Allerfex^® (Tablets) Instructions for Use

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

ATC Code

R06AX26 (Fexofenadine)

Active Substance

Fexofenadine (Rec.INN registered by WHO)

Dosage Forms

	Allerfex®	Film-coated tablets, 30 mg: 10, 20, or 30 pcs.
		Film-coated tablets, 120 mg: 10, 20, or 30 pcs.
		Film-coated tablets, 180 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from pink to dark pink in color, round, biconvex; the core of the tablets on the cross-section is white or almost white.

Excipients: microcrystalline cellulose 102 – 21.5 mg, calcium hydrogen phosphate dihydrate – 5 mg, potato starch – 7.5 mg, croscarmellose sodium (primellose) – 4 mg, magnesium stearate – 0.75 mg, talc – 0.75 mg, colloidal silicon dioxide (aerosil) – 1.5 mg, povidone K30 (medium molecular weight polyvinylpyrrolidone) – 4 mg.

Shell composition hypromellose – 1 mg, polysorbate-80 (tween-80) – 0.4 mg, talc – 0.4 mg, titanium dioxide (E171) – 0.184 mg, aluminum lake based on dye azorubine (E122) – 0.016 mg).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.

Film-coated tablets from pink to dark pink in color, round, biconvex; the core of the tablets on the cross-section is white or almost white.

Excipients: microcrystalline cellulose 102 – 86 mg, calcium hydrogen phosphate dihydrate – 20 mg, potato starch – 30 mg, croscarmellose sodium (primellose) – 16 mg, magnesium stearate – 3 mg, talc – 3 mg, colloidal silicon dioxide (aerosil) – 6 mg, povidone K30 (medium molecular weight polyvinylpyrrolidone) – 16 mg.

Shell composition hypromellose – 4.5 mg, polysorbate-80 (tween-80) – 1.8 mg, talc – 1.8 mg, titanium dioxide (E171) – 0.828 mg, aluminum lake based on dye azorubine (E122) – 0.072 mg).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.

Film-coated tablets from pink to dark pink in color, round, biconvex; the core of the tablets on the cross-section is white or almost white.

Excipients: microcrystalline cellulose 102 – 129 mg, calcium hydrogen phosphate dihydrate – 30 mg, potato starch – 45 mg, croscarmellose sodium (primellose) – 24 mg, magnesium stearate – 4.5 mg, talc – 4.5 mg, colloidal silicon dioxide (aerosil) – 9 mg, povidone K30 (medium molecular weight polyvinylpyrrolidone) – 24 mg.

Shell composition hypromellose – 7 mg, polysorbate-80 (tween-80) – 2.8 mg, talc – 2.8 mg, titanium dioxide (E171) – 1.288 mg, aluminum lake based on dye azorubine (E122) – 0.112 mg).

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Histamine H₁-receptor blocker. Fexofenadine is a pharmacologically active metabolite of terfenadine. Does not have a sedative effect.

The antihistamine effect appears within 1 hour, reaches a maximum after 6 hours, and lasts for 24 hours. After 28 days of administration, no tolerance was observed.

It has been established that when taken orally in the dose range from 10 mg to 130 mg, the efficacy of fexofenadine is dose-dependent.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract, C_max is determined after 1-3 hours. The mean C_max after a 180 mg dose is approximately 494 ng/ml, and after a 120 mg dose – 427 ng/ml. Plasma protein binding is 60-70%. T_1/2 after multiple doses is 11-15 hours. It is excreted in breast milk. 5% of the dose undergoes partial extrahepatic metabolism. It is excreted mainly with bile (80%), 10% is excreted by the kidneys unchanged.

Indications

Relief of symptoms associated with seasonal allergic rhinitis, symptomatic treatment of chronic urticaria.

ICD codes

Dosage Regimen

For adults and children over 12 years of age, the recommended daily dose is 120 mg to 180 mg taken once daily.

Select the appropriate tablet strength to achieve the prescribed total daily dose.

Administer the tablet orally with a glass of water.

Take the dose before a meal to ensure consistent absorption.

For patients with renal impairment, use with caution; a reduced dosage of 60 mg once daily may be necessary.

For patients with hepatic impairment, use with caution and consider a reduced dosage.

Do not exceed the maximum recommended daily dose of 180 mg.

For pediatric patients aged 6 to 11 years, the recommended dose is 30 mg twice daily.

The use of this drug in children under 6 years of age is not recommended.

In elderly patients, use with caution and at the lowest effective dose.

If a dose is missed, take it as soon as remembered; if it is near the time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten one.

Maintain an interval of at least 2 hours between taking this drug and aluminum- or magnesium-containing antacids.

Adverse Reactions

Possible headache, drowsiness, dizziness, fatigue, nausea, lethargy, increased fatigue.

Contraindications

Pregnancy, lactation period, children under 6 years of age, hypersensitivity to fexofenadine.

Use in Pregnancy and Lactation

Fexofenadine is contraindicated for use during pregnancy and during the lactation period (breastfeeding).

Fexofenadine passes into breast milk. If it is necessary to use fexofenadine during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Use with caution in patients with hepatic insufficiency.

Use in Renal Impairment

Use with caution in patients with renal insufficiency.

Pediatric Use

The use of the drug in children under 6 years of age is not recommended.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in elderly patients, in patients with renal or hepatic insufficiency.

The efficacy and safety of fexofenadine in children under 6 years of age have not been studied.

Effect on the ability to drive vehicles and mechanisms

Based on the pharmacodynamic profile and known side effects, it can be assumed that the effect of fexofenadine on the ability to drive a car and engage in activities requiring increased concentration is unlikely. Objective studies have shown that Fexofenadine does not have a significant effect on CNS functions. Nevertheless, it is recommended to check the individual reaction before driving a car or engaging in other potentially hazardous activities.

Drug Interactions

Fexofenadine is not biotransformed in the liver and therefore does not interact with other drugs undergoing hepatic metabolism.

It has been shown that with the simultaneous use of fexofenadine with erythromycin or ketoconazole, the plasma concentration of fexofenadine increases by 2-3 times, which is apparently associated with an increase in absorption from the gastrointestinal tract and with a reduction in either bile excretion or gastrointestinal secretion. At the same time, no changes in the QT interval were observed.

When taking aluminum- or magnesium-containing antacids 15 minutes before taking fexofenadine, a decrease in its bioavailability was observed, most likely due to binding in the gastrointestinal tract. The recommended time interval between taking fexofenadine and antacids containing aluminum or magnesium hydroxide is 2 hours.

Does not interact with omeprazole, with drugs metabolized in the liver.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.