Loratadine tablet 10 mg x30
INSTRUCTIONS for medical use of the drug Loratadine Registration number: Trade name of the drug: Loratadine International nonproprietary name (INN): loratadine Dosage form: tablets Composition: each tablet contains: active substance: loratadine -10.0 mg, excipients: lactose monohydrate ( milk sugar) - 140.0 mg, microcrystalline cellulose - 36.0 mg, corn starch - 9.2 mg, sodium carboxymethyl starch - 3.0 mg, magnesium stearate - 1.8 mg. Description: Round flat-cylindrical tablets of white, or almost white, color, with a chamfer and a notch. Pharmacotherapeutic group: antiallergic agent - H1-histamine receptor blocker. CodeATX:a06AX13 Pharmacological action H1-histamine receptor blocker (long-acting). Suppresses the release of histamine and leukotriene C4 from mast cells. Prevents the development and facilitates the course of allergic reactions. It has antiallergic, antipruritic, antiexudative effects. Reduces capillary permeability, prevents the development of tissue edema, relieves spasms of smooth muscles. The antiallergic effect develops after 30 minutes, reaches a maximum after 8-12 hours and lasts 24 hours. It does not affect the central nervous system and is not addictive (because it does not penetrate the blood-brain barrier). Pharmacokinetics: Rapidly and completely absorbed from the gastrointestinal tract. The time to reach the maximum concentration is 1.3-2.5 hours, food intake slows it down by 1 hour. The maximum concentration in elderly people increases by 50%, with alcoholic liver damage - with an increase in the severity of the disease. Communication with plasma proteins - 97%. Metabolized in the liver to form the active metabolite descarboethoxyloratadine with the participation of cytochrome CYP3A4 isoenzymes and, to a lesser extent, CYP2B6. The equilibrium concentration of loratadine and metabolite in plasma is achieved on the 5th day. introduction. Does not penetrate the blood-brain barrier. The half-life of loratadine is 3-20 hours (average 8.4), the active metabolite is 8.8-92 hours (average 28 hours), in elderly patients, respectively - 6.7-37 hours (average 18.2 hours) and 11-38 hours (17.5 h). With alcoholic liver damage, the half-life increases in proportion to the severity of the disease. Excreted by the kidneys and through the intestines. In patients with chronic renal failure and during hemodialysis, the pharmacokinetics remain virtually unchanged. Indications for use Allergic rhinitis (seasonal and year-round), conjunctivitis, hay fever, urticaria (including chronic idiopathic), Quincke's edema, itchy dermatoses, pseudo-allergic reactions caused by the release of histamine, allergic reactions to insect bites. Contraindications Hypersensitivity. Pregnancy, lactation period, children under 3 years of age. With caution - liver failure. Directions for use and dosage: Inside. Adults and children over 12 years of age: 10 mg (1 tablet) 1 time per day. The daily dose is 10 mg. Children from 3 to 12 years old: 5 mg (1/2 tablet) 1 time per day. Daily dose 5 mg. Children weighing more than 30 kg - 10 mg of the drug once a day. The daily dose is 10 mg. Side effects The adverse events listed below occurred with a frequency of >.2% when using loratadine and approximately the same frequency as when using placebo (“dummy”). In adults: headache, fatigue, dry mouth, drowsiness, gastrointestinal disorders (nausea, gastritis), as well as allergic reactions in the form of a rash. In addition, there have been rare reports of anaphylaxis, alopecia, liver dysfunction, palpitations, and tachycardia. Rarely in children: headache, nervousness, sedation. Overdose Symptoms: drowsiness, tachycardia, headache. In case of overdose, consult a doctor. Treatment: induction of vomiting, gastric lavage, intake of activated charcoal. Interaction with other drugs Ethanol reduces the effectiveness of loratadine. Erythromycin, cimetidine, ketoconazole, when used together with loratadine, increase the concentration of loratadine in plasma, without causing clinical manifestations and without affecting the ECG. Inducers of microsomal oxidation (phenytoin, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce the effectiveness of loratadine. Special instructions During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Release form Tablets 10 mg. 10, 20, 25, 30, 40, 50 tablets in blister packs made of polyvinyl chloride film and printed varnished aluminum foil. 10, 20, 25, 30, 40, 50 or 100 tablets in jars made of polyethylene terephthalate for medicinal products or polypropylene for medicinal products, sealed with high-pressure polyethylene caps with first opening control, or polypropylene caps with “push-turn” system, or lids made of low-density polyethylene with first-opening control. One can or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 blister packs along with instructions for use are placed in a cardboard package (pack). Storage conditions: At a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life: 3 years. Do not use after expiration date. Conditions for dispensing from pharmacies Without a prescription.
