NICOTINELL LOZENGES 1 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

NICOTINE

Available from:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC code:

N07BA

Pharmaceutical form:

LOZENGES

Composition:

NICOTINE 1 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

GSK CONSUMER HEALTHCARE SCHWEIZ AG, SWITZERLAND

Therapeutic group:

DRUGS USED IN NICOTINE DEPENDENCE

Therapeutic indications:

As an aid to smoking cessation and for the relief of nicotine withdrawal symptoms. In smokers currently unable or not ready to stop smoking abruptly the gum may also be used as part of a program to reduce smoking prior to stopping completely.

Authorization date:

2022-03-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed without a doctor's prescription
NICOTINELL LOZENGES 1 MG
NICOTINELL LOZENGES 2 MG
Nicotinell Lozenges 1 mg – Each lozenge contains: 1 mg nicotine
Nicotinell Lozenges 2 mg – Each lozenge contains: 2 mg nicotine
Inactive ingredients and allergens in the preparation – please see
section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have
additional questions, refer to the doctor or the pharmacist.
The medicine is intended for adults over 18 years old.
Take the preparation according to the instructions in the dosage
section of this
leaflet in the “How should you use the medicine?” section. Consult
the
pharmacist if you need more information.
Contact the doctor, if you still need to use the medicine after nine
months of
use.
1. WHAT IS THE MEDICINE INTENDED FOR?
To help stop smoking and relieve nicotine withdrawal symptoms. FOR
ADULTS
ABOVE 18 YEARS OF AGE.
For smokers who are currently unable or unwilling to stop smoking at
once, the
lozenges can also be used as part of a program to reduce smoking
before
stopping completely.
Nicotinell Lozenges contain nicotine, which is one of the ingredients
of
tobacco.
When sucked, the nicotine is released slowly and absorbed through the
oral
mucosa.
THERAPEUTIC CLASS: Medicines used in conditions of nicotine
dependence.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or any of the
additional components the medicine contains (See section 6).
•
You are a non-smoker.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
Before treatment with Nicotinell Lozenges 1 mg and 2 mg inform the
doctor if:
•
You suffer from a heart disease, such as: you have recently had a
heart
attack, heart failure, angina pectoris, variant angina (Prinzmetal’s
angina) or
heart arrhythmias. If you experience worsening of your he

Summary of Product characteristics

_The format of this leaflet was determined by the Ministry of Health
and its content was checked _
_ and approved in _
_June 2017 and updated in March 2022 _
1.
NAME OF THE MEDICINAL PRODUCT
Nicotinell Lozenges 1 mg
Nicotinell Lozenges 2 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece of Nicotinell Lozenges 1 mg contains:
Active substance: 1 mg nicotine (corresponding to 3.072 mg nicotine
bitartrate dihydrate).
Each piece of Nicotinell Lozenges 2 mg contains:
Active substance: 2 mg nicotine (corresponding to 6.144 mg nicotine
bitartrate dihydrate).
Excipient(s) with known effect: aspartame (0.01 g), maltitol (0.9 g)
and sodium (9.8 mg).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenges
White, mint flavoured, round biconvex lozenge
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicotinell Lozenges are indicated in adults.
As an aid to smoking cessation and for the relief of nicotine
withdrawal symptoms.
In smokers currently unable or not ready to stop smoking abruptly the
gum may also be used as
part of a program to reduce smoking prior to stopping completely.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CHILDREN AND ADOLESCENTS (< 18 YEARS)
Nicotinell lozenges should not be used by people under 18 years of
age. There is no experience in
treating adolescents under the age of 18 with Nicotinell lozenges.
RENAL AND HEPATIC IMPAIRMENT:
Use with caution in patients with moderate to severe renal impairment
and/or moderate to severe
hepatic impairment as the clearance of nicotine or its metabolites
maybe decreased with the potential
fr increased adverse effects
POSOLOGY:
ADULTS AND ELDERLY
Nicotinell Lozenges 1 mg is recommended in smokers with a low to
moderate nicotine dependency. It
is not recommended in the case of smokers with a strong or very strong
nicotine dependency.
Nicotinell Lozenges 2 mg is intended to be used by smokers with a
strong or very strong nicotine
dependency and those who have previously failed to stop smoking with
the aid of nicotine
replacement therapy.