Halset
Producer: Biofarm Ltd Biofarm Ltd, Poland
Code of automatic telephone exchange: R02A
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 1,5 mg of chloride cetylpyridinium,
Excipients: sorbitol, mint oil, menthol, magnesium stearate.
Pharmacological properties:
Drug shows soft, local antiseptic, antiinflammatory and tonic action. Has bactericidal effect concerning gram-positive, gram-negative bacteria and mushrooms (Candida albicans), does not influence mycobacteria. Cetylpyridinia chloride as well as other cationic surface-active connections, metabolism of bacteria oppresses, blocking important fermental systems, exerts impact on cytoadhesive mechanisms of a bacterium, increases permeability of a cytoplasmatic cover of microorganisms and destroys it. In poorly alkaline environment cetylpyridinium chloride is in the ionized form causing efficiency of medicine; at рН below the 3rd medicine completely loses the activity.
Pharmacokinetics. In the tablets Halseg® local action cetylpyridinium of chloride which of a GIT is soaked up very badly, as much as possible for 15% is used. In process of growth of acid reaction in a GIT it everything is more inactivated. Anionny substances and lipids also inactivate it. In the concentration observed after medicine reception inside in the recommended doses does not cause systemic action. It is brought out of an organism in not changed look.
The preclinical data concerning safety
Cetylpyridinia chloride is safe substance. The difference between a therapeutic dose at people and lethal at laboratory animals reaches, taking into account body weight, about several thousand. LD50 of river of the lake at mice makes 125 mg/kg of body weight, and at rabbits - 400 mg/kg of body weight. In the researches chloride cetylpyridinium conducted on laboratory animals mutagen, teratogenic and cancerogenic action was not revealed.
Indications to use:
— for prevention and treatment of slight and medium-weight infections and inflammatory processes of an oral cavity and a throat.
Route of administration and doses:
Хальсет® appoint inside. To rassasyvat slowly on 1 tablet.
Adults and teenagers: to rassasyvat on one tablet each 1-2 h (at most 8 tablets in).
Children are more senior than 6 years: to rassasyvat on one tablet each 2-3 h (at most 6 tablets in).
Medicine is not recommended to children to appoint younger than 6 years. It is not recommended to accept along with meal.
Features of use:
Regardless of administration of drug of Halset®, at heavy inflammatory processes of the upper respiratory tracts or pharyngalgias proceeding with high temperature, a headache, nausea and vomiting it is necessary to consult with the doctor, especially if the clinical picture of a disease accrues or does not decrease within three days.
It is not necessary to accept in the presence of open wounds in an oral cavity since cetylpyridinium chloride slows down their healing.
With care to the women planning pregnancy at pregnancy and in the period of a lactation.
Use of bigger quantity of tablets, than is recommended, does not increase efficiency of effect of medicine, in too time can cause irritation of a mucous membrane of an oral cavity or diarrhea (especially in children), nausea and vomiting.
In view of lack of sugar, Halset® does not cause development of caries.
It can be applied by persons with not complicated diabetes mellitus.
The medicine Halset® contains sorbitol therefore it should not be applied to patients at whom the intolerance of fructose is revealed.
In case of allergic reaction the patient has to see a doctor.
Influence on ability to driving of motor transport and to control of mechanisms
Drug does not limit ability to control of vehicles and service of moving mechanisms.
Side effects:
There can seldom come quickly passing allergic reactions (for example: skin rash), nausea and disorder of taste, developing of diarrhea is possible.
Interaction with other medicines:
Interactions cetylpyridinium of the chloride applied in the form of tablets to suction with concentration of active ingredient of 0.2% are unknown, Halset® most effectively works in poorly alkaline environment; in strongly acid medium - it is inactivated.
Food and milk reduce the antiseptic and locally anesthetizing effects.
Contraindications:
— hypersensitivity to medicine components, intolerance of fructose which can be formed of sorbitol (seldom shown metabolic disease).
— not to apply at children up to 6 years, considering a possibility of accidental hit of a tablet in respiratory tracts.
Use of drug HALSET at pregnancy and feeding by a breast
The data concerning safety of use of Tsetilpiridiniya of chloride for women during this period either are absent, or are insufficient, however it should be noted that this substance long since is everywhere applied without the expressed clinical effects. The data concerning use of the medicine Halset® during pregnancy and a lactation no.
Overdose:
The sorbitol which is quantitatively the main component of tablets at considerable overdose can cause diarrhea with the accompanying dehydration. Tsetilpiridiniya's overdose of chloride can lead to irritation of a mucous membrane of an oral cavity, diarrhea (especially at children), nausea and vomiting. In case of suspicion on medicine overdose the patient has to see immediately a doctor behind consultation. Actions which should be applied in case of poisoning: gastric lavage, support of activity of respiratory and cardiovascular systems. At emergence of spasms - it is necessary to appoint barbiturates in small doses.
Storage conditions:
To store drug in the place, dry and unavailable to children, at a temperature below 25 °C.
Issue conditions:
Without recipe
Packaging:
24 tablets in blisters (on 6 tablets in the blister) placed in a cardboard box.