Instructions for Helpex Lar throat rinse solution 120 mg + 150 mg bottle 200 ml
Composition
active ingredients: chlorhexidine digluconate, benzydamine hydrochloride;
100 ml of solution contain chlorhexidine digluconate 20% solution in terms of chlorhexidine digluconate 120 mg, benzydamine hydrochloride 150 mg;
excipients: glycerin, polysorbate 20, peppermint flavoring, sodium saccharin, sodium bicarbonate, concentrated hydrochloric acid, purified water, ethanol 96%.
Dosage form
Throat rinse, solution.
Main physicochemical properties: transparent colorless or yellowish solution.
Pharmacotherapeutic group
Means for use in dentistry. Other means for local use in the oral cavity. ATX code A01A D02.
Pharmacological properties
Pharmacodynamics.
Helpex® LAR is an antiseptic, analgesic, anti-inflammatory agent for the treatment of inflammatory and infectious diseases of the oral cavity and throat, accompanied by pain, inflammation and irritation: pharyngitis, tonsillitis, gingivitis, stomatitis and aphthae. It has an antiseptic effect in the oral cavity, facilitates swallowing. It is used for preventive purposes before and after dental procedures. It reduces the formation of dental plaque and manifestations of gingivitis, is used as an alternative to oral hygiene procedures.
Benzydamine is a nonsteroidal anti-inflammatory drug (NSAID) of local action; it has anti-inflammatory, analgesic and antiexudative effects, and when applied topically, it has an anesthetic effect on the oral mucosa.
The clinical efficacy of benzydamine has been demonstrated in clinical studies conducted in patients with localized inflammatory processes in the oral cavity and pharynx, accompanied by pain. The analgesic effect of benzydamine has been reported more often in models with experimental inflammation than in pain without inflammation. Its efficacy when applied topically is due to its ability to penetrate the epithelial layer and reach effective concentrations in inflamed tissues.
Benzydamine inhibits the synthesis of prostaglandins and pro-inflammatory cytokines (TNF-α) and (IL-1β).
Further mechanisms of action are associated with inhibition of the neutrophil oxidative burst, as well as membrane stabilization by inhibiting granule release from neutrophils and stabilizing lysosomes. Local anesthetic activity is associated with interaction with cation channels.
Chlorhexidine is a cationic biguanide antiseptic; when applied topically, it has antibacterial, bactericidal and prolonged bacteriostatic action on a wide range of gram-positive (Micrococcus sp., Staphylococcus sp., Streptococcus sp., Bacillus sp., Clostridium sp., Corynebacterium sp., etc.) and gram-negative bacteria, yeast (Candida albicans and others), fungi, lipophilic viruses (influenza, herpes, HIV, etc.) and is thus active against the most important pathogenic species of microorganisms of the oral microflora. It binds to the mucous membrane and inhibits the growth of bacteria due to its delayed surface action. Chlorhexidine is a strong base with affinity for oral structures, including hydroxyapatite of tooth enamel, the surface layer of the tooth, bacterial protein and salivary protein.
Absorbed by phosphate-containing areas of the microbial cell wall, which disrupts the integrity of the cell membrane. Provides long-lasting persistent antimicrobial activity, preventing the reproduction of microorganisms for at least 6 hours after application of the drug. In the presence of blood, pus and saliva, the antimicrobial activity of chlorhexidine gluconate does not decrease.
Effective in a wide range of pathological conditions of the oropharynx. Reduces the formation of dental plaque and associated gingivitis, which is manifested by redness, swelling or bleeding of the gums. Reduces the incidence of aphthous ulcers and increases the speed of healing after surgical intervention. Reduces the development of dental plaque and gingivitis when normal oral hygiene measures are not possible.
Pharmacokinetics.
Absorption
Due to the cationic nature of chlorhexidine digluconate, it binds to mucosa and other tissues when applied topically and is extremely poorly absorbed. Blood levels of chlorhexidine were not detectable after topical application.
When applied topically, benzydamine is absorbed by the oral mucosa and exhibits anti-inflammatory and anesthetic effects at the site of application. When the drug is used in solution, the amount of benzydamine that enters the systemic circulation is so small that it cannot exert any systemic pharmacological action.
Distribution
The drug acts locally, according to the specified method of administration it should not be swallowed. Systemic absorption and distribution are not expected after application of the drug.
Biotransformation
Since chlorhexidine digluconate is poorly absorbed, it is not possible to measure it in blood plasma. Benzydamine is metabolized mainly by oxidation and conjugation.
Breeding
Benzydamine and its metabolites, entering the systemic circulation, are excreted mainly in the urine.
