Strepsils^® Vitamin C (Tablets) Instructions for Use

Marketing Authorization Holder

Reckitt Benckiser Healthcare International, Ltd. (United Kingdom)

Contact Information

Reckitt Benckiser Healthcare LLC (Russia)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Dichlorobenzyl alcohol (Grouping name)

Amylmetacresol (Rec.INN registered by WHO)

Dosage Form

Strepsils® with vitamin C

Sucking tablets (orange) 1.2 mg+0.6 mg+100 mg: 24 pcs.

Dosage Form, Packaging, and Composition

Lozenges (orange) orange in color, round, with the letter “S” depicted on both sides of the tablet; a white coating, uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the edges are allowed.

Excipients: orange flavor PHL 105288 – 3.12 mg, levomenthol – 2 mg, propylene glycol – 3 mg, color sunset yellow – 0.162 mg, color ponceau 4R – 0.0162 mg, tartaric acid – 26 mg, liquid sucrose, liquid dextrose [dextrose, oligo- and polysaccharides] (liquid glucose) – to make a tablet with a mass of 2.6 g.

12 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

2,4-Dichlorobenzyl alcohol and Amylmetacresol have an antiseptic effect. They are active against a wide range of gram-positive and gram-negative microorganisms in vitro.

Ascorbic acid is a source of vitamin C, replenishes the need for vitamin C in infectious and inflammatory diseases.

Pharmacokinetics

Data on the pharmacokinetics of the drug Strepsils^® with vitamin C are not available.

Indications

• Symptomatic treatment of sore throat in infectious and inflammatory diseases.

ICD codes

Dosage Regimen

The drug is used topically.

Children aged 6-18 years are recommended to dissolve 1 tab. every 4 hours. Do not take more than 5 tablets within 24 hours.

Adults over 18 years are recommended to dissolve 1 tab. every 2-3 hours. Do not take more than 8 tablets within 24 hours.

Do not exceed the indicated dose.

The duration of the treatment course is no more than 3 days. If symptoms persist after taking the drug for 3 days, it is necessary to stop treatment and consult a doctor.

Adverse Reactions

The following adverse reactions were noted with short-term use of the drug at recommended doses. When treating chronic conditions and with long-term use, other adverse reactions may occur.

The assessment of the frequency of adverse reactions is based on the following criteria: very common (≥1/10), common (from ≥1/100 to <1/10), uncommon (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000), very rare (<1/10000), frequency not known (data insufficient to estimate frequency).

From the immune system: frequency not known – hypersensitivity reactions (including angioedema, urticaria, rash, bronchospasm, hypotension with fainting).

From the gastrointestinal tract: frequency not known – nausea, abdominal pain, discomfort in the oral cavity (burning or tingling sensation, swelling).

If the above or any other adverse reactions not listed in the instructions occur, the patient should stop using the drug and consult a doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Children under 6 years of age;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution: pregnancy, breastfeeding period, diabetes mellitus.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, the drug should be used only if the intended benefit to the mother outweighs the potential risk to the fetus and child.

The minimum daily requirement for ascorbic acid in the second and third trimesters of pregnancy is about 60 mg. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid taken by the pregnant woman, and then the newborn may develop withdrawal syndrome.

The minimum daily requirement for ascorbic acid during lactation is 80 mg. A mother’s diet containing an adequate amount of ascorbic acid is sufficient to prevent ascorbic acid deficiency in the breastfed infant. Theoretically, there is a danger to the child when the mother uses ascorbic acid in high doses (it is recommended that a nursing mother does not exceed the daily requirement for ascorbic acid).

The use of the drug during pregnancy and breastfeeding is possible only under medical supervision.

Pediatric Use

The use of the drug is contraindicated in children under 6 years of age.

Special Precautions

It is recommended to take the drug for the shortest possible course and at the minimum effective dose necessary to relieve symptoms.

Patients with diabetes should take into account that each tablet contains about 2.6 g of sugar (0.22 XE).

High doses of ascorbic acid increase the excretion of oxalates, promoting the formation of kidney stones.

“Rebound” scurvy may be observed in newborns whose mothers took high doses of ascorbic acid, and in adults who took high doses of ascorbic acid.

With long-term use of high doses of ascorbic acid, suppression of the function of the insular apparatus of the pancreas is possible.

In patients with increased iron content in the body, ascorbic acid should be used in minimal doses.

Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests (content of glucose, bilirubin in blood and urine, activity of liver transaminases and LDH).

Effect on ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and mechanisms, as well as to engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Overdose is unlikely.

Symptoms: gastrointestinal discomfort – nausea. High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances such as nausea, stomach discomfort, frequent urination, nephrolithiasis.

Treatment: symptomatic therapy, forced diuresis.

Drug Interactions

No clinically significant interaction of the drug with other drugs has been identified.

Simultaneous use of the drug with other topical antimicrobial agents is possible.

Ascorbic acid increases the absorption of penicillin group antibiotics and iron, reduces the clinical effect of heparin and indirect anticoagulants, increases the risk of crystalluria during treatment with salicylates and short-acting sulfonamides, slows down the renal excretion of acids, increases the excretion of drugs with an alkaline reaction (including alkaloids), and reduces the concentration of oral contraceptives in the blood.

It increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.

Quinoline drugs, calcium preparations, salicylates, and corticosteroids with long-term use deplete ascorbic acid reserves.

With simultaneous use, Ascorbic acid reduces the chronotropic effect of isoprenaline.

With long-term use or use in high doses, Ascorbic acid may interfere with the interaction of disulfiram and ethanol.

In high doses, Ascorbic acid increases the renal excretion of mexiletine.

Barbiturates and primidone increase the renal excretion of ascorbic acid.

Ascorbic acid reduces the therapeutic effect of antipsychotic drugs (neuroleptics) – phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.