Allercaps capsules 10mg №10×2

Name:
Allercaps caps.10mg in a cell. pack No. 10×2
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Capsules hard gelatin cylindrical shape with hemispherical ends of white color (capsules with a dosage of 5 mg). Capsules hard gelatin cylindrical shape with hemispherical ends, green cap and white body (capsules with a dosage of 10 mg). The main active ingredient Cetirizine Form of release capsules Dosage 10 mg Indications for use Alpercaps is indicated for the treatment in adults and children aged 6 years and older: symptoms of seasonal and persistent allergic rhinitis and conjunctivitis (the maximum duration of treatment for seasonal allergic rhinitis in children is 4 weeks); symptoms of chronic idiopathic urticaria. Dosage and administration Alpercaps is administered orally. Adults: The recommended dose is 1 10 mg capsule once a day, preferably in the evening. Children and adolescents: Children aged 12 years and over: The recommended dose is 1 10 mg capsule once daily, preferably in the evening. Children aged 6 to 12 years: The recommended dose is 1 capsule of 5 mg 2 times a day in the morning and evening. With seasonal rhinitis and allergic conjunctivitis – the maximum duration of the drug is 4 weeks. In children aged 2 to 6 years, an adequate dose is recommended in the form of drops. The efficacy and safety of cetirizine in children under 2 years of age has not been established. Special Patient Populations: Elderly: Based on available data, age is not a reason to reduce the dose if renal function is normal. The need for dose adjustment may occur with impaired renal function in elderly patients (see section “Patients with impaired renal function”). Patients with impaired renal function: The dose of the drug should be selected individually, taking into account renal function. The table below helps you select the correct dose. To use this table, it is necessary to determine the creatinine clearance (CC) in ml/min. To do this, it is necessary to determine the level of serum creatinine and calculate the CC using the following formula: CC = 140-age (years)? body weight (kg)? 0.85 (in women) 72? creatinine concentration (mg / dl) Patients with impaired function liver Patients with only impaired liver function do not need dose adjustment. Patients with impaired liver and kidney function Dose adjustment is recommended. Method of application For oral administration. The capsules should be taken with a glass of liquid, with or without food. If you forget to take an Allercaps capsule, it is important that you take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. Use during pregnancy and lactation Pregnancy There are very rare clinical observations of exposure to cetirizine during pregnancy. Experimental studies in animals have not revealed any direct or indirect effects that adversely affect pregnancy, embryo/fetal development, childbirth or postnatal development (see “Preclinical safety studies”). There is no data on the potential risk to humans. During pregnancy, the drug should be administered with caution. Breast-feeding The drug should not be administered to lactating women, as cetirizine passes into breast milk. Precautions At therapeutic doses, no clinically significant interaction with alcohol has been identified (for a blood alcohol level of 0.5 g / l), however, care should be taken when taking the drug together with alcohol; should be used with caution in patients with epilepsy and those at risk of developing seizures; for patients with impaired renal function, the dosage of the drug should be selected individually (see section “Method of application and doses”); in elderly patients, impaired renal function is possible, in such cases it is necessary to adjust the dose of the drug; should be used with extreme caution in patients prone to urinary retention (eg, with lesions of the medulla oblongata, prostatic hyperplasia), since cetirizine may increase the risk of urinary retention; since cetirizine can cause severe drowsiness, caution should be exercised when combined with alcohol or drugs that inhibit the nervous system. The drug “Alpercaps”, capsules 10 mg contains dyes E-133 and E-104, which can cause allergic reactions. Children and adolescents The use of capsules is not recommended in children under 6 years of age, since this form of the drug does not allow for an adequate dosage; The efficacy and safety of cetirizine in children under 2 years of age has not been established. Interactions with other drugs Based on the pharmacokinetics, pharmacodynamics and tolerability profile of the drug, interactions of this drug with other medicinal products are not expected. In interaction studies, no pharmacodynamic or significant pharmacokinetic interactions were observed with pseudoephedrine, theophylline (400 mg/day), cimetidine, ketoconazole, erythromycin, or azithromycin. According to the results of in vitro studies, cetirizine does not affect the binding of warfarin to blood proteins. Co-administration with erythromycin, azithromycin, ketoconazole, theophylline or pseudoephedrine did not reveal significant changes in laboratory parameters, vital signs and ECG. In one study, the co-administration of theophylline (400 mg/day) and cetirizine (20 mg/day) caused a slight but statistically significant increase in the AUC24 of cetirizine (by 19%) and theophylline (by 11%) and Cmax of cetirizine (by 7.7 %) and theophylline (by 6.4%). At the same time, in individuals who first received theophylline, with a subsequent combination with cetirizine, a decrease in cetirizine clearance by 16% and theophylline clearance by 10% was observed. However, in individuals who initially received cetirizine, the subsequent addition of theophylline did not cause significant changes in the pharmacokinetic parameters of theophylline. A single dose of cetirizine 10 mg did not cause a significant increase in the effect of alcohol (0.8%). A clinically significant interaction was observed with diazepam 5 mg, but only in one of the 16 psychometric tests used. Simultaneous use of 10 mg / day. cetirizine with glipizide caused a slight, clinically insignificant decrease in glucose levels. However, it