Translation of the instruction Mose

Evkafilipt® ksilospry nasal dosed 0.1%

Instruction

On medical use of medicine

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Evkafilipt®

(eucaphylipt xylo)

Ingredients:

Active ingredient: xylomethazolinum hydrochloride;

1 mg contains

1 ml of solution xylomethazolinum of a hydrochloride;

excipients: sodium dihydrophosphate, dihydrate; sodium hydrophosphate, dodecahydrate; sodium chloride, a chloride benzalkoniya solution, dinatrium edetat, menthol (left menthol), oil eucalyptus, sorbite (E 420), the castor oil polyethoxylated, hydrogenated; the water purified.

Dosage form.

Spray nasal, dosed.

Main physical and chemical properties: transparent or opalescent solution from colourless till white color, with a smell of menthol or menthol and an eucalyptus.

Pharmacotherapeutic group.

Means, applied at nasal cavity diseases. antiedematous and other medicines for topical administration at nasal cavity diseases. sympathomimetics, plain medicines.

ATX R01A A07 Code.

Pharmacological properties.

Pharmacodynamics.

Xylomethazolinum is the sympathomimetic agent acting on α-adrenergic receptors.

Xylomethazolinum at nasal application causes narrowing of blood vessels of a mucous membrane of a nose and adjacent sites of a nasopharynx, eliminating thus hypostasis and hyperaemia of a mucous membrane of a nose and nasopharynx and also reduces the increased mucifying connected with it and facilitates removal of the blocked discharges from a nose that leads to clarification of nasal passes and simplification of nasal breath.

Effect of medicine begins

within 2 minutes after application and remains till 12 o'clock.

Drug is well transferred by

, including patients with a sensitive mucous membrane, and does not reduce mukotsiliarny function. Results of laboratory analyses showed that xylomethazolinum reduces infectious activity of a rhinovirus of the person who is associated with common cold.

Thanks to moisturizing component sorbitol the medicine Evkafilipt Ksilo, spray nasal, helps at dryness and irritation of a mucous membrane of the nasal courses. Drug has the balanced value rn in the limits inherent to a nasal cavity.

Pharmacokinetics.

medicine is practically not absorbed by

At topical administration, concentration of xylomethazolinum in blood plasma are so small that are practically not found (concentration in blood plasma is close to a definition limit).

Xylomethazolinum has no mutagen properties. Also in researches on animals the teratogenic influence of xylomethazolinum was not revealed.

Clinical characteristics.

Indication.

Symptomatic treatment of congestion of a nose at cold, hay fever, at other allergic rhinitises, sinusitis.

For simplification of outflow of a secret at diseases of adnexal bosoms of a nose.

Auxiliary therapy in cases of average otitis (for elimination of hypostasis of a mucous membrane).

For simplification of carrying out a rinoskopiya.

Contraindication.

Hypersensitivity to xylomethazolinum or to any other component of medicine, sharp coronary diseases, coronary asthma, a hyperthyroidism, closed-angle glaucoma, transfenoidalny hypophysectomy and surgical interventions with exposure of a meninx in the anamnesis, dry rhinitis (rhinitis sicca) or atrophic rhinitis. the accompanying treatment by Mao's inhibitors and within 2 weeks after the termination of their application.

Interaction with other medicines and other types of interactions.

Monoamine oxidase inhibitors (Mao's inhibitors): xylomethazolinum can exponentiate effect of inhibitors of Mao and induce hypertensive crisis. not to apply xylomethazolinum to patients who accept or accepted Mao's inhibitors within the last two weeks.

Three - and tetracyclic antidepressants: at simultaneous application three - or tetracyclic antidepressants and sympathomimetic medicines strengthening of sympathomimetic effect of xylomethazolinum is possible therefore simultaneous application of such means is not recommended.

At application together with β-blockers the bronchial spasm or a lowering of arterial pressure can cause

.

Feature of application.

should not use Drug longer than 10 days in a row. too prolonged or excessive use can lead to resuming of congestion of a nose and/or a mucosal atrophy of a nose.

