Characteristics

Minimum age: 18 years

Amount in a package: 100 tablets

Maximum allowable storage temperature: 25 °C

Best before date: 36 months

Food conditions: in a dry place

Release form: Tablet

Manufacturer country: Bulgaria

Prescription: No prescription

Active substance: Cytisine

Scope of application: Treatment of alcoholism, drug addiction and smoking

Pharmacological group: N07BA Drugs used in nicotine dependence

Instructions for use

Active ingredients

Cytisine

Release form

Tablets

Composition

Cytisine 1.5 mg.

Excipients: lactose monohydrate - 28 mg, microcrystalline cellulose - 67.5 mg, talc - 2 mg, magnesium stearate - 1 mg. The composition of the film shell: Opadry II brown 85F26948 - 3 mg (polyvinyl alcohol partially hydrolyzed - 1.2 mg, titanium dioxide (E171) - 0.654 mg, macrogol 3350 - 0.606 mg, talc - 0.444 mg, iron oxide yellow (E172) - 0.062 mg, iron oxide red (E172) - 0.018 mg, iron oxide black (E172) - 0.016 mg).

Pharmacological effect

Remedy for the treatment of nicotine addiction, n-cholinomimetic. The alkaloid cytisine is the active substance of Sopharma Tabex, has an n-cholinomimetic effect. Its effects are expressed as follows: it excites the ganglia of the autonomic nervous system, reflexively excites respiration, causes the release of adrenaline from the adrenal medulla, and increases blood pressure. While closely similar to the mechanism of action of nicotine, cytisine has a much lower toxicity and a broader therapeutic index. Cytisine competitively suppresses the interaction of nicotine with the corresponding receptors, which leads to a gradual decrease and disappearance of nicotine (tobacco) dependence.

Indications

• treatment of nicotine addiction (to facilitate smoking cessation). Physical and psychological dependence on nicotine is considered a certain type of disease that leads to the inability to abstinence from smoking, even with understanding of its negative effects.

Contraindications

• hypersensitivity to the active or any of the excipients of Sopharma Tabex; - acute myocardial infarction; - unstable angina pectoris; - cardiac arrhythmia; - recent stroke (within 1 month before starting Sopharma Tabex); - atherosclerosis; - severe arterial hypertension; - pregnancy - period of breastfeeding; - age up to 18 years; - patients over 65 years of age; - lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome (Sopharma Tabex contains lactose).

Precautionary measures

With caution, Sopharma Tabex should be used in other forms of coronary artery disease (stable angina pectoris, asymptomatic (silent) myocardial ischemia, vasospastic angina, syndrome X (microvascular angina pectoris)), heart failure, high blood pressure, cerebrovascular disease, obliterating arterial diseases, hyperthyroidism , with peptic ulcer of the stomach, with diabetes mellitus, renal or hepatic insufficiency, with some forms of schizophrenia, with chromaffin tumors of the adrenal glands, gastroesophageal reflux disease, people with a long history of smoking and people over 40-45 years old. The use of Sopharma Tabex in patients with diseases listed in this leaflet, is possible only after consulting a doctor.

Use during pregnancy and lactation

Sopharma Tabex should not be used by women during pregnancy and while breastfeeding.

Dosage and administration

Tablets are taken orally as a whole, washed down with a sufficient amount of liquid. Do not exceed recommended doses. It is advisable to start taking Sopharma Tabex after setting the patient to a complete cessation of smoking.

Sopharma Tabex should be used according to the following scheme:

• from 1 to 3 days - 1 tablet 6 times/day every 2 hours, gradually reducing the number of cigarettes smoked. The tablet should be taken between smoking episodes to lengthen the intervals between smoking cigarettes in order to reduce their consumption as much as possible. The interval of reception every 2 hours must be respected. If it is not possible to reduce the daily consumption of cigarettes, treatment should be stopped and after 2-3 months you can start it again.

With a good effect, treatment is continued according to the following scheme:

• from 4 to 12 days of admission - 1 tablet 5 times/day, every 2.5 hours.
• from 13 to 16 days - 1 tablet 4 times/day, every 3 hours.
• from 17 to 20 days - 1 tablet 3 times/day, every 5 hours.
• from 21 to 25 days - 1-2 tablets per day.

It is strongly recommended to stop smoking no later than 5 days from the start of treatment. The combination of drug therapy with consultations, incl. with measures of psychological support for the patient, significantly increases the effectiveness of treatment.

Side effects

Conducted clinical studies and post-marketing observations show good tolerability of Sopharma Tabex. Observed adverse reactions are mild or moderate. Most of them occur at the beginning of treatment and go away on their own. Most often they are associated with quitting smoking and are manifested by dizziness, headache and insomnia. At the recommended doses, Sopharma Tabex does not cause serious adverse effects.

The following side reactions are possible:

Cardiovascular system: tachycardia, slight increase in blood pressure, palpitations.

Central nervous system: headache, dizziness, insomnia or drowsiness, irritability.

Respiratory system: shortness of breath.

Gastrointestinal tract: dry mouth, nausea, abdominal pain, constipation, diarrhea, changes in taste and appetite.

Musculoskeletal and connective tissue: muscle pain.

Metabolism and nutrition: weight loss, increased sweating.

Other: chest pain.

Overdose

Symptoms: nausea, vomiting, dilated pupils, general weakness, tachycardia, clonic convulsions, respiratory paralysis. Overdose symptoms occur when the patient does not comply with the dosing regimen and takes Sopharma Tabex in doses several times higher than the therapeutic ones. In case of overdose, you should immediately consult a doctor!

Treatment: taking activated charcoal, gastric lavage, infusion of water-salt solutions, as well as 5% or 10% glucose solution, anticonvulsants, cardiotonics, respiratory analeptics and other symptomatic agents. It is necessary to monitor the work of the respiratory system, blood pressure and heart rate.

Interaction with other drugs

After smoking cessation, the side effects of theophylline, ropinirole, clozapine and olanzapine may increase. With the simultaneous use of Sopharma Tabex with acetylcholine, carbachol, galantamine, pyridostigmine, rivastigmine, distigmine, cholinomimetic side effects may increase (salivation, lacrimation, bronchial secretion with cough and the risk of an asthma attack, pupillary constriction, colic, nausea, vomiting, frequent urination, increased muscle tone or sudden muscle contractions). The use of Sopharma Tabex simultaneously with lovastatin, simvastatin, fluvastatin, pravastatin, etc. increases the risk of muscle pain. Simultaneous use of Sopharma Tabex with antihypertensive drugs (propranolol, etc.) can weaken their effect.

Special instructions

Sopharma Tabex should be used only if the patient has a serious intention to stop smoking. For people with a long history of smoking and people over 40-45 years old, Sopharma Tabex should be used only after consulting a doctor. When using Sopharma Tabex should not exceed the recommended dose. Treatment with Sopharma Tabex and continued smoking can lead to increased side effects of nicotine (nicotine intoxication). Sopharma Tabex contains the excipient lactose. Patients with rare hereditary problems of galactose intolerance, the lactase deficiency (Lapp) or glucose-galactose malabsorption should not use Sopharma Tabex.