Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
CHAMPIX is indicated for smoking cessation in adults.
The recommended dose is 1 mg varenicline twice daily following a 1-week titration as follows:
| Days 1–3: | 0.5 mg once daily. |
| Days 4–7: | 0.5 mg twice daily. |
| Day 8–End of treatment: | 1 mg twice daily. |
The patient should set a date to stop smoking. CHAMPIX dosing should usually start at 1-2 weeks before this date (see section 5.1). Patients should be treated with CHAMPIX for 12 weeks.
For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHAMPIX at 1 mg twice daily may be considered for the maintenance of abstinence (see section 5.1).
A gradual approach to quitting smoking with CHAMPIX should be considered for patients who are not able or willing to quit abruptly. Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period. Patients should then continue taking CHAMPIX for an additional 12 weeks for a total of 24 weeks of treatment (see section 5.1).
Patients who are motivated to quit and who did not succeed in stopping smoking during prior CHAMPIX therapy, or who relapsed after treatment, may benefit from another quit attempt with CHAMPIX (see section 5.1).
Patients who cannot tolerate adverse reactions of CHAMPIX may have the dose lowered temporarily or permanently to 0.5 mg twice daily.
In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment. In patients with a high risk of relapse, dose tapering may be considered (see section 4.4).
No dosage adjustment is necessary for elderly patients (see section 5.2). Because elderly patients are more likely to have decreased renal function, prescribers should consider the renal status of an elderly patient.
No dosage adjustment is necessary for patients with mild (estimated creatinine clearance >50 ml/min and ≤80 ml/min) to moderate (estimated creatinine clearance ≥30 ml/min and ≤50 ml/min) renal impairment.
For patients with moderate renal impairment who experience adverse reactions that are not tolerable, dosing may be reduced to 1 mg once daily.
For patients with severe renal impairment (estimated creatinine clearance <30 ml/min), the recommended dose of CHAMPIX is 1 mg once daily. Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily. Based on insufficient clinical experience with CHAMPIX in patients with end stage renal disease, treatment is not recommended in this patient population (see section 5.2).
No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
CHAMPIX is not recommended for use in paediatric patients because its efficacy in this population was not demonstrated (see sections 5.1 and 5.2).
CHAMPIX is for oral use and the tablets should be swallowed whole with water.
CHAMPIX can be taken with or without food
No cases of overdose were reported in pre-marketing clinical trials.
In case of overdose, standard supportive measures should be instituted as required.
Varenicline has been shown to be dialyzed in patients with end stage renal disease (see section 5.2), however, there is no experience in dialysis following overdose.
Bottles: 2 years.
Blisters: 3 years.
Blisters: Store below 30°C.
HDPE Bottle: This medicinal product does not require any special storage conditions.
Treatment initiation packs:
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg film-coated tablets and a second clear blister of 14 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg film-coated tablets and a second clear blister containing 14 × 1 mg film-coated tablets in a carton.
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg and 14 × 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg film-coated tablets and a second clear blister of 14 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg film-coated tablets and a second clear blister containing 14 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 × 0.5 mg and 14 × 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 × 1 mg film-coated tablets in secondary heat sealed card packaging.
One outer carton containing:
PCTFE/PVC blisters with aluminium foil backing containing one clear blister of 11 × 0.5 mg and 14 × 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 × 1 mg film-coated tablets in one secondary heat sealed card pack and PCTFE/PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 × 1 mg film-coated tablets.
One outer carton containing:
PVC blisters with aluminium foil backing containing one clear blister of 11 × 0.5 mg and 14 × 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 × 1 mg film-coated tablets in one secondary heat sealed card pack and PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 × 1 mg film-coated tablets.
Maintenance packs:
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 × 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 × 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing in a pack containing 28 × 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing in a pack containing 56 × 0.5 mg film-coated tablets in secondary heat sealed card packaging.
High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil /polyethylene induction seal containing 56 × 0.5 mg film-coated tablets
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 × 1 mg film-coated tablets in a carton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 × 1 mg film-coated tablets in a carton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 112 × 1 mg film-coated tablets in a carton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 140 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing in a pack containing 28 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing in a pack containing 56 × 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC blisters with aluminium foil backing in a pack containing 28 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing in a pack containing 56 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing in a pack containing 112 × 1 mg film-coated tablets in a carton.
PVC blisters with aluminium foil backing in a pack containing 140 × 1 mg film-coated tablets in a carton.
High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil/polyethylene induction seal containing 56 × 1 mg film-coated tablets
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
