Ambroxol Angenerico 7, 5 mg/ml Ambroxol Solution to Nebulize Bottle 50 ml

Solution based on ambroxol hydrochloride.

Therapeutic indications

Ambroxol Hydrochloride 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 and children over 5 years of age: 2-3 ml of solution 1-2 times a day.
• Children under 5 years of age: 2 ml of solution 1-2 times a day.

Since coughing may occur in deep breathing of aerosols, one should try to breathe normally during inhalation. It is recommended to warm the solution to body temperature before inhalation. In patients with bronchial asthma it is recommended to administer the usual bronchospasmolytic before inhalation. Do not use ambroxol for prolonged treatments.

Overdose

No specific symptoms of overdose in humans have been reported to date. The symptoms observed in cases of accidental overdose and / or in cases of medication errors are consistent with the expected side effects of Ambroxol at recommended doses and may require symptomatic treatment.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Severe hepatic and / or renal disorders.
• Taking the medicine is contraindicated in case of rare hereditary diseases that may be incompatible with one of the excipients

Side effects

Adverse reactions are listed below by system organ class and by frequency according to the following categories: Very common (≥1 / 10) Common (≥1 / 100 to <1/10) Uncommon (≥1 / 1,000 to <1/100) Rare (≥1 / 10,000 to <1 / 1,000) Very rare (<1 / 10,000) Not known: frequency cannot be estimated from the available data:

- 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 cutaneous adverse reactions (including erythema multiforme, Steven-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis.

- Nervous system disorders

• Common: dysgeusia (change in taste)

- Gastrointestinal, respiratory, thoracic and mediastinal disorders

• Common: nausea, pharyngeal and oral hypoesthesia
• Uncommon: vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth Not known: dry throat, heartburn.

Pregnancy and breastfeeding

Ambroxol hydrochloride crosses the placental barrier. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal development. Although preclinical studies and extensive clinical experience have not shown any harmful effects after the 28th week of gestation, it is recommended that normal precautions be taken when taking medicines during pregnancy. Especially during the first trimester it is not recommended to take Ambroxolo Angenerico.

Ambroxol hydrochloride is excreted in breast milk. Although no adverse effects are anticipated in breast-fed infants, Ambroxol Angeneric is not recommended for use during breastfeeding.

Special warnings

Ambroxol should be administered with caution to patients with peptic ulcer. There have been reports of severe skin reactions such as erythema multiforme, Steven-Jhonson syndrome (SJS) / toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of ambroxol. Most of these could be explained by the severity of underlying disease or other concomitant medications. Also in the early stage of Stevens Johnson syndrome or toxic epidermal necrolysis (NET), patients may initially experience non-specific flu-like symptoms, such as fever, chills, rhinitis, cough and sore throat. Due to these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. 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 the doctor consulted. If new lesions of the skin or mucous membranes occur, consult your doctor immediately and precautionary discontinue treatment with ambroxol hydrochloride. In case of mild or moderate renal insufficiency, Ambroxol Angenerico can only be used after consulting your doctor. As with any drug metabolised by the liver and eliminated by the kidney, accumulation of the metabolites of ambroxol generated in the liver can occur in the presence of severe renal insufficiency.

The drug contains contains sodium metabisulfite; Rarely it can cause severe hypersensitivity reactions and bronchospasm. The drug contains contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: May cause allergic reactions (even delayed) and, exceptionally, bronchospasm.

Expiration 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. Do not store above 25 °.

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

Composition

100 ml of Ambroxol Angenerico Solution contain:

Active principle

750 mg of ambroxol hydrochloride

Excipients

Methyl parahydroxybenzoate - propyl parahydroxybenzoate - sodium metabisulfite - citric acid monohydrate - sodium hydroxide - purified water.