Champix - instructions for use, dose, side effects, contraindications

Active substanceVareniclineVarenicline

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Champix®

pills inwards

Pfizer Inc. USA

Dosage form: & nbspfilm-coated tablets

Composition:

Each tablet, film-coated, with a dosage of 0.5 mg contains:

active substance: varenicline 0.5 mg (in the form of varenicline tartrate 0.85 mg);

Excipients: cellulose microcrystalline 62.57 mg, calcium hydrophosphate 33.33 mg, croscarmellose sodium 2.00 mg, silicon dioxide colloid 0.50 mg, magnesium stearate 0.75 mg; film shell: opadray white YS-1-18202-A (contains hypromellose, titanium dioxide and macrogol) 4,00 mg; opadray transparent YS-2-19114-A (contains hypromellose and triacetin) 0.50 mg.

Each tablet, film-coated, with a dosage of 1 mg contains:

active substance: varenicline 1 mg (in the form of varenicline tartrate 1.71 mg);

Excipients: cellulose microcrystalline 125.13 mg, calcium hydrophosphate 66.66 mg, croscarmellose sodium 4.00 mg, silicon dioxide colloid 1.00 mg, magnesium stearate 1.50 mg; film shell: opadray transparent YS-2-19114-A (contains hypromellose and triacetin) 1.00 mg; opadray blue 03B90547 (contains hypromellose, titanium dioxide, macrogol and aluminum lacquer based on indigo carmine) 8.00 mg.

Description:

Tablets with a dosage of 0.5 mg: white or almost white capsular biconvex tablets covered with a film membrane, with an inscription "Pfizer" on one side and "CHX 0.5" on the other side

Tablets with a dosage of 1 mg: light blue capsular biconvex tablets covered with a film sheath, with the inscription "Pfizer" on one side and "CHX 1.0" on the other side

Pharmacotherapeutic group:nicotine addiction treatment

ATX: & nbsp

N.07.B.A Drugs used in nicotine addiction

N.07.B.A.03 Varenicline

Pharmacodynamics:

Varenicline with high affinity and selectivity binds to α4β2 nicotinic acetylcholine receptors of the brain, for which he is a partial agonist (but to a lesser extent than nicotine), and an antagonist in the presence of nicotine. Electrophysiological research in vitro and neurochemical studies in vivo showed that varenicline binds to α4β2 nicotinic acetylcholine receptors and stimulating them, but to a much lesser extent than nicotine.

Nicotine competitively binds to the same receptor site to which varenicline has a higher affinity. In this way, varenicline effectively blocks the ability of nicotine to stimulate α4β2 receptors and activate Mesolimbic dopamine system - neuronal mechanism, which underlies the implementation of mechanisms formation of nicotine addiction (getting pleasure from smoking).

The efficacy of varenicline as a means for treating nicotine dependence is due to its partial agonism with respect to α4β2 nicotinic receptors, binding to which reduces craving for smoking and facilitates the manifestation of the withdrawal syndrome, while also reducing the sense of pleasure from smoking (antagonism in the presence of nicotine).

In two placebo-controlled double-blind clinical trials examining the efficacy of varenicline and bupropion, varenicline demonstrated a statistically significant superiority. During active treatment, cravings for smoking and manifestation of the "withdrawal" syndrome were significantly reduced in patients randomized to the varenicline group, but compared with placebo. Varenicline also significantly reduced the effects of reinforcement arising from smoking, which can strengthen the habit of smoking in patients who smoked during treatment, compared with placebo. Impact varenicline for smoking cravings, withdrawal syndrome and reinforcement effects were not evaluated in subsequent follow-up, when no medication was given.

Placebo-controlled blind clinical The study demonstrated the effectiveness of an additional 12 weeks of varenicline therapy for abstinence from smoking compared with placebo.

Patients who do not want or are not able to set a goal to quit for 1-2 weeks can be offered to begin treatment, with the option of choosing their own date for quitting within 5 weeks.

Patients who previously tried to quit using varenicline and who re-treated with varenicline, had the best level of confirmed persistent abstinence compared with placebo.

In a placebo-controlled, double-blind clinical trial in patients not able or unwilling to quit for 4 weeks but wishing to gradually reduce smoking for 12 weeks before quitting, a higher level of persistent abstinence compared with placebo was confirmed;

When using the drug varenicline in patients with chronic obstructive pulmonary disease, there were no differences in the safety profile compared to healthy patients.

