Fexosun

Allergic rhinitis
: Adifex is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, in adults and children 12 years of age and over. Symptoms treated effectively include sneezing, rhinorrhea, lacrimation, itchy, red eyes and itchy nose/palate/throat
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Allergic rhinitis
: Adifex is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, in adults and children 12 years of age and over. Symptoms treated effectively include sneezing, rhinorrhea, lacrimation, itchy, red eyes and itchy nose/palate/throat. Adifex improves health-related quality of life and work/activity productivity.
Chronic idiopathic urticaria
: Adifex is indicated for the relief of symptoms associated with chronic idiopathic urticaria in adults and children 12 years of age and older. Adifex significantly reduces the signs and symptoms of chronic idiopathic urticaria, the number of wheals, and pruritus. Adifex improves health-related quality of life and work/activity productivity.

Allergic Rhinitis-
Adults and children 12 years and older:
Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily
Children from 6 to 11 years:
Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily
Children from 2 to 11 years
Suspension: 30 mg or 5 ml twice daily
In case of impaired renal function: 30 mg or 5 ml once daily
Chronic Idiopathic Urticaria-
Adults and children 12 years and older:
Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
In case of impaired renal function: 60 mg once daily
Children from 6 to 11 years:
Tablet: 30 mg twice daily or 60 mg once daily
In case of impaired renal function: 30 mg once daily
Children from 6 months to less than 2 years:
Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily
Children from 2 to 11 years:
Suspension: 30 mg or 5 ml (1 tsp) twice daily
In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

The following frequency rating has been used, when applicable: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000 and not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo: Nervous system disorders- Common: headache, drowsiness, dizziness; Gastrointestinal disorders- Common: nausea; General disorders and administration site conditions- Uncommon: fatigue. In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (cannot be estimated from available data): Immune system disorders- hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis; Psychiatric disorders- insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria); Cardiac disorders- tachycardia, palpitations; Gastrointestinal disorders- diarrhea; Skin and subcutaneous tissue disorders- rash, urticaria, pruritus

As with most new medicinal products there is only limited data in the older people and renally or hepatically impaired patients. Adifex should be administered with care in these special groups. Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations.
Effects on ability to drive and use machines: On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that Adifex tablets will produce an effect on the ability to drive or use machines. In objective tests, Adifex has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.

The H1 histamine receptor is responsible for mediating hypersensitivity and allergic reactions. Exposure to allergen results in the degranulation of mast cells and basophils, which then release histamine and other inflammatory mediators. Histamine binds to, and activates, H1 receptors, which results in the further release of pro-inflammatory cytokines, such as interleukins, from basophils and mast cells. These downstream effects of histamine binding are responsible for a wide variety of allergic symptoms, such as pruritus, rhinorrhea, and watery eyes.
Fexofenadine is considered an "inverse agonist" of the H1 receptor because it binds to and stabilizes the inactive form of the receptor, preventing its activation and subsequent downstream effects. It has a potent and selective affinity for H1 receptors, and there is no evidence that it carries antidopaminergic, antiserotonergic, anticholinergic, sedative, or adrenergic blocking activity. Fexofenadine does not cross the blood-brain barrier and thus is unlikely to cause significant CNS effects.