Presentation and Status in Health Basket
Adults and children 12 years of age and over: One Clarinase Repetabs tablet twice daily with a glass of water.
The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared. It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine may diminish. After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with loratadine alone, if necessary.
Paediatric population: The safety and efficacy of Clarinase Repetabs in children below the age of 12 years have not been established. No data are available. Clarinase Repetabs are not recommended for use in children below the age of 12 years.
Elderly patients: The combination product should not be administered to patients above 60 years of age.
Patients 60 years or older are more likely to experience adverse reactions to
Patients with renal or hepatic impairment: The combination product should not be used in patients with impaired renal or hepatic function.
Method of administration: Oral use. The tablet must be swallowed entirely (without crushing, breaking or chewing it). The tablet may be taken without regard to mealtime.
Clarinase Repetabs is indicated for the relief of symptoms of seasonal allergic rhinitis when both the antihistaminic properties and the nasal decongestant activity are desired.
Hypersensitivity to the active substances or to any of the excipients, or
to adrenergic medicinal products.
As Clarinase Repetabs contains pseudoephedrine, it is also contraindicated in patients who are receiving irreversible monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment, and in patients with:
– narrow-angle glaucoma
– urinary retention
– cardiovascular diseases such as ischaemic heart disease, tachyarrhythmia and severe hypertension
– a history of haemorhagic stroke or with risk factors which could increase the risk of haemorhagic stroke. This is due to the alpha-mimetic activity of pseudoephedrine, in combination with other vasoconstrictors such as bromocripitine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant medication used as a nasal decongestant, either by oral route or by nasal route (such as phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline).
Do not exceed the recommended dosage and the duration of treatment.
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.
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.
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.
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 linezolide [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 should be informed that treatment with pseudoephedrine could lead to positive dope-tests.
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.
The administration of Clarinase Repetabs should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
Very Common: Insomnia.
Common: Thirst, nervousness, somnolence, depression, agitation, anorexia, dizziness, tachycardia, pharyngitis, rhinitis, constipation, nausea, dry mouth, headache, fatigue.
See prescribing information for full details.
When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.
CYP3A4 and CYP2D6 inhibitors have been shown to increase loratadine and desloratadine exposure. However, due to the wide therapeutic index of loratadine, no clinically relevant interactions are expected and none were observed with co-administration of erythromycin, ketoconazole and cimetidine in the conducted clinical trials.
Concurrent administration of monoamine oxidase inhibitors (reversible or irreversible) and sympathomimetic medicines can cause critical hypertension reactions.
Sympathomimetic medicines may reduce the effect of antihypertensive medicines.
The following combinations are not recommended: Bromocriptine, cabergoline, lisuride, pergolide: risk of vasoconstriction and increase in blood pressure.
Dihydroergotamine, ergotamine, methylergometrine: risk of vasoconstriction and increase in blood pressure.
Reversible and irreversible MAO inhibitor(s): risk of vasoconstriction and increase in blood pressure.
Other vasoconstrictors used as nasal decongestant, by oral or nasal route, (such as phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline): risk of vasoconstriction.
Antacids increase the rate of pseudoephedrine sulphate absorption, kaolin decreases it.
Paediatric population: Interaction studies have only been performed in adults.
Pregnancy and Lactation
Pregnancy: Neither loratadine nor the combination of loratadine and pseudoephedrine were teratogenic in animal studies. The safe use of Clarinase Repetabs during pregnancy has not been established; however experience from a large number of exposed pregnancies in humans does not reveal any increase in the frequency of malformations as compared to the incidence in the general population.
Because animal reproduction studies are not always predictive of human response, and due to the vasoconstrictive properties of pseudoephedrine, Clarinase Repetabs should not be used during pregnancy.
Lactation: Physico-chemical data suggest excretion of loratadine and pseudoephedrine/metabolites in human milk. Decreased milk production in nursing mothers has been reported with pseudoephedrine. A risk to the newborns/infants cannot be excluded. Therefore Clarinase Repetabs should not be used during breast-feeding.
Symptoms of overdose: Symptoms of overdose are mostly of a sympathomimetic nature, except for slight sedation that can be caused by loratadine at doses many times higher than the recommended dose.
Symptoms may vary from CNS depression (sedation, apnoea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to CNS stimulation (insomnia, hallucination, tremors, convulsions) with possible fatal outcome. Other symptoms may include: headache, anxiety, micturition difficulty, muscle weakness and tenseness, euphoria, excitement, respiratory failure, cardiac arrhythmias, tachycardia, palpitations, thirst, perspiration, nausea, vomiting, precordial pain, dizziness, tinnitus, ataxia, blurred vision and hypertension or hypotension. CNS stimulation is particularly likely in children, as are atropine-like symptoms (dry mouth, fixed and dilated pupils, flushing, hyperthermia, and gastrointestinal symptoms). Some patients may present with a toxic psychosis with delusions and hallucinations.
Management of overdose: In the event of overdosage, start symptomatic and supportive treatment immediately and maintain it for as long as necessary. Adsorption of active substance remaining in the stomach may be attempted by administration of active charcoal suspended in water.
Perform gastric lavage with physiologic saline solution, particularly in children. In adults, tap water can be used. Remove as much as possible of the amount administered before the next instillation. Loratadine is not removed by haemodialysis and it is not known if loratadine is eliminated by peritoneal dialysis. After emergency treatment, continue to monitor the patient medically.
Treatment of the pseudoephedrine overdosage is symptomatic and supportive. Stimulants (analeptics) must not be used. Hypertension can be controlled with an alpha-blocking agent and tachycardia with a beta-blocking agent. Short acting barbituates, diazepam or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or hypothermia blanket. Apnoea is treated with respiratory assistance.