Nicochew Fruit 4 mg medicated chewing-gum

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Nicotine

Tilgængelig fra:

Clonmel Healthcare Ltd

ATC-kode:

N07BA; N07BA01

INN (International Name):

Nicotine

Dosering:

4 milligram(s)

Lægemiddelform:

Medicated chewing-gum

Recept type:

Product not subject to medical prescription

Terapeutisk område:

Drugs used in nicotine dependence; nicotine

Autorisation status:

Not marketed

Autorisation dato:

2012-09-14

Indlægsseddel

1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICOCHEW FRUIT 2 MG MEDICATED CHEWING-GUM
NICOCHEW FRUIT 4 MG MEDICATED CHEWING-GUM
Nicotine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
-
You must talk to a doctor if you cannot refrain from smoking after 6
months’ treatment with Nicochew
Fruit.
WHAT IS IN THIS LEAFLET:
1.
What Nicochew Fruit is and what it is used for
2.
What you need to know before you use Nicochew Fruit
3.
How to use Nicochew Fruit
4.
Possible side effects
5.
How to store Nicochew Fruit
6.
Contents of the pack and other information
1.
WHAT NICOCHEW FRUIT IS AND WHAT IT IS USED FOR
Nicochew Fruit is used to help people stop smoking.
The nicotine in Nicochew Fruit relieves nicotine withdrawal symptoms
and cravings when you stop smoking
or temporarily reduce smoking in order to facilitate smoking
cessation. It thereby counteracts a smoking
relapse in smokers who are motivated to stop smoking.
Nicochew Fruit is indicated for smokers aged 18 years and above.
When you suddenly stop providing nicotine from tobacco to your body,
you may feel different kinds of
discomfort, called withdrawal symptoms. By means of Nicochew Fruit you
can prevent or at least reduce this
discomfort, by continuing to provide a small amount of nicotine to
your body during a short period of time.
Advice and support normally improve the success rate.
You must talk to a doctor if you cannot refrain from smoking after 6
months treatment with Nicochew Fruit.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NICOCHEW FRUIT
DO NOT USE NICOCHEW FRUIT
-
if you are allergic to nicotine or any of the other i

Produktets egenskaber

Health Products Regulatory Authority
10 November 2019
CRN008YJH
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicochew Fruit 4 mg medicated chewing-gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewing-gum contains 4 mg nicotine as nicotine resinate.
Excipients with known effect:
Each Nicochew Fruit 4 mg chewing-gum contains:
Butylated hydroxytoluene up to 0.5 mg
Maltitol 188 mg
Sorbitol 211 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated Chewing gum
White to yellowish chewing gum, slightly convex, rectangular with an
approximate size of 18x12x5 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicotine is indicated for the treatment of tobacco dependence by
relieving nicotine withdrawal symptoms including cravings
(see section 5.1), thereby facilitating smoking cessation or temporary
smoking reduction in smokers motivated to quit smoking.
Permanent cessation of tobacco use is the eventual objective.
Nicochew Fruit is indicated in adults.
Advice and support normally improve the success rate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The strength of the chewing-gum should be selected based on the
user’s dependence on nicotine. For low nicotine
dependence a 2 mg chewing-gum is indicated. For high nicotine
dependence (FTND ≥ 6 or smoking of 20 cigarettes or more
per day) or previous failure with 2 mg, a 4 mg chewing-gum is
indicated.
Initially one piece of gum can be taken every 1-2 hours. In most cases
8-12 chewing-gums a day will be sufficient. For smoking
cessation the maximum daily dose is 24 chewing-gums. For smoking
reduction when used in between periods of smoking the
maximum daily dose is 24 chewing-gums of 2 mg or 12 chewing-gums of 4
mg.
_Paediatric population_
Nicochew Fruit chewing-gum should not be used in children below 18
years of age unless prescribed by the physician.
The safety and efficacy of Nicochew Fruit chewing-gum in children
below 18 years of age has not been established.
Health Products Regulatory A