Allergy - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline - 23.0 mg, 92.0 mg, 138.0 mg, calcium hydrophosphate - 5.0 mg, 20.0 mg, 30.0 mg, potato starch - 7.5 mg, 30.0 mg, 45 , 0 mg, croscarmellose sodium 4.0 mg, 16.0 mg, 24.0 mg, magnesium stearate 0.75 mg, 3.0 mg, 4.5 mg, talc 0.75 mg, 3.0 mg, 4.5 mg, silicon colloidal dioxide (aerosil) 1.5 mg, 6.0 mg, 9.0 mg, low molecular weight polyvinylpyrrolidone (povidone) 2.5 mg, 10.0 mg, 15.0 mg .

composition of the shell: opedrai II (polyvinyl alcohol 0.88 mg, 3.96 mg, 6.16 mg, talc 0.4 mg, 1.8 mg, 2.8 mg, titanium dioxide 0.3384 mg, 1.7253 mg , 2,6838 mg, macrogol 3350 - 0,247 mg, 1,1115 mg, 1,729 mg, soy lecithin - 0.07 mg, 0.315 mg, 0.49 mg, dye azorubin - 0.0102 mg, 0.0459 mg, 0 , 0714 mg, dye crimson 4R 0.0082 mg, 0.0369 mg, 0.0574 mg, indigo carmine dye 0.0012 mg, 0.0054 mg, 0.0084 mg).

Description:

The tablets covered with a film cover from pink to dark pink color, round, biconcave form. Tablets on a break of white or almost white color.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

R.06.A.X.26 Fexofenadine

Pharmacodynamics:

Fexofenadine is a histamine H blocker₁-receptors, practically devoid of sedation.

Fexofenadine is a pharmacologically active metabolite of terfenadine.

The antihistamine effect is manifested 1 hour after admission, reaches maximum after 6 hours and lasts for 24 hours. After 28 days reception there is no development of tolerance. When taken orally in the dose range from 10 mg to 130 mg, there is a linear dose-effect. "For a 24-hour effectiveness of the drug (for allergic rhinitis), a dose of 120 mg is sufficient.In a dose up to 240 mg, the drug is not caused changes in the QT interval.

Pharmacokinetics:

Fexofenadine after oral administration is quickly absorbed, the time to reach the maximum concentration (TC_max) - 1-3 hours The average value of the maximum concentration (C_max) after taking a dose of 120 mg once a day of approximately 427 ng / ml, and after taking a dose of 180 mg once a day - approximately 494 ng / ml.

Fexofenadine binds to plasma proteins by 60-70%.

Fexofenadine undergoes a minor metabolism (hepatic and extrahepatic). Biphasic withdrawal. The half-life (T_1/2) - 11 to 15 hours after taking multiple doses. In patients with moderate (creatinine clearance 41-80 ml / min) and severe (11-40 ml / min) renal failure T_1/2increases by 59 and 72%, respectively; in patients on hemodialysis, T_1/2 increases by 31%.

Pharmacokinetics with a single and repeated use of fexofenadine (up to 120 mg twice a day orally) is linear.

The main way of elimination is excretion with bile, up to 10% of the dose taken is excreted unchanged in urine.

Indications:

Pollinosis (hay fever), incl. seasonal allergic rhinitis (sneezing, itching, runny nose, reddening of the mucous membrane of the eye and other symptoms of pollinosis).

Chronic urticaria: redness, itching, and other symptoms of hives.

Contraindications:

For tablets of 120 and 180 mg:

Hypersensitivity to any of the components of the drug, child; age up to 12 years.

For tablets of 30 mg:

Hypersensitivity to any of the components of the drug, children under 6 years.

Carefully:

Elderly age, chronic renal failure, hepatic insufficiency.

In patients with chronic renal failure, the half-life increases depending on the creatinine clearance and, accordingly, a dose reduction is recommended.

Pregnancy and lactation:

Contraindicated for use during pregnancy and during breastfeeding.

Dosing and Administration:

Inside.

The recommended dose of fexofenadine for seasonal allergic rhinitis for adults and children over 12 years of age is 120 mg once a day.

The recommended dose of fexofenadine for chronic urticaria for adults and children over 12 years is 180 mg once a day.

The recommended dose of fexofenadine for allergic rhinitis and hay fever for children 6 to 12 years is 30 mg twice daily.

The recommended dose of fexofenadine for patients with hepatic insufficiency is 30 mg once.

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization (WHO): very often (≥ 10 %); often (≥ 1%, <10%); infrequently (≥ 0.1%, <1%); rarely (≥ 0.01%, <0.1%); very rarely (<0.01%), including isolated cases.

From the nervous system: often - headache, drowsiness, dizziness.

From the gastrointestinal tract: often - nausea.

From the skin and subcutaneous tissues: rarely - exanthema.

Other: often fatigue; infrequently, weakness.

Post-marketing research (frequency unknown)

From the immune system: hypersensitivity reactions (Quincke's edema, difficulty breathing, shortness of breath, skin flushing, systemic anaphylactic reactions).

From the nervous system and psyche: insomnia, nervousness, sleep disturbance. nightmarish dreams.

From the cardiovascular system: tachycardia, palpitation.

From the gastrointestinal tract: diarrhea.

From the skin and subcutaneous tissues: rash, hives, itching.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: dizziness, drowsiness and dry mouth.

Treatment: in case of an overdose, standard measures for removal from the gastrointestinal tract of unabsorbed drug (gastric lavage, the appointment of activated charcoal).

Symptomatic and supportive therapy is recommended.

Hemodialysis is ineffective.

Interaction:

With the combined use of fexofenadine with erythromycin or ketoconazole, the concentration of fexofenadine in plasma increases 2-3 times.

There is no significant influence on the increase in the QT interval.

There is no interaction between fexofenadine and omeprazole.

Taking antacids containing aluminum or magnesium 15 minutes before taking fexofenadine leads to a decrease in bioavailability of the latter (the time interval between their intake should be at least 2 hours).

Special instructions:It is recommended that the time interval between taking fexofenadine and antacids containing aluminum or magnesium hydroxide is 2 hours.

Effect on the ability to drive transp. cf. and fur:

When taking the drug Allerfex®, it is possible to perform works that require a high concentration of attention and speed of psychomotor reactions (with the exception of people who have a non-standard reaction to medicines). Thus, before you begin to perform these works (driving vehicles, control mechanisms), you must first check the individual reaction to the drug.

Form release / dosage:

The coated tablets are 30 mg, 120 mg and 180 mg.

Packaging:

For 10 tablets in a planar cell package.

For 10, 20, 30, 50 or 100 tablets in a can of light-protective glass or in a can of polymer or a polymer bottle.

Each jar or bottle, 1, 2, 3, 5 or 10 contour mesh packages together with the instruction for use is placed in a pack of cardboard.

Packing for hospitals.

For 200 or 1000 contour mesh packages with the appropriate number of instructions for use are placed in boxes of corrugated cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002217

Date of registration:11.11.2011 / 23.04.2013

Expiration Date:Unlimited

The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia

Manufacturer: & nbsp

NORTH STAR, CJSC Russia

Representation: & nbspNORTH STAR CJSC NORTH STAR CJSC Russia

Information update date: & nbsp10.07.2017

Illustrated instructions

Instructions

Allerfex® (Allerfex®)