Instructions for the medical use of the medicinal product

FEXORA

Trade title

Fexora, Фексора 

International non-proprietary name

Fexofenadine hydrochloride USP,  Фексофенадина гидрохлорид USP

Compound

Each film -coated tablet contains:

active substance: Fexofenadine hydrochloride USP 120 mg substances: Q. _ S

Colour: titanium dioxide BP

Dosage form Tablets.

Pharmacological properties Mechanism actions

Fexofenadine hydrochloride is non-sedating H 1-antihistamine means. Fexofenadine is pharmacologically active metabolite terfenadine.

Indications for use Fexofenadine hydrochloride 180 mg is indicated adults and children older 12 years to relieve symptoms associated with chronic idiopathic urticaria.

Contraindications

Hypersensitivity to the active substance or to any from auxiliary substances.

Special instructions and precautions

As with most new drugs funds, data about use in the elderly and patients with renal or hepatic limited by insufficiency. These special groups of fexofenadine hydrochloride should be administered With caution.

Patients With cardiovascular diseases in anamnesis or with current cardiovascular diseases should be warned about what antihistamines drugs how Class drugs are associated with adverse reactions, tachycardia and speeded up heartbeat.

Nadine hydrochloride 180 mg Film-coated tablets also contain Allura Red AC lake , which maybe call allergic reactions.

side action

•          swelling of the face, lips, tongue, or throat, flushing, chest tightness, and breath, So how it may to be sign serious allergic reaction.

Common side effects: headache pain, drowsiness, bad well-being (nausea), dizziness.

Uncommon side effects effects: fatigue, drowsiness.

Interaction with other drugs

Fexofenadine is not biotransformed in liver and, therefore will not interact with other drugs through the liver mechanisms. established, what a joint introduction fexofenadine hydrochloride With erythromycin or keto conazole leads to   an increase in the level of fexofenadine in plasma by 2-3 times. The changes were not accompanied by any effect on the QT interval and were not associated with an increase in adverse reactions. on comparison With drugs prescribed separately.

Research on the animals showed that the increase in plasma levels of fexofenadine observed after concomitant use of erythromycin or ketoconazole appears to associated with increased gastrointestinal absorption tract and decline excretion in the bile or secretions in the gastrointestinal tract respectively.

Interactions between fexofenadine and omeprazole were not observed. However, administration of an antacid containing aluminum and magnesium hydroxide gels 15 minutes prior to administration of fexofenadine hydrochloride caused a decrease in bioavailability, quicker Total, due to binding in the gastrointestinal tract. Between taking fexofenadine hydrochloride and antacids, containing aluminum and magnesium hydroxide, it is desirable to leave 2 hours.

Dosage and administration The recommended dose of fexofenadine hydrochloride for adults is 120 mg one once in day before food. Fexofenadine is a pharmacologically active metabolite terfenadine.

Overdose

Overdose of fexofenadine hydrochloride has been reported with dizziness, drowsiness fatigue and dry mouth. Single doses up to 800 mg and doses before 690 mg two times in day in for 1 month or 240 mg once a day for 1 year were administered to healthy volunteers without the development of clinically significant adverse reactions compared with placebo. The maximum tolerated dose of fexofenadine hydrochloride is not installed.

Terms storage

Store below 30° C , protected from light and moisture.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the package.

Holiday conditions

Released by prescription.

Release form

10 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.