Hifast^® (Tablets) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

ATC Code

R06AX26 (Fexofenadine)

Active Substance

Fexofenadine (Rec.INN registered by WHO)

Dosage Forms

	Hifast®	Film-coated tablets, 120 mg: 10, 15, 20, 30, 40, 45, 60 or 90 pcs.
		Film-coated tablets, 180 mg: 10, 15, 20, 30, 40, 45, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brownish-pink in color, biconvex, oblong in shape with rounded ends, with a score; the core on the cross-section is white or almost white.

Excipients: microcrystalline cellulose, corn starch pregelatinized, colloidal silicon dioxide (aerosil), povidone (kollidon 30), crospovidone (kollidon CL-M), sodium croscarmellose, magnesium stearate.

Shell composition opadry 85F34554 pink [partially hydrolyzed polyvinyl alcohol, macrogol 3350 (polyethylene glycol 3350), talc, titanium dioxide, dye sunset yellow aluminum lake, iron oxide yellow, iron oxide red].

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (1) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.

Film-coated tablets brownish-pink in color, biconvex, oblong in shape with rounded ends, with a score; the core on the cross-section is white or almost white.

Excipients: microcrystalline cellulose, corn starch pregelatinized, colloidal silicon dioxide (aerosil), povidone (kollidon 30), crospovidone (kollidon CL-M), sodium croscarmellose, magnesium stearate.

Shell composition opadry 85F34554 pink [partially hydrolyzed polyvinyl alcohol, macrogol 3350 (polyethylene glycol 3350), talc, titanium dioxide, dye sunset yellow aluminum lake, iron oxide yellow, iron oxide red].

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
15 pcs. – contour cell packaging (1) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Fexofenadine hydrochloride is a non-sedating blocker of H₁-histamine receptors and is a pharmacologically active metabolite of terfenadine.

The antihistamine effect appears 1 hour after administration, reaches a maximum after 6 hours, and lasts for 24 hours. Tolerance development was not observed upon repeated use. It does not have cholinergic or adrenolytic, sedative effects. It does not cause changes in the function of calcium and potassium channels, or the QT interval at therapeutic doses.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract, T_max – 1-3 hours. The mean C_max after a 180 mg dose is approximately 494 ng/ml, after a 120 mg dose – 427 ng/ml. Plasma protein binding is 60-70% (primarily with albumin and alpha 1-glycoprotein). It does not penetrate the blood-brain barrier.

T_1/2 after multiple doses is 14.4 hours. In patients with moderate (creatinine clearance 41-80 ml/min) and severe (11-40 ml/min) renal impairment, T_1/2 increases by 59% and 72%, respectively; in patients on hemodialysis, T_1/2 increases by 31%.

It undergoes (5% of the dose) partial extrahepatic metabolism. It is excreted primarily (80%) with bile, 11% – by the kidneys unchanged.

Indications

• Seasonal allergic rhinitis;
• Chronic urticaria.

ICD codes

Dosage Regimen

Administer orally with water.

For the treatment of seasonal allergic rhinitis, the recommended dose for adults and children over 12 years is 120 mg once daily.

For the treatment of chronic urticaria, the recommended dose for adults and children over 12 years is 180 mg once daily.

Take the tablet with or without food; however, avoid taking with fruit juices (e.g., apple, orange, grapefruit) as they may reduce bioavailability.

For patients with moderate to severe renal impairment (creatinine clearance less than 80 mL/min), reduce the dose to 60 mg once daily.

Do not exceed the recommended daily dose.

Initiate treatment based on symptom presentation and discontinue after symptoms resolve, unless otherwise directed by a physician.

The tablet is scored and can be split for accurate dosing if required.

Adverse Reactions

Headache, drowsiness, nausea, dizziness.

Rarely (less than 1 in 1000 prescriptions): feeling of fatigue, insomnia, nervousness, sleep disorder.

In isolated cases: skin rash, urticaria, skin itching, other hypersensitivity reactions (angioedema, dyspnea).

Contraindications

• Pregnancy;
• Lactation period;
• Children under 12 years of age;
• Hypersensitivity.

With caution: chronic renal failure. (The recommended daily dose for such patients is 60 mg once).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Renal Impairment

With caution: chronic renal failure. (The recommended daily dose for such patients is 60 mg once).

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

When taking Hifast^®, it is possible to perform work requiring high concentration of attention and speed of psychomotor reactions (except for people with an unusual reaction to medications). Thus, before starting such work (driving a car, operating machinery), it is necessary to first check the individual reaction to the drug.

Overdose

Symptoms dizziness, drowsiness, and dry mouth. In case of overdose, it is recommended to take standard measures to remove the unabsorbed drug from the gastrointestinal tract. Symptomatic and supportive therapy is recommended. Hemodialysis is not effective.

Drug Interactions

When used concomitantly with erythromycin or ketoconazole, the plasma concentration of fexofenadine increases 2-3 times. Taking aluminum- or magnesium-containing antacids 15 minutes before taking fexofenadine leads to a decrease in its bioavailability (the time interval between their intake should be at least 2 hours). It does not interact with omeprazole, or with drugs metabolized in the liver.

Storage Conditions

In a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

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.