Source: Marketing Authorisation Holder Revision Year: 2021 Publisher: Manufacturer tablets: UCB Farchim S.A., Z.I. de Planchy, 10 Chemin de Croix Blanche, CH-1630 Bulle, Switzerland Packager: Aesica Pharmaceuticals S.r.l., Via Praglia 15, I 10044 Pianezza, Italy
Zyrtec-D is contraindicated in:
Due to the presence of pseudoephedrine, Zyrtec-D should be used with caution in patients with diabetes mellitus, hyperthyroidism, arterial hypertension, tachycardia, cardiac arrhythmia, ischaemic heart disease, moderate renal or hepatic insufficiency, and also in the elderly. Caution is also required in patients taking:
There have been rare cases of posterior reversible encephalopathy (PRES)/reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine. Symptoms reported included sudden onset of severe headache, nausea, vomiting, and visual disturbances. Most cases improved or resolved within a few days following appropriate treatment. Psuedoephedrine should be discontinued immediately and medical advice sought if signs/symptoms of PRES/RCVS develop.
Caution should also be taken in patients with factors which could increase the risk of haemorrhagic stroke (including concomitant use of vasoconstrictors such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine), or any other decongestant drug used as nasal decongestant, either by oral route or by nasal route (for example phenylpropanolamine, phenylephrine, ephedrine), due to the risk of vasoconstriction and increased blood pressure.
Due to vasoconstrictor effect of pseudoephedrine, caution is recommended in patients who are at risk for hypercoagulability, as in inflammatory bowel disease.
Caution is required in hypertensive patients who are treated concomitantly with non-steroidal antiinflammatory drugs (NSAIDs), because both pseudoephedrine and NSAIDs can increase blood pressure.
This product may act as a cerebral stimulant giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform convulsions.
As for other centrally acting stimulants, abuse has been observed for pseudoephedrine.
Zyrtec-D is contraindicated in children under 12 years of age due to the presence of pseudoephedrine and because this combination has not been studied in this age group (see Section Contraindications).
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
No interaction studies have been performed with the combination cetirizine-pseudoephedrine.
Pharmacokinetic interaction studies were conducted with cetirizine and cimetidine, ketoconazole, erythromycin, azithromycin, antipyrine (phenazone) and pseudoephedrine; no pharmacokinetic interactions were observed.
Studies with cetirizine and cimetidine, glipizide, diazepam, and pseudoephedrine have revealed no evidence of adverse pharmacodynamic interactions.
Studies with cetirizine and azithromycin, erythromycin, ketoconazole, theophylline, antipyrine (phenazone) and pseudoephedrine have revealed no evidence of adverse clinical interactions. In particular, concomitant administration of cetirizine with macrolides or ketoconazole has never resulted in clinically relevant ECG changes.
In a multiple dose study of theophylline (400 mg once a day) and cetirizine, there was a small (16%) decrease in clearance of cetirizine, while the elimination of theophylline was not altered by concomitant cetirizine administration.
In a multiple dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of exposure to cetirizine was increased by about 40% while the steady-state AUC (area under the curve) value for ritonavir was slightly altered (-11%) by concomitant cetirizine administration.
Concomitant use of sympathomimetic amines with monoamine oxidase (MAO) inhibitors can result in hypertensive crisis. Due to the long duration of action of MAO inhibitors, this interaction is still possible 15 days after discontinuation of their administration (see Section Contraindications).
Concomitant administration of linezolid and pseudoephedrine can increase arterial pressure in normotensive patients.
Sympathomimetic amines may reduce the anti-hypertensive effects of beta-adrenergic blockers and of drugs that interfere with sympathetic nervous system activity such as methyldopa, guanethidine and reserpine (see Section Warnings and Precautions).
Tricyclic antidepressants can potentiate the hypertensive effect of pseudoephedrine.
The ectopic pacemaker activity can be increased when pseudoephedrine is used with cardiac glycosides, such as digoxin or digitoxin; the use of Zyrtec-D therefore should be avoided in patients treated with cardiac glycosides (see Section Warnings and Precautions).
