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NIQUITIN 4MG LOZENGES

Active substance(s): NICOTINE RESINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NiQuitin 4 mg Lozenges

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 4 mg nicotine (as nicotine resinate). For excipients see Section
6.1.

3

PHARMACEUTICAL FORM
Lozenge
White, round lozenge with convex surfaces, debossed NL4 on one side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
NiQuitin Lozenges relieve and/or prevent craving and nicotine
withdrawal symptoms associated with tobacco dependence. They are
indicated to aid smokers wishing to quit or reduce prior to quitting, to
assist smokers who are unwilling or unable to smoke, and as a safer
alternative to smoking for smokers and those around them.
NiQuitin Lozenges are indicated in pregnant and lactating women
making a quit attempt.
NiQuitin Lozenges should preferably be used in conjunction with a
behavioural support programme.

4.2

Posology and method of administration
Directions for use:
NiQuitin 4 mg Lozenges are suitable for smokers who have their first cigarette
of the day within 30 minutes of waking up.
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
20 – 30 minutes). The lozenge should not be chewed or swallowed whole.

Users should not eat or drink while a lozenge is in the mouth.
Behavioural therapy, advice & support will normally improve the success rate.
Adults (18 years and over):
Abrupt cessation of smoking:
Users should make every effort to stop smoking completely during treatment
with NiQuitin Lozenges.
Recommended treatment schedule:
Step 1
Weeks 1 to 6

Step 2
Weeks 7 to 9

Step 3
Weeks 10 to 12

Initial treatment period

Step down treatment period

Step down treatment period

1 lozenge every 1 to
2 hours

1 lozenge every 2 to
4 hours

1 lozenge every 4 to 8 hours

During weeks 1 to 6 it is recommended that users take a minimum of 9
lozenges per day. Users should not exceed 15 lozenges per day.
To help stay smoke free beyond 12 weeks, users may take 1-2 lozenges per
day only on occasions when they are strongly tempted to smoke
Those who quit smoking but have difficulty discontinuing using the lozenges
are recommended to seek additional help and advice from a healthcare
professional.
Gradual cessation of smoking:
For smokers who are unwilling or unable to quit abruptly.
Use a lozenge whenever there is a strong urge to smoke in order to reduce the
number of cigarettes smoked as far as possible and to refrain from smoking 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 consumption has not been achieved after 6 weeks of
treatment, a healthcare professional should be consulted.
Reduced tobacco consumption should lead to complete cessation of smoking.
This should be attempted as soon as possible. When the number of cigarettes
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 an 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.
Reduction in smoking:
For smokers who wish to cut down with no immediate plans to quit.

Use a lozenge whenever there is a strong urge to smoke in order to reduce the
number of cigarettes smoked as far as possible and to refrain from smoking as
long as possible. Users should be encouraged to stop smoking 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 cravings. Users should not take more than 15 lozenges per day.
Users should be encouraged to stop smoking completely as soon as possible.
If users are still feeling the need to 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.
Adolescents and children:
Adolescents (12-17 years) should follow the schedule of treatment for abrupt
cessation of smoking as given above. Where adolescents are unwilling or
unable to quit smoking abruptly, advice from a healthcare professional should
be sought.
Safety and effectiveness in children who smoke has not been evaluated.
NiQuitin Lozenges are not recommended for use in children under 12 years of
age.

4.3

Contraindications
NiQuitin Lozenges are contraindicated in:

4.4



those with hypersensitivity to nicotine or any of the excipients;



children under the age of 12 years and non-smokers.

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.

Patients hospitalised for MI, severe dysrhythmia or CVA who are considered
to be haemodynamically unstable should be encouraged to stop smoking with
non-pharmacological interventions. If this fails, NiQuitin 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,
with or without NRT as catecholamines released by nicotine can affect
carbohydrate metabolism, so it is important for diabetics to monitor their blood
glucose levels more closely than usual 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 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.

Phenylketonuria: NiQuitin Lozenges are sugar free, but do contain aspartame
which metabolises to phenylalanine, which is of relevance for those with
phenylketonuria.
Sodium content: Each NiQuitin Lozenge contains 15 mg of sodium. People on
a low sodium diet should take this into account.

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.
Smoking cessation itself may require the adjustment of some drug therapy.

