NiQuitin Strips Mint 2.5mg oral films

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Nicotine

Disponible des:

Omega Pharma Ltd

Codi ATC:

N07BA01

Designació comuna internacional (DCI):

Nicotine

Dosis:

2.5mg

formulario farmacéutico:

Orodispersible film

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04100200; GTIN: 5000347091889 5000347091872

Informació per a l'usuari

The Marketing Authorisation Holder is Omega Pharma Ltd, 32 Vauxhall
Bridge Road,
London, SW1V 2SA, UK and all enquiries should be sent to this address.
NIQUITIN is a registered trade mark of ELAN PHARMA INTERNATIONAL LTD
This leaflet was prepared in October 2015.

Fitxa tècnica

OBJECT 1
NIQUITIN STRIPS 2.5MG ORAL FILM
Summary of Product Characteristics Updated 31-Dec-2015 | Omega Pharma
Ltd
1. Name of the medicinal product
NiQuitin Strips Mint 2.5 mg Oral Film
2. Qualitative and quantitative composition
Each orodispersible film contains 2.5 mg nicotine
Contains ethanol, no more than 3.9 mg per film
For full list of excipients, see section 6.1
3. Pharmaceutical form
Orodispersible Film
Transparent film approximately 20 mm by 30 mm
4. Clinical particulars
4.1 Therapeutic indications
NiQuitin Strips relieve and/or prevent craving and nicotine withdrawal
symptoms associated with tobacco
dependence. They are indicated to aid smokers wishing to quit or
reduce prior to quitting, to assist
smokers who are unwilling or unable to smoke, and as a safer
alternative to smoking for smokers and
those around them.
NiQuitin Strips are indicated in pregnant and lactating women making a
quit attempt.
NiQuitin Strips should preferably be used in conjunction with a
behavioural support programme.
4.2 Posology and method of administration
_DIRECTIONS FOR USE:_
NiQuitin Strips are suitable for smokers who have their first
cigarette of the day more than 30 minutes
after waking up.
Place one film on the tongue. Close the mouth and press the tongue
gently to the roof of the mouth until
the nicotine film dissolves (approximately 3 minutes). The film should
not be chewed or swallowed
whole.
Users should not eat or drink while a nicotine film is in the mouth.
Behavioural therapy, advice and support will normally improve the
success rate.
ADULTS (18 YEARS AND OVER):
_ABRUPT CESSATION OF SMOKING:_
Users should make every effort to stop smoking completely during
treatment with NiQuitin Strips.
_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 nicotine film every 1 to 2 hours
1 nicotine film every 2 to 4 hours
1 nicotine film every 4 to 8 hours
During weeks 1 to 6 it is recommended that users ta