Leitlinien & Arzneimittelsicherheit

HOS-094672 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile In clinical trials involving 414 adults the most frequent of adverse reactions reported were insomnia (8.9 %), dry mouth (7.2 %) and headache (3.1 %). Tabulated list of adverse reactions Adverse reactions considered by investigators to be causally related to Aerinaze are listed below by System Organ Class. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 6 System Organ Class Frequency Adverse reactions seen with Aerinaze Metabolism and nutrition Common Decreased appetite disorders Uncommon Thirst, glycosuria, hyperglycaemia Psychiatric disorders Common Insomnia, somnolence, sleep disorder, nervousness Uncommon Agitation, anxiety, irritability Nervous system disorders Common Dizziness, psychomotor hyperactivity Uncommon Hyperkinesia, confusional state Eye disorders Uncommon Vision blurred, dry eye Cardiac disorders Common Tachycardia Uncommon Palpitation, supraventricular extrasystoles Respiratory, thoracic and Common Pharyngitis mediastinal disorders Uncommon Rhinitis, sinusitis, epistaxis, nasal discomfort, rhinorrhea, dry throat, hyposmia Gastrointestinal disorders Common Constipation Uncommon Dyspepsia, nausea, abdominal pain, gastroenteritis, abnormal faeces Skin and subcutaneous Uncommon Pruritus tissue disorders Renal and urinary disorders Uncommon Dysuria, micturition disorder General disorders and Common Headache, fatigue, dry mouth administration site conditions Uncommon Chills, flushing, hot flush Investigations Uncommon Hepatic enzymes increased 7 Other adver

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HOS-094668 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to adrenergic medicinal products or to loratadine. As Aerinaze contains pseudoephedrine sulphate, it is also contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment. Aerinaze is also contraindicated in patients with: • narrow-angle glaucoma, • urinary retention, • cardiovascular diseases such as ischaemic heart disease and tachyarrhythmia, • severe hypertension or uncontrolled hypertension, • hyperthyroidism, • a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic stroke. This is due to the alpha-mimetic activity of pseudoephedrine sulphate in combination with other vasoconstrictors such as bromocripitine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant medicinal product used as a nasal decongestant, either by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…), • severe acute or chronic kidney disease/renal failure.

HOS-094667 · has-indication-information · PDF-Seite 2

Aerinaze is indicated in adults and adolescents 12 years and older for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.

HOS-094670 · has-interaction-information · PDF-Seite 5

Aerinaze The following combinations are not recommended: • digitalis (see section 4.4) • bromocriptine • cabergoline • lisuride, pergolide: risk of vasoconstriction and increase in blood pressure. No interaction studies have been performed with the combination of desloratadine and pseudoephedrine sulphate. The interaction with Aerinaze and alcohol has not been studied. However, in a clinical pharmacology trial desloratadine taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol. No significant differences were found in the psychomotor test results between desloratadine and placebo groups, whether administered alone or with alcohol. Alcohol use should be avoided during Aerinaze treatment. Desloratadine No clinically relevant interactions or changes in desloratadine plasma concentrations were observed in clinical trials with desloratadine in which erythromycin or ketoconazole were co-administered. The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded. Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein. Pseudoephedrine sulphate Antacids increase the rate of pseudoephedrine sulphate absorption, kaolin decreases it. Sympathomimetics Reversible and irreversible MAO inhibitor(s) may cause: risk of vasoconstriction and increased blood pressure. Concurrent administration with other sympathomimetics (decongestants, anorexogenics or amphetamine-type psychostimulants, antihypertensive medicinal products, tricyclic antidepressants and other antihistamines) may result in critical hypertension reactions (see section 4.4). Dihydroergotamine, ergotamine, methylergometrine: risk of vasoconstriction and increase in blood pressure. Other vasoconstrictors used as nasal decongestant, by oral or nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…): risk of vasoconstriction. Sympathomimetic medicines reduce the antihypertensive effect of α-methyldopa, mecamylamine, reserpine, veratrum alkaloids, and guanethidine.

HOS-094671 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of the combination of desloratadine and pseudoephedrine sulphate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Aerinaze during pregnancy. Breast-feeding Desloratadine and pseudoephedrine sulphate have been identified in breastfed newborns/infants of 5 treated women. There is insufficient information on the effects of desloratadine and pseudoephedrine sulphate in newborns/infants. Decreased milk production in nursing mothers has been reported with pseudoephedrine sulphate. Aerinaze should not be used during breast-feeding. Fertility There are no data available on male and female fertility.

HOS-094669 · has-warning-information · PDF-Seite 3

Cardiovascular and general effects Patients should be informed that the treatment should be discontinued in case of hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any other neurological sign (such as headache or increased headache). Caution should be exercised in the following patient groups: • Patients with cardiac arrhythmias • Patients with hypertension • Patients with a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or positive anamnesis of bronchospasm • Patients receiving digitalis (see section 4.5) Gastrointestinal and genitourinary effects Use with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and obstruction of the vesical cervix. Central nervous system effects Caution should also be exercised in patients being treated with other sympathomimetics (see section 4.5). These include: • decongestants • anorexogenics or amphetamine-type psychostimulants • antihypertensive medicinal products • tricyclic antidepressants and other antihistamines. Caution should be exercised in patients suffering from migraine who are currently being treated with ergot alkaloid vasoconstrictors (see section 4.5). 3 Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Cases of PRES and RCVS have been reported with the use of pseudoephedrine containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment. Convulsions Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children, being more susceptible to develop new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic a

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