NARHIMED CLOSED NOSE GTT RINOL

NARHIMED CHIUS

active ingredients

NARHIMED NASO CHIUSO 1 mg/ml nasal drops, solution. 1 ml of solution contains: Active ingredient: xilometazoline hydrochloride 1 mg. Each drop dispenses 0.025 mg xilometazoline hydrochloride NARHIMED NASO CHIUSO 1 mg/ml nasal spray, solution. 1 ml of solution contains: Active ingredient: xilometazoline hydrochloride 1 mg. Each spray nebulization dispenses 0.14 mg xilometazoline hydrochloride Eccipiente with known effects: benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Nasal drops, solution - nasal spray, solution Sodium phosphate monobasic dihydrate; sodium phosphate dibasic dodecaidrate; sodium edetate; benzalconio chloride; sorbitol 70%; ipromellosa; sodium chloride; purified water.

Therapeutic indications

Decongestant of nasal mucosa (in case of colds, hay colds or other allergic rhinitis, sinusitis).

Contraindications

- Hypersensitivity to xylometazoline or any of the excipients listed in the paragraph 6.1. - Glucoma at a closed angle. - Chronic rhinitis. - Patients with dry or atrophic rhinitis. - Pregnancy (see paragraph 4.6). - Children under the age of 12. Like other vasoconstrictors, do not use Narhimed closed nose in patients subjected to transfenoidal hypophysictomy or surgical interventions with exposure of the hard mother.

Population

The use of the medicinal product is limited to adults and adolescents (aged between 12 years and 18 years). Posology. Nasal drops, solution: Instill in each nostril 2-3 drops of the solution for 1-3 times a day, depending on the need. Do not exceed 3 applications in each nostril per day. Nasal spray, solution: 1 nebulization of Narhimed nose closed spray, 1-3 times a day, depending on the need. Do not exceed 3 applications in each nostril per day. Mode of administration. Narhimed nose closed nasal drops, solution: 1) Clean the nose. 2) Pull the head back in a comfortable position or, if you lie down in bed, bend the side. 3) Instill the drops in each nostril and keep the head reclined backwards for a while to allow the drops to spread in the nose. 4) Immediately after use clean and dry the dropper before placing it in the bottle. To avoid the possible spread of the infection, the bottle must be used by one person. Narhimed nose closed nasal spray, solution: Before the initial application, press the pump to operate it 4 times. Once pressed, the pump will normally remain charged throughout the daily treatment period. The pump must be recharged by pressing 4 times if, completely pressing the spout, the spray should not escape or if the product was not used for more than 7 days. For administration follow the instructions below, paying attention not to spray the spray in the eyes. 1) Clean the nose. 2) Keep the bottle in vertical position with the thumb below the base and the spout between the two fingers 3) Tilt slightly forward and insert the spout into a nostril. 4) Spray and simultaneously breathe gently with the nose. 5) Immediately after use clean and dry the dispenser before putting the plug back. To avoid the possible spread of infections, each spray pack must be used by one person. Pediatric population: The medicinal product should not be used in children under 12 years of age (see also paragraph 4.3).

Conservation

Store at a temperature below 30°C. Store in the original packaging.

Warnings

Narhimed closed nose, like other sympathomimetic agents, should be used with caution in patients who show a strong reaction to the adrenergic substances manifested with signs of insomnia, dizziness, tremor, heart arrhythmia or high blood pressure. As other vasoconstrictors for local use, Narhimed closed nose should not be used for more than 7 consecutive days: prolonged or excessive use may cause congestion of rebound and/or atrophy of nasal mucosa. Do not exceed the doses indicated, especially in the elderly. Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism or diabetes mellitus, pheochromocytoma as well as in patients with prostate hypertrophy and in patients treated with monoaminoxydasis inhibitors (IMAO) or who have taken them in the last two weeks (see paragraph 4.5). Patients with long-term QT syndrome treated with xylometazoline may be exposed to a greater risk of severe ventricular arrhythmias. Important information about some excipients: Narhimed closed nose contains benzalconio chloride (BAC) as a preservative that, especially when used for long periods, can cause a swelling of the nasal mucosa. If such a reaction is suspected (persistent nasal congestion), it must be used, if possible, a medicine for nasal use without benzalconium chloride. If such medicines for nasal use without benzalconio chloride were not available, it should be considered another pharmaceutical form. It can cause bronchospasm.

Interactions

Monoaminoxydase inhibitors (IMAO): xylometazoline can enhance the action of monoaminoxydase inhibitors and can cause hypertensive crisis. Xilometazoline is not recommended in patients who are taking or taking IMAO in the last two weeks (see paragraph 4.4). Antidepressants and tetracycling: the concomitant use of tricyclic and tetracyclic antidepressants and sympathomimetic can strengthen the sympathomimetic effect of xylometazoline and is therefore not recommended.

Effects

Adverse reactions are listed by classification for organ and frequency systems. The frequencies are defined as: very common (≥1/10); common (≥1/100 a Immune system disorders   Very rare: Hypersensitivity reactions (angioedema, rash, itching) Diseases of the nervous system   City: Cefa Pathologies of the eye   Very rare: Transitional disturbances of sight Heart disease   Very rare: Irregular heart rate and increased heart rate Respiratory, chest and mediastinic pathologies   City: Dryness or nasal discomfort Gastrointestinal diseases   City: Nausea Systemic pathologies and conditions for administration   City: Burn in the application site Other side effects found: arterial hypertension, reflex bradycardia, urination disorders, insomnia and restlessness. 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.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

In case of overdose, strong dizziness, sweating, severe lowering of body temperament, bradycardia, arterial hypertension, tachycardia, photophobia, intense headache, thoracic oppression, coma and seizures may appear, and in children, hypothermia and severe depression of the central nervous system with strong sedation requiring the adoption of adequate emergency measures. In case of excessive instillation of the product in the nose and in the paranasal breasts, repeatedly rinse the nasal cavities with lukewarm isotonic solution, recommending the patient not to ingest such a solution. In case the patient is not conscious, take care that this solution is not ingested during the washing manoeuvres. A symptomatic treatment under medical surveillance is indicated. This includes individual observation for several hours. In the case of strong overdose with cardiac arrest, reanimation must continue for at least 1 hour.

Pregnancy: In view of its potential systemic vasoconstrictor effect, it is recommended to take precaution not to use Narhimed closed nose during pregnancy. Nursing: There is no evidence of adverse effects on the breast-feededed baby. However it is not known if xilometazoline is excreted in breast milk, therefore it must be used caution and Narhimed closed nose should be used during breastfeeding only under doctor’s advice. Fertility: There is no adequate data about the effects of Narhimed nose closed on fertility and no animal studies are available. Since systemic exposure to xilometazoline hydrochloride is very low, the effects on fertility are therefore very unlikely.

Source: Farmadati