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LYDIN-DF

spray for external use, 30 g

Dispensing conditions: NO PRESCRIPTION 

THERAPEUTIC INDICATIONS:

  • treatment of mucous membrane infections of the mouth (stomatitis, gingivitis) and pharynx (pharyngitis);

  • local pain relief for sore throat;

  • relief of symptoms of sore throat and irritation (painful swallowing, irritation).

dwldDownload instructions for use

Composition

100 ml of the product contains

 
active substances:  
- chlorhexidine digluconate 20% 1.064 g
- lidocaine hydrochloride 0.050 g
excipients: citric acid monohydrate, glycerin, saccharin sodium, levomenthol, cineol, 96% ethanol, purified water up to 100 ml

Pharmaceutical formulation

Spray for topical administration, 30 ml

Pharmacotherapeutic group

Medications for respiratory system diseases. Medications for throat diseases.

ATC code R02А

Pharmacological properties

Lidin-DF has a local analgesic and antibacterial effect. The product reduces inflammation of the throat, reducing the possibility of more severe bacterial throat infections, and relieves the pain of irritation and swallowing.

Indications

  • treatment of mucous membrane infections of the mouth (stomatitis, gingivitis) and pharynx (pharyngitis);
  • local pain relief for sore throat;
  • relief of symptoms of sore throat and irritation (painful swallowing, irritation).

Contraindications

  • hypersensitivity to any product component;
  • children under 5 years of age;
  • children with a history of muscle cramps (including febrile cramps), since the product contains levomenthol;
  • alcohol addiction;
  • pregnancy and lactation period.

Posology and method of administration

For topical use.

Adults and adolescents over 12 years of age  3 to 5 successive presses of the atomizer button; repeat the procedure 6 to 10 times a day.

For children over 5 years of age: 2 to 3 consecutive presses of the atomizer button. 3 to 5 times a day.

This product is intended for symptomatic treatment and should not be used for long-term treatment. If the patient's condition does not improve within 3-4 days, consult a doctor.

The product is intended for individual use only. Use by more than one person can spread the infection.

Turn the atomizer perpendicular to the bottle before application.

Open your mouth wide, point the atomizer toward your pharynx and press the atomizer button.

Hold your breath while spraying.

After each use, return the atomizer to its original position downward to lock it in place.

If Lidin-DF will not be used for a period of time, it is recommended that the atomizer orifice be cleaned after the last use, following the instructions below:

  • turn the bottle upside down and press the atomizer button until the solution in the adapter is completely removed (solution spraying stops);
  • remove the spray tube from the spray port and place it in a container of warm water for several minutes;
  • remove the atomizer tube from the water and dry it;
  • to block the spraying, attach the atomizer tube so that it faces downward.

Maximum single dose for adults is 0.85 mg chlorhexidine and 0.21 mg lidocaine.

Maximum daily dose of chlorhexidine 8.5 mg and 2.1 mg of lidocaine. Each press of the nozzle sprays 0.085 ml of solution.

Side effects

The product is well-tolerated when used topically, for a limited time, in the oral cavity and in the pharynx, observing the recommended dose.

Common (1/100, <1/10):

  • skin hypersensitivity reactions;
  • nausea, vomiting, abdominal pain.

Rare (1/10000, <1/1000):

  • severe allergic reactions, including anaphylactic shock;
  • contact dermatitis.

Unknown:

  • methemoglobinemia;
  • delayed allergic reaction (contact allergy, photosensitization) or other local reactions on the skin or teeth;
  • anxiety, excitement, euphoria;
  • Drowsiness, dizziness, disorientation, confusion (including speech confusion), vertigo, tremor, psychosis, nervousness, paresthesia, numbness, seizures, unconsciousness, and coma;
  • visual disturbances, including out-of-focus vision and double vision;
  • buzzing in the ears;
  • breathing difficulties, respiratory failure syndrome, respiratory depression, respiratory arrest;
  • difficulty in swallowing, ulcers on the mucous membrane of the oral cavity;
  • lichenoid reaction;
  • muscle cramps or tremors;
  • general weakness, temporary distortion of the taste or a burning sensation on the tongue, a feeling of hot or cold.

If chlorhexidine is used continuously and for a long period of time in the mouth, brown staining of the teeth may occur temporarily. However, this plaque can be removed. There are no descriptions of cases of staining of teeth when using the product in the pharynx area.

Overdose

Symptoms arising from systemic intoxication:

  • central nervous system disorders: headache, hallucinations, dizziness, drowsiness, agitation, tinnitus, paresthesias, dysarthria, hearing disorders, perioral numbness, metabolic acidosis, nystagmus, muscle tremors, psychosis, seizures, respiratory arrest, epileptic coma, reduced level of consciousness;
  • effects on the cardiovascular system: cardiovascular insufficiency, severe bradycardia, heart rhythm disturbances (sinus node arrest, tachyarrhythmia), cardiac arrest.

Treatment for systemic intoxication:

  • immediate discontinuation of the product;
  • gastric lavage and aspiration of gastric contents, induce vomiting;
  • hospitalization to ensure respiratory function, prevent dehydration, and maintain blood circulation;
  • Diazepam is prescribed for seizures.

Use during pregnancy or breastfeeding

If it is necessary to prescribe the product during pregnancy and lactation, the expected benefit to the mother and the potential risk to the fetus should be assessed.

Pediatric population

Approved for children over 5 years of age.

Special Warnings

In bacterial infections accompanied by elevated body temperature, Lidin-DF is used as an adjunctive medication.

Patients with chronic heart failure or liver dysfunction, as well as those simultaneously taking antiarrhythmic agents of class 1B, should be careful when prescribing the drug, because of the danger of increasing the toxic effect of lidocaine.

Caution should be exercised when using this product in patients prone to allergic reactions.

Lidin-DF can be used by diabetic patients because it does not contain sucrose.

Do not use the product continuously, longer than 3-4 days, or too often. It is necessary to use the product only for the necessary alleviation of the symptoms of pain and irritation.

Effects on ability to drive and use  machines

Studies on the ability to drive or operate potentially dangerous machinery have not been conducted.

Presentation and package

30 ml of the product in dark glass bottles with an atomizer and a protective cap. Each bottle has a label made of label or writing or self-adhesive paper.

One bottle with instructions for use in the state and Russian languages are placed in a carton pack made of chrome-ersatz.

Group and transport containers in accordance with GOST 17768-90.

Storage conditions

Store below 25оС.

Keep out of the reach of children.

Shelf life

5 years

Manufacturer

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.

Marketing authorization holder

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.

Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,

Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

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