Brufix Solution to Nebulize 15 mg/2 ml Ambroxol 20 Vials

Solution to be nebulized based on ambroxol hydrochloride.

Therapeutic indications

Brufix 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: 1 single-dose container 2 or 3 times a day
• Children over 5 years: 1 single-dose container 2 times a day
• Children up to 5 years: ½ single-dose container 2 times a day.

The solution to be nebulized can be administered using normal nebulizer therapy devices. It can also be diluted in distilled water in the ratio 1: 1. 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 BRUFIX 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.

Side effects

Undesirable effects listed by frequency are reported, using the following convention: 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), frequency not known (cannot be estimated from the available data).

- Disorders of the immune system

• Not known: Anaphylactic reactions, including anaphylactic shock, angiodema, pruritus and other hypersensitivity reactions

- Nervous system disorders

• Common: Dysgeusia (e.g. changes in the sense of taste)

- Respiratory, thoracic and mediastinal disorders

• Common: Hypoesthesia of the oral cavity and pharynx
• Rare: Rhinorrhea
• 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, urticaria, contact dermatitis

- Renal and urinary disorders

• Rare: Dysuria

- General disorders and administration site conditions

• Rare: Fatigue

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 BRUFIX. Ambroxol hydrochloride is excreted in breast milk. Although no undesirable effects are anticipated in breastfed infants, the use of BRUFIX is not recommended during breastfeeding.

Special warnings

Ambroxol should be administered with caution to patients with peptic ulcer. 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.

In very few cases, severe skin lesions such as Stevens Johnson syndrome and toxic epidermal necrolysis (NET) have been observed simultaneously with the administration of expectorants such as ambroxol hydrochloride. 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 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, BRUFIX 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.

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. This medicinal product does not require any special storage conditions.

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

Composition

Each vial of Brufix contains:

Active principle

Ambroxol hydrochloride 15 mg

Excipients

Sodium chloride, purified water.