Mucoaricodil 600 mg Ambroxoloo Cloridrato Tosse Sciroppo 200 ml

Syrup based on ambroxol hydrochloride.

Therapeutic indications

Mucoaricodil Syrup is used in the treatment of secretion disorders in acute and chronic bronchopulmonary affections.

Dosage and Posology

The drug should be taken according to the following doses and methods:

• Adults: initially 10 ml 3 times a day, then 5 ml 3 times a day.
• Children from two to five years: 2.5 ml 3 times a day;
• Children over five years old: 5 ml 3 times a day.

Each ml of syrup is equivalent to 3 mg of ambroxoloo hydrochloride. It is recommended to take the tablets after meals with some liquid. A 5 ml measuring spoon with notches corresponding to ½ and ¼ is attached to the syrup package. It is advisable to take the drug during or after main meals.

Overdose

There are no known cases of overdose with Mucoaricodil. Should this happen, it is advisable to induce vomiting and / or resort to gastric lavage. Keep in mind that the patient has not ingested other drugs at the same time.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Subjects with severe hepatic and / or renal disorders.
• Children under the age of 2

Side effects

Adverse reactions are ranked by frequency according to the following definition: very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000, <1 / 1,000); very rare (<1 / 10,000), not known (frequency cannot be estimated from the available data). Within each frequency class, undesirable effects are reported in descending order of severity.

- 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, urticaria Not known: severe skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis).

- Gastrointestinal disorders

• Rare: nausea, gastrointestinal disturbances (heartburn, dyspepsia, nausea and vomiting).

- Respiratory, thoracic and mediastinal disorders

• Not known: bronchial obstruction

- Nervous system disorders

• Rare: headache

Pregnancy and breastfeeding

Studies of teratogenesis and fetal toxicity on animals have not shown any harmful effects of Mucoaricodil even at high doses. However, it is not advisable to use it during the first three months of pregnancy and, in the further period, the drug will be administered only in case of real need and under the direct supervision of the doctor.

The drug is excreted in breast milk, therefore a decision must be made whether to discontinue breastfeeding or treatment with the drug, taking into account the importance of the drug to the mother.

Special warnings

Mucoaricodil should be administered with caution in patients with peptic ulcer. 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 ambroxoloo hydrochloride. If symptoms or signs of progressive skin rash (sometimes associated with blistering or mucosal lesions) are present, treatment with ambroxoloo hydrochloride should be stopped immediately and a physician consulted. 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.

Mucoaricodil syrup contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol can cause stomach problems and diarrhea. Mucoaricodil syrup contains glycerol which is dangerous in high doses: it can cause migraines, gastric problems and diarrhea.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. After opening the bottle the syrup is stable for 6 months. This medicine does not require any special storage conditions.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 ml of Mucoaricodil Syrup contain:

Active principle

Ambroxoloo hydrochloride 300 mg

Excipients

Benzoic acid, glycerol 85%, sorbitol solution 70%, hydroxyethylcellulose, raspberry flavor, purified water.