Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Cetirizine dihydrochloride
UCB (Pharma) Ireland Limited
R06AE; R06AE07
Cetirizine dihydrochloride
1 milligram(s)/millilitre
Oral solution
Product not subject to medical prescription
Piperazine derivatives; cetirizine
Marketed
1993-03-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZIRTEK 1 MG/ML ORAL SOLUTION Cetirizine dihydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET : 1. What Zirtek is and what it is used for 2. What you need to know before you take Zirtek 3. How to take Zirtek 4. Possible side effects 5. How to store Zirtek 6. Contents of the pack and other information 1. WHAT ZIRTEK IS AND WHAT IT IS USED FOR Cetirizine dihydrochloride is the active ingredient of Zirtek. Zirtek is an antiallergic medication. In adults and children aged 2 years and above, Zirtek 1 mg/ml oral solution is indicated - for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - for the relief of urticaria. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZIRTEK DO NOT TAKE ZIRTEK - if you have a severe kidney disease requiring dialysis; - if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to any piperazine derivatives (closely related active ingredients of other medicines). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Zirtek. If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor. If you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice. If you are an epileptic patient or a p Preberite celoten dokument
Health Products Regulatory Authority 02 October 2023 CRN00DGKH Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zirtek 1 mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg cetirizine dihydrochloride. Excipients with known effect: - one ml of solution contains 450 mg sorbitol (solution at 70 %, non crystallizing) - one ml of solution contains 1.35 mg methylparahydroxybenzoate - one ml of solution contains 0.15 mg propylparahydroxybenzoate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution Clear and colorless liquid with slightly sweet taste and a banana flavour 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetirizine dihydrochloride 1 mg/ml oral solution is indicated in adults and children aged 2 years and above: - for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - for the relief of symptoms of chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 10 mg once daily (10 ml oral solution (2 full spoons)). Special population _Elderly_ Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. _Renal impairment _ There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly eliminated via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. Dosing adjustments for adult patients with impaired renal function Group Estimated Glomerular Filtration Rate (eGFR) (ml/min) Dosage and frequency Normal renal function >90 10 mg once daily Mildly decreased renal function 60 - < 90 10 mg once daily Moderately decreased renal function 30 – < 60 5 mg once daily Severely decreased renal function 15 - <30 not requiring dialysis 5 mg once every 2 days End-stage renal disease <15 requiri Preberite celoten dokument