Registration certificate holder and manufacturer RU holder: Ozon LLC, Legal address: 445351, Russia, Samara, , , , region, , , , , , , , , , , , Zhigulevsk, st. Pesochnaya, 11 Manufacturer responsible for quality control: Ozon LLC, Russia, Samara region, Zhigulevsk, st. , , Gidrostroiteley, D. 6. All consumer complaints should be sent to the representative of the holder of the registration , , , , , , , certificate: Ozon LLC 445351, Russia, , , , Samara, , , region, Zhigulevsk, , , st. . , , Gidrostroiteley, 6. Tel.: +79874599991, +79874599992 E-mail: ozо [email protected] ozо-pharm.ru , LSR-000019-0705YU MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION INSTRUCTIONS for the use of a medicinal product for medical use, ENT atadine name of the medicinal product tablets 10 mg dosage form, dosage Ozon LLC. Russia name of manufacturer, country Change No. 3 2310P Date of introduction Changes , , " , " , , 20 , , , , , Old edition , New edition , , , Release form Tablets 10 mg. , , , , 10 , , , , tablets , , , , in , , , , blister packs. 10, 20, 30, 40, 50 or 100 tablets in a polymer container for medicines or a glass bottle with screw-on plastic covers. One container (bottle) or 1, 2, 3, 4, 5, 6, 8 or 10 blister packs, together with instructions for use, are placed in a pack of cardboard. , , , 5, , , , , 10, , , or , , , 20, , , containers (bottles) or 20, 40, 60, 80 and 100, Release form Tablets 10 mg. 10, 20, 25, 30, 40, 50 tablets per blister pack. 10, 20, 25, 30, 40, 50 or 100 tablets in a polymer container for medicinal products or a bottle of , , , , , , , glass melts , , , , , , , with screw-on plastic caps. One container (bottle) or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 contour cell , , , , , packages , , , , , together with instructions , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , application is placed in a cardboard pack. , , , , 5, , , , , , 10, , , , or , , , , 20, , , , containers, LSR-000019-231014, blister packs together with a corresponding number of instructions for use are placed in a box of cardboard (for hospitals). , Change No. 3 to instructions C.2 (bottles) or 20, 40, 60, 80 and 100 blister packs together with the appropriate number of instructions for use are placed in a cardboard box. , , Director of Ozon LLC,
, MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION INSTRUCTIONS for the use of a medicinal product for medical use, . , Loratadine name of the medicinal product tablets 10 mg dosage form, dosage Ozon LLC. Russia name of manufacturer, country Change No. 4 2 *1 p O 1 C, 14.4.-^ ii^ch.11.1.” ^l.,^^.,,1,! , , , , , , » ,„ , , ,' , , » , , '1, 20, , , Old edition, New edition , , , By , , 10, , 20, , 25, , 30, , 40, , 50 , or , , 100 , films Composition: each tablet contains: active substance: loratadine - 10 mg, excipients: lactose (milk sugar) - 140.0 mg, sodium carboxymethyl starch 3.0 mg, corn starch - 9, 2 mg, microcrystalline cellulose - 36.0 mg, magnesium stearate - 1.8 mg. Release form Tablets 10 mg. 10, 20, 25, 30, 40, 50 tablets per blister pack. , Composition: each tablet contains: active substance: loratadine - 10 mg, excipients: lactose monohydrate (milk sugar) - 140.0 mg, sodium carboxymethyl starch - 3.0 mg, corn starch 9.2 mg, microcrystalline cellulose, , - , , 36.0 , , mg, magnesium stearate - 1.8 mg. Release form Tablets 10 mg. 10, 20, 25, 30, 40, 50 tablets in a blister pack made of polyvinyl chloride and 95765 tablets in a polymer container for medicines or a glass bottle with screw-on plastic caps. One container (bottle) or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 strip packaging along with instructions for use are placed in a cardboard pack. 5, 10 or 20 containers (bottles) or 20, 40, 60, 80 and 100 blister packs together with the appropriate number of instructions for use are placed in a cardboard box (for hospitals). Storage conditions Store in a dry, protected from light place at a temperature no higher than Change No. 4 to instructions C.2 printed varnished aluminum foil. 10, 20, 25, 30, 40, 50 or 100 tablets in polyethylene terephthalate cans for medicines, sealed with screw caps with first opening control or a “push-turn” system made of polypropylene or polyethylene or polypropylene cans for medicines products, sealed with tamper-evident pull-on lids made of polyethylene, or polypropylene jars for medicines, sealed with tamper-evident pull-on lids made of high-density polyethylene. One can or 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 blister packs along with instructions for use are placed in a cardboard package (pack). Storage conditions Store in a place protected from light, at a temperature not exceeding 95765, 25 °C. Keep out of the reach of children. Shelf life: 3 years. Do not use after expiration date. Legal address: 445351, Russia, Zhigulevsk, Samara, region, st. Pesochnaya, 11. Address , for , correspondence , (actual address , , in , , volume , , including , , for , , receiving claims): , 445351, , Russia, , , , , , Zhigulevsk, , , , , , Samara, , , , region, st. Hydrostroiteley, 6. Tel./fax: (84862) 3-41-09. , Change No. 4 to instructions С.З 25 °С. Keep out of the reach of children. Shelf life: 4, , , years. , , , Do not , , , use , , , after the expiration date. Legal address: 445351, Russia, Samara, , , , , region, , , , , , , Zhigulevsk, st. Pesochnaya, 11 Address of place of production (address for correspondence, including for receiving claims): , 445351, , Russia, Samara, , , , , , region, , , , , , , , , , , , Zhigulevsk, st. Gidrostroiteley, 6. Tel./fax: (84862)3-41-09, , Representative of Ozon LLC Alekhin,