4.6

Fertility, Pregnancy and lactation
Pregnancy
Stopping smoking is the single most effective intervention for improving the health of
both the pregnant smoker and her baby, and the earlier abstinence is achieved the
better. However, if the mother cannot (or is considered unlikely to) quit without
pharmacological support, NRT may be used 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. 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
The relatively small amounts of nicotine found in breast milk during NRT use are less
hazardous to the infant than second-hand smoke. Intermittent dose forms would
minimize the amount of nicotine in breast milk and permit feeding when levels were
at their lowest.

4.7

Effects on ability to drive and use machines
Not applicable.

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 Lozenges have not been found to cause any

serious adverse effects. Excessive consumption of NiQuitin 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 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.
Related adverse events with excess in active compared to placebo group in
a controlled study.
Immune system disorders
Very rare <1/10000: anaphylactic reactions
Platelet bleeding and clotting disorders
Uncommon >1/1000; <1/100: gingival bleeding; nosebleed
Psychiatric disorders
Common >1/100; <1/10: insomnia; anxiety; irritability; increased
appetite
Uncommon >1/1000; <1/100: anger; aggravated anxiety; abnormal
dreaming; abnormal hunger; mood swings; wakefulness
Nervous system disorders
Common >1/100; <1/10: headache
Uncommon >1/1000; <1/100: lightheaded feeling; localised
numbness
Not known: seizures
Heart rate and rhythm disorders
Uncommon >1/1000; <1/100: aggravated palpitations; palpitations;
tachycardia
Vascular (extracardiac) disorders
Uncommon >1/1000; <1/100: vascular disorder; flushing; skin
flushed
Respiratory system disorders
Common >1/100; <1/10: pharyngitis
Uncommon >1/1000; <1/100: laryngismus; aggravated asthma;
lower respiratory tract infection; coughing; nasal irritation; throat
irritation; nasal congestion

Gastrointestinal system disorders
Very common >1/10: nausea
Common >1/100; <1/10: vomiting; dyspepsia, heartburn,
indigestion; hiccup; mouth irritation, mouth ulceration; tongue
ulceration; diarrhoea; belching; flatulence
Uncommon >1/1000; <1/100: peptic ucler; dysphagia; aggravated
dyspepsia; gastroesophageal reflux; hiatus hernia; oesophagitis;
eructation; buccal mucosa ulceration; borborygmus; dry lips; dry
throat; tongue disorder; tooth ache
Special senses other, disorders
Uncommon >1/1000; <1/100: parageusia, metallic taste; taste
perversion
Skin and appendages disorders
Uncommon >1/1000; <1/100: erythema; itching; rash; skin reaction
localised; increased sweating
Musculoskeletal system disorders
Uncommon >1/1000; <1/100: jaw pain
Urinary system disorders
Uncommon >1/1000; <1/100: nocturia
Body as a whole - general disorders
Uncommon >1/1000; <1/100: overdose effect; pain; leg pain;
oedema legs

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
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. The
lozenges replace some of the nicotine provided by tobacco and help reduce the
severity of these nicotine craving and withdrawal symptoms.

5.2

Pharmacokinetic properties
NiQuitin 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 Lozenges is typically
achieved in 20-30 minutes. The peak plasma concentrations of nicotine achieved
after single dose are approximately 10.8 ng/ml. When dosed every 1.5 hours, the
steady state peak and trough concentrations are 26.0 and 19.7 ng/ml respectively.
Ingestion of NiQuitin Lozenges not following dosing instruction (chewed, retained in
the mouth, and swallowed; chewed and immediately swallowed) does not result in
faster or higher absorption, but a substantial amount of nicotine (80-93%) is still
absorbed.
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.
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′-hydroxycotinine, 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 of NiQuitin 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
Lozenges indicate that the potential risk is low and outweighed by the demonstrable
benefit of nicotine therapy in smoking cessation. However, NiQuitin 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
Sodium alginate
Xanthan gum
Potassium bicarbonate
Calcium polycarbophil
Sodium carbonate anhydrous
Aspartame
Magnesium stearate
Menthol mint flavor

6.2

Incompatibilities
None known.

6.3

Shelf life
18 months

6.4

Special precautions for storage
Do not store above 25°C. Store in the original package.

6.5

Nature and contents of container
Clear or opaque Polyvinyl Chloride/Polyethylene/Polyvinylidene Chloride blisters in
packs of 12, 36, 72, 96, 108 and 144.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road
LONDON, SW1V 2SA
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 02855/0260

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29/03/2007

10

DATE OF REVISION OF THE TEXT

03/12/2015

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