Pharmacokinetics:

Suction

The maximum concentration of varenicline (C_mOh) in blood plasma is usually achieved 3-4 hours after ingestion. With subsequent administration in healthy volunteers, the equilibrium state was achieved within 4 days. The drug is almost completely absorbed after ingestion and has a high systemic bioavailability, not related to eating and taking time during the day. After a single dose of 0.1 mg to 3 mg or repeated doses of 1 mg / day to 3 mg / day, the pharmacokinetics of varenicline were linear.

Distribution

Varenicline is distributed in the tissues and penetrates the blood-brain barrier, entering the brain. The degree of binding to plasma proteins is low (<20%) and does not depend on the age and function of the kidneys.

Metabolism

Varenicline undergoes minimal transformation: 92% of the dose is excreted by the kidneys unchanged and less than 10% - in the form of metabolites. Among the metabolites of varenicline in urine are found Ncarbamyl glucuronide varenicline and hydroxyvarienicline. In the blood plasma varenicline 91% circulates unchanged. Among the circulating metabolites found Ncarbamyl glucuronide varenicline and N-glucosylvarenicline.

Excretion

The half-life (T_1/2) varenicline is about 24 hours. The excretion of varenicline by the kidney is carried out, mainly by glomerular filtration in combination with active tubular secretion.

Pharmacokinetics in special groups

The pharmacokinetics of varenicline are not significantly affected by age, race, sex, smoking status, or concomitant therapy.

Impaired renal function

The pharmacokinetics of varenicline did not change in patients with mild renal impairment (creatinine clearance> 50 mL / min and <80 mL / min). In patients with moderate renal insufficiency (creatinine clearance> 30 ml / min and <50 ml / min) AUC varenicline increased 1.5 times compared with that in patients with normal renal function (creatinine clearance> 80 mL / min). In patients with severe renal impairment (creatinine clearance <30 mL / min) AUC varenicline increased by 2.1 times. In patients with terminal stage of renal failure varenicline effectively removed during hemodialysis.

Impaired liver function

Given the absence of a pronounced metabolism of varenicline in the liver, the pharmacokinetics of varenicline should not be altered in patients with impaired function.

Elderly patients

The pharmacokinetics of varenicline in the elderly with normal renal function (age 65 to 75 years) does not change.

Indications:

Nicotine dependence in adults.

Contraindications:

- Hypersensitivity to any component of the drug;

- age to 18 years (not enough clinical data on the efficacy and safety of the drug in this age group);

- pregnancy and lactation;

- terminal stage of renal failure;

Pregnancy and lactation:

Due to the fact that adequate controlled trials of the use of varenicline in pregnant women have not been conducted, the use of the drug during pregnancy is contraindicated.

Information about the isolation of varenicline with breast milk in women is not. If you need to use the drug during lactation, breastfeeding should be discontinued.

Dosing and Administration:

The likelihood of successful treatment with a drug for stopping smoking is increased in Nazis who are motivated to quit smoking, who are given additional counseling and support.

Champix® is taken orally by swallowing tablets whole and with water, regardless of food intake.

The recommended dose of the drug is 1 mg twice a day with a dose titration but the following scheme:

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

Treatment with Champix® should be started 1-2 weeks before the date chosen by the patient for stopping smoking. Either the patient can start taking the drug and stop smoking between the 8th and 35th day of treatment with Champix®.

If the patient does not tolerate the unwanted effects of Champix®, the dose may be temporarily or permanently reduced. Treatment with Champix® is continued for 12 weeks. Patients who successfully quit smoking by the end of the 12th week of treatment are recommended an additional 12-week course of varenicline therapy at a dose of 1 mg twice a day to support quitting.

For patients who are unable or unwilling to abstain from smoking, a gradual approach with varenicline therapy may be considered. In this case, smoking should be reduced within 12 weeks of therapy and quit smoking by the end of this period. After this, patients should take varenicline another 12 weeks, so that the total treatment period is 24 weeks.

Patients who have appropriate motivation but who failed to quit during the previous course of treatment with varenicline, or who have a relapse after treatment, are encouraged to make another attempt, provided that the reasons for the failure of the first attempt have been established and measures have been taken for their elimination.

Data on the efficacy of an additional 12-week course of therapy in patients who failed to quit smoking following a primary course of therapy or with a relapse of smoking, are absent. The risk of recurrence of smoking is increased in people who have recently completed therapy to stop smoking. In patients with a high risk of recurrence, a gradual dose reduction is possible (see section "Special instructions").

