Related to the presence of carbocisteine: Caution is recommended in patients with peptic ulcers.
Related to the presence promethazine: Phenothiazines have been considered hypothetical risk factors in the occurrence of sudden infant death syndrome (SIDS). Use in children at risk of apnea, aged under one year, is not therefore recommended.
Monitoring (clinical and, if necessary, EEG, monitoring) should be increased in epileptic patients due to a possible lowering of the seizure threshold.
Promethazine hydrochloride should be used with care: In elderly subjects presenting with: increased sensitivity to orthostatic hypotension, dizziness and sedation; chronic constipation (risk of paralytic ileus); possible benign prostate hypertrophy.
In subjects with certain cardiovascular disorders, because of the tachycardiac and hypotensive effects of phenothiazines.
In case of severe liver and/or kidney insufficiency (because of the risk of accumulation).
If used in children, the possibility of bronchial asthma or gastroesophageal reflux should be ruled out before using promethazine as an antitussive.
The consumption of alcoholic beverages and alcohol-containing medicinal products is highly inadvisable during the treatment.
In view of the photosensitizing effect of phenothiazines, patients should try not to expose themselves to the sun during treatment.
Related to the pharmaceutical form: In the event of diabetes or hypoglucidic diet, account should be taken of the sucrose content: 2.25 g per measuring spoonful and 6.75 g per tablespoonful.
Effects on ability to drive vehicles or operate machines: Patients who drive or use machines should be warned of the risk of drowsiness associated with this medicinal product, particularly at the start of treatment.
This is exacerbated by alcoholic beverages or medicinal products containing alcohol.