Product Description
Tabex is a medicinal product in tablet form designed to help individuals quit smoking without experiencing the typical symptoms of nicotine withdrawal. Tabex gradually reduces the dependence of a nicotine-addicted individual on the substance in the body, facilitating permanent cessation of nicotine-containing products.
Product Description
Tabex is a medicinal product in tablet form designed to help individuals quit smoking without experiencing the typical symptoms of nicotine withdrawal. Tabex gradually reduces the body’s dependence on nicotine, facilitating permanent cessation of nicotine-containing products.
Indications
Treatment of nicotine addiction.
Composition
Each tablet contains:
Active substance: cytisine 1.5 mg
Excipients: lactose monohydrate, microcrystalline cellulose, talc, magnesium stearate; coating composition (Opadry II): polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, black iron oxide.
Pharmacological Action
Gradual reduction of the body’s dependence on nicotine in smokers.
Dosage and Administration
Always use the product exactly as described in the patient leaflet or according to the instructions of a physician or pharmacist. If in doubt, consult a doctor or pharmacist. Tablets should be taken orally with a sufficient amount of water according to the following schedule:
Treatment Days:
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Days 1–3: 1 tablet every 2 hours, maximum 6 tablets per day
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Days 4–12: 1 tablet every 2.5 hours, maximum 5 tablets per day
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Days 13–16: 1 tablet every 3 hours, maximum 4 tablets per day
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Days 17–20: 1 tablet every 5 hours, maximum 3 tablets per day
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Days 21–25: 1–2 tablets per day, maximum 2 tablets
The smoker should completely stop smoking by the fifth day of treatment at the latest. Once smoking cessation is achieved, not even a single cigarette should be smoked to ensure the durability of the treatment effect. If the therapy outcome is unsatisfactory, treatment should be discontinued and restarted after 2–3 months.
Contraindications
Do not take Tabex in the following cases:
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Hypersensitivity to cytisine or any other ingredients of the product
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Unstable angina pectoris
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Recent myocardial infarction
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Clinically significant cardiac arrhythmias
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Recent cerebrovascular accident (stroke)
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Pregnancy and breastfeeding
Storage
Store below 25°C. Keep in the original package to protect from moisture. Store in a place out of sight and reach of children. Do not use after the expiry date indicated on the package (expiry date refers to the last day of the specified month).
Side Effects
As with any medication, Tabex may cause side effects, although not everyone experiences them.
Common to mild/moderate side effects may include:
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Gastrointestinal disorders: dry mouth, abdominal pain, nausea, vomiting, taste changes, constipation, diarrhea, bloating, burning sensation on the tongue, heartburn, excessive salivation
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Increased appetite, weight gain, irritability
Other possible effects include:
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Fatigue, malaise, drowsiness
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Tearing of the eyes
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Increased or decreased heart rate
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Elevated blood pressure
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Headache, dizziness
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Sleep disturbances (insomnia, drowsiness, unusual dreams, nightmares)
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Mood changes, anxiety
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Difficulty concentrating
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Reduced libido
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Shortness of breath
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Increased expectoration
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Muscle pain
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Rash
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Increased sweating
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Reduced skin elasticity
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Increased liver enzyme activity
These side effects typically occur during the initial phase of treatment and usually resolve with continued use. Some effects may result from nicotine withdrawal rather than the medication itself.
Interactions
Inform your doctor or pharmacist about all medications currently or recently taken, as well as any medications planned for use. Tabex should not be taken concomitantly with anti-tuberculosis drugs.
Warnings and Precautions
Use Tabex with caution in patients with:
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Ischemic heart disease
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Heart failure
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Hypertension
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Pheochromocytoma
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Atherosclerosis
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Peptic ulcer disease
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Gastroesophageal reflux disease
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Hyperthyroidism
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Diabetes
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Certain forms of schizophrenia
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Renal or hepatic impairment
Due to limited experience, use in patients over 65 years is not recommended. Tabex should only be used by individuals seriously motivated to quit smoking. Continuing to smoke while taking Tabex may increase nicotine-related side effects.
Use in Children and Adolescents
Not recommended for individuals under 18 years of age due to limited clinical experience.
Pregnancy and Breastfeeding
Tabex is contraindicated during pregnancy and breastfeeding. Women who are pregnant, suspect pregnancy, plan pregnancy, or are breastfeeding should consult a doctor before using Tabex.
Driving and Operating Machinery
Tabex has no influence on the ability to drive or operate machinery.
Tabex Contains Lactose
Each tablet contains 28 mg of lactose. Patients with a known intolerance to certain sugars should consult a doctor before taking this medicine.
