Antigrippin-Express (Powder) Instructions for Use

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Pheniramine (Rec.INN registered by WHO)

Dosage Forms

	Antigrippin-Express	Powder for preparation of oral solution (black currant) 500 mg+25 mg+200 mg/1 sachet: sachet 13.1 g 6, 9 or 12 pcs.
		Powder for preparation of oral solution (lemon) 500 mg+25 mg+200 mg/1 sachet: sachet 13.1 g 6, 9 or 12 pcs.
		Powder for preparation of oral solution (raspberry) 500 mg+25 mg+200 mg/1 sachet: sachet 13.1 g 6, 9 or 12 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution [black currant] from white to white with a pinkish tint, with a characteristic odor; the presence of loosely caked lumps is allowed; the aqueous solution of the drug, obtained by dissolving the contents of the sachet in 200 ml of warm water, is opalescent, from lilac-red to purple in color, with a characteristic black currant odor.

Excipients : soluble saccharin (sodium saccharin dihydrate) – 20 mg, citric acid (citric acid monohydrate) – 200 mg, natural lemon flavor – 102 mg, natural identical black currant flavor – 215 mg, food color carmoisine – 0.75 mg, food color brilliant black – 0.25 mg, sugar (sucrose) – up to 13.1 g.

13.1 g – heat-sealed sachets (6) – cardboard packs.
13.1 g – heat-sealed sachets (9) – cardboard packs.
13.1 g – heat-sealed sachets (12) – cardboard packs.

Powder for preparation of oral solution [lemon] from white to white with a yellowish tint, with a characteristic odor; the presence of loosely caked lumps is allowed; the aqueous solution of the drug, obtained by dissolving the contents of the sachet in 200 ml of warm water, is opalescent, from colorless to yellowish in color, with a characteristic lemon odor.

Excipients : soluble saccharin (sodium saccharin dihydrate) – 20 mg, citric acid (citric acid monohydrate) – 200 mg, natural lemon flavor – 600 mg, sugar (sucrose) – up to 13.1 g.

13.1 g – heat-sealed sachets (6) – cardboard packs.
13.1 g – heat-sealed sachets (9) – cardboard packs.
13.1 g – heat-sealed sachets (12) – cardboard packs.

Powder for preparation of oral solution [raspberry] from white with a pinkish tint to pink in color, with a characteristic odor; the presence of loosely caked lumps is allowed; the aqueous solution of the drug, obtained by dissolving the contents of the sachet in 200 ml of warm water, is opalescent, from light pink to red-pink in color, with a characteristic raspberry odor.

Excipients : soluble saccharin (sodium saccharin dihydrate) – 20 mg, citric acid (citric acid monohydrate) – 200 mg, natural lemon flavor – 103.5 mg, natural identical raspberry flavor – 215 mg, food color raspberry – 1.5 mg, sugar (sucrose) – up to 13.1 g.

13.1 g – heat-sealed sachets (6) – cardboard packs.
13.1 g – heat-sealed sachets (9) – cardboard packs.
13.1 g – heat-sealed sachets (12) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

Combined medicinal product.

Paracetamol is an analgesic-antipyretic. It has analgesic, antipyretic and weak anti-inflammatory effects. The mechanism of action is associated with inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus.

Pheniramine is an antiallergic agent, a histamine H₁-receptor blocker. It relieves allergic symptoms, has a moderate sedative effect, and also exhibits m-cholinolytic activity.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; increases the body’s resistance to infections, reduces vascular permeability, reduces the need for vitamins B₁, B₂, A, E, folic acid, pantothenic acid. Improves the tolerability of paracetamol and prolongs its action (associated with prolongation of T_1/2).

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in plasma is reached within 10-60 minutes after oral administration. It is distributed in most body tissues. It crosses the placental barrier and is excreted in breast milk. In therapeutic concentrations, binding to plasma proteins is insignificant but increases with increasing concentration. It undergoes primary metabolism in the liver. It is excreted mainly in the urine as glucuronides and sulfates. T_1/2 ranges from 1 to 3 hours.

