Expiration date: 05/2025

Dosage form: nasal Spray

Description: Colorless, transparent solution odorless

Composition in g per 10 ml:0,05% 0,1% Active ingredient Xylometazoline hCl

Pharmacotherapeutic group

Decongestant remedy – vasoconstrictor (alpha-agonists).

Pharmacokinetics

The local application is practically not absorbed, plasma concentrations are so small that they are impossible to define modern analytical methods.

Pharmacological properties

Rhinomaris - medicine for intranasal use.

Xylometazoline has alpha-adrenomimetic action: causes vasoconstriction of the nasal mucosa, eliminating, thus, swelling and hyperemia of the mucous membrane of the nasopharynx. Facilitates nasal breathing in rhinitis. In therapeutic concentrations does not irritate, does not cause hyperemia. The action comes a few minutes after application and lasts for 12 hours.

Sterilized sea water, part of the drug, Rhinomaris, helps to maintain normal physiological state of the mucous membrane of the nasal cavity, thinning the mucus and to normalize its production in goblet cells of the mucous membrane of the nasal cavity.

Micronutrients improve the function of the ciliated epithelium, which helps to reduce adverse local reactions such as irritation and/or dryness of the mucous membrane of the nasopharynx.

Indications for use

• acute respiratory illness with symptoms of rhinitis (runny nose),
  
• allergic rhinitis (hay fever),
  
• sinusitis,
  
• evstahiit,
  
• otitis media (to reduce swelling of the mucous membrane of the nasopharynx),
  
• preparation of the patient for diagnostic procedures in the nasal passages.
  

Contraindications:

Arterial hypertension, tachycardia expressed arteriosclerosis, glaucoma, atrophic rhinitis, hyperthyroidism,surgical interventions on the brain casings (in history), children up to age 6 years (0.1% solution) and 2 years (0.05% solution), hypersensitivity to the drug.

Precautions

Ostorozhnosti apply diabetes, angina (CAD).

Method of application and doses

Rhinomaris, nasal spray, 0.05% is

Children 2 to 6 years: 1 spray into each nostril 1-2 times a day,

Children above 6 years: 1 spray into each nostril 2-3 times a day.

Rhinomaris, nasal spray, 0.1% of

Children older than 6 years and adults: 1 spray into each nostril 2-3 times a day. The drug should not be used more than 4 times per day, the duration of the course of 5-7 days.

Side effects

Frequent and/or long – term use- irritation and/or dryness of the mucous membrane of the nasopharynx, burning sensation, tingling, sneeze, hypersecretion, edema of the nasal mucosa.

Palpitations, tachycardia, arrhythmias, increased blood pressure, headache, vomiting, insomnia, blurred vision, long-term use of high doses – depression.

Special instructions:

Before application it is necessary to clear the nasal passages.

Anomeric should not be used for a long time, for example, in chronic rhinitis.

Pregnancy and lactation:

During pregnancy and lactation the drug should be used only after careful evaluation of the balance of risks and benefits for mother and fetus, it is not allowed to exceed the recommended doses.

Drug interactions

Incompatible with MAO inhibitors and tricyclic antidepressants.

Effects on ability to drive vehicles and management mechanisms:

Xylometazoline, at doses, exceeding recommended, may affect the ability to drive vehicles or equipment.

Overdose:

Symptoms: increased side effects.

Treatment: symptomatic therapy.

Release form

Nasal spray 0.05% and 0.1%.

10 ml of the drug in a plastic bottle fitted with a spray device and protective cover of propylene. One vial with instructions for use placed in a cardboard box.

Storage conditions

Keep at temperature not exceeding 25°C, inaccessible for children place.

Shelf life: 2 years. Do not use after the expiry date printed on the package.