Lomilan, tablets 10 mg 7 pcs

Lomilan is an antihistamine, anti-allergic.

Pharmacodynamics

Loratadine refers to antihistamines of systemic action, blockers of H₁-histamine receptors.

Loratadine has anti-allergic, antipruritic, antiexudative action. It reduces capillary permeability, prevents the development of tissue edema, relieves spasms of smooth muscles. Antiallergic effect shall develop within 30 minutes after the drug intake, it reaches its maximum effect after 8-12 hours and lasts for 24 hours.

It does not affect CNS and is not addictive.

Pharmacokinetics

Loratadine is quickly and completely absorbed from the gastrointestinal tract. The presence of food slows absorption.C_max in serum is reached within 1 h after ingestion. Binding to plasma proteins is more than 95%. It is metabolized in the liver with the formation of the active metabolite descarboethoxyloratadine.

It does not penetrate through the HEB. T_1/2 is about 8 h, increases in the elderly and in chronic alcoholism. It is excreted with the bile and the kidneys.

In chronic renal failure and hemodialysis the pharmacokinetics are virtually unchanged.

Indications

Prevention and treatment of the following diseases and conditions:

seasonal and year-round allergic rhinitis;
allergic conjunctivitis;
allergic skin diseases (including chronic idiopathic urticaria);
pseudoallergic reactions;
allergic reactions to insect bites.

Pharmacological effect

Lomilan – antihistamine, antiallergic.

Pharmacodynamics

Loratadine is a systemic antihistamine, a H1-histamine receptor blocker.

It has antiallergic, antipruritic, antiexudative effects. Reduces capillary permeability, prevents the development of tissue edema, and relieves spasms of smooth muscles. The antiallergic effect develops 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 quickly and completely absorbed from the gastrointestinal tract. The presence of food slows down absorption. Cmax in serum is achieved within 1 hour after administration. Communication with plasma proteins is more than 95%. Metabolized in the liver to form the active metabolite descarboethoxyloratadine.

Does not penetrate the BBB. T1/2 is about 8 hours, and increases in older people and chronic alcoholism. Excreted with bile and kidneys.

In chronic renal failure and hemodialysis, the pharmacokinetics remain virtually unchanged.

Special instructions

Taking the drug should be stopped at least two days before skin allergy tests, since Lomilan® may affect their results.

Special precautions when disposing of unused medicinal product

There is no need for special precautions when disposing of unused Lomilan®.

Impact on the ability to drive vehicles. Wed and fur.:

Active ingredient

Loratadine

Composition

One tablet contains:
active substance: loratadine – 10.00 mg;
excipients:
lactose – 71.30 mg;
corn starch – 15.00 mg;
gelatinized starch – 3.00 mg;
magnesium stearate – 0.70 mg.

Pregnancy

The safety of using Lomilan® during pregnancy has not been established; therefore, the use of the drug during this period is contraindicated.

Lomilan® is excreted into breast milk; therefore, if it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided.

Contraindications

Hypersensitivity to any of the components of the tablets or suspension.
lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
pregnancy;
lactation period;
children under 2 years of age (for suspension); 3 years (for tablets).

With caution: liver failure; severe renal failure (Cl creatinine

Side Effects

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development 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); frequency unknown - based on available data, it was not possible to determine the frequency of occurrence.

From the immune system: very rarely: hypersensitivity reactions (including angioedema and anaphylactic reactions).

From the nervous system often: headache, drowsiness, increased nervous excitability, increased fatigue; uncommon: insomnia; very rarely: dizziness, convulsions.

From the cardiovascular system: very rare: tachycardia, rapid heartbeat, syncope, arrhythmia.

Gastrointestinal tract disorders: uncommon: increased appetite; very rare: nausea, dry mouth, gastritis.

From the liver and biliary tract very rarely: impaired liver function.

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

In addition to the above reactions, children may develop a sedative effect.

Adverse effects from the central nervous system (headache (27%), nervousness (23%) and fatigue (1%)) were detected more often than when taking placebo (“dummy”).

Interaction

Concomitant use of microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, tricyclic antidepressants) reduces 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 the blood plasma, which can lead to increased side effects of the drug.

Overdose

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

Treatment: when taking an excessive amount of Lomilan®, it is recommended to rinse the stomach and prescribe an adsorbent (activated carbon). There is no specific antidote. Lomilan® is not eliminated by hemodialysis. To date, it is also unknown whether Lomilan® is eliminated by peritoneal dialysis. After emergency treatment, it is necessary to monitor the patient medically.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

4 years

Manufacturer

Lek d.d., Slovenia