Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
LORATADINE, PSEUDOEPHEDRINE SULFATE
Bayer SA-NV J.E. Mommaertslaan 14, B-1831 Diegem (Machelen), Belgium
R01BA52
LORATADINE 5 mg PSEUDOEPHEDRINE SULFATE 120 mg
PROLONGED-RELEASE TABLET
LORATADINE 5 mg PSEUDOEPHEDRINE SULFATE 120 mg
OTC
NASAL PREPARATIONS
Authorised
2007-01-02
Clarinase Repetabs BE/H/0121/001 Package leaflet: Information for the user Clarinase Repetabs 5 mg/120 mg prolonged-release tablets loratadine/pseudoephedrine sulphate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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. 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 pharmacisthave 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 . 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 10 days. What is in this leaflet 1. What Clarinase Repetabs is and what it is used for 2. What you need to know before you take Clarinase Repetabs 3. How to take Clarinase Repetabs 4. Possible side effects 5. How to store Clarinase Repetabs 6. Contents of the pack and other information 1 What Clarinase Repetabs is and what it is used for What Clarinase Repetabs is Clarinase Repetabs contains a combination of two medicines (loratadine and pseudoephedrine sulphate). Loratadine is an antihistamine and pseudoephedrine sulphate is a decongestant. How Clarinase Repetabs works Clarinase Repetabs help to reduce your allergy or common cold symptoms by stopping the effects of a substance called "histamine", which is produced by the body when you are allergic to Baca dokumen lengkap
Clarinase Repetabs BE/H/0121/001 SUMMARY OF PRODUCT CHARACTERISTICS Clarinase Repetabs BE/H/0121/001 1. NAME OF THE MEDICINAL PRODUCT CLARINASE®Repetabs 5 mg/120 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 5 mg loratadine and 120 mg pseudoephedrine sulphate. Excipients with known effect: The quantities of sucrose and lactose monohydrate in each prolonged- release tablet are 173.23 mg and 156.80 mg respectively. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet: Round, biconvex, lustrous, white, coated tablet 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Clarinase Repetabs is indicated for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion in adults and children 12 years of age and over. 4.2 Posology and method of administration Posology Adults and children 12 years of age and over: One Clarinase Repetabs prolonged-release tablet twice daily with a glass of water. The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared. It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudoephedrine may diminish. After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with loratadine alone, if necessary. Paediatric population The safety and efficacy of Clarinase Repetabs in children below the age of 12 years have not been established. No data are available. Clarinase Repetabs are not recommended for use in children below the age of 12 years. Elderly patients The combination product should not be administered to patients above 60 years of age. Patients 60 years or older are more likely to experience adverse reactions to sympathomimetic medications (see section 4.4). Clarinase Repetabs BE/H/0121/001 Patients with renal or hepatic impairment The combination product should not be used in patients w Baca dokumen lengkap