Hypersensitivity to the active substance Xylometazoline hydrochloride or to any of the excipients of the drug; dry inflammation of the nasal membrane of the nose with the formation of a crust (dry rhinitis); simultaneous treatment with monoamine oxidase inhibitors (MAO), treatment with MAO inhibitors for two weeks before the start of Rhinoflu, simultaneous treatment with other drugs that can increase blood pressure; it is contraindicated after hypophysiectomy or surgery on the Dura mater; glaucoma; acute coronary diseases; coronary asthma; hyperthyroidism. Due to the content of benzalkonium chloride, which is used as a preservative, the drug Rhinoflu can not be used in the case of established hypersensitivity to this substance.
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active substance: xylometazoline;
1 ml of solution contains 0.5 mg of xylometazoline hydrochloride;
excipients: eucalyptus oil; benzalkonium chloride (50% solution); sodium hydrogen phosphate, dodecahydrate; sodium dihydrogen phosphate, dihydrate; sorbitol (70% aqueous solution); sodium chloride; ethyl alcohol 96%; purified water.
Nasal spray, solution.
Pharmacological properties Rinofliu
Xylometazoline hydrochloride, a derivative of imidazole, is a sympathomimetic active substance with alpha-adrenergic action. The drug has a vasoconstrictive effect, thus reducing the swelling of the mucous membrane. The onset of action is usually observed in 5 – 10 minutes; the drug facilitates nasal breathing, reducing swelling of the mucous membrane and improving the excretion of secretions.
When administered nasally, the absorbed amount may sometimes be sufficient to cause systemic effects, ie manifestations of the central nervous system and cardiovascular system.
To reduce swelling of the nasal mucosa in acute rhinitis, episodes of profuse nasal discharge (vasomotor rhinitis) and allergic rhinitis (allergic rhinitis).
To facilitate the excretion of secretions in the case of paranasal sinusitis and inflammation of the mucous membrane of the middle ear in combination with a cold.
- Hypersensitivity to the active substance of xylometazoline hydrochloride or to any of the excipients of the drug;
- dry inflammation of the nasal membrane with the formation of crusts (dry rhinitis);
- concomitant treatment with monoamine oxidase inhibitors (MAOIs), treatment with MAOIs for two weeks before the start of Rinoflu, concomitant treatment with other drugs capable of
raise blood pressure;
- contraindicated after hypophysectomy or surgery on the dura mater;
- angle-closure glaucoma;
- acute coronary heart disease;
- coronary asthma;
Due to the content of benzalkonium chloride used as a preservative, Rinoflu should not be used in case of hypersensitivity to this substance.
Method of application and dosage
The dose depends on the individual sensitivity of the patient and the clinical effect.
Unless otherwise prescribed, children aged 6 to 12 years are prescribed 1 injection of Rinoflu (0.05% nasal spray) in each nostril up to 3 times a day. Children aged 12 years and adults are prescribed 1 injection of Rinoflu (0.1% nasal spray) in each nostril up to 3 times a day.
To use Rinofliu , a nasal spray, you must first remove the protective cap. Before the first application it is necessary to press the batcher several times before emergence of a uniform stream. The metered spray is ready for further use. Insert the tip of the cap into the nostril and press once, then repeat the introduction into the second nostril. When spraying, inhale slightly through the nose.
Do not spray from top to bottom or diagonally. For hygiene reasons, the spray should be wiped off after each use and a protective cap should be put on.
Duration of treatment
The drug should not be used for more than 3-5 days, unless recommended by a doctor.
Re-use should be started only after a break of a few days and after consulting a doctor. The duration of treatment for children is determined by the doctor individually.
In the case of chronic rhinitis, the drug can be used only under the supervision of a physician due to the risk of atrophy of the nasal mucosa.
Rinofliu 0.05% is intended for the treatment of children aged 6 to 12 years. Rinofliu 0.1% is intended for the treatment of adults and children over 12 years of age.
When used nasally, systemic effects are unlikely due to local vasoconstriction, which inhibits absorption. In the case of systemic absorption, xylometazoline, as an α2-adrenergic agonist, can be expected to have a clonidine-like effect: a brief increase in blood pressure followed by prolonged hypotension and sedation.
Symptoms of intoxication with imidazole derivatives may be clinically unclear, as periods of stimulation may alternate with periods of central nervous system and cardiovascular depression.
Symptoms of central nervous system stimulation include anxiety, agitation, hallucinations, and convulsions.
Symptoms of central nervous system depression include fever, lethargy, drowsiness, and coma.
Additional symptoms are possible: miosis, mydriasis, sweating, nausea, cyanosis, fever, pale skin, tachycardia, bradycardia, cardiac arrest, hypertension, shock hypotension, pulmonary edema, respiratory distress and apnea.
Overdose, especially in children, can significantly affect the central nervous system, causing spasms, coma, bradycardia, apnea and hypertension, which can change to hypotension.
Severe overdose will require hospital treatment. As xylometazoline hydrochloride is rapidly absorbed, activated charcoal (absorbent), sodium sulphate (laxative) or gastric lavage (for large amounts) should be used immediately. Lowering blood pressure can be achieved with non-selective alpha-blockers. Vasoconstrictive drugs are contraindicated. If necessary, use antipyretic and anticonvulsant drugs, as well as artificial oxygen respiration.
- Respiratory, thoracic and mediastinal disorders: Xylometazoline may cause temporary mild signs of irritation (burning or dryness of the nasal mucosa), especially in sensitive patients. reactive redness, nosebleeds, sneezing.
- Prolonged or frequent use of higher doses of xylometazoline hydrochloride may cause burning, tingling, itching, tenderness, dryness or irritation of the nasal mucosa, as well as reactive congestion and medical rhinitis. This effect may occur after 7 days of treatment and after prolonged use of the drug may be irreversible damage to the nasal mucosa with the formation of crusts (dry rhinitis).
- Occasionally, nausea, headache, and temporary visual disturbances may occur.
- There was a return of nasal congestion after discontinuation of treatment, in particular after prolonged use of xylometazoline.
- From the nervous system: headache, insomnia, fatigue.
- From the cardiovascular system: systemic effects of sympathomimetics (rapid heartbeat, rapid pulse, increased blood pressure).
- From the musculoskeletal system and connective tissue: convulsions, especially in children.
- From the immune system: hypersensitivity reactions (angioneurotic edema, rash, itching).
The shelf life of the drug after opening the bottle is 24 weeks.
Store in the original package at a temperature not exceeding 25 ° C.
Keep out of reach of children!