Strepsils Plus oromucosal spray bottle 20 ml

Instructions for Strepsils Plus oromucosal spray bottle 20 ml

Composition

active ingredients: 100 ml of the drug contain amylmetacresol 0.223 g; 2,4-dichlorobenzyl alcohol 0.446 g; lidocaine 0.6 g;

Excipients: ethanol 96%; citric acid, monohydrate; glycerin; sorbitol solution, non-crystallizing (E 420); saccharin; levomenthol; peppermint flavor; anise flavor; carmoisine edicol (E 122); purified water; sodium hydroxide; concentrated hydrochloric acid.

Dosage form

Oromucosal spray.

Main physicochemical properties: transparent, red solution with a characteristic odor.

Pharmacotherapeutic group

Drugs used in throat diseases. Antiseptics. Dichlorobenzyl alcohol. ATX code R02A A03.

Pharmacological properties

Pharmacodynamics

Amylmetacresol and 2,4-dichlorobenzyl alcohol have an antiseptic effect, lidocaine is a local anesthetic. Strepsils Plus is an antiseptic combination drug with a local anesthetic effect. Active against a wide range of gram-positive and gram-negative microorganisms in vitro; also has an antifungal effect.

Pharmacokinetics

2,4-Dichlorobenzyl alcohol is metabolized in the liver to form hippuric acid, which is excreted in the urine. Data on the elimination of amylmetacresol are not available.

Lidocaine is readily absorbed through mucous membranes. The plasma elimination half-life is approximately two hours.

Indication

Symptomatic treatment of infections of the mouth and throat, as well as for the relief of sore throat.

Contraindication

Hypersensitivity to any component of the drug or to other amide local anesthetics. Asthma and bronchospasm. History of methemoglobinemia or suspected methemoglobinemia.

Interaction with other medicinal products and other types of interactions

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

Application features

Do not exceed the specified dose.

If symptoms of the disease persist for more than 3 days, are accompanied by high fever, headache, or other phenomena, additional correction of the treatment regimen is necessary.

The drug should not be used immediately before and during meals to prevent food from entering the respiratory tract due to the local anesthetic effect of lidocaine.

The local anesthetic effect of lidocaine may cause temporary numbness of the mouth and pharynx, and may also affect the swallowing process.

Do not breathe spray. Avoid contact with eyes.

The duration of the course of treatment should not exceed 5 days, as this may lead to an imbalance of the normal microflora of the oral cavity with the risk of bacterial or fungal spread.

Repeated or prolonged treatment of the mucosa may lead to the development of systemic toxic effects of local anesthetics (central nervous system damage with convulsions, cardiovascular failure).

Athletes should be aware that this medicine contains an active substance that may cause a positive test result during anti-doping control.

Patients taking any other medications should consult a doctor before using the spray.

Use with caution in patients with erosive and desquamative changes in the oral mucosa, fresh large wounds in the oral cavity and pharynx.

The medicine contains the dye carmoisine edicol (E 122). May cause allergic reactions.

This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose.

This medicinal product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Ability to influence reaction speed when driving vehicles or other mechanisms

No effects on the ability to drive or use machines have been reported.

Use during pregnancy or breastfeeding

Pregnancy

Animal studies are insufficient to draw a definitive conclusion on toxicity. There are no or limited data on the use of the medicinal product in pregnant women. In addition, the medicinal product contains alcohol. Strepsils® Plus, oromucosal spray, is not recommended for use during pregnancy.

Breastfeeding period

Lidocaine, its metabolites and alcohol are excreted in human milk. It is not known whether amylmetacresol and 2,4-dichlorobenzyl alcohol or their metabolites are excreted in human milk. A risk to the newborn/infants cannot be excluded. Therefore, the use of this medicinal product during breast-feeding is not recommended.

Fertility

There is no information on the effect on human reproductive function.

Method of administration and doses

Use the lowest effective dose for the shortest period of time necessary to treat symptoms.

Prescribed for adults and children over 12 years of age.

The interval between doses should be at least 2 hours.

Irrigate the oral cavity and/or throat by pressing the spray twice, 1-6 times a day.

Children aged 12 to 15 years

Irrigate the oral cavity and/or throat by pressing the spray twice, 1-4 times a day.

Apply the spray after meals.

The bottle contains 20 ml, which is equal to 70 doses and 140 sprays.

Children

Not recommended for use in children under 12 years of age.

Overdose

Overdose may manifest as symptoms of gastrointestinal discomfort such as taste perversion, nausea, vomiting, and may also cause excessive anesthesia of the upper respiratory tract and digestive tract. In such cases, the drug should be discontinued and symptomatic treatment should be administered.

A significant overdose of lidocaine affects the nervous and cardiovascular systems and can also cause methemoglobinemia. Methemoglobinemia is treated with immediate intravenous administration of 1-4 mg/kg methylene blue.

Adverse reactions

The following adverse reactions have been observed with short-term use of 2,4-dichlorobenzyl alcohol, amylmetacresol and lidocaine at non-prescription doses. Additional adverse reactions may occur with long-term treatment of chronic conditions. Additional adverse reactions may occur with long-term use of 2,4-dichlorobenzyl alcohol, amylmetacresol and lidocaine.

Adverse reactions that have occurred with the use of 2,4-dichlorobenzyl alcohol, amylmetacresol and lidocaine are listed by system organ class and frequency of occurrence. The frequency of adverse reactions is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Expiration date

3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Packaging

20 ml in a glass bottle with a dosing device; 1 bottle in a cardboard box.

Vacation category

Without a prescription.

Producer

Delpharm Bladel B.V. / Delpharm Bladel BV

Location of the manufacturer and its business address

Industrieweg 1, 5531 AD Bladel, The Netherlands