Impaired renal function

A change in the dose of Champix® in patients with mild renal impairment (creatinine clearance> 50 mL / min and ≤ 80 mL / min) and moderate renal insufficiency (creatinine clearance> 30 mL / min and ≤ 50 mL / min) is not required .

In patients with moderate renal failure who do not tolerate adverse reactions to Champix®, the daily dose can be reduced to 1 mg once.

In patients with severe renal impairment (creatinine clearance <30 mL / min), the recommended dose of Champix® is 1 mg once daily. Treatment begins with a dose of 0.5 mg once a day, which after 3 days is increased to 1 mg once a day.

Due to a lack of clinical data on the use of Champix® in patients with terminal stage of renal failure, the drug does not it is recommended to appoint such patients (see the section "Contraindications"),

Impaired liver function

Correction of the dose of Champix® in patients with impaired liver function is not required.

Elderly patients

Correction of the dose of Champix® in elderly patients is not required. The elderly are more likely to reduce the function of the kidneys, so it is advisable to evaluate it before starting treatment.

Children

Champix® it is not recommended to prescribe to children and adolescents under 18 years of age, since information on its safety and efficacy in this age group is not sufficient (see section "Contraindications").

Side effects:

Cessation of smoking as a background of therapy with Cumpix®, and without it, is accompanied by various symptoms,in particular, decreased mood and dysphoria, insomnia, irritability, feelings of displeasure and anger, anxiety, impaired concentration, motor anxiety, decreased heart rate, increased appetite, or weight gain.

Refusal to smoke on the background of drug therapy or without it was accompanied by an aggravation of concomitant mental disorders. However, neither during the development of clinical trials of Champix® nor during the analysis of their results, attempts were made to distinguish between undesirable phenomena associated with the use of the study drug and undesirable phenomena possibly associated with the syndrome of "withdrawal" of nicotine.

According to the results of clinical studies, adverse reactions usually appeared within the first week after initiation of treatment, were usually mild or moderate and their frequency was independent of the patient's age, race or sex.

In patients who received Champix® at the recommended dose of 1 mg twice daily after the titration period, the most common of the reported side effects was nausea (28.6%).In most cases, nausea occurred during the early stages of therapy, was mild or moderate and rarely required discontinuation of the drug. The incidence of discontinuation of therapy due to adverse events was 11.4% for the varenicline group and 9.7% for the placebo group. The incidence of discontinuation due to major adverse reactions was as follows: nausea 2.7% and 0.6% in varenicline and placebo, respectively; headache 0.6% and 1.0%; insomnia - 1.3% and 1.2%; unusual dreams - 0.2% and 0.2%.

Against the background of taking Champix®, the following reactions are also possible on the part of organs and systems (frequency assessment criteria: very frequent ≥ 10%, frequent - from ≥ 1% to <10%, infrequent - from ≥ 0.1% to <1%; rare - from ≥ 0.01% to <0.1%, very rare - <0.01%, frequency unknown - can not be determined based on available data):

Infections: very frequent - nasopharyngitis; frequent - bronchitis, sinusitis; Infrequent - fungal infections, viral infections.

Metabolic and nutritional disorders: frequent - decreased appetite, increased appetite; infrequent - anorexia, polydipsia, frequency unknown - hyperglycemia, diabetes mellitus.

Mental disorders: very frequent - unusual dreams, insomnia; infrequent - panic reaction, bradyphrenia, disturbance of thinking,mood swings; frequency is unknown - somnambulism.

Neurological disorders: very frequent - headache; frequent - drowsiness, dizziness, changes in taste, incl. decreased taste sensations; infrequent - tremor, impaired coordination, lethargy, dysarthria, hypertension, motor anxiety, dysphoria, hypoesthesia, apathy, increased libido, decreased libido; rare - a violation of cerebral circulation.

Heart Disease: infrequent - atrial fibrillation, sensation palpitation, angina, tachycardia; frequency unknown - myocardial infarction.

Disorders from the side of the organ of vision: infrequent - scotoma, scleral discoloration, pain in the eyeball, pupil dilated, photophobia, myopia, increased lacrimation, conjunctivitis.

Violations from the organ of hearing and vestibular apparatus: infrequent - noise in the ears.

Disturbances from the respiratory system, thorax and mediastinum: frequent - shortness of breath, cough; infrequent - infections of the upper respiratory tract, hoarseness of the voice, pain in the pharynx and larynx, irritation of the pharynx, congestion in the airways, congestion in the paranasal sinuses, exudation in the nasopharynx, rhinorrhea, snoring, dysphonia, allergic rhinitis.

