Rinomaris Intensive nasal spray (84mcg+70mcg)/dose 10ml №1

Name:
Rinomaris intensive. Release formNasal spray. MNNK silometazoline + ipratropium bromide. FTG Anticongestive agent – vasoconstrictor (alpha-adrenergic agonist). Composition One dose of the drug contains 84 micrograms of ipratropium bromide and 70 micrograms of xylometazoline hydrochloride. Composition Per 1 ml Active substances: Ipratropium bromide – 0.6 mg Xylometazoline hydrochloride – 0.5 mg up to pH 3.7-4.7 Purified water – up to 1.0 ml.
Description:
Transparent, colorless solution. Pharmacotherapeutic groupMeans for the treatment of diseases of the nose. Decongestants and other agents for external use in rhinology. Combinations of sympathomimetics, excluding corticosteroids. ATX code: R01AB06. Pharmacological properties RINOMARIS INTENSIVE is a combined drug containing two active ingredients: xylometazoline hydrochloride and ipratropium bromide. Xylometazoline hydrochloride has a vasoconstrictive effect and reduces nasal congestion, its action begins after 5-10 minutes and lasts for 6-8 hours. Ipratropium bromide reduces the amount of nasal discharge, the effect is achieved within 15 minutes and lasts about 6 hours. RINOMARIS INTENSIVE is used in adults. Indications for use Symptomatic treatment of nasal congestion and rhinorrhea in rhinitis. Method of application and dosage Adults: One injection in each nostril no more than 3 times a day. The time interval between two applications should be at least 6 hours. Do not inject more than 3 doses into each nostril per day. The duration of treatment should not exceed 7 days, since long-term treatment with xylometazoline can lead to swelling of the nasal mucosa and hypersecretion due to increased cell sensitivity, the so-called “reverse effect” (drug rhinitis). In order to minimize the risk of developing adverse reactions (see section “Side Effects”), it is recommended to stop treatment after symptom relief, even if the maximum duration of treatment (7 days) has not been reached. Children and adolescents under 18 years of age: RINOMARIS INTENSIVE is not recommended for use in children and adolescents under 18 years of age due to insufficient data. Elderly Patients There is limited experience with RINOMARIS INTENSIVE in patients over 70 years of age. Before the first use, fill the sprayer by pressing it 4 times. After this pretreatment, the nebulizer will typically remain primed for the period of regular daily drug use. If RINOMARIS INTENSIVE has not been used for more than 6 days, the sprayer should be refilled by pressing it at least 2 times (spray the drug in the air). After use, carefully wipe the atomizer with a clean and dry paper towel and close it with a protective cap. For reasons of hygiene and to prevent the spread of infection, one spray can should only be used by one person. Contraindications RINOMARIS INTENSIVE should not be given to children under the age of 18 due to lack of sufficient data. Hypersensitivity to any of the active substances or to any of the excipients. Known hypersensitivity to atropine or similar substances such as hyoscyamine and scopolamine. After surgery that may have damaged the dura mater, such as in the case of transsphenoidal hypophysectomy or other transnasal surgical procedures. Patients with glaucoma. Patients with dry rhinitis (rhinitis sicca), atrophic rhinitis. Side effects Summary of the safety profile of the medicinal product The most commonly reported adverse reactions are epistaxis (14.8% of patients) and dry nose (11.3% of patients). Many of the reported adverse events are also symptoms of the common cold. Summary table of adverse reactions The following are adverse reactions reported in two randomized clinical trials and one non-interventional post-registration study of the drug. Adverse reactions are listed below, taking into account the system organ class (SOC) and the frequency of their development. The frequency of development is defined as follows: Very often (≥ 1/10) Often (≥ 1/100 – < 1/10) Infrequently (≥ 1/1,000 - < 1/100) Rarely (≥ 1/10,000 - < 1/10) 1000) Frequency unknown (cannot be estimated from available data). Frequency SOC Very often Often Infrequently Rare Frequency is unknown Immune system disorders Hypersensitivity Psychiatric disorders Insomnia Nervous system disorders Dysgeusia, headache Parosmia, dizziness, tremor Visual disturbances Eye irritation, dry eyes Disturbance of accommodation, exacerbation of angle-closure glaucoma, eye pain, photopsia, increased intraocular pressure, iridescent halos in the visual field, mydriasis, blurred vision Cardiac disorders Palpitations, tachycardia Atrial fibrillation Respiratory, thoracic and mediastinal disorders Epistaxis, dry nose Nose discomfort , nasal congestion, dry and irritated throat, nasal pain Nasal ulcer, sneezing, pharyngolaryngeal pain, cough, dysphonia Runny nose Sinus discomfort, spasm larynx, pharyngeal edema Gastrointestinal tract disorders Dry mouth Dyspepsia, nausea Dysphagia Skin and subcutaneous tissue disorders Pruritus, rash, urticaria Kidney and urinary tract disorders Urinary retention General and injection site disorders Discomfort, fatigue Chest discomfort, thirst, systemic allergic reactions