Bula do remedy Rafex

the package insert of the medicine Rafex. Therapeutic class of antihistamine. Active principles Fexofenadine Hydrochloride.

what For?

Rafex is indicated as an antihistamine in the treatment of allergic manifestations such as allergic rhinitis and urticaria.

Use adult and children above 12 years – oral Use


How it works?

Rafex is a product-acting antihistamine used in the symptomatic treatment of allergic manifestations.

After a single dose, and doses of two times a day, orally, of fexofenadine hydrochloride demonstrated that the drug has the effect of anti-histamine, starting within 1 hour and reaching its maximum effect within 2 to 3 hours, and continued for 12 hours at a minimum.


How to use?


  • allergic Rhinitis: adults and children 12 years of age: the recommended dose of fexofenadine hydrochloride is 120 mg once daily or 180 mg once a day orally.
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  • Urticaria: adults and children 12 years of age: the recommended dose of fexofenadine hydrochloride is 180 mg once a day, orally.
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  • Dosing for special cases: it is not necessary to adjust the dose of fexofenadine hydrochloride in patients with impairment of the liver, kidneys or in the elderly.

Side Effects

What are the evils that can cause me?

In the studies placebo-controlled trials involving patients with seasonal allergic rhinitis and idiopathic urticaria chronic, the side effects were comparable in patients treated with placebo or fexofenadine.

The most common side-effects reported in adults include: headache (>3%), drowsiness, dizziness and nausea (1-3%).

The side effects that have been reported during controlled studies involving patients with seasonal allergic rhinitis and urticaria, chronic idiopathic, with an incidence less than 1% and similar to placebo and have been rarely reported post-marketing include: fatigue, insomnia, nervousness, sleep disruption or nightmares.

there have Been reported rare cases of rash, urticaria, pruritus and hypersensitivity reactions such as angioedema, stiffness in chest, difficulty in breathing (dyspnoea), flushing and anaphylaxis systemic.

The side effects reported in studies placebo-controlled idiopathic urticaria chronic were similar to those reported in studies placebo-controlled allergic rhinitis.

In the studies placebo-controlled trials in children aged 6 to 11 years of age with seasonal allergic rhinitis, the side effects were similar to those observed in clinical studies involving adults and children aged 12 years or older with seasonal allergic rhinitis.


When should I not use?

Rafex is contraindicated for use in patients with hypersensitivity to any component of the formula.

This medicine is contraindicated in the age group below 12 years.

Warnings and Precautions

what should I know before using?

Studies conducted with fexofenadine hydrochloride demonstrated no association of the use of the product with the attention to drive motor vehicles or operate machinery, change in the pattern of sleep or other effects on the central nervous system.

always Check the expiration date located on the packaging of the product and check out the name to not be mistakes. Do not use Rafex if there are signs of tampering or damaged cations of the packaging.

there are No studies of the effects of Rafex administered by routes not recommended.

Therefore, for the safety and effectiveness of this medicine, the administration should only be by the oral route.

Rafex in pregnancy and breastfeeding: there is no experience with Rafex in women who are pregnant or nursing.

as Well as with other medications, Rafex should not be used during pregnancy and breastfeeding unless the risk/benefit ratio to be evaluated by the doctor and overcome the possible risks to the fetus and children who still receive breast-feeding, respectively.

In studies that covered reproductive toxicity carried out in mice, the fexofenadine has not harmed the fertility, was not teratogĂȘnica and has not harmed the development of pre-or post-natal.

This medicine should not be used by pregnant women without medical or dental surgeon.

it is Recommended that the tablet be swallowed with sufficient aware net

to Avoid the administration of Rafex along with foods rich in fat.

it is Recommended that the medicine is swallowed with water, avoiding the intake of the medicine along with fruit juices.

Drug Interactions

The concomitant administration of fexofenadine hydrochloride with erythromycin or ketoconazole demonstrated no significantly increase the captive in the QTc interval.

it was reported no difference in adverse effects in the case of these agents have been administered alone or in combination.

there was observed no interaction between fexofenadine and omeprazole.

however, the administration of an antacid containing aluminum hydroxide and magnesium, approximately 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability.

it is Recommended to wait a period of approximately 2 hours between administration of fexofenadine hydrochloride and antacids containing aluminum hydroxide and magnesium.


what to do if someone use a larger amount than is recommended?

the majority of The reports of superdose of fexofenadine hydrochloride present limited information.

However, dizziness, drowsiness and dry mouth have been reported.

In adults, a single dose of up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg daily for 1 year were studied in healthy volunteers without the emergence of side effects clinically significant when compared to placebo.

The maximum tolerated dose of Rafex has not yet been established.

In the case of a superdose accidental, seek emergency medical attention immediately.

In the case of a superdose are recommended the usual measures symptomatic and of support to remove from the body the drug is not absorbed.

hemodialysis does not effectively removes the fexofenadine hydrochloride from the blood.

what should I do when I forget to use this medicine?

If you forget to administer a dose, administer it as soon as possible, however, if it is almost time for your next dose, wait for this time, always in compliance with the range determined by the dosage.

Never should be administered two doses at the same time.