Loragesal, tablets 10 mg 10 pcs

Loragesal (loratadine) is a H₁-antihistamine drug with no central and anticholdinergic action.

When taken orally, the drug is well absorbed from the gastrointestinal tract. Absorption of the drug is not dependent on food intake.

The action of the drug starts 30 minutes after taking one tablet and lasts for 24 hours.

Loratadine is metabolized in the liver to form the active metabolite descarbotoxyloratadine.

The maximum concentrations of loratadine and its active metabolite in blood plasma are reached 1.3 – 2.5 hours after taking one tablet of Loragesal. Loragexal does not cause drowsiness and does not affect psychomotor functions, attention, performance, mental abilities.

Indications

For the treatment of seasonal and year-round rhinitis, conjunctivitis, pollinosis, urticaria, Quincke’s edema, pseudoallergic reactions, itchy dermatosis, allergic reactions to insect bites.

Active ingredient

Composition

Active substance:

Loratadine 10 mg;

Ancillary substances:

Lactose monohydrate, 69.175 mg;

Corn starch, 18 mg;

Colloidal anhydrous silica – 1.825 mg;

Magnesium stearate – 1 mg

How to take, the dosage

Orally, regardless of the time of meals.

Adults, including elderly persons and adolescents over 12 years of age are recommended to take the drug Logakesal® in dose of 10 mg (1 tablet) once daily. When using the drug in elderly patients and in patients with chronic renal Instruction for use of the drug for medical use of Loragesal® deficiency no dose adjustment is required.

In children aged 3 to 12 years with body mass more than 30 kg – 10 mg (1 tablet) once a day. In adults and children with body weight over 30 kg with severe liver dysfunction the initial dose should be 10 mg (1 tablet) once a day.

Interaction

Special Instructions

Contraindications

Hypersensitivity to any of the ingredients of the drug.

Side effects

In clinical trials with adults and adolescents in a number of indications, including allergic rhinitis and chronic idiopathic urticaria, adverse events observed more frequently than placebo (“pacifier”) were observed in 2% of patients taking Loragesal® at the recommended dose of 10 mg daily. The following most frequent adverse events were observed more frequently than in the placebo group: somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). According to the World Health Organization (WHO), adverse reactions were classified according to their frequency of occurrence as follows: very common (≥1/10), common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000) and very rare (< 1/10000); frequency unknown – the incidence could not be determined from available data. Within each group, the frequency of adverse reactions is presented in decreasing order of severity.

Immune system disorders are very rare:

Hypersensitivity reactions (including angioedema and anaphylactic reactions).

Nervous system disorders very rarely:

dizziness, seizures.

Cardiovascular system disorders very rarely:

tachycardia, palpitations.

Gastrointestinal tract disorders very rarely:

nausea, dry mouth, gastritis.

Liver and biliary tract disorders very rarely:

disorder of liver function.

Skin and subcutaneous tissue disorders very rare:

allergic reactions (rash), alopecia.

General disorders and disorders at the site of administration very rarely:

faintness.

Laboratory and instrumental data frequency unknown: weight gain in children.

Paediatric patients

In clinical studies involving children aged 2 to 12 years, adverse events such as headache (2.7%), nervousness (2.3%) and fatigue (1%) were observed more frequently than with placebo (“pacifier”). If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: drowsiness, tachycardia, headache. In case of overdose seek immediate medical attention.

Treatment: symptomatic and supportive therapy. Perhaps gastric lavage, taking adsorbents (crushed activated carbon with water). Loratadine is not excreted during hemodialysis. After emergency care is provided, it is necessary to continue monitoring the patient’s condition.

Pregnancy use

Safety of use of loratadine during pregnancy has not been established. Loratadine use during pregnancy is possible only after consultation with a physician in case if the expected benefits to the mother exceed the potential risk to the fetus.

Breast-feeding period

Loratadine and its active metabolite are excreted into the breast milk, so if the drug is prescribed during breast-feeding, the question of stopping breast-feeding should be considered.

Similarities