GLODAS Tablet

For the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years and older including sneezing, rhinorrhea, itchy nose/palate/throat.

For the treatment of chronic idiopathic urticaria in adults and children 6 years and older.

Dosage and mode of administration

Adults and children 12 years of age and over: 60mg twice daily or 120mg once daily.

A dose of 60mg once daily is recommended as the starting dose in patients with decreased renal function.

Children 6-11 years: as a directed by a physician.

Should not be used within 2 hours of taking of antacids containing aluminium or magnesium gel.

In patients with renal or hepatic impairment.

Frequently, ADR>1/100

- Nervous system: Drowsiness, fatigue, headache, insomnia, dizziness

- GI: Nausea, dyspepsia.

- Others: Viral infection (e.g. cold, influenza), dysmenorrhoea, upper respiratory tract infection, coughing, fever, otitis media, sinusitis, backache.

Occasionally, 1/1000<ADR<1/100

- Nervous system> Tremor, sleep disturbances, paroniria.

- GI: dry mouth, abdominal pain.

Rarely, ADR<1/1000

- Dermatologic reactions: Rash, urticaria, pruritus.

- Sensitivity reactions: Angioedema, chest tightness, dyspnea, flushing, anaphylaxis.

Co-administration with ketoconazole or erythromycin may lead to an increase in the plasma levels of fexofenadine hydrochloride. Concurrent administration with antacids containing aluminium or magnesium such as Maalox may decrease bioavailability of fexofenadine hydrochloride.

Fruit juices including grapefruit may reduce the bioavailability of fexofenadine and use together should be avoided.

Pregnancy

The effects of this drug during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately.

Lactation

It is not known whether fexofenadine appears in breast milk. If the drug is essential to your health, your doctor may advise you to stop nursing until your treatment is finished.

Use with caution in the elderly, in patients with renal of hepatic impairment.

See the package insert about the details below:

- Use in children

- Effects on the ability to drive or operate machinery.

Fexofenadine, an active metabolite of terfenadine, is a non-sedating antihistamine with selective peripheral H1-receptor antagonist activity. It has no significant anticholinergic and properties and has no alpha 1-adrenergic or beta-adrenergic-receptor blocking effects. At the therapeutic dose, it has no sedative or other central nervous system effects. Fexofenadine gives a quick and prolonged action because it slowly binds to H1-receptor, forming a stable complex and slow division.