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Halazolinum

Препарат Галазолин. Polpharma/Medana Pharma S. A. («Польфарма»/ Медана Фарма С. А.) Польша


Producer: Polpharma/Medana Pharma S. A. (Polfarm / Medan of Pharm S.A.) Poland

Code of automatic telephone exchange: R01AA07

Release form: Soft dosage forms. Gel.

Indications to use: Acute rhinitis (cold). Allergic rhinitis (cold). Sinusitis. Eustachitis (Tubo-otitis). Average otitis. Rhinitis (cold).


General characteristics. Structure:

Active ingredient:
Gel of nasal 0,05% - hydrochloride xylomethazolinum 0,5mg
Gel of nasal 0,1% - hydrochloride xylomethazolinum 1,0mg

Excipients: Hydrosodium phosphate, dihydrosodium phosphate, disodium salt of ethylene diamine tetraacetic acid, chloride benzalkoniya, sorbitol, chloride sodium, oksietiltselyulloz, glycerin, water.




Pharmacological properties:

Xylomethazolinum concerns to group of local vasoconstrictors (decongestants). Shows alpha адреномиметическое action. In low concentration has generally alfa2-adrenomimetichesky effect, at high - works also on an alpha 1 adrenoceptors. Narrows vessels in a site of application, reduces puffiness of a mucous membrane of a nose and upper parts of respiratory tracts. At topical nasal administration in therapeutic concentration does not irritate mucous, does not cause a hyperemia.


Indications to use:

Acute rhinitis (including virus, bacterial, allergic), sinusitis, eustachitis, average otitis.


Route of administration and doses:

Every time before to use drug it is necessary to remove a nozzle, and then to press the doser of 3-5 times, until emergence of drug.
Gel for a nose of 0.05%.
One dose at introduction by means of the portioning device contains 0,05 mg of xylomethazolinum.
Children aged from the 3rd up to 6 years: the average dose makes single introduction to each nasal course 1-2 times a day.
Gel for a nose of 0,1%.
One dose at introduction by means of the portioning device contains 0,1 mg of xylomethazolinum.
Adults and children are more senior than 12 years: the average dose makes single introduction to each nasal course 2-3 times a day.
It is not necessary to use drug more than 3 times a day. Drug use duration - no more than 3-5 days. More than 2 weeks are not recommended to use drug.


Features of use:

Prolonged use of antiedematouses for an instillation in a nasal cavity can lead to weakening of their action. Abuse of these means can cause a mucosal atrophy and a reactive hyperemia with medicamentous rhinitis.
It is necessary to avoid long use and overdoses.
Use during pregnancy and a lactation
During pregnancy and a lactation it is not allowed to exceed the recommended dosage. Drug has to be used only after careful assessment of a ratio of risk and advantage for mother and a fruit.
Influence on ability to manage vehicles and the equipment:
After prolonged use of the means for cold containing xylomethazolinum in the dosages exceeding recommended it is impossible to exclude the general influence on cardiovascular and central nervous systems. In these cases ability to manage the vehicle or the equipment can decrease.


Side effects:

Sometimes burning or dryness of nasal covers, sneezing. In rare cases - after there passes the effect of drug use, strong feeling of "congestion" of a nose (reactive hyperemia).


Interaction with other medicines:

The use in xylomethazolinum and reception of tricyclic antidepressants or MAO-inhibitors at the same time or directly before use of xylomethazolinum can be led to increase in arterial pressure. There are no known cases of medicinal incompatibility now.


Contraindications:

- hypersensitivity to drug components;
- atrophic rhinitis;
- the increased intraocular pressure, closed-angle glaucoma;
- arterial hypertension;
- the expressed atherosclerosis;
- tachycardia;
- hyperthyroidism;
- diabetes mellitus;
- pheochromocytoma;
- a concomitant use of MAO inhibitors and the period up to 14 days after the end of their use.


Overdose:

Adults had no messages on cases of overdose of drug.
In rare instances, at accidental poisoning with xylomethazolinum at children increase of pulse and arrhythmia, increase in arterial pressure and sometimes confusion of consciousness were noted. Symptomatic treatment.

At local nasal use results sometimes in such system symptomatic effects as increase of pulse (tachycardia) and increase in arterial pressure.
Seldom or never at use of xylomethazolinum the concern, sleeplessness, headaches and nausea are observed.


Storage conditions:

To store at a temperature from 15 to 25 °C in the place unavailable to children.
To protect from light.


Issue conditions:

Without recipe


Packaging:

Gel of nasal 0.05% and 0,1% about 10 g are packed into polyethylene bottles with the doser and an aluminum cap. One bottle together with the application instruction is placed in a cardboard pack.



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