Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Cetirizine dihydrochloride
IMED Healthcare Ltd.
R06AE; R06AE07
Cetirizine dihydrochloride
Oral solution
Piperazine derivatives; cetirizine
Marketed
2023-08-25
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 Lees het volledige document
Health Products Regulatory Authority 25 August 2023 CRN00DP02 Page 1 of 2 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 _Product imported from Spain:_ Clear and colorless liquid with slightly sweet taste and a banana flavour 4 CLINICAL PARTICULARS As per PA0891/008/003 5 PHARMACOLOGICAL PROPERTIES As per PA0891/008/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sorbitol solution at 70% (non crystallizing) (E420) Glycerol Propylene glycol (E1520) Sodium saccharin Methyl parahydroxybenzoate (E218) Propyl parahydroxyhenzoate (E216) Banana flavour 54.330/A (Firmenich) Sodium acetate Glacial acetic acid Purified water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 25 August 2023 CRN00DP02 Page 2 of 2 After first opening: 3 months 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Amber glass bottle containing volumes of 200 ml, closed with a white polypropylene "child-proof" cap. A 5 ml measuring spoon with a line at 2.5 ml is provided with the bottle. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd, Unit 625 Kilshane Avenue, Northwest Business Park, Ballycoolin, Lees het volledige document