XILOMETAZOLINA EG SPR10ML 10MG

XILOMETAZOLINA EG 1 MG/ML NASAL SPRAY, DEAL

active ingredients

1 ml nasal spray, solution contains 1 mg xilometazoline hydrochloride. Each spray nebulization (about 0.09 ml of solution) contains 0.09 mg of xilometazoline hydrochloride. For the full list of excipients, see paragraph 6.1.

Excellent

Potassium monobasic phosphate Purified sea water Purified water

Therapeutic indications

• Temporary symptomatic treatment of nasal congestion due to rhinitis or sinusitis. XILOMETAZOLINA EG 1 mg/ml nasal spray is intended for children from 12 years of age and adults.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Inflammation of the nasal mucosa (dry retite) - except in the diagnostic examination to identify dry rhinitis or atrophic rhinitis. • Condition that occurs following transfenoidal hypofisectomy or other surgical interventions with exposure of the hard mother.

Population

Population Children from 12 years of age and adults: 1 nebulization in each nostril, depending on the need, up to three times a day. Pediatric population XILOMETAZOLINA EG 1 mg/ml is indicated in children from 12 years of age for administration as described above. XILOMETAZOLINA EG 1 mg/ml should not be used in children under 12 years. Other pharmaceutical dosages may be more suitable for administration in this population. Method of administration XILOMETAZOLINA EG is for nasal use. It is recommended for patients to thoroughly blow their nose before using preparation. The last dose of each day of treatment should be preferably given before going to bed. How to use XILOMETAZOLINA EG • Remove the protective cap. • Before using the spray for the first time, press the vacuum dispenser for at least five times until a uniform nebulization is issued. The dispenser will be ready for immediate use. You should repeat the procedure if the spray is not used for a few days. Follow the following: or 4-14 days not to use: 1 vacuum nebulization; or more than 14 days of non-use: 5 vacuum nebulizations. • Insert the spout into the nostril and press the dispenser once. Spray and simultaneously breathe gently with the nose. Repeat the procedure for the other nostril. • After use, carefully clean the bucket with a clean paper before returning the cap. For hygienic reasons and to avoid infections, each spray pack must be used by one person. Duration of treatment The recommended single dose of XILOMETAZOLINA EG must be administered for maximum three times a day. Do not exceed the recommended dosage. XILOMETAZOLINA EG should not be used for more than 7 days unless the doctor prescribes it. Wait a few days before reuse these medicines. Extended and excessive use may cause reactive hyperemia or rebound congestion (see paragraph 4.4) respectively. In cases of chronic rhinitis can only be administered under medical surveillance due to the risk of nasal mucosa atrophy.

Conservation

This medicine does not require special conditions of conservation.

Warnings

There are isolated reports of severe adverse reactions (especially apnea) occurring following the use of therapeutic doses. Avoid overdose with all means. Like other sympathomimetic agents, it must be used carefully in patients who show a strong reaction to adrenergic substances. The use of this product can cause for example insomnia, dizziness, tremors, arrhythmia or hypertension. Patients with long-term QT syndrome treated with xylometazoline may be exposed to a greater risk of severe ventricular arrhythmias. Xilometazoline can be used exclusively after careful assessment of risk/benefit ratio: • in patients treated with mono-amino-oxidase inhibitors (MAO-I) or with other medicines potentially capable of causing a diary rise; • in case of increased intraocular pressure, especially of narrow angle glaucoma; • in case of severe cardiovascular diseases (e.g. coronary disease, hypertension); • in case of feocromocytoma; • in case of metabolic disorders (e.g. hyperthyroidism, diabetes mellitus); • in case of porphyria; • in case of prostate hypertrophy. Avoid direct contact with your eyes. In case of prolonged treatment with xylometazoline, with the suspension of the therapy you can observe the reappearance of the edema of the mucosa membrane. In these cases, it may also be the so-called "rebound" phenomenon caused by the medicine itself. To avoid this, the duration of treatment must be as short as possible (see paragraph 4.2). Nasal and paranasal infections of bacterial origin must be treated appropriately. Infections can spread if the same spray bottle is used by more people.

