e-cigarettes and heat-not-burn tobacco/heated tobacco):

Use the lozenges whenever there is an urge to smoke or vape.

Sufficient lozenges should be used each day, usually 8-12, up to a maximum of

15.

Continue use for up to six weeks to break the habit of smoking or vaping then gradually reduce lozenge use. When daily use is 1-2 lozenges, use should be stopped.

Treatment with Nicotine lozenge may continue beyond 24 weeks if it is needed to stay cigarette free, or abstinent from vaping.

Those who use the lozenge beyond 9 months should seek additional help from a healthcare professional.

Gradual cessation of smoking or vaping (e-cigarettes and heat-not-burn tobacco/heated tobacco):

For smokers or vapers who are unwilling or unable to quit abruptly.

Use a lozenge whenever there is a strong urge to smoke or vape in order to reduce the number of cigarettes smoked or amount of vape/e-cigarette/heat-not-burn tobacco/heated tobacco consumed as far as possible and to refrain from smoking or vaping for as long as 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 cigarette or vape use has not been achieved after 6 weeks of treatment, a healthcare professional should be consulted.

Reduced consumption should lead to complete cessation of smoking or vaping. This should be attempted as soon as possible. When the number of cigarettes or frequency of vaping has been reduced to a level from which the user feels able to quit completely, then start on the schedule for “abrupt cessation” as given above.

If the attempt to stop smoking or vaping has not been started within 6 months after the beginning of treatment, it is recommended to consult a healthcare professional.

Reduction in smoking or vaping (e-cigarettes and heat-not-burn tobacco/heated tobacco):

For smokers or vapers who wish to cut down with no immediate plans to quit.

Use a lozenge whenever there is a strong urge to smoke or vape in order to reduce the number of cigarettes smoked or use of vapes/e-cigarettes/heat-not-burn tobacco/heated tobacco as far as possible and to refrain from smoking or vaping as long as possible. Users should be encouraged to stop smoking or vaping completely as soon as 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 users are still feeling the need to use the lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Temporary Abstinence:

Use a lozenge every 1-2 hours to control troublesome withdrawal symptoms including craving. Users should not take more than 15 lozenges per day. Users should be encouraged to stop smoking or vaping (e-cigarettes/heat-not-burn tobacco/heated tobacco) completely as soon as possible. If users are still feeling the need to use the lozenges on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.

Combination Nicotine Replacement Treatment (NRT):

In some instances, it may be beneficial to utilise more than one form of NRT concurrently. For example, combination therapy may be used by smokers or vapers, who have relapsed with NRT monotherapy in the past, or who experience breakthrough cravings or have difficulty controlling cravings for cigarettes or other nicotine containing products using single therapy.

Smokers or vapers (e-cigarettes/heat-not-burn tobacco/heated tobacco) can combine the transdermal patches and oral forms of nicotine (lozenges, etc.). The combination of transdermal patches and oral forms of nicotine gives better effectiveness than using transdermal patches alone.

The initial treatment should begin with the determination of the dose of the patch in combination with a dose of oral nicotine.

NiQuitin patch therapy should usually begin with NiQuitin 21 mg and be reduced according to the following dosing schedule:

Light smokers (e.g. those who smoke less than 10 cigarettes per day) and vapers using liquid strengths below 6 mg/ml (0.6%) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg for the final 2 weeks.

The daily intake of oral preparations, when combined with patches, should be around 5 to 6 pieces. When used in combination, the maximum daily dose for 4 mg oral forms is 10 pieces and for 2 mg oral forms is 15 pieces

Recommended dosage for combination therapy

Heavier smokers (over 10 cigarettes per day) and vapers using liquid strengths over 6 mg/ml (0.6%):

*According to the daily number of cigarettes or vapes/e-cigarettes/heat-not-burn tobacco/heated tobacco intake (see above).

**Smokers who smoke more than 20 cigarettes and vapers using liquid strengths > 12 mg/ml (1.2%) should use 4 mg oral dose for the first 6 weeks. Thereafter reducing to a lower strength oral dose. The maximum daily dose for 4 mg oral forms is 10 pieces and for 2 mg oral forms is 15 pieces.

Lighter smokers (10 cigarettes per day or less) and vapers using liquid strengths below 6 mg/ml (0.6%):

*According to the daily number of cigarettes or vapes/e-cigarettes/heat-not-burn tobacco nicotine intake (see above).

