Teoritin^® MF (Tablets) Instructions for Use

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

Manufactured By

OHFK, JSC (Russia)

Valenta Pharm, JSC (Russia)

ATC Code

R06AX (Other systemic antihistamines)

Active Substance

Benzhydrylpiperazinyl butylmethylxanthine succinate (Grouping name)

Dosage Forms

	Teoritin^® MF	Tablets 2 mg: 10, 20, 30, 40, 50 or 60 pcs.
		Tablets 4 mg: 10, 20, 30, 40, 50 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a light brownish tint, flat-cylindrical in shape, with a bevel on both sides.

	1 tab.
Benzhydrylpiperazinyl butylmethylxanthine succinate (teoritin)*	2 mg

* calculated as 100% substance.

Excipients: microcrystalline cellulose, sodium carboxymethyl starch, calcium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.

Tablets from white to white with a light brownish tint, flat-cylindrical in shape, with a bevel on both sides.

	1 tab.
Benzhydrylpiperazinyl butylmethylxanthine succinate (teoritin)*	4 mg

* calculated as 100% substance.

Excipients: microcrystalline cellulose, sodium carboxymethyl starch, calcium stearate.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Histamine H₁-receptor blocker, a purine derivative. It has pronounced antiallergic activity associated with long-term and selective blockade of histamine H₁-receptors, prevents the development and alleviates the course of allergic reactions.

It has antipruritic and anti-exudative effects. It has weak m-anticholinergic and antiserotonin activity. It does not have sedative properties and does not affect the speed of psychomotor reactions.

Pharmacokinetics

It is almost completely absorbed from the gastrointestinal tract. C_max in blood plasma is reached in 3 ± 1.3 hours and is 2.04 ± 0.89 ng/ml. AUC_0-∞ is 26.56 ± 13.06 ng h/ml.

It is most intensively distributed in well-vascularized organs (liver, spleen, lungs, kidneys), and to a somewhat lesser extent (2-3 times) in less vascularized organs (heart, brain, muscles, mesentery).

It has a first-pass effect through the liver. 0.23% and 0.33% of the dose is excreted unchanged in urine and feces, respectively.

T_1/2 is about 11 ± 4.93 hours.

Indications

Symptomatic treatment of chronic idiopathic urticaria; seasonal allergic rhinitis.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
J30.4	Allergic rhinitis, unspecified
L50	Urticaria

ICD-11 code	Indication
CA08.0Z	Allergic rhinitis, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the drug orally, with water, irrespective of meals.

For adults and adolescents over 18 years of age, the standard dose is 2 mg to 4 mg taken once daily.

Select the specific dose within this range based on the severity of symptoms and individual patient response.

The standard treatment course is 14 days.

For patients with mild to moderate hepatic impairment, initiate therapy at the lower end of the dosage range (2 mg once daily).

Use the drug with caution in elderly patients; a starting dose of 2 mg once daily is recommended.

The drug is contraindicated in patients with severe renal impairment or severe hepatic impairment.

Do not exceed the maximum recommended daily dose of 4 mg.

If a dose is missed, take it as soon as remembered, unless it is almost time for the next scheduled dose; in that case, continue with the regular dosing schedule.

Adverse Reactions

From the cardiovascular system: very rarely (isolated cases) – bradycardia, tachycardia.

From the digestive system: frequently – dry mouth; very rarely (isolated case) – dyspepsia, abdominal pain.

From the nervous system: frequently – headache; very rarely (isolated case) – dizziness, weakness.

From the urinary system: very rarely (isolated case) – dysuria.

From laboratory and instrumental data: frequently – increased activity of hepatic transaminases and bilirubin level; rarely – bilirubinuria, proteinuria; very rarely – increased urine pH, change in glycemia level (increase or decrease). On ECG: infrequently – impaired repolarization processes; very rarely – conduction disturbance.

Contraindications

Hypersensitivity to the components of the drug; pregnancy; breastfeeding period; children under 18 years of age; renal failure, hepatic failure.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Use with caution in patients with angle-closure glaucoma, with prostatic hyperplasia, in elderly patients.

Effect on ability to drive vehicles and mechanisms

When using the drug, dizziness and weakness may occur, which may negatively affect the ability to drive vehicles and mechanisms. If the described adverse events occur, one should refrain from performing these activities.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.

Medical Disclaimer