CYTISINICLINE is a Prescription Only Medicine (POM) and is available now in the UK. CYTISINICLINE comes as 1.5mg tablets in a pack of 100 – sufficient for a complete 25-day treatment course. Pharmacies can obtain CYTISINICLINE via all mainline wholesalers. CYTISINICLINE can be prescribed on an FP10.

From 1st November 2025, Cytisine 1.5mg tablets from Consilient Health were renamed Cytisinicline 1.5 mg tablets in line with WHO nomenclature recommendations. The product otherwise remains unchanged. Please note product in “Cytisine” packaging will remain in the supply chain until current stocks are exhausted.

CYTISINICLINE from Conislient Health is supplied with 2 foil strips of 50 tablets; 100 tablets is enough for a complete 25-day course. There are no dosing instructions printed on the foil strips, however, each pack is provided with a Patient Information Leaflet detailing how to take the medication.

Also, Consilient Health has created a supplementary Patient Leaflet & Dosing Guide. This includes a chart that allows patients to mark-off when they have taken each dose throughout the full 25-day treatment course. These can be supplied by Consilient Health (contact us here to request copies or to download as a pdf from our website.)

Due to limited clinical experience based on the clinical trial data available at the time CYTISINICLINE was licensed, the safety and efficacy of CYTISINICLINE in these age groups has not been established and is therefore not recommended.

The SPC states that, due to lack of clinical experience, CYTISINICLINE is not recommended in patients with renal or hepatic impairment. As the SPC does not specify a particular level of hepatic or renal impairment, this implies any impairment.

The CYTISINICLINE SPC contraindicates use in patients with a history of “recent myocardial infarction” or “recent stroke”. However, “recent” is not defined in the SPC as the information was not collected during the original clinical trials, so a specific time period cannot be advised.

The use of CYTISINICLINE is a clinical decision for the prescriber who is familiar with the patient’s underlying condition. CYTISINICLINE can be used in patients with certain cardiovascular conditions, i.e. “ischemic heart disease, heart failure, hypertension, pheochromocytoma, atherosclerosis and other peripheral vascular diseases”, however, the SPC states that it should be used with caution.

For additional information, you may wish to consult the national Patient Group Direction template for CYTISINICLINE. The national PGD template has been produced by the Specialist Pharmacy Service and is available online from the SPS website. https://www.sps.nhs.uk/articles/cytisinicline-for-smoking-cessation/ This includes some guidance on the CYTISINICLINE contraindications.

Intervention and support throughout a smoker’s quit journey from a healthcare professional can have a significant positive impact on the chances of successfully quitting¹. Therefore, the support provided through a 12 week stop smoking programme, irrespective of the treatment provided, is an important factor.

CYTISINICLINE, which has a treatment duration of just 25-days, can easily be incorporated into a 12 week stop smoking programme. Treatment with CYTISINICLINE can be initiated at the start of the programme, with the smoker stopping smoking by day 5, and treatment continuing until day 25. The support provided through the stop smoking service, such as face-to-face appointments, group meetings or phone calls, can carry on as normal for the full 12 weeks.

1. West R, Papadakis S. Stop smoking services: increased chances of quitting. 2019 National Centre for Smoking Cessation and Training (NCSCT) Available at: https://www.ncsct.co.uk/publications/Stop_smoking_services_impact_on_quitting Accessed Jan 2026.

It is difficult to give a single, definitive number for “the quit rate” as the data varies depending on the setting of the smoking cessation service or clinical trial design, how “quitting” is defined, when quit rate is measured, and what support the smoker is offered on their quit journey.

For example, the NSCST “Local Stop Smoking Services and support: commissioning, delivery and monitoring guidance” (April 2024) provides the following estimates for other treatments, with different types of support and at different time periods¹:

CYTISINICLINE (given as a 25-day treatment course) has been shown:

• In an open-label trial, to be superior to combination NRT; CYTISINICLINE was associated with a higher frequency of self-reported adverse events (Walker et al 2014)² For more information click here
• Was inferior to varenicline given for 84 days; CYTISINICLINE was associated with lower frequency of adverse events (Courtney et al 2021, Oreskovic et al 2023)^3,4

1. NCSCT. https://www.ncsct.co.uk/publications/commissioning-delivery-monitoring Accessed Jan 2025
2. Walker N et al. N Engl J Med 2014;371:2353-62
3. Courtney RJ et al. JAMA 2021 326(1)56-64
4. Oreskovic T et al. Nicotine Tob Res. 2023 Aug 19;25(9):1547-1555.

CYTISINICLINE is indicted for smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking; the treatment goal of CYTISINICLINE is the permanent cessation of the nicotine containing products use.

The CYTISINICLINE clinical trials did not include people that used e-cigarettes or vapes, and therefore use in this population cannot be recommended.

The concurrent use of CYTISINICLINE and Nicotine Replacement Therapy (NRT) is not specifically addressed in the CYTISINICLINE Summary of Product Characteristics (SPC) and a search of the published literature did not reveal clinical studies trialling the simultaneous use of both treatments.

The SPC does advise that: “Smoking should be stopped no later than on the 5th day of treatment. Smoking should not be continued during treatment as this may aggravate adverse reactions. Patient should be aware, that the simultaneous administration of the drug and smoking or use of products containing nicotine could lead to aggravated adverse reactions of nicotine.”

Therefore, the use of NRT would not be recommended after day 5 of treatment with CYTISINICLINE.

This is not specifically addressed in the CYTISINICLINE SPC, however, it does advise that: “Smoking should be stopped no later than on the 5th day of treatment. Smoking should not be continued during treatment as this may aggravate adverse reactions. Patients should be aware, that the simultaneous administration of the drug and smoking or use of products containing nicotine could lead to aggravated adverse reactions of nicotine.”

The concurrent use of vapes / e-cigarettes with CYTISINICLINE would therefore not be recommended.

The SPC does not allow for patients to continue treatment beyond 25 days. The CYTISINICLINE SPC does state that, in case of treatment failure, the treatment should be discontinued and may be resumed after 2 to 3 months.

The management of a patient after they have completed treatment with CYTISINICLINE remains a clinical decision for the healthcare professional in discussion with the patient.

The Patient Information Leaflet (PIL) advises that patients should “not take a double dose to make up for a forgotten dose”. A PIL is provided, in each pack of CYTISINICLINE.