BOSFEXO

POSOLOGY, METHOD OF ADMINITRATION

Dosage 

Adults and children aged 12 years and over

+ The recommended dose of fexofenadine hydrochloride for adults and children aged 12 years and over is 180 mg once daily taken before a meal.

+ Fexofenadine is a pharmacologically active metabolite of terfenadine.

Children under 12 years of age

+ The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12.

Special populations

+ Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.

Administration

Oral use.The dose can be taken before a meal.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

WARNINGS AND PRECAUTIONS

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.

Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class, have been associated with the adverse reactions, tachycardia and palpitations.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This product contains iron oxide red, iron oxide yellow, it may cause allergic reactions.

PREGNANCY AND LACTATION

Pregnancy

There are no adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.

Lactation

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 feeding their babies.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, fexofenadine 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 drugs, it is advisable to check the individual response before driving or performing complicated tasks.

STORAGE CONDITION

In a dry place, below 30°C, protect from light.

SHELF LIFE

36 months from the manufacturing date. Do not use after the expiry use

Aluminum/aluminum blister. Box of 03 blisters x 10 film-coated tablets.