Champix pills 1 mg №28

Composition

Film Coated Tablets
Each pill contains varenicline - 0.5 mg or 1 mg (in the form of varenicline tartrate 0.85 mg or 1.71 mg, respectively)

Description
pills 0.5 mg - white or almost white capsule-shaped biconvex tablets, coated, with the inscription "Pfizer" on one side and "CHX 0.5" on the other side
1.0 mg pills are light blue capsule-coated, biconvex, film-pills with the words “Pfizer” on one side and “CHX 1.0” on the other side.

Mechanism of action

Champiks - a drug for the treatment of nicotine addiction. Varenicline with high affinity and selectivity binds to the α4β2 neural nicotinic acetylcholine receptors, for which it is a partial agonist, i.e. simultaneously exhibits agonism (but to a lesser extent than nicotine) and antagonism in the presence of nicotine.

The effectiveness of Champix in the treatment of nicotine addiction is associated with partial agonism of varenicline against the α4β2 nicotinic receptors. Binding of the drug to these receptors reduces the craving for smoking and withdrawal syndrome (agonistic activity) and at the same time reduces the effect of getting pleasure from smoking and then forms dependence by blocking the interaction of nicotine with α4β2 receptors (antagonisticactivity).

Indications and usage

Champix is ​​used as an anti-smoking agent in adults.

Contraindications

Hypersensitivity to the drug.
Champiks should not be used during pregnancy and lactation.

Champiks is not recommended to be prescribed to children and adolescents in a dose up to 18 years, as information about its safety and effectiveness in this age group is insufficient.

Anti-smoking remedies are more effective if patients themselves seek to quit smoking and receive additional help and support.

Before prescribing the drug, the patient should determine the date of cessation of smoking. The drug should be started 1-2 weeks before this date. At the beginning of treatment, the dose is titrated for 1 week according to the scheme

• 1-3 day - 0.5 mg once a day
• 4-7 days - 0.5 mg twice a day
• from day 8 until the end of treatment - 1 mg twice a day

The recommended dose is 1 mg 2 times / day. If the patient does not tolerate the side effects of Champix, the dose can be temporarily or permanently reduced to 500 μg 2 times / day.

The pill should be swallowed whole with water. The drug can be taken with meals or between meals.

The course of treatment is 12 weeks. For patients who quit smoking by the end of 12 weeks, an additional course of treatment with the drug at a dose of 1 mg 2 times / day for 12 weeks can be carried out.

There is no information about the effectiveness of an additional 12-week course of treatment in patients who did not manage to quit smoking during the first course, and in patients who resumed smoking after the completion of therapy.

With the use of anti-smoking agents, the risk of smoking is increased immediately after the end of treatment. If this risk is high, then a gradual reduction in dose is possible.

Adverse reactions

The cessation of smoking with or without treatment is accompanied by various symptoms. For example, patients trying to quit smoking may experience dysphoria or depression; insomnia, irritability, frustration or anger; anxiety; difficulty concentrating; anxiety; decrease in heart rate; increased appetite or weight gain.

The table lists all adverse events, the frequency of which was higher than in the placebo group. Determination of the frequency of adverse reactions: very frequent (> 1/10), frequent (> 1 / 100- <1/10), infrequent (> 1 / 1,000- <1/100) and rare (> 1 / 10,000- <1 / 1,000)

Infections: infrequent - bronchitis, nasopharyngitis, sinusitis, fungal infections, viral infections
Metabolism and nutrition disorders: frequent - increased appetite, infrequent - anorexia, loss of appetite, polydipsia
Psychiatric disorders: very frequent - abnormal dreams, insomnia, infrequent - panic reaction, bradyfrenia, thinking disorders, rapid mood changes
Neurological disorders: very frequent - headache, frequent - drowsiness, dizziness, dysgesia; infrequent - tremor, impaired coordination, dysarthria, hypertension, anxiety, dysphoria, hypoesthesia, decreased taste sensation, apathy, increased libido, decreased libido
From the side of the heart: infrequent - atrial fibrillation, palpitations
On the part of the organ of vision: infrequent - scotoma, discoloration of the sclera, eye pain, pupil dilation, photophobia, myopia, increased tearing
On the part of the organ of hearing and vestibular apparatus: Infrequent - Tinnitus
On the part of the respiratory system: infrequent - shortness of breath, cough, hoarseness, sore throat and larynx, irritation of the pharynx, swelling of the respiratory tract, swelling of the sinuses, runoff of mucus on the back of the nose, nasal discharge, snoring
Gastrointestinal disturbances: very frequent - nausea; frequent - vomiting, constipation, diarrhea, distension of the abdomen, discomfort in the stomach, dyspepsia, flatulence, dry mouth; infrequent - vomiting blood, blood impurities in the stool, gastritis, gastroesophageal reflux disease, abdominal pain, changes in defecation, altered stool, belching, aphthous stomatitis, pain in the gums, furred tongue
Changes in the skin and subcutaneous tissue: infrequent - generalized rash, erythema, pruritus, acne, hyperhidrosis, night sweats
From the musculoskeletal and connective tissue: infrequent - stiffness of joints, muscle spasms, pain in the wall of the chest, costochondritis
Kidney and urinary tract: infrequent - glycosuria, nocturia, polyuria
From the reproductive system: npart - menorrhagia, vaginal discharge, sexual dysfunction
General and local reactions: frequent - fatigue; infrequent - chest discomfort, chest pain, fever, cold sensation, asthenia, circadian rhythm sleep disturbances, malaise, cyst
Research results: infrequent - increased blood pressure, ST segment depression, decreased T wave amplitude, increased heart rate, changes in liver function, decreased platelet count, weight gain, change in sperm, increased C-reactive protein, decreased blood Calcium levels

Special notes

Effects of smoking cessation: Physiological changes associated with stopping smoking while taking Champix® or without treatment can cause disturbances in the pharmacokinetics or pharmacodynamics of some drugs, which may require a change in their dose (for example, theophylline, Warfarin and insulin). Smoking causes an increase in CYP1A2 activity, therefore, smoking cessation can lead to an increase in plasma levels of CYP1A2 substrates.

Smoking cessation with or without pharmacotherapy was accompanied by exacerbation of psychiatric diseases (for example, depression). Care must be taken in patients with psychiatric disorders in history. Patients should be warned about the possibility of exacerbation of such diseases at smoking cessation.

There is no experience of using Champix in patients with epilepsy. Cancellation of Champix after completion of treatment in 3% of patients was accompanied by an increase in irritability, smoking, depression and / or insomnia. The physician should inform the patient about the possible occurrence of such reactions and take into account the possibility of gradually reducing the dose.

Impact on the ability to drive a car and use of equipment
Champiks has a small or moderate impact on the ability to drive and use sophisticated equipment. Champiks can cause dizziness and drowsiness and, accordingly, affect the ability to drive a car and use sophisticated equipment. Patients are discouraged from driving, using sophisticated equipment, or performing other potentially dangerous tasks until they evaluate their response to the drug.

Keep out of the reach of children, at a temperature of 15 to 30 ° C.

Shelf life - 2 years.