Gastrointestinal disorders: highly frequent - nausea; frequent - vomiting, constipation, diarrhea, bloating, stomach discomfort, dyspepsia, flatulence, dryness of the oral mucosa, gastroesophageal reflux disease, abdominal pain, toothache; infrequent - vomiting of blood, an admixture of blood in the stool, gastritis, intestinal disorders, belching, aphthous stomatitis, tenderness of the gums, lined tongue.

Disturbances from the skin and subcutaneous tissues: frequent - a rash, itchy skin; infrequent - generalized rash, erythema, acne, hyperhidrosis, night sweats.

Disorders from the musculoskeletal system and connective tissue: frequent - arthralgia, myalgia, back pain; infrequent - stiffness of the joints, muscle spasms, bone chondrite.

Disorders from the kidneys and urinary tract: infrequent - Glucosuria, nocturia, polyuria, pollakiuria.

Disorders from the reproductive system and breast: infrequent - menorrhagia, vaginal discharge, sexual dysfunction.

General and local reactions: frequent - chest pains, fatigue; infrequent - chest discomfort, fever, sensation of cold, asthenia, disturbed circadian rhythm of sleep, malaise, cyst, flu-like syndrome.

Research results: frequent - increase in body weight; infrequent - increased blood pressure (BP), segment depression ST on the ECG, a decrease in the amplitude of the T wave on the ECG, an increase in the heart rate, the "tides" of blood to the skin of the face, a change in the liver function, a decrease in the number of platelets, a change in sperm, an increase in the concentration of C-reactive protein, a decrease in calcium concentration in the blood.

Cessation of smoking with or without therapy is accompanied by the development of nicotine withdrawal syndrome and exacerbation of concomitant mental disorders.

In the course of post-marketing research In patients who tried to quit smoking with Champix®, cases of depressed mood, agitation, behavioral or thinking disorders, anxiety, psychosis, hallucinations, mood swings, aggressive behavior, suicidal tendencies and suicidal attempts were recorded. Since these phenomena are fixed according to the results of voluntary communication by a population of undetermined size, it is not always possible to establish precisely their frequency or cause-and-effect relationship with the action of the drug.Not all patients described in these reports had a history of mental disorders and not all of them stopped smoking. The role of the Champix® preparation in the development of the reactions described in these reports is not known. Hypersensitivity reactions such as angioneurotic edema and rare but severe cases of skin reactions, including Stevens-Johnson syndrome and erythema multiforme, have also been reported (see "Specific guidance").

Overdose:

No cases of a varenicline overdose have been reported.

Treatment: symptomatic. Varenicline is derived from hemodialysis in patients with severe renal dysfunction, but there is no experience with hemodialysis in overdose.

Interaction:

Clinically significant interactions of varenicline with other drugs have not been identified. Correction of a dose of varenicline or the drugs listed below with simultaneous application is not required.

In studies in vitro it was shown that the active secretion of varenicline through the kidneys is mediated by the transporter of organic human cations (OCT2). When applied simultaneously with OCT2 inhibitors, no dose adjustment for varenicline is required, since no significant increase in the systemic exposure of varenicline tartrate is expected.

Research in vitro evidence that varenicline does not change the pharmacokinetics of drugs that are metabolized by cytochrome P isoenzymes₄₅₀. Since the clearance of varenicline by less than 10% is due to metabolism, it is unlikely that substances that affect the activity of cytochrome P isoenzymes₄₅₀, can affect the pharmacokinetics of varenicline, and therefore correction of its dose is not required.

Varenicline in therapeutic concentrations does not inhibit the renal transport of proteins in humans. Consequently, varenicline should not affect the pharmacokinetics of drugs whose clearance is due to renal secretion (in particular, metformin - see below).

Metformin

Varenicline does not affect the pharmacokinetics of metformin. Metformin does not cause a change in the pharmacokinetics of varenicline.

Cimetidine

Cimetidine causes an increase AUC varenicline by 29% due to a decrease in its renal clearance. In patients with normal renal function or in patients with mild and moderate renal failure, dose adjustment is not required. In patients with severe renal failure, simultaneous use of cimetidine andvarenicline.

Digoxin

Varenicline does not affect the pharmacokinetics of digoxin in the equilibrium state.

