ZERINOL THROAT * SPRAY FL 20ML
Symptomatic treatment of acute pain in sore throat, for adults and children over 12 years of age.
Dosage and method of use
Dosage. Adults and children over 12 years: one 10 mg dose (4 puffs), to be sprayed into the throat, up to 6 times a day. Zerinol Gola 2.5 mg oral mucosal spray solution / actuation cannot be used for more than 3 days. In case of persistence of symptoms or high fever, the patient should consult a doctor. Pediatric population: Zerinol Gola 2.5 mg / actuation oromucosal spray, solution should not be used in children under 12 years of age (see section 4.4). Method of administration: For oral mucosa. Before use, the pump must be operated 5 times until a uniform mist is released. If you have not used the spray for an extended period of time, you need to operate the pump once before using the medicine again. To make a delivery, it is necessary to hold the spray bottle upright with the dispenser facing the throat and, at the same time, press the top of the pump all the way down.
Hypersensitivity to the active substance (ambroxol) or to any of the excipients listed in section 6.1.
Frequency estimated based on available clinical data: very common (≥ 1/10) common (≥ 1/100 y uncommon (≥ 1 / 1,000 a rare (≥ 1 / 10,000 y very rare ( not known (cannot be estimated from the available data) This adverse reaction was observed in post-marketing experience. With certainty of 95%, the frequency category is not higher than uncommon (3/1226), but it may be lower. An accurate frequency estimate cannot be made as the adverse drug reaction did not occur in a clinical trial database of 1226 patients. Disorders of the immune system. Rare: hypersensitivity reactions; Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Skin and subcutaneous tissue disorders. Rare: rash, urticaria; Not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis). As is generally seen with allergies, the severity of allergic reactions may increase if the patient takes the same substance again (see section 4.3). Nervous system disorders. Common: dysgeusia (eg, altered taste). Gastrointestinal disorders and respiratory, thoracic and mediastinal diseases. Common: hypoesthesia of the oral cavity and pharynx (see section 4.4), nausea; Uncommon: upper abdominal pain, dyspepsia, dry mouth; Rare: diarrhea, dry throat; Not known: vomiting. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
Zerinol Gola 2.5 mg oral mucosal spray solution / actuation cannot be used for more than 3 days. If symptoms worsen or persist after 3 days or if the patient has a high fever, a doctor should be consulted. Cases of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) have been reported associated with the administration of ambroxol hydrochloride. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxol hydrochloride should be discontinued immediately and a physician consulted. Episodes of dyspnea can occur in the context of latent disease such as a swollen throat. Local allergic reactions (see section 4.8: angioedema) can also cause dyspnoea. The local anesthetic properties of ambroxol may contribute to alter the sensory perception in the pharyngeal space (see section 4.8: hypoesthesia of the oral cavity and pharynx). Zerinol Gola 2.5 mg / dose of oral mucosal spray, solution is not suitable for the treatment of oral ulcers. In these cases, contact your doctor. In case of impaired renal function or severe liver disease, the 2.5 mg oral mucosal spray solution / actuation of Zerinol Gola can only be used after consultation with your doctor. As with any medicinal product with hepatic metabolism followed by renal elimination, accumulation of metabolites of ambroxol in the liver may occur in severe renal insufficiency. This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose (4 puffs). This medicinal product contains propylene glycol which may cause irritation of the skin and mucous membranes. Pediatric population: Zerinol Gola 2.5 mg / actuation oral mucosal spray, solution should not be used in children under 12 years of age.
Pregnancy and breastfeeding
Pregnancy: Ambroxol hydrochloride crosses the placental barrier. Preclinical studies have not shown any direct or indirect harmful effects on pregnancy, embryonal / fetal development, delivery or postnatal growth. Extensive clinical experience after the 28th week of pregnancy has not shown the appearance of harmful effects on the fetus. Despite this, normal precautions should be taken regarding the use of medicines in pregnancy. Especially during the first trimester, taking the 2.5 mg oral mucosal spray solution / actuation of Zerinol Gola is not recommended. Feeding time: Ambroxol hydrochloride is excreted in breast milk. Although no adverse effects on infants are expected, the use of Zerinol Gola 2.5 mg oral mucosal spray solution / actuation is not recommended during breastfeeding.Fertility: Preclinical studies do not indicate direct or indirect harmful effects with respect to fertility.
Expiration and retention
Do not store above 30 ° C. For storage conditions after first opening see section 6.3.
Interactions with other drugs
No clinically relevant adverse interactions were observed with other drugs.
No specific symptoms of overdose in humans have been reported to date. The symptoms observed in cases of accidental overdose and / or in cases of medication errors are consistent with the known side effects of Zerinol Throat 2.5 mg / actuation oral mucosal spray, solution at recommended doses, and may require an symptomatic treatment.
A single puff contains 2.5 mg of ambroxol hydrochloride. 1 ml of spray contains 17.86 mg of ambroxol hydrochloride. Excipient (s) with known effect: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose (4 puffs), and very small amounts of propylene glycol. For the full list of excipients, see section 6.1.
Citric acid monohydrate Disodium phosphate dihydrate Polysorbate 20 Sucralose Refreshing flavor (contains propylene glycol) Eucalyptus-Menthol flavor (contains propylene glycol) Ethanol Purified water