Instruction for use: Lomilan

Dosage form: Tablets; suspension for oral administration

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

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

T78.4 Unspecified Allergy: Allergic reactions to insulin; Allergic reactions to insect stings; Allergic reactions similar to systemic lupus erythematosus; Allergic diseases; Allergic diseases of mucous membranes; Allergic diseases and conditions resulting from increased release of histamine; Allergic diseases of mucous membranes; Allergic symptoms; Allergic symptoms in the mucous membranes; Allergic reactions; Allergic reactions caused by insect bites; Allergic reactions; Allergic conditions; Allergic laryngeal edema; allergopathy; allergic conditions; Allergy; House dust allergy; Anaphylaxis; Cutaneous reactions to medications; Skin reaction to insect stings; Cosmetic allergy; Drug allergy; Acute allergic reaction; Laryngeal edema allergic genesis and background radiation; Food and drug allergy

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

Tablets - 1 table.

active substance: Loratadine 10 mg

Auxiliary substances: lactose - 71.3 mg; Corn starch - 15 mg; Gelatinized starch - 3 mg; Magnesium stearate - 0.7 mg

Suspension for oral administration 1 ml

active substance: Loratadine 1 mg

Auxiliary substances: polysorbate 80 - 1 mg; Citric acid monohydrate - 1.55 mg; Sodium citrate dihydrate - 0.6 mg; Sodium benzoate - 2 mg; White sugar crystalline - 300 mg; Avicel RC 591 FMC - 16 mg; Aroma of wild cherry - 2.5 mg; Glycerol concentrated - 70 mg; Propylene glycol 50 mg; Purified water - 690.313 mg

Description of dosage form

Tablets: round flat, white or almost white with a facet and a notch on one side.

Suspension for oral administration: homogeneous, from white to almost white.

Pharmachologic effect

Mode of action - anti-allergic, antihistamine.

Pharmacodynamics

Loratadin refers to antihistamines of systemic action, blockers of H1-histamine receptors. It has anti-allergic, antipruritic, anti-exsudative action. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasms of smooth muscles. The antiallergic effect develops 30 minutes after taking the drug, reaches a maximum after 8-12 hours and lasts for 24 hours.

Has no effect on the central nervous system and is not addictive.

Pharmacokinetics

Loratadine is rapidly and completely absorbed from the digestive tract. The presence of food slows down absorption. Cmax in the serum is achieved within 1 h after administration. The connection with plasma proteins is more than 95%. Metabolized in the liver with the formation of an active metabolite of descabroxetoxyloratadine.

Does not penetrate the BBB. T1 / 2 is about 8 hours, in the elderly and with chronic alcoholism increases. It is excreted with bile and kidneys.

With chronic renal failure and hemodialysis, the pharmacokinetics practically does not change.

Indication of the Lomilan

Prophylaxis and treatment of the following diseases and conditions:

Seasonal and year-round allergic rhinitis;

Allergic conjunctivitis;

Skin diseases of an allergic nature (including chronic idiopathic urticaria);

Pseudoallergic reactions;

Allergic reactions to insect bites.

Contraindications

Hypersensitivity to any of the components of the tablets or suspension.

Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

pregnancy;

Lactation period;

Children under 2 years (for suspension); 3 years (for tablets).

With caution: liver failure; Severe renal failure (Cl creatinine <30 mL / min).

Application in pregnancy and breastfeeding

The safety of Lomilan® during pregnancy is not established, so the use of the drug during this period is contraindicated. The drug is excreted in breast milk, so when taking the drug during lactation should resolve the issue of stopping breastfeeding.

Side effects

According to WHO, adverse reactions are classified according to their developmental frequency as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100) , Rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); The frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the side of the immune system: very rarely - anaphylactic reactions.

From the nervous system: often - headache, drowsiness, increased nervous excitability, increased fatigue; Infrequently - insomnia; Very rarely - dizziness.

From the CVS: very rarely - tachycardia, palpitations, syncope, arrhythmia.

From the digestive tract: infrequent - increased appetite; Very rarely - nausea, dry mouth, gastritis.

From the liver and biliary tract: very rarely - a violation of the liver.

From the skin: very rarely - allergic reactions (rash), alopecia.

In addition to the above reactions, children may develop a sedative effect. Undesirable effects from the CNS (headache, drowsiness, increased fatigue) occurred approximately at the same frequency as with the placebo ("pacifiers").

Interaction

Simultaneous reception of inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, tricyclic antidepressants) decreases the effectiveness of loratadine.

Possible interaction of the drug with inhibitors of cytochrome isoenzymes, such as CYP3A4 or CYP2D6 (ketoconazole, quinidine, itraconazole, erythromycin, fluoxetine), increases the concentration of Lomilan® in blood plasma, which can lead to increased side effects of the drug.

Dosing and Administration

Inside, squeezed with water or milk, you can take with food. If necessary, the tablet can be chewed.

Adults and children over 12 years old - 2 dosage spoons (10 ml) 1 time / day; Children from 2 to 12 years with a body weight of more than 30 kg - 2 dosage spoons (10 ml) 1 time / day; With a body weight of less than 30 kg - 1 dosage spoon (5 ml) 1 time / day.

Adults and children over 12 years old - 10 mg (1 table) 1 time / day; Children from 3 to 12 years with a body weight of more than 30 kg - 10 mg (1 table) 1 time / day; With a body weight of less than 30 kg - 5 mg (1/2 table) 1 time / day.

For patients with impaired hepatic function, a reduced daily dose of the drug to adults and children weighing more than 30 kg is 10 mg (2 dosage tablespoons of suspension or 1 tablet) every other day.

For children under 12 years of age, suspension is recommended.

The duration of treatment depends on the duration of the symptoms of the disease. If the patient's condition does not improve within 3 days of starting treatment, then loratadine is ineffective.

Elderly patients or with renal insufficiency do not need dose adjustment.

Patients with severe renal insufficiency (Cl creatinine <30 mL / min). In adults and children from the age of 6, the starting dose should be 10 mg (2 dosage tablespoons suspension or 1 table) every other day; In children from 3 years - 5 mg (1 metering spoon suspension or 1/2 table) every other day.

Overdose

Symptoms: headache, drowsiness, palpitation, which can last a long time.

Treatment: when taking an excess amount of Lomilan® it is recommended to rinse the stomach and prescribe an adsorbent (activated charcoal). There is no specific antidote. Lomilan® is not excreted by hemodialysis. To date, it is also unknown whether Lomilan® is excreted by peritoneal dialysis. After conducting emergency therapy, it is necessary to conduct medical supervision of the patient.

Special instructions

The drug should be discontinued no less than 2 days before the skin allergic tests, t. Lomilan® can influence their results.

Influence on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions. Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Special precautions for the destruction of unused medicinal product. There is no need for special precautions when destroying an unused Lomilan® preparation.

Release form

Tablets, 10 mg. By 7 or 10 tab. In the blister pack. 1 (7 or 10 tablets), 2 or 3 blisters (10 tablets each) in a cardboard bundle.

Suspension for oral administration, 5 mg / 5 ml. For 120 ml in a vial of dark glass, with a capacity of 125 ml with a ring mark (100 ml). The bottle is closed with a screw-on aluminum cap with a LDPE gasket and a control ring. On 1 fl. Together with a dosage spoon in a cardboard bundle.

Manufacturer

Sandoz d.d., Verovshkova 57, 1000, Ljubljana, Slovenia.

Produced: Lek dd, Verovshkova 57, 1526, Ljubljana, Slovenia.

Conditions of leave from pharmacies

Without recipe.

Storage conditions of the drug Lomilan

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Lomilan

4 years.

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