Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
desloratadine, pseudophedrine sulfate
N.V. Organon
R01BA52
desloratadine, pseudoephedrine
Nasal preparations
Rhinitis, Allergic, Seasonal
Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Revision: 22
Authorised
2007-07-30
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AERINAZE 2.5 MG/120 MG MODIFIED-RELEASE TABLETS desloratadine/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, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs or illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. SEE SECTION 4. WHAT IS IN THIS LEAFLET : 1. What Aerinaze is and what it is used for 2. What you need to know before you take Aerinaze 3. How to take Aerinaze 4. Possible side effects 5. How to store Aerinaze 6. Contents of the pack and other information 1. WHAT AERINAZE IS AND WHAT IT IS USED FOR WHAT AERINAZE IS Aerinaze tablets contain a combination of two active ingredients, desloratadine which is an antihistamine and pseudoephedrine sulphate which is a decongestant. HOW AERINAZE WORKS Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced by the body. Decongestants help to clear nasal congestion (blocked/stuffy nose). WHEN AERINAZE SHOULD BE USED Aerinaze tablets relieve symptoms associated with seasonal allergic rhinitis (hay fever), such as, sneezing, runny or itchy nose, and eyes, when accompanied by nasal congestion in adults and adolescents 12 years of age and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AERINAZE DO NOT TAKE AERINAZE : - if you are allergic to desloratadine, pseudoephedrine sulphate, adrenergic medicines, or any of the other ingredients of this medicine (listed in section 6) or to loratadine - if you have high blood pressure, heart or blood vessel disease or a history of stroke - if you have glaucoma, difficulty in urinating, ur Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aerinaze 2.5 mg/120 mg modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each tablet contains 2.5 mg desloratadine and 120 mg pseudoephedrine sulphate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablet. Blue and white bilayer oval tablet with “D12” branded to blue layer. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aerinaze is indicated in adults and adolescents 12 years and older for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Aerinaze is one tablet twice a day. The recommended dosage and the duration of treatment should not be exceeded. 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 sulphate may diminish. After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with desloratadine alone, if necessary. _ _ _Elderly patients _ Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic medicinal products, such as pseudoephedrine sulphate. The safety and efficacy of Aerinaze have not been established in this population, and there are insufficient data to give adequate dose recommendations. Therefore Aerinaze should be used with caution in patients above 60 years of age. _Patients with renal or hepatic impairment _ The safety and efficacy of Aerinaze have not been established in patients with impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations. Aerinaze is not recommended for use in patients with impaired renal or hepatic function. _ _ _Paediatric population _ The safety and efficacy of Aerinaze in c Lees het volledige document