Warfarin

Varenicline does not change the pharmacokinetics of warfarin and does not affect prothrombin time (INR). Cessation of smoking itself can lead to a change in the pharmacokinetics of warfarin.

Alcohol

Data on the simultaneous use of varenicline and alcohol are limited. In the course of post-marketing application varenicline was reported on cases of increased toxic effects of alcohol. The causal relationship between these cases and the use of varenicline has not been established.

Application in combination with other anti-smoking agents

Bupropion

Varenicline does not affect the pharmacokinetics of bupropion in the equilibrium state.

Nicotine replacement therapy (NRT)

With the simultaneous use of varenicline smokers and patches containing nicotine, a statistically significant decrease in mean systolic blood pressure (by 2.6 mm Hg) on the last day of the study was detected within 12 days. At the same time, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was higher with combined therapy than with one NRT.

The safety and efficacy of varenicline in combination with other anti-tobacco drugs have not been studied.

Special instructions:

The effect of smoking cessation on the body

Physiological changes that occur after quitting smoking with or without varenicline therapy can affect the pharmacokinetics or pharmacodynamics of some drugs, which may require correction of their dose (for example, theophylline, warfarin and insulin). Since smoking induces isoenzyme CYP1A2, quitting smoking can lead to an increase in the concentration of substrates of this isoenzyme in the blood plasma.

Neuropsychiatric disorders

Analysis of the data from clinical studies showed no increased risk of developing serious neuropsychiatric disorders with varenicline compared with placebo. In addition, the results of independent observational studies do not confirm an increased risk of developing serious neuropsychiatric disorders with varenicline compared with nicotine replacement therapy or buproprion therapy.

During the post-marketing application of the drug, there were reports of the appearance of psychoneurological symptoms, including impaired behavior or thinking, anxiety, psychosis, mood swings, aggressive behavior, agitation, depressive mood, suicidal tendencies and suicidal behavior in patients attempting to quit using varenicline (see "Side Effects" section). Not all patients stopped smoking at the time of the onset of these symptoms and not all patients had previously experienced mental disorders.

The doctor should explain to patients trying to quit smoking with varenicline, the possibility of developing neuropsychiatric symptoms and to consider the need for a gradual dose reduction. Patients, members of their families or caregivers should be informed of the need to stop taking varenicline and seek immediate medical attention if there is a violation of behavior or thinking, agitation or depressive mood, as well as when a suicidal mood or Suicidal behavior that was not previously characteristic of this patient. In many cases, after the withdrawal of the drug, the disappearance of these symptoms was observed, but sometimes the symptoms persisted.In this regard, further monitoring of patients is recommended until the symptoms disappear. Before starting treatment, patients should be advised to report any mental disorders that they had before. It should also be taken into account that a depressive mood, in rare cases in combination with suicidal thoughts or attempts, can accompany a refusal to smoke. In addition, the process of quitting, together with or without pharmacotherapy, is usually associated with exacerbations of existing mental disorders (eg, depression).

Clinical trials of varenicline have been conducted in patients with major depressive disorder without psychotic phenomena receiving regular antidepressant therapy and / or patients who have undergone a major depressive episode during the past two years and the therapy has been successful. According to the results of the assessment of patients on psychiatric scales, there was no difference between groups of patients receiving varenicline and placebo. Also, there was no worsening of the course of depression during therapy with varenicline in both groups of patients.Care should be taken when using varenicline in patients with mental illness.

Cardiovascular diseases

Meta-analysis of 15 clinical trials with treatment duration> 12 weeks, including 7002 patients (4190 patients were taking varenicline, 2,812 patients taking placebo) was conducted for a systematic evaluation of cardiovascular safety varenicline.

When using Champix® in patients with cardiovascular there was a slight increase in the incidence of complications of these diseases. Such complications often developed in patients with already existing diseases of the cardiovascular system. Total mortality and mortality due to cardio-vascular disease was less in patients receiving varenicline.

Patients receiving varenicline, should inform the attending physician about the appearance of new symptoms of cardiovascular disease or aggravation of the already existing ones. Patients should seek medical help immediately if they develop symptoms for myocardial infarction or stroke.

Use in patients with stable schizophrenia or schizoaffective disorder

There is limited data on the use of varenicline in patients with stable schizophrenia or schizoaffective disorder. Care should be taken when using varenicline in patients with mental illness.

Epilepsy

There is no data on the use of Champix® in patients with epilepsy.

