Instructions for Celista Duo lozenges No. 10
Composition
active ingredients: dequalinium chloride, cinchocaine hydrochloride;
1 tablet contains: dequalinium chloride 0.25 mg, cinchocaine hydrochloride (dibucaine hydrochloride) 0.03 mg;
Excipients: sorbitol (E 420), talc, colloidal anhydrous silicon dioxide, magnesium stearate, mint flavoring, peppermint oil.
Dosage form
Tablets for resorption.
Main physicochemical properties: white or almost white, round tablets with a score on one side and a bevel on both sides.
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 mouth 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
For the local treatment of acute inflammatory diseases of the oral cavity and throat: gingivitis, ulcerative and aphthous stomatitis, tonsillitis, laryngitis and pharyngitis.
The drug Celista® Duo is also recommended for use in the presence of bad breath.
The drug Celista® Duo can be used:
- in cases 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 dequalinium chloride, cinchocaine hydrochloride (dibucaine hydrochloride), other quaternary ammonium compounds (e.g. benzalkonium chloride), or any of the excipients of the drug.
Interaction with other medicinal products and other types of interactions
The antibacterial activity of dequalinium is reduced when used simultaneously with anionic surfactants, which may be part of toothpaste.
The use of the drug should not be combined with the use 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 rare hereditary diseases 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. The drug can be used during pregnancy after consultation with a doctor if the expected therapeutic effect outweighs the possible risk to the fetus.
Breastfeeding. Clinical studies on the penetration of active substances into breast milk have not been conducted, therefore the drug is not recommended for use during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effect of the drug on the ability to drive and use other mechanisms have not been conducted. However, the likelihood of such an effect is very low.
Method of administration and doses
Adults and children aged 12 and over
Prescribe 1 tablet every 2 hours, after the symptoms of inflammation have subsided - 1 tablet every 4 hours.
For children aged 4 and over
Prescribe 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 inflammatory symptoms disappear.
The tablets should be slowly dissolved 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 using the drug.
Children.
The drug 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.
Side effects
Sometimes hypersensitivity reactions may occur after using the drug, such as rash, itching, burning sensation, irritation of the mucous membrane of the mouth and throat. In rare cases, namely in case of abuse, ulceration and necrosis may occur. In case of any unusual reactions, the drug should be discontinued and a doctor should be consulted regarding further therapy.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. It allows for continued monitoring of the benefit-risk balance of the medicinal product in question. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
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
10 tablets in a blister; 1 or 4 blisters in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business
Ukraine, 02093, Kyiv, Boryspilska St., 13.
