Clarinase Special Precautions

Do not exceed the recommended dosage and the duration of treatment (see Dosage & Administration).
Patients should be informed that the treatment should be discontinued in case of hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any other neurologic sign (such as headache or increased headache).
Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines. These effects may be more likely to occur in children, the elderly, or in cases of overdose (see Overdosage).
Acute generalized exanthematous pustulosis (AGEP), a form of severe skin reaction, may occur with pseudoephedrine-containing products in isolated cases. If signs and symptoms such as fever, erythema, or small (generalized) pustules are observed, patients should discontinue to use the drug and consult their physician.
Caution should be exercised in patients receiving digitalis, those with cardiac arrhythmias, hypertension, a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or positive anamnesis of bronchospasm.
Use with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction and obstruction of the vesical cervix.
Oral administration of pseudoephedrine at the recommended dose can cause other sympathomimetic effects, such as increased blood pressure, tachycardia or manifestations of central nervous system excitation.
Concomitant administration of sympathomimetics and reversible MAO inhibitors (such as linezolid [non-selective] and moclobemide [MAO-A selective] are not recommended.
Caution should also be exercised in patients being treated with other sympathomimetics, including decongestants, anorexogenics or amphetamine-type psychostimulants, antihypertensive agents, tricyclic antidepressants and other antihistamines.
Caution should be exercised in patients who are currently being treated with ergot alkaloid vasoconstrictors.
As with other CNS stimulants, pseudoephedrine sulphate carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing. Depression may follow rapid withdrawal.
Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect sympathomimetic agents. Therefore, if surgery is scheduled, it is preferable to discontinue treatment 24 hours before anaesthesia.
Athletes shoul that trd be informedeatment with pseudoephedrine could lead to positive dope-tests.
The administration of Clarinase Repetabs and Clarinase Extended-Release Tablets should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
Renal or hepatic impairment: The safety and efficacy of the combination have not been established in patients with impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations. The combination product should not be used in patients with impaired renal or hepatic function.
Effects on ability to drive and use machines: Clarinase Repetabs and Clarinase Extended-Release Tablets has no or negligible influence on the ability to drive and use machines. In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. However, some people very rarely experience drowsiness, which may affect their ability to drive or use machines.
It is not expected that pseudoephedrine sulphate impairs psychomotor performance.
Use in the Elderly: Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic medications. The safety and efficacy of the combination have not been established in this population, and there are insufficient data to give adequate dose recommendations. The combination product should not be used in patients above 60 years of age.
Repetab: This medicinal product contains lactose and sucrose; thus patients with rare hereditary problems of fructose, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.
ER tab: This medicinal product contains sucrose; thus patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.