Against the background of the use of Champix®convulsions developed (both in the presence and in the absence of seizures in the anamnesis). In the presence of a history of seizures or other conditions that reduce the threshold of convulsive alertness, care must be taken when using Champix®. The causal relationship between the use of varenicline and the development of seizures has not been established.

Completion of therapy

The completion of treatment with varenicline in 3% of patients was accompanied by increased irritability, cravings for smoking, depression and / or insomnia. Patients should be warned about such complications and discuss the possibility of reducing the dose.

Angioedema and hypersensitivity reactions

There are reports of the development of hypersensitivity reactions, including angioedema, in patients taking varenicline. The clinical symptoms of this complication include edema of the face, mouth (tongue, lips, gums), neck (larynx and pharynx), and limbs. In addition, there are rare reports of the development of life-threatening angioedema, the treatment of which may require emergency medical intervention in connection with the danger of respiratory failure. Patients should immediately stop taking varenicline and consult their doctor if any symptoms of reactions develop hypersensitivity.

Severe skin reactions

There are rare reports of severe life-threatening skin reactions, including Stevens-Johnson syndrome and multiform erythema in patients taking varenicline. Since these reactions can be life-threatening, it is necessary to stop using Champix® with the appearance of the first signs of a rash or skin reactions and immediately inform the attending physician about it.

Effect on the ability to drive transp. cf. and fur:

Given that varenicline may cause dizziness and drowsiness,patients are not advised to drive, use complicated equipment or perform other potentially dangerous tasks until they evaluate their reaction to the drug.

Form release / dosage:

Tablets, film-coated, 0.5 mg or 1 mg.

Packaging:

Primary packaging

11 tablets with a dosage of 0.5 mg in a blister of Aklar® UPVC and aluminum foil or PVC and aluminum foil.

11 tablets with a dosage of 0.5 mg and 14 tablets with a dosage of 1 mg in a blister of Aklar® UPVC and aluminum foil or PVC and aluminum foil.

14 or 28 tablets with a dosage of 1 mg in a blister of Aklar® UPBX and aluminum foil or PVC and aluminum foil.

56 tablets 0.5 mg in a can of high-density polyethylene.

56 tablets with a dosage of 1 mg in a can of high-density polyethylene.

Secondary packaging

1 blister containing 11 tablets with a dosage of 0.5 mg, and 1 blister containing 14 tablets with a dosage of 1 mg, in a combination cardboard package, thermally densely glued together with blisters and instructions for use.

Packing for maintenance therapy

1 blister containing 11 tablets with a dosage of 0.5 mg and 14 tablets at a dosage of 1 mg, and 1 blister containing 28 tablets at a dosage of 1 mg,in a combined cardboard package, thermally densely glued together with blisters and instructions for use.

2 blisters containing 14 tablets with a dosage of 1 mg, or 2 blisters containing 28 tablets with a dosage of 1 mg, into a combined cardboard package that is thermally densely glued together with blisters and instructions for use.

1, 2, 4 or 8 blisters containing 14 tablets each with a dosage of 1 mg, in a cardboard box together with instructions for use.

1 jar containing 56 tablets with a dosage of 0.5 mg, in a cardboard bundle together with instructions for use.

1 jar containing 56 tablets with a dosage of 1 mg, in a cardboard box along with the instructions for use.

On a blister containing 11 tablets (both on a single and on a total with 14 tablets, a dosage of 1 mg), an empty contour cell is placed to fix the blister in the production machine.

When packing 1, 2, 4 or 8 blisters containing 14 tablets of 1 mg each, a perforated line of control of the first opening is applied to the front side of the cardboard bundle.

Tertiary packaging for the full course for 12 weeks

1 combined cardboard package containing 1 blister with 11 tablets 0.5 mg and 14 tablets with a dosage of 1 mg,and 1 blister with 28 tablets with a dosage of 1 mg, and 2 combined cardboard packages containing 2 blisters with 28 tablets in a dosage of 1 mg, in a cardboard box.

Storage conditions:

Store at a temperature of 15-30 ° C.

Keep out of the reach of children

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006439/08

Date of registration:11.08.2008

The owner of the registration certificate: Pfizer Inc. Pfizer Inc. USA

Manufacturer: & nbsp

PFIZER, Inc. USA

Representation: & nbspPfizer H. Si. Pi. CorporationPfizer H. Si. Pi. Corporation

Information update date: & nbsp13.12.2015

Illustrated instructions

Instructions

Champix® (Champix®)