Rinogutt Antiallergic Spray 10 ml

WARNINGS
Due to the possibility of systemic absorption, the drug should be used with caution and under medical supervision 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 the elderly use only after consulting a doctor 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 nasal decongestants must in any case be submitted to the doctor's judgment from time to time. The product should be kept out of the reach of children as accidental ingestion can cause severe depression of the central nervous system with marked sedation. 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 consult the doctor to establish a suitable therapy. When the vasoconstrictor effect of the drug ceases, swelling of the nasal mucosa (nasal edema) may occur due to reactive hyperemia. Important information about some of the ingredients of the drug: the solution contains the preservative benzalkonium chloride which can cause irritation of the nasal mucosa.
PHARMACOTHERAPEUTIC CATEGORY
Sinological preparations; sympathomimetics; associations except corticosteroids.
STORAGE
This medicine does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to components or other strictly correlated substances from a chemical point of view; in particular towards tramazoline hydrochloride, chlorpheniramine maleate and benzalkonium chloride or to any of the excipients. Sicca rhinitis, heart disease and severe arterial hypertension. Acute angle glaucoma, hyperthyroidism, prostatic hypertrophy. Pregnancy and breastfeeding. The drug should not be used after nasal cranial surgery. The drug is contraindicated in children younger than 12 years.
NAME
RINOGUTT ANTIALLERGIC NASAL SPRAY 1 MG / ML + 3.5 MG / ML
EXCIPIENTS
Benzalkonium chloride, liquid sorbitol, citric acid, sodium phosphate, sodium chloride, purified water.
SIDE EFFECTS
The following side effects may occur as a result of using the drug. 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 (as a symptom of hypersensitivity '). General disorders and administration site conditions: mucosal edema (as a symptom of hypersensitivity), fatigue. Investigations: increased blood pressure.
PREGNANCY AND BREASTFEEDING
In pregnancy and lactation the product is contraindicated.
INDICATIONS
Symptomatic treatment of allergic rhinitis, such as hay fever.
INTERACTIONS
The medicinal product must not be administered together with antidepressant drugs and in the two weeks following their administration. The concomitant administration with antidepressant drugs (MAO inhibitors or tricyclic antidepressants) or with 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.
DOSAGE
Adults and children over 12 years: after blowing the nose, spray 1-2 times per nostril every 8-12 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, to obtain spray nebulizations. For a correct use of the nebulizer, proceed as follows: after blowing your nose, keeping the head in the normal position, introduce the olive into the nostril and spray by pressing the bottle evenly once or twice with quick and energetic strokes. After the nebulization, inhale deeply with the mouth closed, pressing lightly with the index finger on the other nostril, in order to ensure a distribution of the solution over the entire nasal mucosa. The empty space above the liquid is necessary for a perfect functioning of the bottle as a nebulizer.
ACTIVE PRINCIPLES
1 ml of solution contains: tramazoline hydrochloride 1.18 mg equal to tramazoline 1.01 mg, chlorpheniramine maleate 5.05 mg equal to chlorpheniramine 3.55 mg (10 ml contain: tramazoline hydrochloride 11.8 mg, chlorpheniramine maleate 50.5 mg).