Interactions

The contemporary use of xylometazoline is not recommended with antidepressants triceclic or tetracyclic or inhibitors of mono-amino-oxidase (MAO) or within two weeks of the intake of MAO inhibitors. Due to the potential hypertensive effects, it is preferable to avoid the association of xilometazoline with antihypertensive medicines (e.g. methyldopa). The association of xilometazoline and other medicines with potential hypertensive effects (e.g. doxapram, ergotamine, oxytocin) can cause an increase in their hypertensive effects.

Effects

In this paragraph, the frequencies of unwanted effects are defined as follows: very common (≥ 1/10); common (from ≥ 1/100 to Immune system disorders Not common: hypersensitivity reactions (angioedema, skin rashes, itching) Psychiatric disorders Very rare: restlessness, insomnia, hallucinations (especially in children), drowsiness/sober (especially in children) Diseases of the nervous system Very rare: headache, convulsions (especially in children). Heart disease Rare: palpitations, tachycardia Very rare: arrhythmias Vascular diseases Rare: hypertension Respiratory, chest and mediastinic pathologies Common: burning and dryness of the nasal mucosa, sneezing Not common: rebound congestion as soon as the decongestant effect vanishes, very rare epistaxis: apnea (marked as a result of the use of xilometazoline in small and newborn children) Gastrointestinal diseases Rare: nausea Systemic pathologies and conditions for administration Very rare: fatigue (silence, sedation) Pediatric population Xylometazoline has proven to be safe in children in various clinical studies. Data from clinical studies and cases indicate that the frequency, type and severity of adverse reactions in children should be similar to those found in adults. Most reported adverse reactions in children occurred following overdose of xylometazoline. These include nervousness, insomnia, drowsiness/sopotence, hallucinations and seizures. In children and infants cases of irregular heartbeat were recorded. Reporting of suspicious adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Synonyms The clinical picture of intoxication with imidazole derivatives can be disorienting, since the stages of stimulation can alternate with phases of suppression of the central nervous system and cardiovascular system. Symptoms of central nervous system stimulation are anxiety, agitation, hallucinations and seizures. The secondary symptoms of central nervous system inhibition are lowering body temperature, letargy, drowsiness and coma. The following symptoms may also occur: myosis, midriasis, sweating, fever, pallor, cyanosis, nausea and vomiting, tachycardia, bradycardia, heart arrhythmias, cardiac arrest, palpitation, hypertension, hypotension related to shock, pulmonary edema, respiratory depression and apnea, psychogenic disorders. After overdose, it is common to appear, especially in children, of dominant effects to the central nervous system associated with convulsions and coma, bradycardia, apnea and also hypertension replaced by hypotension. Treatment In case of strong overdose, hospitalization is indicated at an intensive care department. The administration of activated carbon (absorbent), sodium sulphate (laxative) or gastric lavender (following ingestion of large quantities) must be started immediately because the absorption of xylometazoline can be rapid. Administer a non selective alpha-blocker to reduce blood pressure. The vasopressors are contraindicated. Administer antipyretics, anticonvulsants and oxygen if necessary.

Pregnancy The data on a limited number of pregnancies exposed during the first quarter is not sufficient to draw a conclusion on the adverse effects of xylometazoline on pregnancy or health of the fetus/neonate. Other appropriate epidemiological data are not yet available. Animal studies showed reproductive toxicity with the use of dosages higher than therapeutic doses (see paragraph 5.3).

Xilometazolina should only be used after careful assessment of risk/benefit ratio

. Since an overdose can compromise the blood supply to the unborn child, during pregnancy the recommended dose must not be exceeded. Food It is not known whether xylometazoline is excreted in breast milk. There are no risks to infants. It is therefore appropriate to decide whether to continue/suspend breastfeeding or to continue/suspend treatment with xylometazoline taking into account the benefits of breastfeeding for the child and the benefits of the treatment for women. Overdose can cause a reduction in milk production; the recommended dose should not be exceeded during lactation. Fertility No known effects on fertility due to xilometazoline treatment.

Source: Farmadati