Indication
Inflammatory and infectious diseases of the oral cavity and pharynx, accompanied by pain, inflammation and irritation: pharyngitis, tonsillitis, gingivitis, stomatitis and aphthae.
· For oral care before and after dental procedures.
· To reduce plaque.
Contraindication
Hypersensitivity to benzydamine, chlorhexidine or any other component of the drug.
Interaction with other medicinal products and other types of interactions
Chlorhexidine digluconate is a cationic substance and is incompatible with anionic and iodine-containing substances, therefore they should not be used simultaneously.
There are no reports of interactions between benzydamine and other drugs.
Application features
For external use (oral use only); avoid contact with eyes and ears; if in eyes, rinse immediately with plenty of water.
The medicine does not require dilution, it should not be swallowed, and cough should be cleared after each use. If sensitivity occurs during use of the medicine, treatment should be discontinued and a doctor should be consulted.
If you experience a burning or tingling sensation during application, the solution can be diluted with water.
If the patient's condition does not improve after 3–4 days of treatment, a doctor should be consulted to determine further treatment.
Benzydamine should not be used in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
The use of the drug may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients should be warned about this.
In some patients, buccal/pharyngeal ulcers may be due to serious pathological processes. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop a fever or other symptoms, should seek advice from a physician or dentist as appropriate.
Chlorhexidine is incompatible with anionic substances commonly present in toothpastes, so teeth should be brushed before rinsing or at any other time.
The drug may cause temporary reversible discoloration of the teeth and tongue. This can be prevented by reducing the consumption of staining products. In the case of dentures, clean with a regular denture cleaner; in the presence of orthodontic appliances, when regular brushing is not possible and if the discoloration persists, professional cleaning and polishing may be necessary.
It does not contain sugar, so it can be used by patients with diabetes. It does not contain dyes.
For athletes: the use of medicines containing ethyl alcohol may give a positive result in a doping test, taking into account the limits set by some sports federations.
Glycerin has a softening effect on the mucous membrane of the oral cavity.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding due to the lack of adequate data on the safety of use.
Fertility: No cases of negative effects of chlorhexidine digluconate on fertility have been identified, and no studies have been conducted on the effects of benzydamine hydrochloride.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive or use other mechanisms.
Method of administration and doses
Used for rinsing the mouth for adults and children over 12 years of age.
Measure 15 ml of the solution into a measuring cup, use undiluted or diluted (with the same amount of water), rinse 2–3 times a day with an interval of 3–5 hours. If necessary, the number of rinses can be increased to 4 times a day. Keep in the mouth for at least 30 seconds, do not swallow.
Do not use for more than 7 consecutive days without consulting a doctor.
The drug reduces plaque and gingivitis during treatment.
When used as an alternative to oral hygiene procedures, the solution should be kept in the mouth for at least 1 minute.
Children.
The medicine is used in children from 12 years of age.
Overdose
Systemic side effects are not expected if accidentally ingested.
Chlorhexidine is poorly absorbed when ingested, so systemic effects are not expected. The main consequence of ingestion of excessive doses may be irritation of the mucous membranes.
In case of acute overdose, symptomatic and supportive treatment, gastric lavage, treatment of water and electrolyte imbalance, observation and adequate hydration are used.
If a child swallows a significant amount of the drug, alcohol intoxication may occur.
Adverse reactions
Adverse reactions are classified according to frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/100);
On the part of the immune system:
infrequently - photosensitivity reactions;
rarely - hypersensitivity reactions;
very rarely - angioedema;
frequency unknown – itching, rash, urticaria, anaphylactic reaction.
From the respiratory system, chest organs and mediastinum:
very rarely – laryngospasm;
frequency unknown – bronchospasm.
From the nervous system:
frequency unknown – dizziness, headache.
From the digestive system:
very often - plaque on the tongue;
often - dry mouth, numbness in the mouth, change in taste;
rarely – burning sensation in the mouth;
very rarely - discoloration of teeth and tongue, tingling, feeling of cold in the mouth, irritation in the mouth, swelling of the oral mucosa, desquamation, nausea, vomiting, thirst, swelling of the parotid gland.
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
Store out of the reach of children in the original packaging at a temperature not exceeding 25 °C.
Packaging
200 ml of solution in a bottle; 1 bottle with a measuring cup in a cardboard box.
Vacation category
Without a prescription.
Producer
Deva Holding A.S.
Location of the manufacturer and address of its place of business
Cerkezkoy Site I, Cerkezkoy Organization of Industrial Bolgezi, Karaagac Mah., Ataturk Caddesi No. 32, 59510, Kapakli, Tekirdag, Turkey.
Applicant
Movie Health GmbH.
Applicant's location
Bleichstrasse 25, 6340 Baar, Switzerland.
