Clenmysol Sp.

Rx

Indications

• Acute and chronic respiratory tract disorders that result in bronchospasm and changes in the formation and transport of secretions, in particular: acute and chronic bronchitis, bronchial asthma, emphysema, laryngotracheitis, bronchiectasis and mucoviscidosis (cystic fibrosis).

Dosage

• Adults and children over 12 years: 20 ml twice daily
• 6 – 12 years: 15 ml twice daily
• 4 – 6 years: 10 ml twice daily
• 2 – 4 years: 7.5 ml twice daily
• 8 – 24 months: 5 ml twice daily
• Up to 08 months: 2.5 ml x twice daily

Usage

• Administered via oral, can be taken with meals. Use the dosing device included in the box to measure the volume.

• Hypersensitivity to ambroxol and clenbuterol, or to any of the ingredients in this drug.
• Should not be used in patients with thyrotoxicosis, idiopathic subvalvular hypertrophic aortic stenosis, tachyarrhythmias.
• Patients with gastroduodenal ulcer.

Due to clenbuterol

• Especially at the beginning of treatment, feelings of restlessness, slight tremor of the fingers and palpitations may be registered, which usually disappear after 1 to 2 weeks of treatment.

Due to ambroxol

• Ambroxol is well tolerated in virtually all cases where it is administered. Only occasionally and rarely minor dyspeptic disturbances are mentioned.

Rare

• Hypersensitivity reactions,
• Rash, urticaria.

• In hypersensitive patients, fine tremor of the fingers and palpitations may occur at the beginning of treatment, which may disappear with continued therapy.
• In patients with recent myocardial infarction, treatment should be carried out with caution and reduced dosage.
• Mucolytics (ambroxol) have the ability to destroy the gastric barrier, so they should be used with caution in individuals with a history of peptic ulcer.
• There have been reports of serious 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 ambroxol. If symptoms or signs of a progressive rash (sometimes associated with blisters or mucosal lesions) are present, treatment with ambroxol should be immediately discontinued and medical advice sought.
• Cardiovascular effects may be observed with the use of sympathomimetic drugs such as Clenmysol Sp.
• There is some evidence from post-marketing data and the literature that myocardial ischemia is associated with beta-agonists. Patients suffering from severe heart disease (i.e. ischemic heart disease, arrhythmia or severe heart failure) who are being treated with Clenmysol Sp. should be advised to seek medical attention in case of chest pain or other symptoms of worsening coronary disease. Special attention should be given to the onset of symptoms such as dyspnea or chest pain, as they can have both respiratory and cardiac origins.
• In the last days before delivery, Clenmysol Sp. should only be used on medical advice.
• Clenmysol Sp. contains less than 1 mmol sodium (23 mg) per 1 ml syrup, that is to say essentially “sodium free”.
• Clenmysol Sp. contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. This product may cause gastrointestinal discomfort and mild laxative effect.
• Clenmysol Sp. contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This product may be harmful to the teeth.
• Clenmysol Sp. contains sodium benzoate, which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
• Clenmysol Sp. should be avoided during pregnancy and lactation.
• Clenmysol Sp. does not interfere with the ability to drive or use machines.