F.I.R.M.A., Fristamin 10 mg 7 F.I.R.M.A.

“Composition:
Each tablet contains 10 mg of loratadine. The amount of lactose monohydrate in the composition of loratadine 10 mg tablets is 71.3 mg. For a full list of excipients, see section 6.1.
Excipients
lactose monohydrate; corn starch; magnesium stearate.
Therapeutic indications

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

Contraindications
Fristamine is contraindicated in patients with hypersensitivity to the active ingredient or any of the excipients in these drugs.

Dosage
Adults and children over 12 years of age: 10 mg once daily (one tablet once daily). The tablet can be taken regardless of meal time. For children aged 2 to 12 years, the dosage is determined based on body weight: Body weight over 30 kg: 10 mg once daily (one tablet once daily). Body weight less than or equal to 30 kg: the 10 mg tablet is not suitable for children weighing less than 30 kg. The efficacy and safety of Fristamine 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. For adults and children weighing over 30 kg, the recommended initial dose is 10 mg every other day. No dosage adjustment is required in the elderly or in patients with renal impairment.

Warnings and precautions
Fristamine should be administered with caution to patients with severe hepatic impairment (see Contraindications). This medicine contains lactose; Therefore, patients with rare hereditary problems of galactose intolerance, the Lapp syndrome due to lactase deficiency or glucose-galactose malabsorption should not take this medicine. Fristamine should be discontinued at least 48 hours before skin testing, since antihistamines may prevent or reduce positive reactions.

Interactions
According to psychophysical studies, concomitant use of Fristamine with alcohol does not increase its effect. Potential interactions may occur with all known inhibitors of CYP3A4 and CYP2D6 enzymes, resulting in increased blood levels of loratadine (see section 5.2), which may cause increased side effects.

Adverse Reactions
In clinical studies conducted in the pediatric population aged 2 to 12 years, common adverse reactions reported at a rate greater than placebo were headache (2.7%), irritability (2.3%), and fatigue (1%). In clinical studies conducted in adults and adolescents for a range of indications, including RA and CVI, at the recommended dose of 10 mg daily, adverse reactions were reported in more than 2% of patients receiving loratadine compared to patients receiving placebo. Adverse reactions reported more frequently than placebo included somnolence (1.2%), headache (0.6%), increased appetite (0.5%), and insomnia (0.1%). Other adverse reactions that were very rarely reported 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
Liver disorders Liver dysfunction
Skin and subcutaneous tissue disorders Rash, alopecia
General disorders and administration site conditions Fatigue

Pregnancy and breastfeeding
Loratadine has been shown to be non-teratogenic in animal studies. The safety of loratadine during pregnancy has not been established. Therefore, the use of Fristamine during pregnancy is not recommended. Loratadine is excreted in breast milk, therefore, loratadine is not recommended for nursing women.”