TELFAST OD Tablet

For the relief of symptoms associated with chronic idiopathic urticaria in adults and children 12 years of age and older.

Adults and children aged 12 years and over

1 tablet once daily.

Children under 12 years of age

The efficacy and safety has not been studied.

Special risk groups

elderly, renally, hepatically impaired patients

It is not necessary to adjust the dose.

In patients with known hypersensitivity to any of its ingredients.

In controlled clinical trials the most commonly reported aderse events were headache, drowsiness, nausea, dizziness and fatique. The incidence of these events observed with fefxofenadine was similar to that observed with placebo.

Fexofenadine does not not undergo hepatic biotransformation and therefore will not interact with other drugs through hepatic mechanisms. Co-administration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any incrase in adverse events cocmpared to the drugs given singly.

Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary, excretion or gastrointestinal secretion, respectively.

No in teraction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastriubtestubak tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.

No animal reproduction studies have been performed with fexofenadine hydrochloride. Supportive pharmacokinetic studies with terfinadine have been performed and show exposure to fexofenadine at the high dose level in animal reproduction studies performed with terfenadine to be higher than is achieved at the recommended clinical fexofenadinedose. In these studies no evidence of teratogenicity or effects on male fertility were observed. Effects on female fertiliry and on peri and post natal development were seen only at meternally toxic doses.

There is no experience with fexofenadine hydrochloride in pregnant women. As with other medications fexofenadine hydrochloride shoud not be used during pregnancy unless the expected benefit to the patient outweighs any possible risk to the foetus.

There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore fexofenadine hydrochloride is not recommended for mothers breast feedin their babies.

As with most new drugs there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups.