ZERINOL THROAT MINT * 18PAST 20MG
Symptomatic treatment of acute pain in sore throat.
Dosage and method of use
Dosage Adults and children over 12 years old: up to 6 tablets per day, to be dissolved in the mouth. Zerinol Throat mint 20 mg lozenges should not be used for more than 3 days. If symptoms or a high fever persist, the patient should consult a doctor.Pediatric populationZerinol Throat mint 20 mg lozenges should not be used in children under 12 years of age.Method of administrationFor oral mucosa. Zerinol Throat mint 20 mg lozenges are suitable for diabetics.
Hypersensitivity to the active substance 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 euncommon (≥ 1 / 1,000 andrare (≥ 1 / 10,000 every rare (not known (cannot be estimated from the available data)This adverse reaction was observed in post-marketing experience. With 95% certainty, the frequency category is not greater than uncommon (3/1226), but it could be lower. A precise estimate of the frequency is not possible as the adverse drug reaction did not occur in a clinical trial database of 1226 patients.).Disorders of the immune systemRare: hypersensitivity reactions. Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus.Skin and subcutaneous tissue disordersRare: 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 observed for allergies, the severity of allergic reactions may increase if the patient takes the same substance again (see section 4.3).Nervous system disordersCommon: dysgeusia (eg, altered taste).Gastrointestinal and respiratory, thoracic and mediastinal disordersCommon: hypoesthesia of the oral cavity and pharynx (see section 4.4), nausea. Uncommon: diarrhea, upper abdominal pain, dyspepsia, dry mouth. Rare: dry throat. Not known: vomiting.Reporting of suspected adverse reactionsReporting 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.
There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) 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 alter the sensory perception in the pharyngeal space (see section 4.8: hypoesthesia of the oral cavity and pharynx). Zerinol Gola mint 20 mg tablets are not suitable for the treatment of oral ulcers. In these cases, contact your doctor. In case of impaired kidney function or severe liver disease, Zerinol Gola mint 20 mg tablets can only be used after consulting 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 medicinal product contains 8.2 g of sorbitol per maximum recommended daily dose (1.37 g per tablet). Patients with a rare hereditary condition of fructose intolerance should not take this medicine. One Zerinol Throat Mint 20 mg lozenge lozenge contains less than 1 mg of lactose. This dose does not normally cause disturbances in lactose intolerant subjects. However, patients with rare hereditary problems of galactose intolerance, lactase deficiency or with glucose / galactose malabsorption problems should use Zerinol Gola Mint 20 mg lozenges with caution.Pediatric populationZerinol Throat mint 20 mg lozenges should not be used in children under 12 years of age.
Pregnancy and breastfeeding
PregnancyAmbroxol hydrochloride crosses the placental barrier. Non-clinical studies have shown no 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 when taking medication during pregnancy. Especially during the first trimester, the use of Zerinol Throat mint 20 mg lozenges is not recommended.Feeding timeAmbroxol hydrochloride is excreted in breast milk. Although no adverse effects on infants are expected, the use of Zerinol Throat mint 20 mg lozenges is not recommended during breastfeeding.FertilityNon-clinical studies do not indicate direct or indirect harmful effects with respect to fertility.
Expiration and retention
Do not store above 30 ° C.
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 20 mg lozenges at recommended doses, and may require symptomatic treatment.
One tablet contains 20 mg of ambroxol hydrochloride. Excipient (s) with known effect: One tablet contains sorbitol (E420) (1.37 g tablet) and lactose monohydrate (less than 1 mg per tablet). For the full list of excipients, see section 6.1.
Mint flavor (gum arabic, Chinese mint oil, maltodextrin, lactose monohydrate) Sorbitol (E420) Saccharin sodium Macrogol 6000 Talc