**The maximum daily dose for 2 mg oral forms is 15 pieces.

The treatment duration depends on the needs of each smoker or vaper. In general, the duration of use of oral nicotine NRT preparations is 2-3 months, then use may be reduced gradually. When daily use is reduced to 1-2 doses, use should be stopped.

Paediatric population:

Adolescents (12-17 years) should follow the schedule of treatment for abrupt cessation of smoking or vaping as given above, but as data are limited, duration of use of NRT in this age group is restricted to 12 weeks. If longer treatment is required, or where adolescents are not ready or able to stop smoking or vaping abruptly, advice from a healthcare professional should be sought.

Safety and effectiveness in children who smoke has not been evaluated. NiQuitin Minis Mint 4 mg Lozenges are not recommended for use in children under the age of 12.

Method of administration

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 10 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

NiQuitin Minis Mint 4 mg Lozenges are contraindicated in:

• Hypersensitivity to nicotine or any of the excipients listed in section 6.1;
• Children under the age of 12 years
• Non-smokers or non-vapers or occasional and in-frequent smokers or vapers.

4.4 Special warnings and precautions for use

The risks associated with the use of NRT are substantially outweighed in virtually all circumstances by the well-established dangers of continued smoking. NRT also provides controlled doses of nicotine to people dependent on high nicotine consumption from vaping nicotine-containing liquids and heat-not-burn tobacco/heated tobacco products. This allows them to use NRT to reduce and quit their dependence on nicotine in a structured way.

Patients hospitalised for myocardial infarction, severe dysrhythmia or cerebrovascular accident who are considered to be hemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, NiQuitin Minis Mint 4 mg Lozenges may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision. Once patients are discharged from hospital, they can use NRT as normal. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the lozenge dose should be reduced or discontinued.

• Diabetes: Blood glucose levels may be more variable when stopping smoking or vaping, with or without NRT as catecholamines released by nicotine can affect carbohydrate metabolism, so it is important for diabetics to closely monitor their blood glucose levels while using this product.
• Allergic reactions: susceptibility to angioedema and urticaria.

A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:

• 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.
• GI disease: Swallowing of nicotine may exacerbate symptoms in persons suffering from active oesophagitis, oral or pharyngeal inflammation, gastritis, gastric ulcer, or peptic ulcer and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.
• Seizures: Potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anti-convulsant therapy or with a history of epilepsy as cases of convulsions have been reported in association with nicotine.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers or vapers 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.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops this may result in a slower metabolism and a consequent rise in blood levels of such drugs.

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

Sodium: This medicinal product contains less than 1 mmol (23 mg) per lozenge, that is to say essentially sodium-free.

4.5 Interaction with other medicinal products and other forms of interaction

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 increase pain response (anginapectoris type chest pain) provoked by adenosine administration. Smoking cessation itself may require the adjustment of some drug therapy.

4.6 Fertility, pregnancy and lactation

Fertility

Studies in male rats have shown that nicotine can decrease testis weight, cause a reversible decrease in Sertoli cell numbers with impairment of spermatogenesis, and result in a variety of changes in the epididymis and vas deferens. However, similar effects have not been reported to occur in humans.

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.

Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be recommended by a healthcare professional to assist a quit attempt as the risk to the foetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but NRT may be used in pregnancy as a safer alternative to smoking. The risk of using NRT to the foetus is lower than that expected with tobacco smoking, due to lower maximal plasma nicotine concentration and no additional exposure to polycyclic hydrocarbons and carbon monoxide.

However, as nicotine passes to the foetus affecting breathing movements and has a dose dependent effect on placental/foetal circulation, 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.

Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the foetus would not normally be exposed to nicotine.

Lactation

Nicotine from smoking and NRT is found in breast milk. However the amount of nicotine the infant is exposed to from NRT is relatively small and less hazardous than the second-hand smoke they would otherwise be exposed to.

Ideally smoking cessation during lactation should be achieved without NRT. However for women unable to quit on their own, NRT may be recommended by a healthcare professional to assist a quit attempt.

Using intermittent dose NRT preparations, compared with patches, may minimize the amount of nicotine in the breast milk as the time between administrations of NRT and feeding can be made as long as possible. Women should try to breastfeed just before they take the product.

4.7 Effects on ability to drive and use machines

NiQuitin Minis 4 mg Lozenges has no or negligible influence on the ability to drive and use machines. However, users of nicotine replacement products should be aware that cessation of smoking or vaping can cause behavioral changes.

