Instructions for Amilar IS lozenges, orange-flavored blister pack No. 16
Composition
active ingredients: dequalinium chloride, dibucaine hydrochloride;
1 tablet contains dequalinium chloride 0.25 mg, dibucaine hydrochloride 0.03 mg;
excipients: sorbitol (E 420), colloidal anhydrous silicon dioxide, talc, magnesium stearate, flavoring (mint or cherry natural, or orange natural).
Dosage form
Tablets for resorption.
Main physicochemical properties: tablets of white or almost white color, flat-cylindrical shape with a bevel.
Pharmacotherapeutic group
Drugs used in throat diseases. ATX code R02A.
Pharmacological properties
Pharmacodynamics.
As a bactericidal and fungistatic agent, dequalinium chloride acts on microorganisms that cause mixed infections of the oral cavity and throat. The spectrum of action of this local chemotherapeutic agent is broad and includes most gram-positive and gram-negative bacteria, as well as fungi, spirochetes and pathogenic microorganisms that cause mixed infections of the oral cavity and throat. The accumulation of dibucaine hydrochloride in the body relieves the pain symptom that accompanies infections of the oral cavity and throat.
Microorganisms resistant to dequalinium chloride are unknown.
Does not cause caries.
Pharmacokinetics.
The main active ingredient is absorbed in very small amounts.
Indication
Local treatment of acute inflammatory diseases of the oral cavity and throat: gingivitis, ulcerative and aphthous stomatitis, tonsillitis, laryngitis and pharyngitis. Amilar IS is also recommended for use in the presence of unpleasant breath odor.
Amilar IS can be used in case of mixed infection of the oral cavity and throat (on the recommendation of a doctor); as an auxiliary drug in the treatment of catarrhal angina, lacunar angina and Plaut-Vincent angina; in case of candidiasis of the oral cavity and pharynx.
Recommended in the postoperative period after tonsillectomy and tooth extraction.
Contraindication
Hypersensitivity to any of the ingredients of the medicinal product. Allergy to quaternary ammonium compounds (e.g. benzalkonium chloride).
Interaction with other medicinal products and other types of interactions
The antibacterial activity of dequalinium is reduced when used simultaneously with anionic surfactants, for example, with toothpaste. The use of the drug should not be combined with the intake of cholinesterase inhibitors.
Application features
Since the medicine does not contain sugar, it is suitable for use by diabetics.
The medicine contains sorbitol, so it should not be used in patients with a rare hereditary disease such as fructose intolerance syndrome.
Use with caution in patients with low plasma cholinesterase levels.
Use during pregnancy or breastfeeding
Pregnancy
Controlled studies have not been conducted. In these circumstances, the drug can be used during pregnancy after consultation with a doctor if the therapeutic effect outweighs the possible risk to the fetus.
Breastfeeding period
Clinical studies on the penetration of active substances into breast milk have not been conducted. The drug is not recommended for use during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted on the effect of the drug on the ability to drive and use machines. However, the possibility that the drug may have any negative effect in this regard is very unlikely.
Method of administration and doses
Adults and children aged 12 and over
Apply 1 tablet every 2 hours, after the symptoms of inflammation have subsided – 1 tablet every 4 hours.
For children aged 4 and over
Apply 1 tablet every 3 hours, after the symptoms of inflammation have subsided - 1 tablet every 4 hours.
The maximum daily dose is 10–12 tablets during the acute phase and 6 tablets after the symptoms of inflammation disappear.
The tablets should be dissolved slowly, without chewing. The duration of treatment is determined by the doctor individually. The patient should consult a doctor if the symptoms have not disappeared or worsened after 5 days of treatment with the drug.
Children.
The medicine in this dosage form should not be prescribed to children under 4 years of age.
Overdose
The drug is generally well tolerated. In case of overdose, nausea, vomiting, and in rare cases, ulcers and necrosis of the esophagus are possible.
Treatment of overdose is symptomatic; if necessary, enveloping agents can be used.
Do not induce vomiting or perform gastric lavage.
Adverse reactions
In rare cases, namely with abuse, ulceration and necrosis may occur.
If any unusual reactions occur, you should stop using the medicine and be sure to consult a doctor regarding further therapy.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
8 tablets in a blister; 1 or 2 blisters in a pack.
Vacation category
Without a prescription.
Producer
Additional Liability Company "INTERCHEM".
Location of the manufacturer and address of its place of business.
Ukraine, 65025, Odessa, 21st km. Starokyivska Road, 40-A.
