NiQuitin Mint 2mg lozenges

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Nicotine

Beschikbaar vanaf:

Omega Pharma Ltd

ATC-code:

N07BA01

INN (Algemene Internationale Benaming):

Nicotine

Dosering:

2mg

farmaceutische vorm:

Lozenge

Toedieningsweg:

Oromucosal

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04100200; GTIN: 5000347003714 5000347003752

Bijsluiter

H9V00SXJ4 - Leaflet [Generic]
LF21665C
PACKAGE LEAFLET: INFORMATION FOR THE USER
NiQuitin Mint 2 mg and 4mg Lozenges
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, pharmacist or
nurse has told you.
-
Keep this leaflet. You may need to read it
again.
-
Ask your pharmacist if you need more
information or advice.
-
You must talk to a doctor if you do not feel
better or if you feel worse after 6 months
-
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
IN THIS LEAFLET:
1. What NiQuitin Mint 2mg and 4mg
Lozenges are and what they are used
for
2. What you need to know before you take
NiQuitin Mint 2mg and 4mg Lozenges
3. How to take NiQuitin Mint 2mg and 4mg
Lozenges
4. Possible side effects
5. How to store NiQuitin Mint 2mg and
4mg Lozenges
6. Contents of the pack and other
information
1. What NiQuitin Mint 2mg and
4mg Lozenges are and what
they are used for
_NiQuitin Mint 2mg and 4mg Lozenges _are
used to help people stop smoking. This type of
treatment is called Nicotine Replacement
Therapy (NRT).
_NiQuitin Mint 2mg and 4mg Lozenges_ can
reduce your urge to smoke by providing some
of the nicotine previously inhaled from
cigarettes and helps you resist cigarettes.
_NiQuitin Mint 2mg and 4mg Lozenges_ do not
have the health dangers of tobacco because
they do not contain the tar or carbon
monoxide of cigarette smoke.
This medicine contains:
• nicotine resin which when sucked, nicotine
is released slowly from the resin and
absorbed through the lining of the mouth.
This nicotine relieves some of the cravings
and unpleasant withdrawal symptoms, such
as feeling ill or irritable, that smokers
frequently feel when they try to give up.
If possible, when giving up smoking these
lozenges should be used with a stop smoking
behavioural support programme. For fur

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
NiQuitin Mint 2 mg Lozenges
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each compressed lozenge contains 2mg Nicotine (as 13.33mg Nicotine
Resinate)
Excipients with known effect
Aspartame [E951] 6.10 mg
Mannitol [E421]
Each lozenge contains 15 mg of Sodium
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Compressed Lozenge
Cream/white, biconvex round lozenge, embossed ‘L344’
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicotine Perrigo 2mg Lozenges are indicated for the treatment of
tobacco dependence
by relieving
nicotine withdrawal symptoms including cravings, associated with
smoking cessation.
Permanent
cessation of tobacco use is the eventual objective.
Nicotine Perrigo 2mg Lozenges should preferably be used in conjunction
with a
behavioural
support programme.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS (18 YEARS AND OVER):
Users should make every effort to stop smoking completely during
treatment
with NiQuitin Mint 2 mg Lozenges
Recommended treatment schedule:
STEP 1
WEEKS 1 TO 6
STEP 2
WEEKS 7 TO 9
STEP 3
WEEKS 10 TO 12
Initial treatment period
Step down treatment
period
Step down treatment
period
1 lozenge every 1 to 2
hours
1 lozenge every 2 to 4
hours
1 lozenge every 4 to
8 hours
During weeks 1 to 6 it is recommended that users take a minimum of 9
lozenges per day. Users should not exceed 15 lozenges per day.
To help stay smoke free beyond 12 weeks, users may take 1-2 lozenges
per
day only on occasions when they are strongly tempted to smoke.
Lozenges should not be used for more than 6 months. If users still
feel the
need for treatment, a healthcare professional should be consulted.
Behavioural therapy, advice and support will normally improve the
success
rate.
_Paediatric population _
NiQuitin Mint 2 mg Lozenges should only be used in adolescents (12-17
years) with the advice of a healthcare professional.
NiQuitin Mint 2 mg Lozenges are contraindicated in children under the
age of
12 years in