ZERINOL GOLA LIMO 18PAST 20MG

ZERINOL GOLA 20 MG PASTIGLI

active ingredients

A pill contains 20 mg of ambroxol hydrochloride. Excipient(s) with known effects: A pill contains 1,37 g of sorbitol (E 420) and 6,3 mg of sucrose. For the full list of excipients, see paragraph 6.1.

Excellent

Lemon aroma (containing sucrose) Aroma Coolfort Sorbitol (E420) Sucralosio Macrogol 6000 Talco

Therapeutic indications

Syntomatic treatment of acute pain in the sore throat.

Contraindications

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

Population

Population Adults and children over 12 years: up to 6 tablets per day, to be dissolved in the mouth, with a maximum of 1 pill per dose. Zerinol Gola 20 mg tablets can be used up to 3 days. If symptoms or high fever persist, the patient should consult a doctor. Pediatric population Zerinol Gola 20 mg tablets should not be used in children under 12 years of age. Method of administration For oral mucosa.

Conservation

Do not store at temperature above 30°C.

Warnings

Zerinol Gola 20 mg tablets can be used up to 3 days. If symptoms worsen or persist after 3 days or if the patient has high fever, you should consult a doctor. Cases of severe skin reactions such as multiform erythema, Stevens-Johnson syndrome (SJS)/ Toxic epidermal necrolysis (TEN) and generalized acute acute edema (AGEP) were reported. If there are symptoms or signs of progressive skin rash (sometimes associated with bladders or mucosa lesions), treatment with ambroxol hydrochloride should be stopped immediately and a doctor should be consulted. Episodes of dispnea can occur in a context of latent disease such as the inflated throat. Local allergic reactions (see paragraph 4.8: angioedema) may also cause dispnea. The local anesthetic properties of ambroxol can alter the sensory perception at the pharyngeal space level (see paragraph 4.8: hypoesthesia of the oral cable and pharynxe). Zerinol Gola 20 mg pills is not suitable for treating oral cavity ulcers. In these cases, contact the doctor. In case of compromised kidney function or severe hepatopathy, Zerinol Gola 20 mg tablets can only be used after consulting the doctor. As with every medication with liver metabolism followed by kidney elimination, in case of severe kidney failure, the accumulation of ambroxol metabolites in the liver may occur. This medicine contains 8.2 g of sorbitol per recommended daily maximum dose (1.37 g per pill) and 37.8 mg of sucrose per recommended daily maximum dose (6.3 mg per pill). Patients with rare hereditary condition of fructose intolerance should not take this medicine. Pediatric population Zerinol Gola 20 mg tablets should not be used in children under 12 years of age.

Interactions

No clinically relevant adverse interaction with other drugs has been observed.

Effects

Estimated frequency based on clinical data available: very common (≥ 1/10) common (≥ 1/100 and not common (≥ 1/1.000 and rare (≥ 1/10.000 and very rare ( not known (can not be defined on the basis of the available data). This adverse reaction was observed in the post-marketing experience. With 95% certainty, the frequency category is not greater than non-common (3/1226), but may be lower. It is not possible to estimate the frequency, since the adverse reaction to the drug did not occur in a database of clinical studies consisting of 1226 patients. Immune system disorders Rare: hypersensitivity reactions. Notable: anaphylactic reactions, including anaphylactic shock, angioedema and itching. Pathologies of skin and subcutaneous tissue Rare: rash, hives. Notable: severe skin adverse reactions (including multiform erythema, Stevens-Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). As is generally observed for allergies, the severity of allergic reactions may increase if the patient takes the same substance again (see paragraph 4.3). Diseases of the nervous system Municipality: disgeusia (p.es. altered taste). Gastrointestinal pathologies and respiratory, thoracic and mediastinic diseases Common: hypoesthesia of the oral cable and pharynx (see paragraph 4.4), nausea. Not common: diarrhea, pain of the upper quadrants of the abdomen, despair, dry mouth. Rare: dry throat. Don't note: I throw up. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

So far no specific symptoms of overdose have been reported in man. Symptoms observed in cases of accidental overdose and/or in cases of errors in the administration of the medicinal product are consistent with the undesirable known effects of Zerinol Gola 20 mg tablets at recommended doses, and may require symptomatic treatment.

Pregnancy

Ambroxol Hydrochloride crosses the placental barrier. Preclinical studies have shown no direct or indirect harmful effect on pregnancy, embryo/fetal development, childbirth or postnatal growth. A vast clinical experience after the 28th week of pregnancy did not highlight the appearance of harmful effects on the fetus. In spite of this, normal precautions should be taken on the intake of pregnant medicines. Especially during the first quarter, the use of Zerinol Gola 20 mg pills is not recommended.

Food

Ambroxol Hydrochloride is excreted in breast milk. Although no side effects are expected, the use of Zerinol Gola 20 mg tablets is not recommended during breastfeeding.

Fertility

Preclinical studies indicate no direct or indirect harmful effects on fertility.

Source: Farmadati