Fristamin 10 mg - treatment of allergic rhinitis 7 tablets

Product Description

Tablets

Composition:

Each tablet contains 10 mg of loratadine. The amount of lactose monohydrate in the composition of the 10 mg loratadine tablet is 71.3 mg. For the full list of excipients, see section 6.1.

Excipients

Lactose monohydrate; maize starch; magnesium stearate.

Therapeutic indications

Fristamin is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

Contraindications

Fristamin is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients in these formulations.

Dosage

Adults and children over 12 years of age: 10 mg once a day (one tablet once a day). The tablet can be taken regardless of mealtimes. In children aged 2 to 12 years, the dosage is based on weight: Body weight greater than 30 kg: 10 mg once a day (one tablet once a day). Body weight less than or equal to 30 kg: The 10 mg tablet is not recommended. Suitable for children weighing less than 30 kg. The efficacy and safety of Fristamin in children under 2 years of age have not been established. Patients with severe hepatic impairment should be given a lower initial dose as they may have reduced clearance of loratadine. A starting dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg. No dosage adjustments are required in the elderly or in patients with renal insufficiency.

Warnings and precautions

Fristamin should be administered with caution in patients with severe hepatic impairment (see section 4.2). This medicinal product contains lactose; therefore, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Fristamin administration should be stopped at least 48 hours before skin tests as it may cause a decrease in the clearance of loratadine. Antihistamines may prevent or reduce positive reactions.

Interactions

Concomitant use of Fristamin with alcohol does not enhance its effects, as assessed in studies on psychophysical performance. Potential interactions may occur with all known inhibitors of the CYP3A4 and CYP2D6 enzymes, resulting in high levels of loratadine in the blood (see section 5.2), which may cause an increase in adverse effects.

Undesirable effects

In clinical studies conducted in a pediatric population of children aged 2 to 12 years, common adverse effects whose frequency exceeded that of placebo were: headache (2.7%), irritability (2.3%), and fatigue (1%). In clinical studies conducted in adults and adolescents in a variety of indications, including RA and CIU, at the recommended dose of 10 mg daily, adverse reactions were reported with loratadine in 2% of patients compared to placebo. Adverse reactions reported more frequently than with placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%), and insomnia (0.1%). Other side effects reported very rarely during marketing are listed in the table below.

Immune system disorders Anaphylaxis
Nervous system disorders Dizziness
Cardiac disorders Tachycardia, palpitations
Gastrointestinal disorders Nausea, dry mouth, gastritis
Hepatobiliary disorders Abnormal liver function
Skin and subcutaneous tissue disorders Rash, alopecia
General disorders and administration site conditions Fatigue

Pregnancy and breastfeeding

Loratadine has not been shown to be teratogenic in animal studies. The safety of loratadine during pregnancy has not been established. Therefore, the use of Fristamin during pregnancy is not recommended. Loratadine is excreted in breast milk, therefore taking loratadine is not recommended in breastfeeding women.