Rinogutt nasal spray 1 mg / ml - decongestant 1 bottle of 10 ml

Product Description

Nasal Spray Solution

Active ingredients

1 ml of solution contains: tramazoline hydrochloride 1.18 mg equivalent to tramazoline 1.01 mg (10 ml contain: tramazoline hydrochloride 11.8 mg). For the full list of excipients, see section 6.1.

Excipients

Benzalkonium chloride, liquid sorbitol, citric acid, sodium phosphate, sodium chloride, purified water.

Therapeutic indications

Nasal mucosa decongestant.

Contraindications

Hypersensitivity to the active substance or to any of the excipients; in particular to tramazoline hydrochloride, benzalkonium chloride. Dry rhinitis, heart disease, and severe arterial hypertension. Acute angle glaucoma, hyperthyroidism, prostatic hypertrophy. Pregnancy and breastfeeding. Rinogutt Nasal Spray Solution should not be used after nasal cranial surgery. The drug is contraindicated in children under 12 years of age.

Dosage

Adults and children over 12 years of age: After blowing your nose, spray 1–2 times in each nostril every 6–8 hours. Do not exceed the recommended dose. If a complete therapeutic response is not achieved within a few days, consult your doctor; in any case, treatment should not be continued for more than 4 days. The bottle should be held vertically to obtain spray nebulizations. For correct use of the nebulizer, follow these instructions: after blowing your nose, keeping your head in a normal position, insert the olive into the nostril and nebulize by pressing the bottle evenly once or twice with quick, forceful strokes. After nebulization, inhale deeply with your mouth closed, pressing lightly with your index finger on the other nostril to ensure the solution is distributed over the entire nasal mucosa. The empty space above the liquid is necessary for the bottle to function perfectly as a nebulizer.

Warnings and precautions

Due to the possibility of systemic absorption, Rinogutt Nasal Spray Solution should be used with caution and under medical supervision in patients suffering from arterial hypertension, prostatic hypertrophy, pheochromocytoma and porphyria. Caution should be exercised in patients being treated with MAO inhibitors, tricyclic antidepressants, vasopressor drugs and antihypertensives (see section 4.5). In elderly patients, use only after consulting a doctor due to the risk of urinary retention. The product is intended for adults and children over 12 years of age. Scrupulously adhere to the recommended doses. If accidentally ingested or used for a long period at excessive doses, the product may cause toxicity. In patients with cardiovascular disease, especially in hypertensive patients, the use of nasal decongestants should always be subject to a doctor's judgment. The product should be kept out of the reach of children as accidental ingestion may cause severe central nervous system depression with marked sedation (see section 4.9). It should not be used orally. Avoid contact of the liquid with eyes to avoid irritation. Prolonged use of topical nasal vasoconstrictors can alter the normal function of the nasal mucosa and paranasal sinuses, causing chronic inflammation and atrophy. It can also lead to drug addiction. Repeated applications for long periods may be harmful. The use, especially if prolonged, of topical products may give rise to sensitization phenomena; in this case, it is necessary to discontinue treatment and consult a doctor to establish appropriate therapy. When the vasoconstrictor effect of the drug ceases, swelling of the nasal mucosa (nasal edema) may occur due to reactive hyperemia. Rinogutt Nasal Spray Solution contains the preservative benzalkonium chloride, which may cause irritation of the nasal mucosa.

Interactions

Rinogutt Nasal Spray Solution should not be administered during therapy with antidepressant drugs and within two weeks of the last administration of the latter. The administration of Rinogutt Nasal Spray Solution in conjunction with antidepressant drugs (MAO inhibitors or tricyclic antidepressants) or vasopressor drugs may cause an increase in blood pressure. Use in combination with tricyclic antidepressants may 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.

Undesirable effects

The following undesirable effects may occur following the use of Rinogutt Nasal Spray Solution: 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 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 Tests Diagnostics: Increased blood pressure * as a symptom of hypersensitivity.

Pregnancy and breastfeeding

Rinogutt Nasal Spray Solution should not be used during the first trimester of pregnancy. In the second and third trimesters of pregnancy and during breastfeeding, the product can only be used on medical advice. Safety during breastfeeding has not been established.