CLOBUNIL Tablet

Indication:

Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport.

Dosage:

Adults: 1 tablet 3 times daily. The therapeutic effect may be enhanced by administering 2 tabs 2 times daily and should be taken with liquid.

This dosage regimen is for initial treatment; the dosage may be halved after 14 days.

In acute respiratory indications, medical advice should be sought if symptoms do not improve or worsen in the course of therapy.

Known hypersensitivity to ambroxol hydrochloride or to any of the excipients of Clobunil.

In case of rare hereditary conditions that may be incompatible with an excipient of Clobunil.

Gastrointestinal Disorders: Dyspepsia, nausea, vomiting, diarrhoea and abdominal pain.

Respirato1y, Mediastinal and Thoracic Disorders: Oral and pharyngeal hypoaesthesia, dry mouth and dry throat.

Nervous System Disorders: Dysgeusia (eg, changed taste).

Immune System Disorders: Anaphylactic reactions including anaphylactic shock.

Skin and Subcutaneous Tissue Disorders: Angioedema, rash, urticaria, pruritus and other hypersensitivity.

Please inform your doctor of all undesirable effects upon drug administration.

No clinically relevant unfavourable interaction with other medications have been reported.

Ambroxol hydrochloride crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or oostnatal develooment. Extensive clinical experience after the 28th week of pregnancy has shown no evidence of harmful effects on the foetus. Nonetheless, the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during the 1st trimester, the use of Clobunil is not recommended.

Ambroxol hydrochloride is excreted in breast milk. Although unfavourable effects on breastfed infants would not be expected, Clobunil is not recommended for use in nursing mothers.

There have been very few reports of severe skin lesions eg, Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants eg, ambroxol hydrochloride. Mostly these could be explained by the severity of the patient's underlying disease and/or concomitant medication. In addition, during the early phase of a Stevens-Johnson Syndrome or TEN, a patient may fust experience nonspecific influenza-like prodromes. It is possible that a symptomatic treatment is started with a cough and cold medication.

Therefore, if new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with ambroxol discontinued as a precaution.

In the presence of impaired renal function, Clobunil may be used only after consulting a physician.

Keep out of reach of children.

Preclinically, ambroxol hydrochloride, the active ingredient of Clobunil, has been shown to increase respiratory tract secretion. It enhances pulmonary surfactant production and stimulates ciliary activity. These actions result in improved mucus flow and transport (mucociliary clearance). Improvement of mucociliary clearance has been shown in clinical pharmacologic studies. Enhancement of fluid secretion and mucociliary clearance facilitates expectoration, and eases cough.