Viks Active Sinex - instructions for use, dose, side effects, contraindications

Excipients: sorbitol 5.0 g, sodium citrate dihydrate 0.875 g, tyloxapol 0.7 g, chlorhexidine bigluconate (20% solution) 0.27 g, citric acid anhydrous 0.2 g, aloe vera 0.1 g, benzalkonium chloride (50% solution) 0.04 g, levomentol 0.015 g, potassium acesulfame 0.015 g, cineole 0.013 g, L-carvone 0.01 g, disodium edetate 0.01 g, sodium hydroxide (0.1 M solution) to pH 5.4, water distilled to 100 ml.

Description:

Colorless or colorless with a yellowish hue, a clear solution with a characteristic odor, with no visible inclusions.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

S.01.G.A.04 Oxymetazoline

Pharmacodynamics:

Oksimetazolin belongs to the group of alpha-adrenostimulators for topical application. Has vasoconstrictive effect. With intranasal administration reduces the swelling of the mucous membrane of the upper respiratory tract, which leads to the relief of nasal breathing and the opening of the mouth of the paranasal sinuses and Eustachian tubes. The drug appears after 5 minutes after application and lasts for 8-12 hours.

Pharmacokinetics:

With topical application oxymetazoline practically not absorbed.

Indications:

To facilitate nasal breathing with "cold" diseases or viral infections of the upper respiratory tract, sinusitis, rhinitis of any etiology.

Contraindications:

- Hypersensitivity to the components of the drug: atrophic (dry) rhinitis;

- administration of monoamine oxidase inhibitors (MAO) during the previous 2 weeks and within 2 weeks after their cancellation;

- an angle-closure glaucoma;

- condition after transsphenoidal hypophysectomy;

- children's age till 6 years;

- Pregnancy;

- lactation period;

- surgical interventions on the dura mater (in the anamnesis).

Carefully:

FROM caution should be used in patients suffering from cardiovascular diseases (arterial hypertension, coronary heart disease, chronic heart failure, tachycardia, arrhythmias), a violation of carbohydrate metabolism (diabetes mellitus), thyroid function (hyperthyroidism), pheochromocytoma, chronic renal failure, hyperplasia of the prostate (urinary retention), porphyria and in patients taking tricyclic antidepressants and bromocriptine.

Pregnancy and lactation:

Pregnancy

There are no clinical data on exposure to oxymetazoline during pregnancy.

Animal studies do not confirm a direct or indirect effect on the course of pregnancy, embryo / fetus development, childbirth or neonatal development, however, the use of Vix Active Cinex during pregnancy is not recommended.

Breast-feeding

It is not known whether oxymetazoline hydrochloride is excreted in breast milk, the use of Vix Active Sinex during breastfeeding is not recommended.

Dosing and Administration:

Intranasally.

Adults and children over 10 years of age - 1-2 injections in each nasal passage as much as 2-3 times a day.

Children from 6 to 10 years - 1 injection in each nasal passage as much as 2-3 times a day.

Duration of treatment

It is not recommended to use the drug for more than 7 days. With frequent or prolonged use of the drug, a feeling of difficulty in nasal breathing may reappear or worsen. If these symptoms appear, discontinue treatment and consult a doctor.

When injecting, do not tilt the head back and do not spray in prone position.

Side effects:

Sometimes burning or dryness of the mucous membranes of the nose, dryness in the mouth and throat, sneezing, increase in the amount of secret secreted from the nose.

In rare cases - after the effect of the drug has passed, a strong sense of "stuffiness" of the nose (reactive hyperemia).

Side effects caused by the systemic effect of the drug: increased blood pressure, headache, dizziness, severe palpitations, tachycardia, increased anxiety, sedation, irritability, sleep disturbances (in children), nausea, insomnia, exanthema, visual impairment (eye contact).

Preservative benzalkonium chloride, which is part of the drug, can cause swelling of the nasal mucosa. If this happens, it is necessary to change the drug to another, which does not contain preservatives.

Overdose:

Symptoms: anxiety, anxiety, hallucinations, convulsions, lowered body temperature, lethargy, drowsiness, coma, narrowing or dilating pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, lowering blood pressure, nausea , vomiting, respiratory depression, respiratory arrest.

Treatment: gastric lavage, reception of activated charcoal (with accidental ingestion of the drug inside); symptomatic.

Interaction:

When used simultaneously with MAO inhibitors (including the period within 14 days after their cancellation) and tricyclic antidepressants, an increase in blood pressure may be observed.

The drug slows the absorption of local anesthetic drugs, lengthens their action.

Co-administration of other vasoconstrictor drugs increases the risk of side effects.

Special instructions:

In the recommended dose without consulting a doctor, use no more than 7 days.

If the symptoms increase or the improvement does not occur within 3 days, you should consult your doctor.

Avoid contact with eyes.

To avoid the spread of infection, it is necessary to use the drug individually.

Effect on the ability to drive transp. cf. and fur:

After a prolonged use of funds from the cold, containing oxymetazoline, in doses exceeding the recommended, one can not exclude the general effect on the cardiovascular system and the central nervous system.In these cases, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Spray nasal, 0.05%.

Packaging:

15 ml in bottles of dark glass.

Each vial with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000070

Date of registration:07.12.2010 / 25.02.2016

Expiration Date:Unlimited

The owner of the registration certificate:Procter and Gamble Distributing Company, LLC Procter and Gamble Distributing Company, LLC Russia

Manufacturer: & nbsp

PROCTER & GAMBLE Manufacturing, GmbH Germany

Information update date: & nbsp11.03.2017

Illustrated instructions

Instructions

Viks Active Sinex (Vicks Active Sinex)