RINAZINA DOUBLE AZ 10ML5MG+6MG

RINAZINA DOPPY ACTION 0.5 MG/ML + 0.6 MG/ML NASAL SPRAY, DEVELOPMENT

active ingredients

1 ml contains 0.5 mg of xilometazoline hydrochloride and 0.6 mg of bromide ipratrope. 1 nebulization (about 140 microliters) contains 70 micrograms of xilometazoline hydrochloride and 84 micrograms of bromide ipratrope. For the full list of excipients, see paragraph 6.1

Excellent

Edetate disode, glycerol (85%), hydrochloric acid (for pH correction), hydroxide sodium (for pH correction), purified water.

Therapeutic indications

Symptomatic treatment of nasal congestion and rhyrrhea associated with common colds.

Contraindications

Rinazine Double Action should not be given to children under 18 years of age due to lack of sufficient documentation. Hypersensitivity to active ingredients or any of the excipients listed in the section 6.1. Hypersensitivity known to atropin or similar substances, such as iosciamine and purposelamine. After surgery in which the hard mother may have been exposed: transfenoidal hypophysiectomy or other transnasal interventions. In patients with glaucoma. In patients with dry rhinitis.

Population

Posology. Adults: 1 nebulization in each nostril up to 3 times a day. They must spend at least 6 hours in two doses. Do not exceed 3 daily applications in each nostril. The duration of treatment shall not exceed 7 days (see section 4.4). It is recommended to stop treatment, when symptoms are decreased, even before the maximum duration of treatment of 7 days, in order to minimize the risk of adverse reactions (see section 4.8). Pediatric population: The use of Rinazina Double Action is not recommended in children and adolescents under 18 years of age for lack of sufficient documentation. Seniors: There is only a limited experience of use in patients aged over 70. Method of administration: Before the initial application, press the pump to operate it 4 times. Once pressed, the pump will normally remain charged throughout the continuous daily treatment period. If the spray is completely pressed, or if the product has not been used for more than 6 days, the pump will need to be recharged with the 4 pressures performed at the beginning.

Conservation

Do not store at temperature above 25°C.

Warnings

The medicine should be administered with caution in patients with: - hypertension, cardiovascular diseases. Patients with long-term QT syndrome treated with xylometazoline may be exposed to a greater risk of severe ventricular arrhythmias; - hyperthyroidism, diabetes mellitus; - prostate hypertrophy, ureteral stenosis; - feocromocytoma. It is recommended caution in patients prepared to: - closed angle glaucoma; - epistassi (e.g. elderly); - the paralytical one; - cystic fibrosis. It may occur immediate hypersensitivity, including hives, angioedema, rash, bronchospasm, pharyngeal edema and anaphylaxis. The medicinal product must be used with caution in patients who are sensitive to adrenergic agents, which can give symptoms such as sleeping disorders, dizziness, tremor, heart arrhythmias or hypertension. The duration of the treatment should not exceed 7 days, as chronic treatment with xylometazoline hydrochloride can cause swelling of the nasal mucosa and hypersecretion due to increased cellular sensitivity, “rebound effect” (medicamentous retite). Patients should be instructed to avoid spraying Rinazina Double Action around or in the eyes. If Rinazina Double Action comes into contact with the eyes, you can verify the following eventualities: temporary blurred vision, irritation, pain, reddened eyes. An aggravation of the closed angle glaucoma may occur. The patient should be instructed to wash his eyes with cold water if Rinazina Double Action comes in direct contact with the eyes and to turn to a doctor if he feels eye pain or has a blurred vision.

Interactions

Monoaminoxydase inhibitors (MAO inhibitors): concurrent use or use in the last 2 weeks of sympathomimetic preparations can induce severe hypertension and therefore is not recommended. Preparations based on sympathomimetics release catecholamines, and this leads to a greater release of norepinephrine that vice versa has a vasoconstrictor effect leading to an increase of blood pressure. In severe cases of hypertension, treatment with Rinazine Double Action should be suspended and hypertension should be treated. Tri- and tetra-cyclic antidepressants: concurrent use or use in the last 2 weeks of tricyclic antidepressants and sympathomimetic preparations can lead to an increase in the sympathomimetic effect of xylometazoline and therefore is not recommended. Concurrent administration of others anti-linergical medicines can increase the anticholinergic effect. The interactions mentioned above have been studied individually for both active ingredients of Rinazina Double Action, not in combination. No formal interaction studies have been conducted with other substances.

