Rinogutt Eucalyptus Nasal Spray 1mg/ml Tramazolin 10ml

NAME
RINOGUTT 1 MG / ML NASAL SPRAY, SOLUTION WITH EUCALYPTOL - 10 ML BOTTLE

PHARMACOTHERAPEUTIC CATEGORY
Sympathomimetics, not associated.

ACTIVE PRINCIPLES
Tramazoline.

EXCIPIENTS
Citric acid, sodium hydroxide, benzalkonium chloride, hypromellose, polyvinylpyrrolidone, glycerol, magnesium sulfate, magnesium chloride, calcium chloride, sodium bicarbonate, sodium chloride, eucalyptol, menthol, camphor, purified water.

INDICATIONS
Decongestant of the nasal mucosa.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; in particular towards tramazoline hydrochloride, benzalkonium chloride, rhinitis sicca, heart disease and severe arterial hypertension; acute angle glaucoma, hyperthyroidism, prostatic hypertrophy; pregnancy and breastfeeding; the drug with eucalyptol should not be used after nasal cranial surgery. The drug is contraindicated in children younger than 12 years.

DOSAGE
Adults and children over 12 years: after blowing the nose, spray 1-2 times per nostril every 6-8 hours. Do not exceed the recommended dose. If there is no complete therapeutic response within a few days, consult your doctor; in any case, the treatment must not be continued for more than 4 days. The bottle must be used, holding it vertically. The bottle is equipped with a nebulizer pump with nasal adapter. For correct use of the product, follow the instructions below: activate the vacuum pump 5 times by pressing downwards with your fingers resting on the sides of the adapter; after blowing your nose, keeping the head in a normal position, insert the adapter into the nostril and spray; after nebulization, inhale deeply with your mouth closed in order to ensure that the solution is distributed over the entire nasal mucosa. The empty space above the liquid is necessary for a perfect functioning of the bottle as a nebulizer.

STORAGE
No storage conditions.

WARNINGS
Due to the possibility of systemic absorption, the drug should be used with caution in patients with arterial hypertension, prostatic hypertrophy, pheochromocytoma and porphyria. Caution should be exercised in patients being treated with MAO inhibitors, tricyclic antidepressants, vasopressors and antihypertensive drugs. In elderly subjects use only after medical consultation due to the danger of urinary retention. The product is reserved for adults and children over 12 years. Follow the recommended doses scrupulously. The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena. In patients with cardiovascular diseases and especially in hypertensive patients, the use of salts decongestants must in any case be subjected to the judgment of the doctor from time to time. It must not be used orally. Avoid contact of the liquid with the eyes so as not to cause irritation. Prolonged use of vasoconstrictors for topical nasal use can alter the normal function of the mucous membrane of the nose and paranasal sinuses, causing chronic inflammation and atrophy, and can also induce addiction to the drug. Repeating applications for long periods can be harmful. The use, especially if prolonged, of topical products can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and institute a suitable therapy. When the vasoconstricting effect of the drug ceases, swelling of the mucosanasal mucosa (nasal edema) may occur due to reactive hyperemia. The drug contains the preservative benzalkonium chloride which can cause irritation of the nasal mucosa and bronchospasm.

INTERACTIONS
The medicinal product must not be administered during therapy with antidepressant drugs and in the two weeks following administration of the latter. The administration of the product concomitantly with antidepressant drugs (MAO inhibitors or tricyclic antidepressants) or vasopressor drugs, can cause an increase in blood pressure. The use in combination with tricyclic antidepressants can also cause arrhythmias. Interactions with antihypertensive drugs, especially those whose action involves the sympathetic nervous system, can be complex and lead to various cardiovascular effects.

SIDE EFFECTS
The following side effects may occur as a result of using the drug with eucalyptol. Immune system disorders: hypersensitivity '. Psychiatric disorders: hallucinations, insomnia, restlessness. Nervous system disorders: drowsiness, sedation, headache, dizziness, dysgeusia. Cardiac disorders: arrhythmias, tachycardia, palpitations. Respiratory, thoracic and mediastinal disorders: epistaxis, nasal edema, burning in the nose, nasal dryness, rhinorrhea, sneezing. Gastrointestinal disorders: nausea. Skin and subcutaneous tissue disorders: rash, pruritus, skin edema. General disorders and administration site conditions: mucosal edema, fatigue. Investigations: increased blood pressure.

PREGNANCY AND BREASTFEEDING
The medicine should not be used during the first trimester of pregnancy. In the second and third trimester of pregnancy and during lactation the product can 'be used only on medical indication. Safety during breastfeeding has not been established.