Nicorette 4mg Medicated Chewing-gum

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nicotine

Available from:

PCO Manufacturing Ltd.

ATC code:

N07BA; N07BA01

INN (International Name):

Nicotine

Dosage:

4 milligram(s)

Pharmaceutical form:

Medicated chewing-gum

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Drugs used in nicotine dependence; nicotine

Authorization status:

Authorised

Authorization date:

2017-10-27

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICORETTE
®
4mg 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.
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 DO NOT SMOKE

IN CHILDREN
! 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 stroke).

IF YOU HAVE HIGH BLOOD PRESSURE, BAD CIRCULATION.

IF YOU HAVE PERSISTENT INDIGESTION OR PAINS IN THE CHEST.

IF YOU HAVE A STOMACH ULCER, duodenal ulcer, inflammation of the
stomac

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorette 4mg Medicated Chewing-gum
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each piece of medicated chewing gum contains 4 mg nicotine as a resin
complex.
Excipients 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, yellow medicated chewing-gum
4 CLINICAL PARTICULARS
As per PA0823/049/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0823/049/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Chewing gum base (contains Butylhydroxytoluene (E321))
Sorbitol (E420)
Sodium carbonate
Quinoline yellow (E104)
Flavourings
Polacrilin
Glycerol
Talc
6.2 INCOMPATIBILITIES
None known.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
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