Lomilan tablets 10mg, No. 10

Prevention and treatment of the following diseases:

• seasonal and perennial allergic rhinitis;

• allergic conjunctivitis;

• treatment of allergic skin diseases (including chronic idiopathic urticaria);

• pseudo-allergic reactions;

• allergic reactions to insect bites.

Inside. May be taken with food.

The tablet can be chewed if necessary.

Drink with water, milk.

Adults and children over 12 years old:

10 mg once a day, i.e. 1 tablet or 2 dosing spoons (10 ml) of suspension

Children from 2 to 12 years old (or with a body weight of less than 30 kg): 5 mg once a day, i.e. 1 dosing spoon (5 ml) or 1/2 tablet. With a body weight of 30 kg or more - 10 mg - 2 dosage spoons (10 ml) or 1 tablet once a day.

For patients with impaired liver function or renal failure, the initial dose of the drug is 10 mg - 1 tablet or 2 dosage spoons of the suspension every other day.

For children under 12 years old, the use of a suspension is recommended.

One tablet contains:
Active ingredient: loratadine -10mg
Excipients: lactose, corn starch, gelatinized starch, magnesium stearate.

Suspension for oral administration
Active ingredient: loratadine - 5 mg / 5 ml.
Excipients: polysorbate 80, citric acid monohydrate, sodium citrate dihydrate, sodium benzoate, crystalline white sugar, avicel RC 591 FMC, wild cherry aroma, glycerol conc., Propylene glycol, purified water.

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

CAREFULLY:

It should be used in case of liver failure.
There are no data on the safety and efficacy of LomilanЃ in children under 2 years of age.

TRADE NAME OF THE PREPARATION

LOMILANЃ

INTERNATIONAL NON-PROPERTY NAME:

Loratadine

DOSAGE FORM:

Tablets
Oral suspension

COMPOSITION:

One tablet contains:

Active substance: loratadine -10mg

Excipients: lactose, corn starch, gelatinized starch, magnesium stearate.

Oral suspension

Active ingredient: loratadine - 5 mg / 5 ml.

Excipients: polysorbate 80, citric acid monohydrate, sodium citrate dihydrate, sodium benzoate, crystalline white sugar, avicel RC 591 FMC, wild cherry aroma, glycerol conc., Propylene glycol, purified water.

DESCRIPTION:

Tablets: round flat tablets of white or almost white color with a chamfer and a notch on one side.
Suspension for oral administration: a homogeneous suspension from white to almost white.

PHARMACOTHERAPEUTIC GROUP:
antiallergic agent - H1-histamine receptor blocker

ATX code: R06A X13

PHARMACOLOGICAL PROPERTIES:

Loratadine refers to antihistamines of systemic action, blockers of H1-histamine receptors. It has antiallergic, antipruritic, antiexudative effect. Reduces capillary permeability, prevents the development of tissue edema, relieves spasms of smooth muscles.
The antiallergic effect develops within 30 minutes after taking the drug, reaches a maximum after 8-12 hours and lasts 24 hours.
It has no effect on the central nervous system and is not addictive.

Pharmacokinetics:

Loratadine is rapidly and completely absorbed from the gastrointestinal tract. The presence of food slows down absorption. The maximum serum concentration is reached within 1 hour after ingestion. The connection with plasma proteins is more than 95%. It is metabolized in the liver to form an active metabolite of descarboethoxyloratadine. Does not penetrate the blood-brain barrier. The half-life is about 8 hours, in the elderly and in chronic alcoholism it increases. It is excreted in the bile and kidneys.
In chronic renal failure and hemodialysis, pharmacokinetics practically does not change.

INDICATIONS FOR USE:

Prevention and treatment of the following diseases:

• seasonal and perennial allergic rhinitis;

• allergic conjunctivitis;

• treatment of allergic skin diseases (including chronic idiopathic urticaria);

• pseudo-allergic reactions;

• allergic reactions to insect bites.

CONTRAINDICATIONS:

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

CAREFULLY:

It should be used in case of liver failure.
There are no data on the safety and efficacy of LomilanЃ in children under 2 years of age.

APPLICATION DURING PREGNANCY AND LACTATION:

The use of Lomilan during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. The drug is excreted in breast milk, therefore, when taking the drug during lactation, the issue of stopping breastfeeding should be decided.

DOSAGE AND APPLICATION:

Inside. May be taken with food.

The tablet can be chewed if necessary.

Drink with water, milk.

Adults and children over 12 years old:

10 mg once a day, i.e. 1 tablet or 2 dosing spoons (10 ml) of suspension

Children from 2 to 12 years old (or with a body weight of less than 30 kg): 5 mg once a day, i.e. 1 dosing spoon (5 ml) or 1/2 tablet. With a body weight of 30 kg or more - 10 mg - 2 dosage spoons (10 ml) or 1 tablet once a day.

For patients with impaired liver function or renal failure, the initial dose of the drug is 10 mg - 1 tablet or 2 dosage spoons of the suspension every other day.

For children under 12 years old, the use of a suspension is recommended.

SIDE EFFECT:

In adults: headache, dry mouth and drowsiness, fatigue, nausea, gastritis. Liver dysfunction, allergic reactions (rash), anaphylactic reactions, and alopecia are rare.
In children (rarely): headache, nervousness, sedation.
The incidence of these side effects with LomilanЃ was at the same level as with placebo.

OVERDOSE:

Symptoms: headache, drowsiness, palpitations, which can last for a long time. There is no specific antidote.
When taking an excess amount of LomilanЃ, the drug should be removed from the gastrointestinal tract as soon as possible and its absorption should be reduced if possible (gastric lavage, activated charcoal).

INTERACTIONS:
With the simultaneous use of ketoconazole and cimetidine, the concentration of loratadine in the blood increases. Concomitant use of inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, tricyclic antidepressants) reduces the effectiveness of loratadine.

SPECIAL INSTRUCTIONS:

The drug should be discontinued at least two days before the allergic skin tests, since LomilanЃ may affect their results.
There are no data on the negative effect of LomilanЃ in recommended doses on the ability to drive or work with mechanisms. At the same time, patients who exceed the dose of the drug or note non-standard effects when taking Lomilan should be careful when engaging in potentially hazardous activities that require increased concentration of attention and speed of reactions.

RELEASE FORM:

Tablets 10 mg: 10 tablets in a blister, 1, 2 or 3 blisters in a cardboard box with instructions for medical use; 7 tablets in a blister, 1 blister in a cardboard box with instructions for medical use,

Suspension for oral administration 5 mg / 5 ml: 120 ml in a dark glass bottle, 1 bottle each with a dosage spoon and instructions for medical use in a cardboard box.

STORAGE CONDITIONS:

Suspension for oral administration: at a temperature not exceeding 25 ? C, out of the reach of children.

Tablets: at a temperature not exceeding 25 ? —, in a dry, dark place, out of the reach of children.

SHELF LIFE:

4 years.
Do not use the drug after the date indicated on the package.

TERMS OF RELEASE FROM PHARMACIES:

Without recipe.