Instruction for use: Clargotil

Dosage form: Tablets

Active substance: Loratadinum

ATX

R06AX13 Loratadine

Pharmacological groups:

H1-antihistamines

The nosological classification (ICD-10)

H10.1 Acute atopic conjunctivitis: Allergic conjunctivitis; Allergic eye diseases; Allergic conjunctivitis; Allergic conjunctivitis caused by chemical and physical factors; Allergic rhinoconjunctivitis; Allergic inflammation of the eyes; Spring Qatar; Spring keratitis; Spring conjunctivitis; Conjunctivitis allergic; Year-round allergic conjunctivitis; Exacerbation of pollinosis in the form of rhinoconjunctival syndrome; Acute allergic keratoconjunctivitis; Acute allergic conjunctivitis; Superficial bacterial infection of the eyes; Rhinoconjunctivitis; Seasonal allergic conjunctivitis; Seasonal conjunctivitis; SENSORY; Chronic allergic keratoconjunctivitis; Chronic allergic conjunctivitis

J30 Vasomotor and allergic rhinitis: Allergic rhinopathy; Allergic rhinosinusopathy; Allergic diseases of the upper respiratory tract; Allergic rhinitis; Allergic rhinitis seasonal; Vasomotor runny nose; Prolonged allergic rhinitis; All-year-round allergic rhinitis; All-year allergic rhinitis; Year-round or seasonal allergic rhinitis; All-the-year-round rhinitis of an allergic nature; Rhinitis vasomotor allergic; Exacerbation of pollinosis in the form of rhinoconjunctival syndrome; Acute allergic rhinitis; Edema of the nasal mucosa; Edema of the nasal mucosa; Edema of the mucous membrane of the nasal cavity; Swelling of the nasal mucosa; Swelling of the nasal mucosa; Pollinosis; Permanent allergic rhinitis; Rhinoconjunctivitis; Rhinosinusitis; Rhinosinusopathy; Seasonal allergic rhinitis; Seasonal allergic rhinitis; Hay rhinitis; Chronic allergic rhinitis; Allergic diseases of the respiratory tract

L20 Atopic dermatitis: Allergic diseases of the skin; Allergic skin disease noninfectious etiology; Allergic skin disease etiology nemikrobnoy; Allergic skin diseases; Allergic skin lesions; Allergic reactions on the skin; atopic dermatitis; Allergic dermatosis; Allergic diathesis; Allergic itching dermatosis; Allergic skin disease; Allergic skin irritation; allergic Dermatitis; atopic Dermatitis; allergic dermatoses; exudative diathesis; Itchy atopic eczema Itchy allergic dermatosis; Allergic skin disease; Cutaneous allergic reaction to drugs and chemicals; Cutaneous reactions to medications; Skin and allergic disease; Acute eczema; common neurodermatitis; Chronic atopic dermatitis; Exudative diathesis

L23 Allergic contact dermatitis: Allergic dermatitis;Purulent allergic dermatopathies; Contact allergic reaction; Contact allergic dermatitis; Contact allergic dermatitis; Photoallergic contact dermatitis

L29 Itching: Itching with partial obstruction of the biliary tract; Dermatitis itchy; Dermatosis with persistent itching; Other itching dermatoses; Itching dermatoses; Itching allergic dermatosis; Itching dermatitis; Itching dermatosis; Itching itch; Excruciating itching; Severe itching; Endogenous itching; Skin itching with dermatosis; Restricted itchy dermatitis; Itching of the skin; Itchy scalp; Itching eczema

L50 Urticaria: Idiopathic chronic urticarial; Injury Urticaria; Chronic urticarial; Hives of the newborn

T78.3 Angioedema: Edema Quincke; Laryngeal exacerbation with angioneurotic edema; Recurrent angioedema; Allergic edema; Recurrent swelling of Quincy

W57 Bite or sting with a non-toxic insect and other non-venous arthropods: An allergic reaction to insect bites; Skin reaction after insect bite; Reactions to insect bites; Mosquito bite; Bite of bloodsucking insects; A bite of an insect; The bite of the wasp

Composition and release form

Tablets - 1 table.

Loratadine 10 mg

Auxiliary substances: MCC; Lactose monohydrate; Aerosil; Magnesium stearate

In contour acheikova packing 10 pcs .; In a pack of cardboard 1 package.

Description of dosage form

Tablets of white color, flat-cylindrical, on one side with an engraving "L" above the risk.

Pharmachologic effect

Mode of action - antiallergic, antipruritic, antiexudative.

