Strepsils® plus
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STREPSILS® PLUS (STREPSILS® PLUS)
Composition:
Active substances: 100 mL of the preparation contains amylenmetacresol 0.223 g; 2,4-dichlorobenzyl alcohol 0.446 g; lidocaine 0.6 g;
Excipients: ethanol 96%; citric acid monohydrate; glycerol; sorbitol solution, non-crystallizing (E 420); saccharin; levomenthol; peppermint flavor; anise flavor; carmoisine edicol (E 122); purified water; sodium hydroxide; hydrochloric acid concentrated.
Pharmaceutical form. Oromucosal spray.
Main physicochemical properties: clear, red-colored solution with a characteristic odor.
Pharmacotherapeutic group.
Preparations used for throat disorders. Antiseptics. Dichlorobenzyl alcohol. ATC code R02A A03.
Pharmacological properties.
Pharmacodynamics.
Amylmetacresol and 2,4-dichlorobenzyl alcohol exert antiseptic effects; lidocaine acts as a local anesthetic. Strepsils Plus is a combined antiseptic preparation with local anesthetic action. It is active in vitro against a broad spectrum of gram-positive and gram-negative microorganisms and also exerts antifungal activity.
Pharmacokinetics.
2,4-Dichlorobenzyl alcohol is metabolized in the liver to form hippuric acid, which is excreted in urine. Data regarding elimination of amylmetacresol are lacking.
Lidocaine is readily absorbed through mucous membranes. The plasma elimination half-life is approximately two hours.
Clinical characteristics.
Indications.
Symptomatic treatment of infections of the oral cavity and throat, as well as for relief of sore throat.
Contraindications.
Hypersensitivity to any component of the medicinal product or to other amide-type local anesthetic agents.
Asthma and bronchospasm.
History of methemoglobinemia or suspicion of methemoglobinemia.
Interaction with other medicinal products and other forms of interaction.
No clinically significant interactions of the medicinal product with drugs from other groups have been identified.
Special precautions for use
Do not exceed the recommended dose.
If symptoms persist for more than 3 days, are accompanied by high fever, headache or other symptoms, additional adjustment of the treatment regimen is required.
The product should not be used immediately before or during eating 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 oral cavity and pharynx and may affect the swallowing process.
Do not inhale the spray. Avoid contact with eyes.
The duration of treatment should not exceed 5 days, as prolonged use may lead to imbalance of the normal oral flora, increasing the risk of bacterial or fungal overgrowth.
Repeated or prolonged treatment of mucous membranes may lead to development of systemic toxic effects of local anesthetics (central nervous system toxicity with seizures, cardiovascular collapse).
Athletes should be aware that this medicinal product contains an active substance that may lead to a positive result in anti-doping tests.
Patients taking any other medicinal products should consult a physician before using the spray.
Use with caution in patients with erosive or desquamative lesions of the oral mucosa, or large fresh wounds in the oral cavity and pharynx.
The medicinal product contains the dye carmoisine edicol (E 122), which may cause allergic reactions.
This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose. It is not recommended for patients with liver disease, alcoholism, epilepsy, and also for pregnant women and children under 12 years of age.
This medicinal product contains sorbitol. It is contraindicated in patients with hereditary fructose intolerance. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.
Use during pregnancy or breastfeeding
Pregnancy
There are insufficient animal studies to draw definitive conclusions regarding toxicity. There is no or only limited data on the use of this medicinal product in pregnant women. In addition, the product contains alcohol. Therefore, Strepsils® Plus oromucosal spray is not recommended during pregnancy.
Breastfeeding period
Lidocaine, its metabolites, and alcohol are excreted in breast milk. It is unknown whether amylmetacresol and 2,4-dichlorobenzyl alcohol or their metabolites are excreted in breast milk. Risk to newborns/infants cannot be excluded. Therefore, use of this medicinal product during breastfeeding is not recommended.
Fertility
There is no information available on the effect on human reproductive function.
Ability to affect reaction speed when driving or operating machinery
No effects on the ability to drive or operate machinery have been reported.
Method of Administration and Dosage
Use the lowest effective dose for the shortest duration necessary to treat symptoms.
For use in adults and children aged 12 years and older.
The interval between doses should be at least 2 hours.
Adults and children aged 15 years and older
Spray the oral cavity and/or throat by pressing the pump twice, 1–6 times daily.
Children aged 12 to 15 years
Spray the oral cavity and/or throat by pressing the pump twice, 1–4 times daily.
Use the spray after eating.
Remove the cap. Turn. Press the pump twice to spray the oral cavity and/or throat.
The bottle contains 20 ml, equivalent to 70 doses and 140 sprays.
Children.
Not recommended for use in children under 12 years of age.
Overdose.
Overdose may manifest as gastrointestinal discomfort, including taste disturbances, nausea, vomiting, and may also cause excessive anesthesia of the upper respiratory and gastrointestinal tracts. In such cases, the drug should be discontinued and symptomatic treatment initiated.
Significant lidocaine overdose affects the nervous and cardiovascular systems and may also cause methemoglobinemia. Methemoglobinemia is treated by immediate intravenous administration of 1–4 mg/kg of methylene blue.
Adverse reactions.
The adverse reactions listed below were observed during short-term use of 2,4-dichlorobenzyl alcohol, amylopectin, and lidocaine at over-the-counter doses. Additional adverse effects may occur with long-term treatment of chronic conditions. When treating chronic diseases, prolonged use may lead to additional adverse effects.
Adverse reactions associated with the use of 2,4-dichlorobenzyl alcohol, amylopectin, 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 (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), and frequency not known (cannot be estimated from available data). Within each frequency group, adverse reactions are listed in order of decreasing severity.
| System organ class |
Frequency |
Adverse reactions |
| Blood and lymphatic system disorders |
Unknown |
Methemoglobinemia |
| Immune system disorders |
Unknown |
Hypersensitivity, anaphylactic reactions, allergic reactions including rash, burning sensation in the mouth or throat and swelling of the mouth and throat, urticaria, angioneurotic edema, bronchospasm and hypotension with loss of consciousness. |
| Skin and subcutaneous tissue disorders |
Unknown |
Rash, pruritus |
| Gastrointestinal disorders |
Unknown |
Nausea, discomfort in the mouth, temporary numbness of the tongue and food entering the trachea, abdominal pain, stomatitis, dyspepsia, heartburn |
| Nervous system disorders |
Unknown |
Dysgeusia |
Shelf life.
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 reach of children.
Packaging.
20 ml in a glass vial with a dosing device; 1 vial in a cardboard box.
Release category.
Over-the-counter.
Manufacturer.
Delpharm Bladel B.V. / Delpharm Bladel B.V.
Manufacturer's address and place of business.
Industrieweg 1, 5531 AD, Bladel, The Netherlands /
Industrieweg 1, 5531 AD Bladel, The Netherlands