This briefing refers to both the generic versions and the proprietary Champix and uses varenicline as an example of what is needed to make stop smoking medications locally available to people who smoke and who want to stop, including implementing a Patient Group Direction (PGD).
This briefing contains a checklist of actions for services to undertake to ensure the availability of generic varenicline and/or Champix to clients and patients, a refresher on varenicline and links to further resources, including the NCSCT online Stop Smoking Medications module.
There is no difference between the Champix Summary of Product Characteristics (SPC) and the ones for generic varenicline. The SPCs are where you can find all the information on usage, side effects, and drug interactions of varenicline - and they are essential reading.
Link to SPC for Champix Initiation Pack: Champix Initiation Pack
Link to SPC for Champix 1mg Maintenance Pack: Champix 1mg Maintenance Pack
Link to SPC for Champix 0.5mg Maintenance Pack: Champix 0.5mg Maintenance Pack
The full Summary of Product Characteristics (SPC) for the Brown & Burk and Wave Pharma versions of varenicline are below.
The NHS Specialist Pharmacy Service (SPS) has developed a Patient Group Direction (PGD) as a template for you to develop your own local PGD.
This link will take you to the Specialist Pharmacy Service PGD page so that, if the PGD is ever updated, you will have the most up-to-date version: Varenicline for smoking cessation – Specialist Pharmacy Service – The first stop for professional medicines advice.
NCSCT consultants have experience in the development and implementation of a PGD for varenicline. If you would like some advice, please contact enquiries@ncsct.co.uk.
Despite the evidence on safety and efficacy, getting local medicines management and prescribers to accept varenicline as an equal first-choice treatment option was in some cases difficult.
This briefing, first published in 2013, was intended as a resource for commissioners, managers and staff of stop smoking services and is set out as answers to a series of questions.
This document was written about, and based upon evidence from research investigating, Champix. Generic versions of varenicline are now available and the evidence in this briefing, and the conclusions drawn, are equally applicable to generic varenicline.
Date of last review: February 2025
When varenicline first became available in the UK in 2006, there was reporting on the incidence of cardiovascular serious adverse events among those using the medication and a call to evaluate the association of these events with its use.
Two meta-analyses have reviewed existing evidence. Whilst findings were not uniform, based on the findings of these reviews, the risk of cardiovascular events associated with the use of varenicline is judged to be minimal and clinically insignificant.
This document was written in 2013 about, and based upon evidence from research investigating, Champix. Generic versions of varenicline are now available and the evidence in this briefing, and the conclusions drawn, are equally applicable to generic varenicline.
Note: The recent changes to the varenicline Summary of Product Characteristics (SPC) do not substantially change the points raised in this briefing nor the advice that it is safe and effective.