Pharmacodynamics

Loratadin - prevents development and facilitates the course of allergic reactions. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasms of smooth muscles.

The antiallergic effect of the drug develops 30 minutes after ingestion, reaches a maximum after 8-12 hours and lasts for 24 hours. Clargotil does not affect the central nervous system (because it does not penetrate the BBB) and is not addictive.

Pharmacokinetics

When ingested, the drug is rapidly absorbed from the digestive tract, food intake slows the time to reach Cmax for 1 hour. It is metabolized in the liver by the cytochrome P450 system with the formation of an active metabolite, dexarboethoxyloratadine. Loratadine binds to plasma proteins by 97-99%.

Cmax loratadine and its active metabolite in blood plasma is achieved 1-2.5 hours after administration, in older people Cmax increases by 50%, with alcoholic liver damage - with increasing severity of the disease. The average T1 / 2 loratadine is 8 hours (increases with alcoholic liver damage, with increasing severity of the disease), descarbonethoxyloratadine - about 28 hours. Loratadin is excreted by the kidneys and with bile.

In patients with chronic renal failure and hemodialysis, the pharmacokinetics practically does not change.

Indications for the Clargotil

Seasonal and all-the-year-round allergic rhinitis, conjunctivitis (to eliminate symptoms - sneezing, itching of the nasal mucosa, rhinorrhea, sensation of itching and burning eyes).

Hives (including chronic idiopathic).

Allergic itching dermatosis and other skin diseases of allergic origin in adults and children aged 2 years, pseudoallergic reactions, allergic reactions to insect bites, itching of various etiologies. Allergic conjunctivitis, pollinosis, angioedema.

Contraindications

Hypersensitivity to the drug or its components. Pregnancy, lactation.

With caution - liver failure.

Application in pregnancy and breastfeeding

When pregnancy and lactation should refrain from using Clargotila.

Side effects

From the side of the nervous system: rarely - fatigue, anxiety, agitation (in children), dizziness, headache, asthenia, drowsiness, blepharospasm, dysphonia, hyperkinesia, paresthesia, tremor, amnesia, depression.

From the skin and subcutaneous fat: dermatitis.

On the part of the genitourinary system: rarely - a change in the color of urine, painful urge to urinate, dysmenorrhea, menorrhagia, vaginitis.

From the side of metabolism: rarely - weight gain, sweating, thirst.

On the part of the musculoskeletal system: in single cases - cramps calf muscles, arthralgia, myalgia.

From the digestive system: rarely - nausea, vomiting, dry mouth, taste change, anorexia, constipation or diarrhea, dyspepsia, gastritis, flatulence, increased appetite, stomatitis.

From the respiratory system: rarely - cough, bronchospasm, dry nasal mucosa, sinusitis.

From the senses: rarely - visual impairment, conjunctivitis, pain in the eyes and ears.

From the cardiovascular system: a decrease or increase in blood pressure, rarely - a heartbeat.

Allergic reactions: rarely - hives, itching, photosensitivity, in isolated cases - angioedema.

Other: in some cases, possible - back pain, chest pain, fever, chills, pain in the mammary glands.

Interaction

Clargotil does not enhance the effect of alcohol. Erythromycin, ketoconazole, cimetidine when used together with Clargotil increase the concentration of loratadine in blood plasma, but this does not manifest itself clinically, incl. According to the ECG. Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) decrease the effectiveness of loratadine.

Dosing and Administration

Inside, not less than 1 hour before meals, without chewing, squeezed a small amount of water.

For adults, incl. Elderly, and children 12 years of age, the recommended dose of Clargotil is 10 mg (1 table) once a day.

For children aged 2 to 12 years, a body weight of less than 30 kg is 5 mg Clargotila (0.5 tablets) once a day. With a body weight of more than 30 kg - 10 mg (1 table) 1 time per day.

With liver failure, the initial dose is 5 mg / day.

Overdose

Symptoms: when taking the drug in doses that are significantly higher than recommended, there may be headache, drowsiness, tachycardia.

Treatment: necessary symptomatic measures (emetics, gastric lavage, laxatives, activated charcoal). Clargotil is not excreted from the body during hemodialysis, peritoneal dialysis is ineffective.

Special instructions

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions. On the psychophysical activity and the ability to drive vehicles, the use of the drug in the recommended doses does not affect.

Manufacturer

CJSC Gedeon Richter-RUS.

Storage conditions of the drug Clargotil

At a temperature not higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Clargotil

3 years.

Do not use after the expiry date printed on the package.