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95765, LSR-000019-280307, G, Release form Tablets 10 mg. 10 tablets per blister pack. 10, 20, 30, 40, 50 or 100 tablets in a polymer container for medicines or a glass bottle with screw-on plastic caps. , , One container (bottle) or 1, 2, 3, 4, 5, 6, 8 or 10 blister packs along with instructions for use are placed in a cardboard pack. 5, 10 or 20 containers (bottles) or 20, 40, 60, 80 and 100 blister packs together with the corresponding number of instructions for use are placed in a cardboard box (for hospitals). Storage conditions Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life: 3 years. Do not use after expiration date. Conditions for dispensing from pharmacies Without a prescription. , Russia Legal address: 445351 Russia, Zhigulevsk, Samara region, st. Pesochnaya, 11. Tel. (84862) 3-07-09, 3-07-05. Address for correspondence (actual address, including for receiving claims): 445351 Russia, Zhigulevsk, Samara region, st. Hydrostroiteley, 6. Tel. (84862) 3-41-09. , , ,
Loratadine Farmland tablets 10 mg No. 10x1
Name
Loratadine tablet 10mg cont cell pack No. 10x1
Description
Tablets are white or white with a yellowish tint, flat-cylindrical, chamfered, with a score on one side.
Main active ingredient
Loratadine
Release form
pills
Dosage
10 mg
Indications for use
For the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
Directions for use and doses
Adults and children over 12 years old – 1 tablet (10 mg) 1 time per day. Children 5-12 years old weighing more than 30 kg - 1 tablet (10 mg) 1 time per day. Children 5-12 years old weighing less than 30 kg - ? tablets (5 mg) 1 time per day. For children 2-5 years old, the drug (5 mg) is prescribed in the form of syrup. The tablet dosage form is not recommended for children under six years of age. The effectiveness and safety of the drug in children under 2 years of age have not been established. In adults with impaired liver and kidney function (creatinine clearance less than 30 ml/min), the initial dose should be 1 tablet (10 mg) every other day. In children 2-5 years old with impaired liver and kidney function, the initial dose is 5 ml (in the form of syrup) every other day.
Use during pregnancy and lactation
The safety of loratadine in pregnant women has not been established, so the drug should be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus. Loratadine is excreted into breast milk, so use of the drug during breastfeeding is not recommended.
Precautionary measures
In adults with impaired liver and kidney function (creatinine clearance less than 30 ml/min), the initial dose should be 1 tablet (10 mg) every other day. In children 2-5 years old with impaired liver and kidney function, the initial dose is 5 ml (in the form of syrup) every other day. The tablet dosage form is not recommended for children under six years of age. It is recommended to discontinue treatment at least 1 week before performing a skin test for allergens. The drug contains lactose and is therefore not recommended for patients with rare hereditary cases of galactose intolerance, Lapp-lactase deficiency or glucose-galactase malabsorption.
Interaction with other drugs
With simultaneous use of the drug with ketoconazole, erythromycin, cimetidine, an increase in the concentration of loratadine in the blood plasma is observed, but without any clinical manifestations. Reduces plasma erythromycin levels by 15%. Does not potentiate the effect of alcohol on the central nervous system.
Contraindications
Hypersensitivity to the drug.
Compound
Active ingredient: loratadine – 10 mg Excipients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate, lactose monohydrate.
Overdose
In case of overdose, drowsiness, tachycardia, and headache may develop. In this case, it is necessary to rinse the stomach and administer activated charcoal.
Side effect
From the nervous system: headache, drowsiness, fatigue, in 2% or less - dizziness, nervousness, insomnia, anxiety, excitability (in children), fainting, depression, pain in the ears and eyes, tinnitus. Very rarely – convulsions. From the gastrointestinal tract: dry mouth, nausea, vomiting, dyspepsia, gastritis, constipation or diarrhea, taste disturbance. From the respiratory system: nasal congestion, sneezing, sinusitis, dry nose, cough, bronchitis, upper respiratory tract infections. From the genitourinary system: change in urine color, dysmenorrhea, vaginitis, decreased libido, impotence, very rarely - edema. Allergic reactions: hyperemia, urticaria, rash, itching. From the cardiovascular system: hypertension or hypotension, palpitations, tachycardia. Other: thirst, asthenia, malaise, chills, increased sweating, weight gain.
Storage conditions
In a place protected from moisture and light at a temperature not exceeding +25°C.