C_max of pheniramine in plasma is reached in approximately 1-2.5 hours. T_1/2 of pheniramine is 16-19 hours. 70-83% of the dose is excreted from the body in the urine as metabolites or unchanged.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Binding to plasma proteins is 25%. It is excreted as metabolites in the urine. Ascorbic acid, taken in excessive amounts, is rapidly excreted unchanged in the urine.

Indications

Acute respiratory viral infections (symptomatic therapy); allergic rhinitis; rhinopharyngitis; pain syndrome (mild to moderate): arthralgia, myalgia, neuralgia, migraine, toothache and headache, algodysmenorrhea; pain from injuries, burns.

ICD codes

Dosage Regimen

Prepare the solution immediately before use.

Dissolve the contents of one sachet completely in 200 ml of warm water.

Administer orally. The prepared solution is for single use.

For adults and children over 15 years, take one sachet 2 to 4 times per day.

Maintain a minimum 4-hour interval between doses.

Do not exceed the maximum daily dose of 4 sachets (equivalent to 2000 mg paracetamol).

The total duration of self-treatment without medical consultation should not exceed 3 days for fever and 5 days for pain.

For patients with chronic renal failure (creatinine clearance 10 ml/min), increase the dosing interval to 8 hours.

Adjust dosage carefully in elderly patients and those with hepatic impairment.

Adverse Reactions

From the digestive system: nausea, pain in the epigastric region; rarely – dry mouth; with long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired liver function increases.

From the hematopoietic system rarely – anemia, thrombocytopenia, methemoglobinemia.

From the urinary system rarely – urinary retention; with long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired renal function increases.

Allergic reactions skin rash, itching, urticaria, angioedema.

Other rarely – accommodation paresis, drowsiness.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase); renal failure; portal hypertension; chronic alcoholism; children under 15 years of age (for dosage forms intended for adults); first and third trimesters of pregnancy; lactation period (breastfeeding); hypersensitivity to the components of the combination.

With caution

Hepatic failure, angle-closure glaucoma, prostatic hyperplasia, congenital hyperbilirubinemias (Gilbert, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, in elderly patients.

Use in Pregnancy and Lactation

Contraindications: first and third trimesters of pregnancy; lactation period (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated for use in impaired liver function.

Use in Renal Impairment

With caution renal failure.

In chronic renal failure (CrCl 10 ml/min) the interval between doses is 8 hours.

Pediatric Use

Contraindication – children under 15 years of age (for dosage forms intended for adults).

Special Precautions

If hyperthermia persists for more than 3 days and pain syndrome for more than 5 days, a doctor’s consultation is required.

It distorts the indicators of laboratory tests in the quantitative determination of glucose and uric acid in plasma.

During treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

During the treatment period, it is necessary to refrain from consuming ethanol (the development of a hepatotoxic effect is possible).

Effect on ability to drive vehicles and mechanisms

During the treatment period, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Ethanol enhances the sedative effect of antihistamine drugs.

Antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives) increase the risk of side effects (urinary retention, dry mouth, constipation).

Glucocorticosteroids increase the risk of developing glaucoma.

Microsomal oxidation inducers (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication with small overdoses.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic action.

Paracetamol reduces the effectiveness of uricosuric drugs .

With simultaneous use of oral contraceptives, the concentration of ascorbic acid in the blood plasma decreases. An increase in the concentration of ethinyl estradiol in the blood plasma is possible with its simultaneous use as part of oral contraceptives.

With simultaneous use with iron preparations, Ascorbic acid, due to its reducing properties, converts ferric iron into ferrous iron, which contributes to improved absorption.

With simultaneous use with warfarin, a decrease in the effects of warfarin is possible.

With simultaneous use, Ascorbic acid increases the excretion of iron in patients receiving deferoxamine .

With simultaneous use with tetracycline, the excretion of ascorbic acid in the urine increases.

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.