Gistafen tablets 50mg №10×2

Name:
Histafen tablets 50mg in a cell. pack No. 10×2 The main active ingredient Sehifenadine Release form Tablets Composition Active ingredient: sechifenadine hydrochloride. One tablet contains 50 mg of sechifenadine hydrochloride (in terms of anhydrous substance). Excipients: lactose monohydrate, microcrystalline cellulose (E460), corn starch (E1422), magnesium stearate (E572), anhydrous colloidal silicon dioxide (E551).
Description:
Flat-cylindrical tablets of white or almost white color with a chamfer and a risk on one side of the tablet. Dosage 50 mg Pharmacological properties Pharmacodynamics The active substance of the drug – sechifenadine hydrochloride (hereinafter referred to as sechifenadine) is a blocker of histamine H1 receptors, also moderately blocks serotonin HT1 receptors, thus weakening the action of histamine and serotonin allergy mediators. Histamine causes clinical manifestations of allergic inflammation: edema (capillary permeability increases), skin hyperemia (vasodilation), skin itching and pain. The peculiarity of sechifenadine is that it has an antihistamine effect, not only blocking H1 receptors, but also reducing the content of histamine in tissues by accelerating its metabolism by the enzyme diamine oxidase, which breaks down endogenous histamine. In allergic diseases, the level of serotonin in the blood also increases. Serotonin increases blood pressure, causes bronchospasm, increases capillary permeability, enhances the action of inflammatory mediators – histamine, bradykinin, prostaglandins. Sehifenadine prevents or weakens the spasmodic effect of histamine and serotonin on the smooth muscles of the bronchi, intestines, blood vessels; intoxication caused by histamine and serotonin; violation of capillary permeability and the development of edema. Sekhifenadine has a pronounced antipruritic and antiexudative effect of a long-term nature. Sehifenadine affects the immunological reactivity of the body, reducing the number of antibody-forming and rosette-forming T-lymphocyte cells in the spleen, bone marrow, lymph nodes, and also reduces the increased concentration of class A and G immunoglobulins. CNS, however, in some cases, with individual hypersensitivity, a slight sedative effect is observed. When taking sechifenadine, there are no changes in the biochemical parameters of blood and urine, the drug does not affect blood pressure, electrocardiogram (ECG), blood sugar and cholesterol concentrations, and does not affect electroencephalogram parameters. Pharmacokinetics The drug is rapidly absorbed from the gastrointestinal tract. The maximum concentration of the active substance in the blood plasma is reached after 1-2 hours. The body accumulates mainly in the lungs, liver, the lowest concentration – in the brain. Sechifenadine is metabolized by oxidation, forming a pharmacologically inactive metabolite. After taking a single dose of 50 mg, the half-life of the active substance from blood plasma is 12 hours, and after repeated doses, the half-life is shortened to 5.8 hours, i.e. sechifenadine does not accumulate in the body. 50% of the dose is excreted from the body with bile, more than 20% – with urine. About 30% of the dose is excreted unchanged, 40-50% as metabolites. Data on the pharmacokinetics of the drug in elderly patients and patients with impaired liver and / or kidney function are not available. Indications for use Acute and chronic allergic diseases: hay fever, allergic rhinitis, rhinosinusopathy (atopic and infectious-allergic); allergic reactions associated with the use of medicines, foods, household chemicals. Allergic and other diseases accompanied by skin itching (allergic or atopic dermatitis, skin vasculitis, neurodermatitis, lichen planus). Prevention of allergic diseases (up to seasonal exacerbation) and maintenance therapy. Contraindications Hypersensitivity to the active substance or excipients of the drug, pregnancy and lactation, age up to 18 years. Simultaneous reception of MAO inhibitors. Use during pregnancy and lactation Use during pregnancy and lactation is contraindicated. The safety of the use of Gistafen tablets in pregnant women has not been studied. During lactation, the use of antihistamines is not recommended due to the possibility of adverse effects on the infant’s central nervous system. It is necessary to resolve the issue of stopping breastfeeding. Influence on the ability to drive vehicles Persons whose work requires a quick physical or mental reaction (for example, transport drivers) should first be established (by short-term appointment) whether the drug has a sedative or hypnotic effect. These people need to be careful. Dosage and administration Histafen tablets are taken orally after meals with water. Acute and chronic allergic diseases: adults: 50-100 mg 2-3 times a day. Usually the therapeutic effect occurs 1-3 days after the start of treatment. The duration of the course of treatment is 5-15 days. If necessary, the course of treatment is repeated. Prevention of allergic diseases (before seasonal exacerbation, maintenance therapy): adults, 50 mg 2 times a day. For prevention, it is recommended to start using the drug 2 weeks before the expected allergic reaction. Gistafen tablets can be combined with topical preparations (ointment, compress, eye drops, nasal drops). Features of the use of the drug in patients with impaired renal function Patients with impaired renal function should be careful and start treatment with a minimum dose of the drug (see also section Precautions). Features of the use of the drug in patients with impaired liver function There are no data on the need to reduce the dosage, however, caution should be exercised in this group of patients (see also section Precautions). Features of the use of the drug in elderly patients (under the age of 70 years) There are no data on the need to reduce the dosage in this group of patients, but a possible decrease in kidney and / or liver function should be taken into account. If a dose is missed, take the drug as soon as you remember it, but skip it if the next dose is approaching. Never take double doses. Side effectsThe tolerance of the drug is good. The frequency of side effects according to the MedDRA classification system (Medical Dictionary of Regulatory Terminology): Very common -? 1/10; Frequent – ?1/100 to <1/10; Infrequent -? 1/1000 to <1/100; Rare - ?1/10,000 to <1/1000; Very rare - <1/10,000; Unknown (cannot be determined from available data). Blood and lymphatic system disorders: rare - eosinophilic leukopenia. Nervous system disorders: frequent - drowsiness (average - 13.3%) - dose-dependent; at doses of Histafen 150 mg per day, drowsiness is observed in 1.97% of patients, with an increase in dose to 400 mg per day - in 24.6% of patients. In most cases, drowsiness decreases or disappears after 2-5 days from the start of treatment. Uncommon: headache. Rare - agitation, insomnia, which are more common with high doses of the drug. Disorders from the gastrointestinal tract: frequent - dry mouth - in 9.5% of patients. Infrequent - mild pain in the epigastrium, dyspeptic disorders in 2.4% of patients, especially when taking the drug on an empty stomach. In persons with chronic diseases of the gastrointestinal tract, the possibility of side effects increases. Side effects disappear in the first days of treatment and there is no need to discontinue the drug or significantly reduce the dose. Very rare - increased appetite. From the side of the kidneys and urinary tract: rare - a weak diuretic effect. From the reproductive system and breast diseases: rare - menstrual disorders. If you experience any side effects that are not listed in this leaflet, or any of the side effects mentioned are particularly pronounced, you should consult a doctor. Overdose The drug has low toxicity. No cases of overdose have been reported. Symptoms: dry mucous membranes, headache, vomiting, abdominal pain and other dyspeptic phenomena. Measures: carry out symptomatic therapy. The specific antidote is not known. Interaction with other drugsHistafen does not enhance the inhibitory effect of hypnotics and alcohol on the central nervous system. However, during the treatment period, you should refrain from drinking alcohol. Patients using MAO inhibitors are contraindicated in the use of antihistamines. Precautions Be careful with violations of kidney function (treatment starts with a minimum dose), severe diseases of the cardiovascular system, gastrointestinal tract, liver. Lactose. The tablet contains lactose. The drug should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption. Storage conditions Store in a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Gistafen tablets 50mg No. 10x2