BEROTEC Inhaler Ref.[50446] Active ingredients:

Special Precautions

When using the new formulation of BEROTEC metered dose inhaler for the first time, some patients may notice that the taste is slightly different from that of the CFC-containing formulation. Patients should be made aware of this when changing from one formulation to the other. They should also be told that the formulations have been shown to be interchangeable for all practical purposes and that the difference in taste has no consequences in terms of the safety or the efficacy of the new formulation.

Other sympathomimetic bronchodilators should only be used with BEROTEC 100 HFA under medical supervision. Anticholinergic bronchodilators may however be inhaled at the same time.

In the following conditions BEROTEC 100 HFA should only be used after careful risk/benefit assessment, especially when doses higher than recommended are used: Insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma.

In the case of acute, rapidly worsening dyspnoea (difficulty in breathing) a doctor should be consulted immediately.

Prolonged use:

• On demand treatment (symptom oriented) may be preferable to regular use.
• Patients should be evaluated for the addition or the increase of anti-inflammatory therapy (e.g. inhaled corticosteroids) to control airway inflammation and to prevent long term lung damage.

If bronchial obstruction deteriorates it is inappropriate and possibly hazardous to simply increase the use of beta₂-agonists containing products such as BEROTEC 100 HFA beyond the recommended dose over extended periods. The use of increasing amounts of beta₂-agonists containing products on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. In this situation, the patient’s therapy plan, and in particular the adequacy of anti-inflammatory therapy, should be reviewed to prevent potentially life threatening deterioration of disease control.

Not to be used in children under six years of age.

Beta-adrenergics, anticholinergics, and xanthine derivatives (such as theophylline) may enhance the effect of fenoterol. The concurrent administration of other beta-mimetics, systemically available anticholinergics and xanthine derivatives (e.g. theophylline) may increase the side-effects.

A potentially serious reduction in bronchodilatation may occur during concurrent administration of beta-blockers.

Beta-adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta-adrenergic agonists may be enhanced.

Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of beta-agonists.

Safety of use in pregnancy and lactation has not been established.

Fenoterol may inhibit uterine contractions in pregnancy.

Pre-clinical studies have shown that fenoterol is excreted into breast milk.

Frequent undesirable side-effects of BEROTEC 100 HFA are fine tremor of skeletal muscles and restlessness, headache, dizziness, tachycardia and palpitations.

Nausea, vomiting, sweating, weakness and myalgia/muscle cramps may occur.

Hypokalaemia may occur.

Overdosage may cause cardiac effects.

High dosages may increase the risk of serious side-effects, including cardiac dysrhythmias.

The risk is further aggravated if administered concomitantly with other medicines that cause hypokalaemia and cardiac dysrhythmias or in the presence of hypoxia and acidosis.

It is recommended that serum potassium levels are monitored in such situations.

The maximum dose should not be exceeded.

Particularly after higher doses, a decrease in diastolic blood pressure, an increase in systolic blood pressure or arrhythmias may occur.

Cough, local irritation and less common, paradoxical bronchoconstriction have been reported.

In less frequent cases skin reactions or allergic reactions have been reported, especially in hypersensitive patients.

In individual cases psychological changes have been reported with inhalation therapy with beta-mimetics.