Zinpel Oral Nebul Soluz 15 Monod 2ml 15mg/2ml

NAME
ZINPEL

PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with cough suppressants; mucolytics.

ACTIVE PRINCIPLES
15 mg / 2 ml solution for nebulisation and oral: ambroxol hydrochloride 15 mg. 15 mg / 5 ml syrup in single-dose container: ambroxol hydrochloride 15 mg. 15 mg / 5 ml multidose syrup 200 ml: 5 ml of syrup contain 15 mg ambroxol hydrochloride.

EXCIPIENTS
Nebuliser and oral solution: sodium chloride, water for injections. Syrup in single-dose container: maltisorb (Maltitol75%), glycerol 98%, citric acid monohydrate, water for injectable preparations. Syrup in multidose bottle: maltisorb (Maltitol 75%), glycerol 98%, citric acid monohydrate, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, water for injections.

INDICATIONS
Treatment of secretion disorders in acute and chronic bronchopulmonary affections.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Severe hepatic and / or renal disorders. The drug is contraindicated in case of rare hereditary pathologies which may be incompatible with one of the excipients. Pediatric population: the drug is contraindicated in children younger than 2 years (for oral use).

DOSAGE
Nebulizer and oral solution: each single-dose container contains 2ml and has a notch at the volume of 1ml (half dose). Solution to be sprayed. Adults and children older than five years: 2 ml (one container) 2 times a day. Children younger 'less than five years: 1-2 ml (half container - one container) 1-2 times a day. The solution can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in the ratio 1: 1. Oral solution. Adults: 2-4 ml (1-2 containers) 3 times a day. Children older than five years: 1-2 ml (half container - one container), 2-3 times a day. Children aged between two and five years: 1 ml (half container) 2-3 times a day. Dilute the solution in a little water, tea, milk or fruit juice. The medicine should be taken with meals. Syrup in multidose bottle. Adults: at the beginning of the treatment 10 ml 3 times a day, then 5 ml 3 times a day. Children older than five years: 5 ml 3 times a day. Children aged between two and five years: 2.5 ml 2-3 times a day. The measuring cup enclosed in the bottle package has notches at volumes of 2.5 ml, 5 ml and 10 ml. The medicine should be taken with meals. Syrup in single-dose container: each single-dose container of syrup contains 5 ml and has a notch at the volume of 2.5 ml (half dose). Adults: at the beginning of treatment 10 ml (two containers) 3 times a day, then 5 ml (one container) 3 times a day. Children over five years of age: 5 ml (one container) 3 times a day. Children aged between two and five years: 2.5 ml (half container) 2-3 times a day. The medicine should be taken with meals.

STORAGE
This medicinal product does not require any special storage conditions. After opening the foil pouch containing the single-dose containers, the medicine must be used within three months; after this period, any unused medicinal product should be discarded. When using half a dose of the single-dose container, the re-closed container should be stored at 2 degrees - 8 degrees C (in the refrigerator) for a maximum of 12 hours; after this period the residual medicinal product must be discarded. After opening the syrup bottle, the medicine should be used within one month; after this period the residual medicinal product must be discarded.

WARNINGS
Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children younger 'less than 2 years. The drug should be administered with caution in patients with peptic ulcer. There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnsons syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of Ambroxol. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with Ambroxol should be stopped immediately and a physician consulted. Most of these cases can be explained by the severity of the patient's underlying disease and / or by concomitant therapy. Also, during the early stage of Steven-Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially experience nonspecific flu-like prodromes such as fever, body aches, rhinitis, cough, and sore throat. Because of these misleading, nonspecific, flu-like prodromes it is possible that symptomatic treatment with cough and cold medications may be instituted. Therefore, if new lesions of the skin or mucous membranes occur, it is necessary to consult a doctor immediately and to stop the treatment with ambroxol hydrochloride as a precaution. In the presence of mild or moderate renal insufficiency or severe liver disease, the drug should only be used after consulting your doctor. In severe renal insufficiency, accumulation of the metabolites of ambroxol generated in the liver may occur. During the administration of the solution to be nebulized, since irritation cough may arise in the too deep inhalation of the aerosols, it is necessary to try to inhale and exhale normally. In particularly sensitive patients, a pre-heating of the inhaled to body temperature can be recommended. For patients suffering from bronchial asthma it is advisable to resort to a bronchial spasmolytic before inhalation. The syrup in single-dose container and in multi-dose bottle contains maltitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup in multidose bottle contains para-hydroxybenzoates which can cause allergic reactions (including delayed type).

INTERACTIONS
Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No clinically relevant interactions with other medicinal products have been observed.

SIDE EFFECTS
At the recommended doses the medicine is normally well tolerated. The following undesirable effects have been observed during therapy with ambroxol hydrochloride, with frequencies: very common> = 1/10, common> = 1/100, <1/10, uncommon> = 1 / 1,000, <1 / 100, rare> = 1 / 10,000, <1 / 1,000, very rare <1 / 10,000, not known. Disorders of the immune system. Rare: hypersensitivity reactions'; not known: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Nervous system disorders. Common: dysgeusia (eg taste disturbance); rare: headache. Respiratory, thoracic and mediastinal disorders: Common: hypoesthesia of the oral cavity and pharynx; not known: bronchial obstruction. Gastrointestinal disorders. Common: nausea; uncommon: vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth; not known: dry throat. 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). Report any suspected adverse reactions via the national reporting system at.

PREGNANCY AND BREASTFEEDING
Ambroxol hydrochloride crosses the placental barrier. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal development. Clinical studies and extensive clinical experience after the 28th week of pregnancy have shown no evidence of harmful effects on the fetus. However, it is recommended to observe the usual precautions regarding the use of medicines during pregnancy. Particularly during the first trimester, use is not recommended. Ambroxol hydrochloride is excreted in breast milk. Although undesirable effects on infants are not expected, its use is not recommended in nursing mothers.