ZERINOL THROAT LIMO * 18PAST 20MG

ZERINOL THROAT LIMO * 18PAST 20MG

Therapeutic indications

Symptomatic treatment of acute pain in sore throat.

Dosage and method of use

Dosage Adults and children over 12 years:up to 6 tablets per day, to be dissolved in the mouth, with a maximum of 1 tablet per dose. Zerinol Throat 20 mg lozenges can be used for up to 3 days. If symptoms or a high fever persist, the patient should consult a doctor.Pediatric populationZerinol Throat 20 mg lozenges should not be used in children under 12 years of age.Method of administrationFor oral mucosa.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with fructose intolerance should not take Zerinol Gola 20 mg lozenges, as these contain significant amounts of sorbitol (see section 4.4 Special warnings and precautions for use).

Side effects

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 higher than uncommon (3/1226), but it could 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 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.

Special warnings

Zerinol Throat 20 mg lozenges can be used for up to 3 days. If symptoms worsen or persist after 3 days or if the patient has a high fever, a doctor should be consulted. 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 sensory perception in the pharyngeal space (see section 4.8: hypoaesthesia of the oral cavity and pharynx). Zerinol Gola 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 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) and 37.8 mg of sucrose per maximum recommended daily dose (6.3 mg per tablet). Patients with a rare hereditary condition of fructose intolerance should not take this medicine.Pediatric populationZerinol Throat 20 mg lozenges should not be used in children under 12 years of age.

Pregnancy and breastfeeding

PregnancyAmbroxol 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 when taking medication during pregnancy. Especially during the first trimester, the use of Zerinol Gola 20 mg tablets is not recommended.Feeding timeAmbroxol hydrochloride is excreted in breast milk. Although no adverse effects on infants are expected, the use of Zerinol Throat 20 mg tablets is not recommended during breastfeeding.FertilityPreclinical studies do not indicate direct or indirect harmful effects with respect to fertility.

Expiry and retention

Do not store above 30 ° C.

Interactions with other drugs

No clinically relevant adverse interactions were observed with other drugs.

Overdose

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 tablets at recommended doses, and may require symptomatic treatment.

Active principles

One tablet contains 20 mg of ambroxol hydrochloride. Excipient (s) with known effect: One tablet contains 1.37 g of sorbitol (E 420) and 6.3 mg of sucrose. For the full list of excipients, see section 6.1.

Excipients

Lemon flavor (containing sucrose) Fresh flavor Sorbitol (E420) Sucralose Macrogol 6000 Talc