Instructions for Helpex lar spray 30 ml
Composition
active ingredients: chlorhexidine digluconate, benzydamine hydrochloride;
30 ml of solution contain chlorhexidine digluconate 20% solution in terms of chlorhexidine digluconate 36 mg, benzydamine hydrochloride 45 mg;
excipients: glycerin, polysorbate 20, peppermint flavoring, sodium saccharin, sodium bicarbonate, concentrated hydrochloric acid, purified water, ethanol 96%.
Dosage form
Oral spray, 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 used for inflammatory and infectious diseases of the oral cavity and throat, accompanied by pain, inflammation and irritation: pharyngitis, tonsillitis, gingivitis, stomatitis and aphthae.
Benzydamine is a nonsteroidal anti-inflammatory drug (NSAID); 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 trials conducted with benzydamine in patients with localized inflammatory processes in the oral cavity and pharynx accompanied by pain. The analgesic effect of benzydamine was reported more often in models with experimental inflammation than in pain without inflammation.
Its effectiveness when applied topically is due to its ability to penetrate the epithelial layer and reach effective concentrations in inflamed tissues.
Benzydamine inhibits cyclooxygenase and lipoxygenase and suppresses prostaglandin synthesis.
Further mechanisms of action are associated with inhibition of the oxidative burst of neutrophils, as well as membrane stabilization by inhibition of granule release from neutrophils and stabilization of lysosomes. Local anesthetic activity is associated with interaction with cation channels.
Chlorhexidine is a cationic biguanide antiseptic; it has an antibacterial bactericidal and prolonged bacteriostatic effect when applied topically on a wide range of gram-positive and gram-negative bacteria, yeasts, dermatophyte 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 mucosa and inhibits bacterial growth through delayed surface action. Chlorhexidine is a strong base with affinity for oral structures including hydroxyapatite of tooth enamel, tooth surface coating, bacterial protein and salivary protein.
Absorbed by phosphate-containing areas of the microbial cell wall, which disrupts the integrity of the cell membrane.
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 tartar 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 an anti-inflammatory and anesthetic effect at the site of application; when the drug is used in the form of an oral spray, the amount of benzydamine that enters the systemic circulation is so small that it cannot exert any pharmacological effect.
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
Chlorhexidine does not accumulate in the body and is metabolized only to a small extent. Approximately 10% of chlorhexidine that enters the stomach is excreted by the kidneys after absorption; 90% of the unabsorbed amount is excreted in the feces.
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.
Contraindication
Hypersensitivity to benzydamine, chlorhexidine or any other component of the drug.
Chlorhexidine digluconate is a cationic substance and is incompatible with anionic substances. Chlorhexidine should not be used simultaneously with oral preparations containing iodine.
There are no reports of interactions between benzydamine and other drugs.
Application features
For external (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 you should cough after each use.
If sensitivity occurs while using the medicine, treatment should be discontinued and a doctor should be consulted.
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.
The drug may cause discoloration of the teeth and tongue. Before using the drug, you should brush your teeth to minimize discoloration.
The drug contains a small amount (less than 100 mg) of ethanol (alcohol) in each dose.
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.
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: There are no data on adverse effects on fertility.
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
Adults and children over 12 years of age: 4 sprays every 1.5–3 hours, up to 5 times a day.
The dose is applied directly to the inflamed area.
Before first use, the bottle sprayer must be directed away from the face and the pump must be pressed several times to obtain a fine spray.
The bottle must be stored in the box in an upright position.
Children
The medicine is used in children from 12 years of age.
Overdose
The drug cannot cause systemic side effects even if accidentally swallowed.
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.
Benzydamine can cause intoxication only if taken orally in amounts greater than 300 mg (which is hundreds of times the possible doses of this dosage form), which can cause, especially in children, agitation, convulsions, tremors, nausea, increased sweating, ataxia, vomiting. In case of acute overdose, symptomatic and supportive treatment, observation and adequate hydration are used.
Adverse reactions
Adverse reactions are classified according to frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); frequency unknown (cannot be estimated from the available data).
On the part of the immune system:
rarely - hypersensitivity reaction;
very rarely - itching, rash, urticaria, photosensitivity reactions, angioedema;
frequency unknown - anaphylactic reaction.
Respiratory, thoracic and mediastinal disorders:
very rarely - laryngospasm;
frequency unknown - bronchospasm.
From the nervous system:
frequency unknown - dizziness, headache.
From the digestive system:
often - burning sensation in the mouth;
rarely - dry mouth;
frequency unknown - oral hypoesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste changes, irritation in the oral cavity, feeling of cold in the oral cavity.
When using chlorhexidine, temporary discoloration of the teeth and tongue, and tartar deposition are also possible. There have been no such reports when using the drug for the treatment of throat diseases.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after the marketing authorisation of a medicinal product plays an important role. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national pharmacovigilance system.
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
30 ml of solution in a glass bottle with a sprayer in a cardboard box.
Vacation category
Without a prescription.
Producer
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.
