Product Description:

CHAM PIX is indicated for smoking cessation in adults

How to use:

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.

CHAM PIX dosing should usually start at 1-2 weeks before this date.

Patients should be treated with CHAM PIX for 12 weeks.

Caution & Warnings:

Hypersensitivity to the active substance or to any of the excipients.Clinical signs included swelling of the face, mouth (tongue, lips, and gums), neck (throat and larynx) and extremities.

Effect of smoking cessation: Physiological changes resulting from smoking cessation, with or without treatment with CHAMP IX, may alter the pharmacokinetics or pharmacodynamics of some medicines, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin).

Neuropsychiatric symptoms: suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with CHAMPIX in the post-marketing experience.

Depressed mood, rarely including suicide attempt, may be a symptom of nicotine withdrawal.

CHAM PIX should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

Treatment discontinuation: At the end of treatment, discontinuation of CHAM PIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients.

Cardiovascular events: notify your doctor of new or worsening cardiovascular symptoms

pregnancy and lactation:

Pregnancy: A moderate amount of data on pregnant women indicated no malformative or fetal/neonatal toxicity of varenicline. Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of varenicline during pregnancy.

Breast-feeding: It is unknown whether varenicline is excreted in human breast milk. Animal studies suggest that varenicline is excreted in breast milk. A decision on
whether to continue/discontinue breast-feeding or to continue/discontinue therapy with CHAMPIX should be made taking into account the benefits of breast-feeding to the child and the benefits of CHAMPIX therapy to the woman.

Patients with renal impairment:

No dosage adjustment is necessary for patients with mild to moderate renal impairment.

For patients with severe renal impairment, the recommended dose of CHAM PIX 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.

Patients with hepatic impairment:

No dosage adjustment is necessary for patients with hepatic
impairment.

Pediatric population:

The safety of CHAMPIX in children or adolescents below 18 years have not yet been established

Ingredients:

varenicline 0.5,1 mg.

Product Description:

CHAM PIX is indicated for smoking cessation in adults

How to use:

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.

CHAM PIX dosing should usually start at 1-2 weeks before this date.

Patients should be treated with CHAM PIX for 12 weeks.

Caution & Warnings:

Hypersensitivity to the active substance or to any of the excipients.Clinical signs included swelling of the face, mouth (tongue, lips, and gums), neck (throat and larynx) and extremities.

Effect of smoking cessation: Physiological changes resulting from smoking cessation, with or without treatment with CHAMP IX, may alter the pharmacokinetics or pharmacodynamics of some medicines, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin).

Neuropsychiatric symptoms: suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with CHAMPIX in the post-marketing experience.

Depressed mood, rarely including suicide attempt, may be a symptom of nicotine withdrawal.

CHAM PIX should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

Treatment discontinuation: At the end of treatment, discontinuation of CHAM PIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients.

Cardiovascular events: notify your doctor of new or worsening cardiovascular symptoms

pregnancy and lactation:

Pregnancy: A moderate amount of data on pregnant women indicated no malformative or fetal/neonatal toxicity of varenicline. Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of varenicline during pregnancy.

Breast-feeding: It is unknown whether varenicline is excreted in human breast milk. Animal studies suggest that varenicline is excreted in breast milk. A decision on
whether to continue/discontinue breast-feeding or to continue/discontinue therapy with CHAMPIX should be made taking into account the benefits of breast-feeding to the child and the benefits of CHAMPIX therapy to the woman.

Patients with renal impairment:

No dosage adjustment is necessary for patients with mild to moderate renal impairment.

For patients with severe renal impairment, the recommended dose of CHAM PIX 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.

Patients with hepatic impairment:

No dosage adjustment is necessary for patients with hepatic
impairment.

Pediatric population:

The safety of CHAMPIX in children or adolescents below 18 years have not yet been established

Ingredients:

varenicline 0.5,1 mg.

Product Description:

CHAM PIX is indicated for smoking cessation in adults

How to use:

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.

CHAM PIX dosing should usually start at 1-2 weeks before this date.

Patients should be treated with CHAM PIX for 12 weeks.

Caution & Warnings:

Hypersensitivity to the active substance or to any of the excipients.Clinical signs included swelling of the face, mouth (tongue, lips, and gums), neck (throat and larynx) and extremities.

Effect of smoking cessation: Physiological changes resulting from smoking cessation, with or without treatment with CHAMP IX, may alter the pharmacokinetics or pharmacodynamics of some medicines, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin).

Neuropsychiatric symptoms: suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with CHAMPIX in the post-marketing experience.

Depressed mood, rarely including suicide attempt, may be a symptom of nicotine withdrawal.

CHAM PIX should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

Treatment discontinuation: At the end of treatment, discontinuation of CHAM PIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients.

Cardiovascular events: notify your doctor of new or worsening cardiovascular symptoms

pregnancy and lactation:

Pregnancy: A moderate amount of data on pregnant women indicated no malformative or fetal/neonatal toxicity of varenicline. Animal studies have shown reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of varenicline during pregnancy.

Breast-feeding: It is unknown whether varenicline is excreted in human breast milk. Animal studies suggest that varenicline is excreted in breast milk. A decision on
whether to continue/discontinue breast-feeding or to continue/discontinue therapy with CHAMPIX should be made taking into account the benefits of breast-feeding to the child and the benefits of CHAMPIX therapy to the woman.

Patients with renal impairment:

No dosage adjustment is necessary for patients with mild to moderate renal impairment.

For patients with severe renal impairment, the recommended dose of CHAM PIX 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.

Patients with hepatic impairment:

No dosage adjustment is necessary for patients with hepatic
impairment.

Pediatric population:

The safety of CHAMPIX in children or adolescents below 18 years have not yet been established

Ingredients:

varenicline 0.5,1 mg.