Instructions for Strepsils Plus Lozenges No. 16
Composition
active ingredients: lidocaine hydrochloride, amylmetacresol, 2,4-dichlorobenzyl alcohol.
1 lollipop contains: lidocaine hydrochloride 10 mg; amylmetacresol 0.6 mg; 2,4-dichlorobenzyl alcohol 1.2 mg;
excipients: levomenthol, peppermint oil, star anise oil, tartaric acid, sodium saccharin, sucrose solution, glucose solution, quinoline yellow (E 104), indigo carmine (E 132).
Dosage form
Lollipops.
Main physicochemical properties: round, pale blue-green lollipop with an S embossed on both sides.
Pharmacotherapeutic group
Drugs used in throat diseases. Antiseptics. Dichlorobenzyl alcohol. ATX code R02A A03.
Pharmacological properties
Pharmacodynamics
2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties. Lidocaine is a local anesthetic of the amide type, the action of which causes a reversible loss of sensitivity as a result of preventing the formation and transmission of sensory nerve impulses at the site of application or their reduction. Depolarization of the neuronal membrane and ion exchange are reversibly inhibited. An analgesic effect is provided due to the blockade of neuronal transmission.
Pharmacokinetics
Lidocaine is readily and rapidly absorbed from the mucous membrane. The plasma half-life is approximately 2 hours. Lidocaine is metabolized in the liver to form active metabolites, including glycine xylidide. Less than 10% of lidocaine is excreted unchanged by the kidneys. Metabolites are also excreted in the urine.
2,4-Dichlorobenzyl alcohol is metabolized by the liver to form hippuric acid, which is excreted in the urine. There are no data on the metabolism and elimination of amylmetacresol.
Indication
Symptomatic treatment of infections of the mouth and throat, including severe sore throat.
Contraindication
Allergic reaction to any of the components of the drug or to other amide local anesthetic drugs.
Fructose intolerance, glucose-galactose malabsorption syndrome, sucrose-isomaltose.
History of methemoglobinemia or suspected methemoglobinemia.
Bronchial asthma or bronchospasm.
Interaction with other medicinal products and other types of interactions
Theoretically, interactions with lidocaine are possible, but they are unlikely to be clinically significant for patient safety when the drug is used topically.
The toxicity of oral lidocaine may be increased when the drug is taken in combination with the following drugs:
erythromycin;
itraconazole;
cimetidine;
fluvoxamine;
beta-blockers;
other antiarrhythmic drugs (e.g. mexiletine).
Application features
If symptoms of the disease persist for more than 3 days, are accompanied by high fever, headache, or other symptoms, you should consult a doctor.
The drug may cause numbness of the tongue, so you should be careful when consuming food and drinks after taking the drug.
Patients with diabetes should note that 1 Strepsils® Plus lollipop contains approximately 2.6 g of sugar.
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 drug may cause mild transient taste disturbances, so caution should be exercised when consuming hot food and water.
The local anesthetic effect of lidocaine may cause temporary numbness of the mouth and pharynx, and may also affect the swallowing process.
Use with caution in patients with erosive and desquamative changes in the oral mucosa, fresh large wounds in the oral cavity and pharynx.
Do not exceed recommended doses.
Use during pregnancy or breastfeeding
Pregnancy
The safety of this medicinal product for use in pregnant women has not been established. However, available data on pregnant women (300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of lidocaine. There are no or limited amount of data from the use of amylmetacresol and 2,4-dichlorobenzyl alcohol in pregnant women.
Therefore, it is not recommended to use this medicine during pregnancy, unless the patient is under medical supervision.
Breastfeeding period.
Lidocaine/metabolites are excreted in breast milk, but no effects on the breastfed newborn/infants are expected at therapeutic doses. It is not known whether amylmetacresol and 2,4-dichlorobenzyl alcohol or their metabolites are excreted in breast milk. A risk to the newborn/infants cannot be excluded. Therefore, this medicinal product is not recommended during breast-feeding, unless under medical supervision.
Fertility.
There are no data on the effect of active substances on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effects on the ability to drive or use machines have been reported.
Method of administration and doses
Use the lowest dose for the shortest time needed to relieve symptoms.
Recommended for adults and children aged 12 and over.
Apply 1 lollipop every 2 hours as needed.
The lozenge should be slowly sucked until completely dissolved. Do not use more than 8 lozenges in 24 hours. There is no need to reduce the dose for the elderly.
Children
Not recommended for use in children under 12 years of age.
Overdose
Given the form of release of the lozenges, accidental or intentional overdose is very unlikely. Overdose primarily causes excessive loss of sensitivity of the upper digestive tract and may manifest itself as symptoms of gastrointestinal discomfort. In this case, the drug should be discontinued. Treatment of potentially toxic overdose should be symptomatic and supportive and carried out under the supervision of a physician.
A significant overdose of lidocaine affects the nervous and cardiovascular systems, can lead to severe hypotension, asystole, bradycardia, apnea, convulsions, coma, cardiac arrest, respiratory arrest, and death, and can also cause methemoglobinemia. Methemoglobinemia is treated with immediate administration of 1-4 mg/kg methylene blue intravenously.
Adverse reactions
The following adverse reactions have been observed with short-term use of 2,4-dichlorobenzyl alcohol and amylmetacresol at non-prescription doses. Additional adverse effects may occur with long-term treatment of chronic conditions.
Adverse reactions that have occurred with the use of 2,4-dichlorobenzyl alcohol and amylmetacresol 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.
| Organ system class | Frequency | Side effects |
| On the part of the immune system | Unknown | Hypersensitivity1, anaphylactic reactions, allergic reactions including rash, burning sensation in the mouth or throat and swelling of the mouth and throat, urticaria, angioedema. |
| Blood and lymphatic system disorders | Unknown | Methemoglobinemia. |
| Skin and subcutaneous tissue disorders | Unknown | Rash, itching. |
| Gastrointestinal tract | Unknown | Nausea, oral discomfort, abdominal pain, stomatitis, dyspepsia, heartburn. |
| From the nervous system | Unknown | Dysgeusia. |
1 Hypersensitivity reactions to lidocaine may manifest as rash, angioedema, urticaria, bronchospasm and hypotension with loss of consciousness, including swelling of the face, neck, throat or tongue, which may affect breathing.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
8 lozenges in a blister; 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Reckitt Benckiser Healthcare International Limited.
Location of the manufacturer and its business address
Nottingham site, Thane Road, Nottingham, NG90 2DB, United Kingdom.
