ZYRTEC-D Prolonged release tablet (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Zyrtec-D.
2. Qualitative and quantitative composition
Each tablet contains 5 mg cetirizine dihydrochloride in an immediate release form and 120 mg pseudoephedrine hydrochloride in a prolonged-release form.
3. Pharmaceutical form
Prolonged release tablet is white to off-white, round biconvex film-coated tablet having a circular logo on one side.
4.1. Therapeutic indications
Zyrtec-D is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis with nasal congestion, and hypersecretion, nose and/or eye itching and watery eyes. It should ...
4.2. Posology and method of administration
The tablet should be swallowed whole with some liquid, and must not be broken, chewed or crushed. It may be taken with or without food. After consultation with the doctor, duration of treatment should ...
4.3. Contraindications
Zyrtec-D is contraindicated in: known hypersensitivity to the active substances or excipients, to ephedrine or any other piperazines, severe hypertension or severe ischaemic heart disease, severe renal ...
4.4. Special warnings and precautions for use
General precautions Due to the presence of pseudoephedrine, Zyrtec-D should be used with caution in patients with diabetes mellitus, hyperthyroidism, arterial hypertension, tachycardia, cardiac arrhythmia, ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with the combination cetirizine-pseudoephedrine. Lack of interactions Pharmacokinetic interaction studies were conducted with cetirizine and cimetidine, ketoconazole, ...
4.6. Pregnancy and lactation
Fertility Studies conducted in rats showed no significant effect on fertility. There are no available data on fertility in humans. Pregnancy Zyrtec-D should not be used during pregnancy. There are no adequate ...
4.7. Effects on ability to drive and use machines
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 ...
4.8. Undesirable effects
Clinical Trial Data 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 ...
4.9. Overdose
Symptoms and Signs Cetirizine Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anti-cholinergic effect. Pseudoephedrine In ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Nasal decongestants for systemic use <b>ATC Code:</b> R01BA52 Mechanism of Action and Pharmacodynamic effects The pharmacodynamic activitiy of cetirizine-pseudoephedrine ...
5.2. Pharmacokinetic properties
There was no evidence for a relevant pharmacokinetic interaction between cetirizine and pseudoephedrine. Absorption and Distribution Cetirizine After oral administration, cetirizine is rapidly and almost ...
5.3. Preclinical safety data
Not relevant for this product.Animal studies have shown no toxic doses equal or higher than 30 mg/kg/day in rats and 40 mg/kg/day in the Cynomolgus monkey (≥8 and 11 times the recommended dose in humans). ...
6.1. List of excipients
Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate Lactose monohydrate Croscarmellose sodium Titanium dioxide (E171) Macrogol 400
6.2. Incompatibilities
There are no relevant data available
6.3. Shelf life
As registered locally.
6.4. Special precautions for storage
Store in original packaging, below 30°C in a dry place. Keep out of the reach and sight of children. Do not use after the expiry date stated on the carton box and blister.
6.5. Nature and contents of container
The tablets are packed in PVC-Aclar Rx 160/Aluminium foil blisters or child resistant OPA/Alu/PVCAlu/Paper blisters placed in a cardboard box containing 10 and 50 tablets.
6.6. Special precautions for disposal and other handling
There are no special requirements for use or handling of this product.
7. Marketing authorization holder
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
10. Date of revision of the text
24 January 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