Effects

Security profile summary: The most commonly reported adverse reactions are epistaxis occurred in 14.8% of patients and nasal dryness in 11.3% of patients. Many of the adverse events reported are also symptoms of the common cold. Tabulate list of adverse reactions: The following adverse reactions were reported in two randomized clinical trials and in a non-interventional study with the product after marketing and during post-marketing surveillance. Adverse reactions are listed by classification for systems and organs and frequency. The frequencies are as definitive as: Very common (≥1/10); Common (≥1/100, Not common (≥ 1/1.000, Rare (≥ 1/10.000, Very rare ( Notable (frequency cannot be defined on the basis of available data).

Frequency Classification	Very common	Town	Not common	Rare	Notable
Immune system disorders					Hypersensitivity
Psychiatric disorders			Insomnia
Diseases of the nervous system		Disgeusia, headaches	Parosmia, dizziness, tremor
Pathologies of the eye			Eye irritation, eye dryness		Accomo-dation disorders, worsening of closed angle glaucoma, eye pain, photopsy, increased intraocular pressure, blurred vision, midriasis, visual alonies
Heart disease			Palpitations, tachycardia		Atrial fibrillation
Respiratory, chest and mediastinic pathologies	Epistassi, nasal dryness	Nasal disorder, nasal congestion, mouth dryness, throat irritation, inhalation	Nasal ulcer, sneezing, oropharyngeal pain, cough, dysphony	Rinorrea	Satisfaction with paranasal breasts, laryngeospasm, pharyngeal edema
Gastrointestinal diseases		Bucket dryness	Dispepsia, nausea		Default
Pathologies of skin and subcutaneous tissue					Prurito, rash, hives
Kidney and urinary pathologies					Urinary retention
Systemic pathologies and conditions for administration			Disagio, fatigue		Chest disorder, thirst

Description of specific adverse reactions: Many of the adverse reactions listed under “Note” have only been reported once for the product in clinical trials or have only been reported during post-marketing surveillance, so there is no frequency estimate based on the number of patients treated with Rinazina Double Action. 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

An overdose of xylometazoline hydrochloride by mouth or excessive administration by topical means may cause severe dizziness, sweating, sudden hypothermia, headache, bradycardia, hypertension, respiratory depression, coma and seizures. Hypertension can be followed by hypotension. Small children are more toxic than adults. As the absorption after nasal or oral administration is very poor, acute overdose after the administration of intranasal bromide hypertrope is unlikely, but if an overdose occurs the symptoms are dryness of the skins, difficulty of visual tachycardia and tachycardia. Treatment is symptomatic. A considerable overdose can give rise to anti-linergical symptoms at the expense of SNC such as hallucinations, which must be treated with anti-cynethetics. Appropriate support measures should be initiated in all persons with suspected overdose and, when justified, an urgent symptomatic treatment under the supervision of the doctor. This includes subject observation for at least 6 hours. In case of severe overdose with cardiac arrest, the reanimation activity must be continued for at least 1 hour.

Pregnancy: There are no sufficient evidence about the use of Rinazina Double Action in pregnant women. Studies in the animal are not enough about pregnant effects, embryo/fetal development, childbirth and postnatal development. The potential risk in man is unknown. Rinazine Double Action should not be used during pregnancy if there is no clear need. Nursing: It is not known whether the bromide hypertrope and xilometazoline hydrochloride are excreted in breast milk. Systemic exposure to bromide hypertrope and xilometazoline hydrochloride is low. The effects on breast-feeding infants are therefore unlikely. The need for treatment with Rinazina Double Action for the mother and the benefits of breastfeeding must be weighed against the potential risks for the newborn.

Source: Farmadati