RINOGUTT SPRAY NASALE 10ML EU

RINOGUTT 1 MG/ML NASAL SPRAY, ONLY WITH EUCALIPTOLO - FLACONE DA 10 ML

active ingredients

1 ml of solution contains: monohydrate hydrochloride 1.265 mg weaveline 1,01 mg (10 ml contain: weavezoline monohydrate hydrochloride 12,65 mg). Excipient with known effect: 0.2 mg of benzalconium chloride in 1 ml (see paragraph 4.4). For the full list of excipients, see paragraph 6.1.

Excellent

citric acid, sodium hydroxide, benzalconium chloride, ipromellose, polyvinylpyrrolidone, glycerol, magnesium sulphate, magnesium chloride, calcium chloride, sodium bicarbonate, sodium chloride, eucalyptus, menthol, canphur, purified water.

Therapeutic indications

Decongestant of nasal mucosa.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients; in particular towards weavezoline hydrochloride, benzalconio chloride. Sick rhinitis, heart disease and severe arterial hypertension. Acute angle glaucoma, hyperthyroidism, prostate hypertrophy. Pregnancy and nursing. Rinogutt Nasal Spray Solution with eucalyptus should not be used after cranial surgery performed nasally. The drug is contraindicated in children under the age of 12.

Population

Adults and children over 12 years: after blowing your nose, spray 1-2 times for nostril every 6-8 hours. Do not exceed the recommended doses. In the absence of complete therapeutic response within a few days, consult your doctor; in any case the treatment should not be protracted for over 4 days. The bottle should be used, keeping it vertically. The bottle is equipped with a spray pump with nasal adapter. For proper use of the product follow the following: activate the vacuum pump for 5 times pressing down with your fingers resting on the sides of the adapter. After blowing your nose, holding your head in normal position, introducing the adaptor into the nostril and spraying. After the nebulization inhale deeply in the closed mouth in order to ensure a breakdown of the solution on the whole nasal mucosa. The vacuum space above the liquid is necessary for a perfect operation of the bottle as a nebulizer.

Conservation

No condition of conservation.

Warnings

For the possibility of systemic absorption Rinogutt Nasal Spray Solution with eucalyptus must be used with caution and under medical control in patients suffering from arterial hypertension, diabetes mellitus, prostate hypertrophy, feochromocytoma and porphyria. Caution should be given in patients treated with MAO inhibitors, antidepressants, vasopressants and antihypertensive drugs (see section 4.5). In elderly individuals use only after consulting the doctor for the danger of urinary retention. The product is reserved for adults and children over 12 years. Strictly adhere to the recommended doses. The product if accidentally ingested or if used for a long period at excessive doses, can determine toxic phenomena. In patients with cardiovascular disease and especially in hypertensives, the use of nasal decongestants must be subjected to the doctor’s judgement. The product must be kept away from the reach of children since accidental ingestion can cause severe depression of the central nervous system with strong sedation (see section 4.9). It should not be used orally. Avoid the contact of the liquid with the eyes not to cause irritations. Prolonged use of nasal topical vasoconstrictors can alter the normal function of the mucosa of the nose and of the paranasal breasts, causing chronic inflammation and atrophy, moreover it can also induce drug addiction. Repeating applications for long periods may be harmful. The use, especially if prolonged, of topical products can give rise to phenomena of awareness; in such case it is necessary to stop treatment and consult the doctor to establish suitable therapy. When the vasoconstrictor effect of the drug ceases, swelling of the nasal mucosa ( nasal edema) may occur for reactive hyperemia. Rinogutt Nasal Spray Solution with eucalyptus contains the preservative benzalconio chloride This medicine contains 0.2 mg of benzalconium chloride in 1 ml (2 mg in 10 ml). Prolonged use can cause nasal mucosa edema. In this case, a nasal medication without benzalconio chloride should be used. If such medicines for nasal use without benzalconio chloride were not available, it should be considered another pharmaceutical form.

Interactions

Rinogutt Nasal Spray Solution with eucalyptus should not be administered during therapy with antidepressant drugs and in the next two weeks the administration of the latter. The administration of Rinogutt Spray Nasal Solution with eucalyptol in conjunction with antidepressant drugs (MAO inhibitors or tricyclic antidepressants) or vasopressor drugs, can cause an increase in blood pressure. Use in combination with tricyclic antidepressants can also cause arrhythmia. Interactions with antihypertensive drugs, especially those whose action involves the sympathetic nervous system, can be complex and lead to various cardiovascular effects.

Effects

The following Convention has been used for the classification of unwanted effects: very common (≥1/10), common (≥1/100, immune system disorders: Notable: Hypersensitivity Psychiatric disorders: Notable: Hallucinations, insomnia Not common: Restlessness Diseases of the nervous system: Notable: Sleeplessness, uncommon sedation: Headache Rara: Vertigo, disgeusia Heart disease: Notable: Aritmie, tachycardia Not common: Palpitations Respiratory, chest and mediastinic pathologies: Rara: Epistassi Comune: Not common: Nasal edema, nasal dryness, rhyros, sneezing Gastrointestinal diseases: Not common: Nausea Pathologies of skin and subcutaneous tissue: Note: Rash, itching, skin edema* Systemic pathologies and conditions for administration: Notable: Edema di mucose*, fatigue Diagnostic examinations: Notable: Increased blood pressure * as a symptom of hypersensitivity Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Synonyms An increase in blood pressure and tachycardia can, especially in children, be followed by a decrease in blood pressure, by temperatures under the norm, by shock and by reflected bradycardia. Similarly to other alpha-simpaticomimetic drugs, the clinical picture of an intoxication with Rinogutt Nasal Spray Solution with eucalyptol can be confused, since phases of stimulation and depression of the Central Nervous System and cardiovascular system can be alternated. Especially in children, intoxication produces effects on the Central Nervous System such as convulsions and coma, bradycardia, respiratory depression. Symptoms of Central Nervous System stimulation are anxiety, agitation, hallucinations and seizures. Symptoms of depression of the Central Nervous System are hypothermia, lethargy, drowsiness and coma. The following symptoms may also occur: midriasis, myosis, sweating, fever, pallor, lip cyanosis, cardiovascular dysfunctions, including cardiac arrest, respiratory dysfunctions, including respiratory failure and respiratory arrest, psychological alterations. Therapy In case of nasal overdose wash or immediately clean nasal mucosa. Syntomatic treatment may be necessary.

Pregnancy

Rinogutt Nasal Spray Solution with eucalyptus should not be used during the first trimester of pregnancy. In the second and third trimester of pregnancy the product can be used only on indication of the doctor.

Food

Safety during breastfeeding was not established. During the breastfeeding period, the product should only be used on medical indication.

Fertility

Studies have not been conducted to investigate the effects of Rinogut Nasal Spray Solution on Human Fertility. Based on the available pre-clinical data there are no indications about the possible effects of the use of monohydrate monohydrate weft.

Source: Farmadati