Nicabate Extra Fresh Mint 2mg medicated chewing gum

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

nicotine

Available from:

Beecham Group PLC

ATC code:

N07BA01

INN (International Name):

nicotine

Dosage:

2mg

Pharmaceutical form:

Medicated Chewing Gum

Administration route:

Oral use

Units in package:

packs of 4, 10, 30, 100 and 200

Prescription type:

GSL - General Sales List

Manufactured by:

GlaxoSmithKline Consumer Healthcare

Therapeutic group:

Drugs used in nicotine dependence

Therapeutic indications:

It is used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms including cravings during a quit attempt

Authorization status:

Authorised

Authorization date:

2015-05-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

NICABATE EXTRA FRESH MINT 2 MG OR
4MG  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 healthcare professional has told you. 
- 
Keep this leaflet. You may need to read it again. 
- 
Ask a healthcare professional e.g. doctor, nurse, smoking
cessation advisor or pharmacist  if you 
need more information or advice. 
- 
If you get any side effects, talk to your healthcare professional. This includes any possible side
effects 
not listed in this leaflet. See section 4. 
- 
You must talk to a doctor if you have not been able
to stop smoking after 9 months of treatment 
with Nicabate Extra Fresh Mint 2 mg or
4mg Medicated Chewing Gums.  
- 
Throughout this leaflet Nicabate Extra Fresh Mint 2 mg and 4 mg Medicated Chewing Gums are 
referred to as Nicabate Extra Fresh Mint Gums. 

WHAT IS IN THIS LEAFLET 
1. 
What Nicabate Extra
Fresh Mint Gums are and what they are used for 
2. 
What you need to know before you use Nicabate Extra
Fresh Mint Gums  
3. 
How to use Nicabate Extra Fresh Mint Gums 
4. 
Possible side effects 
5. 
How to store Nicabate Extra Fresh Mint Gums 
6. 
Contents of the pack and other information 

1. 
WHAT NICABATE EXTRA FRESH MINT GUMS ARE AND WHAT THEY ARE USED
FOR 

Nicabate Extra Fresh Mint Gums are used to help people
stop smoking. This type of treatment is called 
Nicotine Replacement Therapy or NRT. 

It is the nicotine in cigarettes that can make
you physically addicted to them.  
•  Nicabate Extra
Fresh Mint Gums help you to give up smoking by replacing
some of the nicotine you ge

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Nicabate Extra Fresh Mint 2 mg medicated chewing gum  

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each chewing gum contains 2 mg nicotine (equivalent to 14.20
mg nicotine 
resinate) 

Excipients with known effect: 
Butylated Hydroxytoluene (E321) 0.4266 mg/piece gum 
Sorbitol (E420) 148.65 mg/piece gum 
Sodium 10.5 mg/piece gum 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Medicated Chewing Gum 

Off-white rectangular pillow shaped gum and is approximately 20
x 12 mm. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Nicabate Extra Fresh Mint Gum is used for the treatment of
tobacco 
dependence by relief of nicotine withdrawal symptoms
including cravings 
during a quit attempt (see section 5.1). Permanent cessation of
tobacco use is 
the eventual objective. 

Nicabate Extra Fresh Mint Gum should preferably be used in
conjunction with 
a behavioural support programme. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

Users should make every effort to stop
smoking completely during treatment 
with Nicabate Extra Fresh Mint Gums. 
_ _
_Adults (18 years and over) _
_ _
Nicabate Extra Fresh Mint Gum 2mg is suitable for smokers who
smoke fewer 
than 20 cigarettes a day. 

Behavioural therapy, advice and support will normally improve the
success 
rate. 

The initial dosage should be individualised on the basis of the
patients nicotine 
dependence. 
One piece of Nicabate Extra Fresh Mint Gums should be chewed as
directed 
whenever there is an urge to smoke, to maintain
complete abstinence from 
smoking. 

Sufficient gums should be used each day usually 8-12, up to a
maximum of 
15. 

The treatment duration depends on the needs of each
smoker. In general the 
use of the medicated chewing gum is 2- 3 months, then the use
of gums may 
be red