Antacids and proton pump inhibitors increase the rate of pseudoephedrine absorption; kaolin decreases it.
Concurrent use with halogenated anaesthetic agents may provoke or worsen ventricular arrhythmia.
Antihistamines can interfere with allergy tests and an appropriate wash-out period is required before conducting such tests.
A high fat meal was not found to modify the bioavailability of both active ingredients, but it resulted however in a reduced and delayed peak plasma concentration of cetirizine.
Studies conducted in rats showed no significant effect on fertility. There are no available data on fertility in humans.
Zyrtec-D should not be used during pregnancy. There are no adequate data on the use of Zyrtec-D in pregnant women. The use of pseudoephedrine during pregnancy has been associated with an increased frequency of gastroschisis (a developmental defect in the abdominal wall with intestinal herniation) and a small bowel atresia (congenital obstruction of small bowel).
Due to the vasoconstrictive properties of pseudoephedrine, this product should not be used during pregnancy as it can induce a reduction in uteroplacental circulation. Data on a limited number of exposed pregnancies indicate no adverse effects of cetirizine on pregnancy or on the health of the foetus/newborn child. There is insufficient animal data with respect to pregnancy, embryonal/foetal development, parturition or post natal development.
Zyrtec-D should not be used during breast-feeding. Cetirizine and pseudoephedrine are excreted into human milk.
Patients intending to drive, engaging in potentially hazardous activities or operating machines should not exceed the recommended dose and should take their individual response to the medicinal product into account. However it should be noted that the effects of these drugs may vary depending on the individual response: clinical studies have shown cases of drowsiness. Effects on the central nervous system may occur with doses higher than those usually recommended. If patients experience drowsiness or vertigo, they should not drive.
Objective measurements of driving ability, sleep latency and assembly line performance, following the administration of cetirizine, have not demonstrated any clinically relevant effects at the recommended dose of 10 mg/day. No negative effects associated with the use of pseudoephedrine have been reported and are expected to occur. Concurrent use of cetirizine with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.
In controlled clinical trials, adverse reactions reported in more than 1% of the patients receiving the combination cetirizine/pseudoephedrine, were not different from those reported for cetirizine or pseudoephedrine alone.
Undesirable effects encountered with cetirizine are mainly related to CNS depressant or paradoxical CNS stimulation effects, to anti-cholinergic activity or hypersensitivity reactions (including anaphylactic shock), while the undesirable effects of pseudoephedrine are more likely related to CNS stimulation, and cardiovascular disorders. Cases of abnormal hepatic function with increased hepatic enzymes levels, accompanied by elevated bilirubin, where reported; the majority of the cases were resolved after interrupting the treatment with cetirizine dihydrochloride. Isolated cases of stroke and ischaemic colitis associated with pseudoephedrine use have been identified in literature.
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency.
Frequencies are defined as: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1000 to <1/100, Rare ≥1/10000 to <1/1000, Very rare <1/10000, Not known (cannot be estimated from the available data).
Rare: hypersensitivity reactions (including anaphylactic shock)
Common: nervousness, insomnia
Uncommon: anxiety, agitation
Rare: hallucination
Very rare: psychotic disorder
Common: vertigo, dizziness, headache, somnolence
Rare: convulsions, tremor
Very rare: dysgeusia, cerebrovascular accident (stroke)
Not known: accommodation disorder, vision blurred, mydriasis, eye pain, visual impairment, photophobia
Common: tachycardia
Rare: arrhythmia
Not known: palpitations
Rare: pallor, hypertension
Very rare: circulatory collapse
Not known: dyspnoea
Common: dry mouth, nausea
Rare: vomiting
Very rare: colitis ischaemic
Rare: hepatic function disorders (increase in transaminases, alkaline phosphatase, gamma-GT, bilirubin)
Rare: dry skin, rash, hyperhidrosis, urticaria
Very rare: fixed drug eruption, angioneurotic oedema
Not known: acute generalized exanthematous pustulosis
Rare: dysuria
Not known: erectile dysfunction
Common: asthenia
There are no relevant data available
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