Celista Duo

APPROVED WITH Administrative Order of the Ministry of Health of Ukraine No. 673 dated 22.04.2022
Registration certificate No. UA/19330/01/01

INSTRUCTIONS
for medical use of CELISTA® DUO medicinal product

Composition:

Active substances: dequalinium chloride, cinchocaine hydrochloride;

1 tablet contains: 0.25 mg of dequalinium chloride, 0.03 mg of cinchocaine hydrochloride (dibucaine hydrochloride);

Excipients: sorbitol (E 420), talc, colloidal anhydrous silicon dioxide, magnesium stearate, peppermint flavouring, peppermint oil.

Medicinal form. Orodispersible tablets

Basic physicochemical properties: tablets of white or almost white colour of round shape with a breaking line on one side and a chamfer on both sides.

Pharmacotherapeutic group. Medical preparation used in treating throat diseases.

ATC 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 action spectrum of this local chemotherapeutic agent is wide 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.

Accumulation of dibucaine hydrochloride in the body relieves the painful symptom that accompanies infections of the mouth and throat.

Microorganisms resistant to dequalinium chloride are unknown.

Does not cause the formation of caries.

Pharmacokinetics.

The main active component is absorbed in a very small amount.

Clinical characteristics.

Indication.

The preparation is intended for local treatment of acute inflammatory diseases of the oral cavity and throat: gingivitis, ulcerative and aphthous stomatitis, tonsillitis, laryngitis and pharyngitis.

The Celista® Duo is also recommended for use in the presence of bad breath.

The Celista® Duo medicinal product may be used:

‒ in cases of mixed infection of the oral cavity and throat (on the doctor's recommendation);

‒ as an auxiliary preparation for treatment of catarrhal angina, lacunar angina and Plaut-Vincent's angina;

‒ in the case of candidiasis of the oral cavity and pharynx.

It is recommended during the postoperative period after tonsillectomy and tooth extraction.

Contraindication.

Hypersensitivity to dequalinium chloride, cinchocaine hydrochloride (dibucaine hydrochloride), other quaternary ammonium compounds (for example, benzalkonium chloride), or any auxiliary component of this medicinal product.

Interaction with other medicinal products and other types of interactions.

The antibacterial activity of dequalinium shall be impaired during simultaneous use with anionic surfactants, which can be a part of a toothpaste.

The use of the medicinal product should not be combined with the use of cholinesterase inhibitors.

Special warning and precautions for use

Since the medicine does not contain sugar, it is suitable for use by patients with diabetes.

This medicinal product contains sorbitol, so it should not be used in patients with rare hereditary diseases such as fructose intolerance syndrome.

It should be used with caution in patients with low plasma cholinesterase levels.

Use during pregnancy or breastfeeding.

Pregnancy. No controlled studies were conducted. The medicinal product can be used during pregnancy after consulting a doctor, if the expected therapeutic effect outweighs the possible risk to the foetus.

Breastfeeding period. No clinical studies were conducted on the penetration of active substances into breast milk, therefore the drug is not recommended for use during breastfeeding.

The ability to influence the speed of reaction when driving vehicles or other mechanisms.

Studies on the effect of the drug on the ability to drive a car and work with other mechanisms were not conducted. However, the probability of such an effect is very small.

Method of administration and dosage.

Adults and children over 12 years old

Prescribe one tablet every 2 hours or one tablet every 4 hour after diminution of the inflammation symptoms.

For children aged 4 and over

Prescribe one tablet every 3 hours or one tablet every 4 hour after diminution of the inflammation symptoms.

The maximum daily dose shall be 10‒12 tablets during the acute phase and 6 tablets when the inflammatory symptoms disappear.

Tablets should be slowly dissolved in the mouth without chewing. The duration of the treatment course shall be determined by the doctor individually. The patient should consult a doctor if after 5 days of using the drug the symptoms have not disappeared or even acerbated.

Children

The medicinal product in this dosage form should not be prescribed to children under 4 years of age.

Overdose

In general, the medical product is well tolerated. Nausea, vomiting, and in rare cases - ulcers and necrosis of the oesophagus are possible if overdosed.

Treatment of overdosing is symptomatic; if necessary, enveloping agents can be used.

Do not induce vomiting and use gastric lavage.

Adverse reactions.

Sometimes hypersensitivity reactions may occur after using this drug, such as rash, itching, burning sensation, irritation of the mucous membrane of the oral cavity and throat. In rare cases, namely with abuse, ulceration and necrosis may occur. In case of occurrence of any unusual reactions, the use of the medicinal product should be stopped and a doctor should be consulted regarding further therapy.

Reporting of suspected adverse reactions.

The reporting of suspected adverse reactions after the registration of a medicinal product is an important procedure. This allows us to continue monitoring of the benefit/risk ratio for the respective medicinal product. Healthcare professionals should report any suspected adverse reactions through the national reporting system.

Storage life is 1.5 years.

Storage conditions.

The preparation must be stored in its 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.

Medicinal product dispensing. Without prescription

Manufacturer: PrJSC Darnitsa Pharmaceutical Firm

The manufacturer place of business address and location

13 Boryspilska Street, 02093, Kyiv, Ukraine.

Last revision date 22.04.2022.