4.8 Undesirable effects

NRT can cause adverse reactions similar to those associated with nicotine administered in other ways, including smoking. These may be attributed to the pharmacological effects of nicotine, some of which are dose dependent. At recommended doses NiQuitin Minis Mint 4 mg Lozenges have not been found to cause any serious adverse effects. Excessive consumption of NiQuitin Minis 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, and insomnia may be related to withdrawal symptoms associated with cessation of smoking or vaping. Subjects quitting smoking by any means could expect to suffer from headache, dizziness, sleep disturbance, increased coughing, or a cold.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: 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) and very rare (<1/10,000), not known (cannot be estimated from the available data).

Not known Asthenia***, fatigue***, malaise***, influenza like illness***

* observed in users taking anti-convulsant therapy or with a history of epilepsy

**individuals with a tendency to experience indigestions may suffer initially from minor degrees of indigestion or heartburn if the 4 mg dose is used - slower chewing in the case of or the use of the 2 mg dose (if necessary, more frequently) will usually overcome this problem. ***These events may also be due to withdrawal symptoms following smoking cessation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

The minimum lethal dose of nicotine in a non tolerant man has been estimated to be 40 to 60 mg. Even small quantities of nicotine may be dangerous in children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.

Symptoms

Signs and symptoms of an overdose from nicotine lozenges would be expected to be the same as those of acute nicotine poisoning, including pallor, cold sweat, salivation, nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion and weakness. Prostration, hypotension, respiratory failure, rapid or weak or irregular pulse, circulatory collapse and convulsions (including terminal convulsions) may ensue with large overdoses.

Management

In the event of an overdose (e.g. too many lozenges ingested) the user should seek medical attention immediately. All nicotine intake should cease immediately and the patient be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastrointestinal absorption of nicotine.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in nicotine dependence. ATC Code: N07B A01

Nicotine 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 abstinence is linked to craving and withdrawal symptoms. 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. Cravings and other symptoms of nicotine withdrawal are at their most intense during the first few weeks of a quit attempt, diminishing thereafter. The lozenges replace some of the nicotine provided by tobacco and clinical studies measuring intensity of cravings and other withdrawal symptoms have been shown to alleviate these symptoms when they are at their most intense

5.2 Pharmacokinetic properties

NiQuitin Minis Mint Lozenges dissolve completely in the oral cavity, and the entire amount of nicotine contained in the lozenge becomes available for buccal absorption or ingestion (swallowing). The complete dissolution of NiQuitin Minis Mint Lozenges is typically achieved in 10 minutes. The mean peak plasma concentrations of nicotine achieved after single 4 mg dose are approximately 9.1 ng/ml.

As the plasma protein binding of nicotine is low (4.9%), 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.

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 nicotine. Cotinine is further oxidized to trans-3′-hydroxy cotinine, which is the most abundant metabolite of nicotine in the urine. Both nicotine and cotinine undergo glucuronidation.

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.

5.3 Preclinical safety data

The general toxicity of nicotine is well known and taken into account in the recommended posology. Nicotine was not mutagenic in appropriate assays. The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine. In studies in pregnant animals, nicotine showed maternal toxicity, and consequential mild fetal toxicity. Additional effects included pre- and postnatal growth retardation and delays and changes in postnatal CNS development.

Effects were only noted following exposure to nicotine at levels in excess of those which will result from recommended use NiQuitin Minis Mint Lozenges. Effects on fertility have not been established.

Comparison of the systemic exposure necessary to elicit these adverse responses from preclinical test systems with that associated with the recommended use of NiQuitin Minis Mint Lozenges indicate that the potential risk is low and outweighed by the demonstrable benefit of nicotine therapy in smoking cessation. However, NiQuitin Minis Mint Lozenges should only be used by pregnant women on medical advice if other forms of treatment have failed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Mannitol (E421)

Sodium alginate (E401)

Xanthan gum (E415)

Potassium bicarbonate (E501)

Calcium polycarbophil

Sodium carbonate anhydrous (E500)

Acesulfame potassium (E950)

Mint Flavour

Magnesium Stearate (E470b)

Sucralose (E955)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Child resistant polypropylene tablet container/cap incorporating a molecular sieve desiccant (sodium aluminosilicate) and containing 20 lozenges.

Packs may contain 1, 3 or 5 tablet containers in a blistercard or 5 tablet containers in a cardboard box.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Omega Pharma Ltd.

Wrafton, Braunton,

Devon, EX33 2DL,

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 02855/0249

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

05/11/2024

10 DATE OF REVISION OF THE TEXT

08/02/2026