Nicorette 2mg Medicated Chewing-gum

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Nicotine

Dostopno od:

PCO Manufacturing Ltd.

Koda artikla:

N07BA; N07BA01

INN (mednarodno ime):

Nicotine

Odmerek:

2 milligram(s)

Farmacevtska oblika:

Medicated chewing-gum

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

Drugs used in nicotine dependence; nicotine

Status dovoljenje:

Authorised

Datum dovoljenje:

2017-10-27

Navodilo za uporabo

_ _
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PACKAGE LEAFLET: INFORMATION FOR THE USER
NICORETTE
®
2 mg medicated chewing gum
nicotine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist have 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.
WHAT IS IN THIS LEAFLET
1.
What Nicorette Gum is and what it is used for
2.
What you need to know before you use Nicorette Gum
3.
How to use Nicorette Gum
4.
Possible side effects
5.
How to store Nicorette Gum
6.
Contents of the pack and other information
1. WHAT NICORETTE GUM IS AND WHAT IT IS USED FOR
Nicorette Gum is a nicotine replacement therapy (NRT).
It is used to relieve withdrawal symptoms and reduce the cravings for
nicotine that you
get when you try to stop smoking, or when you are cutting down the
number of
cigarettes you smoke while trying to stop smoking.
Nicorette Gum can also be used to relieve cravings and withdrawal
symptoms when you
cannot smoke, e.g. in smoke free areas such as on a plane or at the
cinema.
Nicorette 2mg Gum can sometimes be used in combination with Nicorette
Invisi 10mg
and 15mg Patch for the treatment of tobacco dependence as part of a
stop smoking
programme.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NICORETTE GUM
X DO NOT USE NICORETTE GUM:

if you ARE ALLERGIC to nicotine or any of the other ingredients of
this medicine (listed
in section 6).

if you are PREGNANT OR BREAST FEEDING, unless advised by your doctor.

if you are a non-smoker or are under 18 years of age.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, NURSE OR PHARMACIST BEFORE USING NICORETTE GUM...

IF YOU ARE IN HOSPITAL BECAUSE OF HEART DISEASE (including heart
attack, disorders
of heart rate or rhythm, or

Lastnosti izdelka

Health Products Regulatory Authority
17 December 2020
CRN00C1F2
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette 2mg Medicated Chewing-gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece of medicated chewing gum contains 2 mg nicotine as a resin
complex.
Excipient(s) with known effect
Each piece contains Sorbitol (E420) and Butylhydroxytoluene (E321).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated Chewing-gum
_Product imported from the UK_
A square, beige medicated chewing-gum
4 CLINICAL PARTICULARS
As per PA0330/037/014
5 PHARMACOLOGICAL PROPERTIES
As per PA0330/037/014
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Chewing gum base (contains Butylhydroxytoluene (E321))
Sorbitol (E420)
Sodium carbonate
Sodium bicarbonate
Flavourings
Polacrilin
Glycerol
Talc
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The she lf lif e e xpir y da t e of this pr oduc t sha l l be t h e da
te s how n on thec onta i ne r a nd oute r p ac ka ge of the pr
oduc t on t he mar ke t in the c ountr y of or i gin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Health Products Regulatory Authority
17 December 2020
CRN00C1F2
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packed strips each containing 15 pieces supplied in packs of
30 or 210 pieces.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/187/005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 27
th
October 2017
10 DATE OF REVISION OF THE TEXT
December 2020