Drug, as well as other sympathomimetics, it is necessary to appoint with care to patients who have strong reactions to adrenergic means which are shown in the form of insomnia, dizziness, a shiver, cardiac arrhythmia or increase in arterial blood pressure.

should not exceed the recommended medicine dose, especially at treatment of children and elderly people.

Should appoint by

with care medicine to patients with cardiovascular diseases, arterial hypertension, sick diabetes, with a pheochromocytoma, a prostatauxe and also not to apply to patients who received the accompanying treatment by MAO inhibitors and within 2 weeks after the termination of their application.

Patients with a syndrome of the extended interval of QT which applied xylomethazolinum can have the increased risk of serious ventricular arrhythmias.

Drug the benzalkoniya contains chloride which can cause irritation of a mucous membrane of a nose.

Drug contains the castor oil polyethoxylated, hydroginezirovanny which can cause skin reactions.

Use during pregnancy or feeding by a breast.

Drug cannot be used during pregnancy because of potential vasoconstrictive influence.

Proof of any undesirable influence on the baby are absent. It is unknown whether xylomethazolinum in breast milk is excreted therefore the care is necessary, and medicament during feeding by a breast should be used only on doctor's orders.

Fertility.

Appropriate data on influence of the medicine Evkafilipt Ksilo on fertility are absent. As system exposure of xylomethazolinum of a hydrochloride very low, probability of influence on fertility too very low.

Ability to influence speed of response at control of motor transport or other mechanisms.

Usually medicine has no

or has insignificant impact on ability to steer vehicles or to work with mechanisms.

Route of administration and doses.

to use Drug to adults and children from 12 years on 1 injection in each nasal course to 3 times a day. to apply no more than 3 times in each nasal course in day. duration of treatment depends on a course of the disease and should not exceed 10 days in a row.

Dosed spray provides to

accuracy of dosing and appropriate distribution of solution on a nose cover mucosal surface. At each injection 0.14 ml of solution are entered that corresponds to 0.14 mg of xylomethazolinum.

Before application needs to set ready the portioning device by implementation of several injecting movements until spray begins to be emitted in air. At further application the portioning device will be ready for immediate application.

needs to Apply spray as follows:

carefully to clean with

• a nose before use of medicine;
• should hold a bottle vertically, supporting a bottom by a thumb and having a tip between two fingers;
• slightly to incline a bottle and to insert a tip into a nostril;
• to carry out injection and at the same time to carry out an easy breath through a nose;
• after application before closing a tip a cap, it is necessary to clean and dry up a tip;
for the purpose of prevention of infection each bottle with medicine only one patient can use
• .

Last application is recommended to be carried out just before a dream.

Children.

not to use Drug to children up to 12 years.

Overdose.

Excessive topical administration of xylomethazolinum of a hydrochloride or its accidental hit inside can lead

to developing of the expressed dizziness, the increased sweating, considerable decrease in body temperature, a headache, bradycardia, arterial hypertension, to respiratory depression, a coma and spasms. the increased arterial blood pressure can change on lowered. children of younger age are more sensitive to toxicity, than adults.

to All patients with suspicion should appoint by

relevant supporting activities and also, in case of need, urgent symptomatic treatment under medical supervision to overdose. Medical care has to include observation of the patient within several hours. In case of the heavy overdose which is followed by cardiac arrest, resuscitation actions have to continue not less than 1 hour.

Side reactions.

from the immune system:

it is very rare (

from nervous system:

it is frequent (≥1/100,

from organs of sight:

it is very rare (

from a cardiovascular system:

it is very rare (

from respiratory organs, a thorax and mediastinum:

it is frequent (≥1/100,

from digestive system:

it is frequent (≥1/100,

General violations and reactions in the injection site:

it is frequent (≥1/100,

Expiration date.

2 years.

not to apply

after the expiration date specified on packing.

Storage conditions.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Packing.

On 10 ml in a bottle glass with the spray nasal or in a bottle polymeric with the spray nasal. on 1 bottle in a pack from cardboard.

Category of a holiday.

Without recipe.

Producer.

Public joint stock company "chemical pharmaceutical plant "red star".

Location of the producer and address of the place of implementation of its activity.

61010, Ukraine, Kharkiv, st. gordiyenkovsky, 1.