ZERINOL GOLA MENT 18PAST 20MG

ZERINOL GOLA MENT 20 MG PASTIGLIE

active ingredients

A pill contains 20 mg of ambroxol hydrochloride. Excipient(s) with known effects: A pastel contains sorbitol (E420) (1.37 g to pastel) and lactose monohydrate (less than 1 mg to pastel). For the full list of excipients, see paragraph 6.1.

Excellent

Aroma mint (Arabic rubber, Chinese mint oil, maltodextrin, lactose-monoidrate) Sorbitol (E420) Sodium saccharin 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.

Population

Population Adults and children over 12 years: up to 6 pills per day, to melt in the mouth. Zerinol Gola mint 20 mg tablets should not be used for more than 3 days. If symptoms or high fever persist, the patient should consult a doctor. Pediatric population Zerinol Gola mint 20 mg tablets should not be used in children under 12 years of age. Method of administration For oral mucosa. Zerinol Gola mint 20 mg pills is suitable for diabetics.

Conservation

Do not store at temperature above 30°C.

Warnings

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 inflated throat). Local allergic reactions (see paragraph 4.8: angioedema) can also be cause of 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 mint 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 mint 20 mg tablets can be used only 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). Patients with rare hereditary condition of fructose intolerance should not take this medicine. A pill of Zerinol Gola mint 20 mg tablets contains less than 1 mg 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 problems of glucose/galactose mal absorption, should use Zerinol Gola mint 20 mg tablets with caution. Pediatric population Zerinol Gola mint 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 available data) This adverse reaction was observed in the post-marketing experience. With a 95% certainty, the frequency category is not greater than non-common (3/1226), but may be lower. A precise frequency estimate is not possible as the adverse reaction to the drug did not occur in a clinical trial database 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 Not known: vomiting. 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 mint 20 mg tablets at recommended doses, and may require symptomatic treatment.

Pregnancy

Ambroxol Hydrochloride crosses the placental barrier. Non-clinical 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 trimester, the use of Zerinol Gola mint 20 mg tablets is not recommended.

Food

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

Fertility

Non-clinical studies do not indicate direct or indirect harmful effects on fertility.

Source: Farmadati