is recommended to take these drugs separately – glipizide in the morning, 3 cetirizine in the evening. Eating does not reduce the absorption of cetirizine, although the rate of absorption decreases. In a study with repeated doses of ritonavir (600 mg twice daily) and cetirizine (10 mg once daily), ritonavir exposure was increased by approximately 40%, while cetirizine exposure was only slightly altered (11%). Antihistamines inhibit allergic skin reactions during tests. Therefore, the drug should be discontinued at least 3 days before an allergic skin test. Contraindications Contraindications for use are: Hypersensitivity to the active substance, any other component of the drug listed in the “Composition” section, to hydroxyzine or piperazine derivatives; severe renal dysfunction if creatinine clearance <10 ml / min; since Alpercaps contains lactose monohydrate, it should not be prescribed to patients with rare hereditary disorders of galactose tolerance, hereditary lactose deficiency of the Saami or glucose-galactose malabsorption syndrome; during pregnancy; when breastfeeding, tk. cetirizine passes into breast milk; in children under 6 years of age; with severe renal impairment. Influence on the ability to drive a car, work with machinery Cetirizine can cause severe drowsiness, so Alpercaps can affect the ability to drive vehicles and work with mechanisms. One capsule contains: active substance - cetirizine dihydrochloride - 5 mg or 10 mg. Excipients: magnesium stearate, potato starch, lactose. The composition of the capsule shell for a dosage of 5 mg: gelatin, glycerin, sodium lauripsulfate, purified water, titanium dioxide. The composition of the capsule shell for a dosage of 10 mg: gelatin, glycerin, sodium lauryl sulfate, purified water, titanium dioxide, dyes brilliant blue E-133 and quinoline yellow E-104. Overdose Symptoms of overdose Symptoms observed with an overdose of cetirizine are usually associated with its effect on the central nervous system or with effects suggestive of anticholinergic activity. The following adverse reactions have been reported after taking a dose of cetirizine 5 times the recommended daily dose: confusion, diarrhea, dizziness, fatigue, feeling unwell, mydriasis, pruritus, restlessness, sedation. Drowsiness, stupor, tachycardia, tremor and urinary retention. Treatment There is no specific antidote for cetirizine. In case of overdose, symptomatic and supportive therapy is recommended. Gastric lavage may only make sense if the drug was taken shortly before. Hemodialysis is not effective in removing cetirizine. Side effects According to clinical studies, cetirizine at all recommended doses can cause only minimal adverse reactions from the central nervous system, such as drowsiness, fatigue, dizziness and headache. In some cases, paradoxical stimulation of the CNS was observed. Despite the fact that cetirizine is a selective peripheral H1 receptor antagonist, and has relatively no anticholinergic activity, urinary disorders, visual accommodation and dry mouth have been observed in isolated cases. There have been cases of abnormal liver function with an increase in the level of liver enzymes with an accompanying increase in the level of bilirubin. In most cases, these changes resolve when treatment with cetirizine dihydrochloride is discontinued. Clinical studies In double-blind controlled clinical or pharmacoclinical studies of cetirizine compared with placebo or other antihistamines at the recommended doses (for cetirizine this was 10 mg/day), for which quantitative safety data are available, 3200 patients were included receiving cetirizine . Children and adolescents Adverse reactions observed with a frequency of 1% or more in clinical or pharmacoclinical studies in children aged 6 months to 12 years are listed below: In addition to the above adverse reactions observed during clinical studies, in some isolated cases in post-marketing period, the following adverse reactions were noted. A rough estimate of the frequency of these less frequently observed adverse effects was made on the basis of experience with the use in the post-marketing period. Adverse reactions are listed below by frequency and system organ class: very common (>1/10), frequent (?1/100 – <1/10), infrequent (?1/1000 - <1/100), rare (? 1/10,000 - <1/1,000): Blood and lymphatic system disorders Very rare: thrombocytopenia. Immune system disorders Rare: hypersensitivity. Very rare: anaphylactic shock. Metabolic and nutritional disorders Frequency unknown: increased appetite. Psychiatric disorders Uncommon: agitation. Rare: aggression, confusion, depression, hallucinations, insomnia. Very rare: teak. Frequency unknown: Suicidal thoughts. Nervous system disorders Uncommon: paresthesia. Rare: convulsions, movement disorders. Very rare: taste disturbances, syncope, tremor, dystonia, dyskinesia. Frequency unknown: numbness, amnesia, memory impairment. Visual disturbances Very rare: disturbance of visual accommodation, blurred vision, oculogyric syndrome. Frequency unknown: vasculitis. On the part of the organ of hearing and labyrinth disorders Frequency unknown: dizziness of the central type (vertigo). Cardiac disorders Rare: tachycardia. Gastrointestinal disorders Uncommon: diarrhea. Liver and biliary tract disorders Rare: changes in liver function (increased transaminases, alkaline phosphatase, ?-HT and bilirubin). Skin and subcutaneous tissue disorders Uncommon: itching, rash. Rare: urticaria. Very rare: angioedema, fixed erythema (reaction that occurs in the same place). Renal and urinary disorders Very rare: dysuria, enuresis. Frequency unknown: urinary retention. General disorders and disorders at the injection site Uncommon: asthenia, feeling unwell. Rare: edema. Influence on the results of laboratory and instrumental studies: Rare: weight gain. If any of the listed side effects occur, or if any side effects are not mentioned in the package leaflet, you should consult a doctor. Storage conditions Store in a place protected from moisture and light at a temperature of 15°C to 25°C. Store out of the reach of children. Buy Allercaps capsules 10mg No. 10x2 Price for Allercaps capsules 10mg No. 10x2