ZERINOL THROAT * SPR 20ML 2,5MG / ER

ZERINOL THROAT * SPR 20ML 2,5MG / ER

Therapeutic indications

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 old: one 10 mg dose (4 puffs), to be sprayed into the throat, up to 6 times a day. The 2.5 mg oral mucosal spray solution / actuation of Zerinol Gola cannot be used for more than 3 days. If symptoms persist or a high fever occurs, the patient should consult a physician.Pediatric populationZerinol 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 administrationFor oral mucosa. Before use, the pump must be operated 5 times until a uniform mist is released. If the spray is not used for a long time, the pump must be operated once before using the medicine again. To make a dispensing, 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.

Contraindications

Hypersensitivity to the active substance (ambroxol) or to any of the excipients listed in section 6.1.

Side effects

Frequency estimated based on available clinical data:very common (≥ 1/10) common (≥ 1/100 yuncommon (≥ 1 / 1,000 arare (≥ 1 / 10,000 yvery 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 system. Rare: hypersensitivity reactions; Not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus.Skin and subcutaneous tissue disorders. Rare: rash, hives; 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 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 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-s ospetta-adverse-reaction.

Special warnings

The 2.5 mg oral mucosal spray solution / actuation of Zerinol Gola 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. 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 contribute to altering sensory perception in the pharyngeal space (see section 4.8: hypoesthesia of the oral cavity and pharynx). Zerinol Throat 2.5 mg / dose spray for oral mucosa, 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 populationZerinol Gola 2.5 mg / actuation oral mucosal spray, solution 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 regarding the use of medicines in pregnancy. Especially during the first trimester the intake of the 2.5 mg oral mucosal spray solution / actuation of Zerinol Gola is not recommended.Feeding timeAmbroxol 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.FertilityPreclinical studies do not indicate direct or indirect harmful effects with respect to fertility.

Expiry 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.

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 2.5 mg / actuation oral mucosal spray, solution at recommended doses, and may require an symptomatic treatment.

Active principles

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.

Excipients

Citric acid monohydrate Disodium phosphate dihydrate Polysorbate 20 Sucralose Refreshing flavor (contains propylene glycol) Eucalyptus-Menthol flavor (contains propylene glycol) Ethanol Purified water