IT SHOULD NOT BE USED IN ANIMALS

AMBROX MYLAN GENERICS 15 MG/5 ML

active ingredients

5 ml of syrup contain 15 mg of ambroxol hydrochloride. Excipients with known effects: glycerol, sorbitol, metil–para–hydroxybenzoate, propil–para–hydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Sorbitol, propil–para–hydroxybenzoate, metil–para–hydroxybenzoate, glycerol, raspberry essence, glycyrrizinate ammonium, purified water.

Therapeutic indications

Treatment of secretion turbs in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Severe liver and/or kidney alterations. Pediatric population The medicinal product is contraindicated in children under 2 years of age.

Population

Population Adults and teenagers At the beginning of treatment: 10 ml 3 times a day, then 5 ml 3 times a day. Pediatric population Children from 2 to 5 years: 2.5 ml 3 times a day. Children over 5 years: 5 ml 3 times a day. Ambroxolo Mylan Generics is contraindicated in children under 2 years of age (see paragraph 4.3). At the beginning of the treatment the dose may be increased or even doubled to the doctor’s judgment. Method of administration 5 ml syrup corresponds to 15 mg of ambroxol hydrochloride. The measurin acclusive contains graduated heels of 10 ml, 7.5 ml, 5 ml, 2,5 ml. The syrup must be taken at meals.

Conservation

No special precaution for conservation.

Warnings

Mucolitics may induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age range, due to the physiological characteristics of the respiratory tract. They must not be used in children under 2 years of age (see paragraph 4.3). Ambroxol should be administered with caution in patients carrying peptic ulcer. 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 must be stopped immediately and should be consulted by your doctor. Most of these cases can be explained by the severity of the underlying disease of the patient and/or concomitant therapy. In addition, during the initial phase of StevensâE syndrome. “Johnson or TEN, patients could accuse symilâE prodromas.“ Aspecific influenzas such as fever, muscle pain, rhinitis, cough and throat pain. Due to these misleading similâE prodromas.“aspecific influenzas, a symptomatic treatment with cough and cold medicines can be established. Therefore, if new lesions of the skin or mucous membranes occur, you must immediately consult your doctor and precautionally stop the treatment with ambroxol hydrochloride. In the presence of mild or moderate kidney failure or severe hepatopathy, Ambroxolo Mylan Generics should only be used after consulting the doctor. As with any medicinal product having a hepatic metabolism followed by renal elimination, in the presence of kidney failure, the accumulation of ambroxol metabolites generated in fegato.Non use for protracted treatments. Warnings related to some excipients Ambroxolo Mylan Generics contains sorbitol. Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. Ambroxol Mylan Generics contains benzoate parahydroxys that can cause allergic reactions (also delayed).

Interactions

Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxima, erythromycin) in bronchopolmonary secretions and saliva are increased. No interactions with other medicines have been observed.

Effects

During therapy with ambroxol hydrochloride the undesirable effects reported below, with the frequencies: Very common (≥1/10); Common (≥1/100, Classification for systems and organs Action against Frequency Immune system disorders Reactions of hypersensitivity Rare Anaphylactic reactions, including anaphylactic shock, angioedema and itching Notable Diseases of the nervous system Disgeus Town Cefa Rare Respiratory, chest and mediastinic pathologies Hypoesthesia of the oral cable and pharynx Town Bronchial obstruction Notable Gastrointestinal diseases Nausea Town Vomito, diarrhea, dispepsia and abdominal pain, mouth dryness, pyrosis Not common Dry gorge Notable Pathologies of skin and subcutaneous tissue Rash, hives Rare Severe skin adverse reactions (including multiform erythema, Stevens–Johnson syndrome/toxic epidermal necrolysis and generalized acute exantematic pustolosis). Notable 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 to theindirizzowww.aifa.gov.it/content/segnalazioni–reactions–adverse.

Overdosing

Based on accidental overdose reports and/or administration errors, the observed symptoms are consistent with the expected effects of ambroxol at recommended doses. Syntomatic treatment may be necessary. Make sure the patient didn't ingest other medicines at the same time.

Pregnancy

Ambroxol Hydrochloride crosses the placental barrier. Animal studies showed no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or postnatal development. Clinical studies and extensive clinical experience after the 28th week of pregnancy showed no evidence of harmful effects on the fetus. However, it is recommended to observe the usual precautions regarding the use of medicines during pregnancy. In particular during the first quarter, the use of Ambroxolo Mylan Generics is not recommended.

Food

The medicine is excreted in breast milk. Although there are no side effects on infants, the use of Ambroxolo Mylan Generics is not recommended in nursing mothers.

Source: Farmadati