Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Desloratadine
Mylan
R06AX27
Desloratadine
5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5016695004792
PAGE 1 OF 6 PACKAGE LEAFLET PAGE 2 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DESLORATADINE MYLAN 5 MG FILM-COATED TABLETS desloratadine 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. WHAT IS IN THIS LEAFLET 1. What Desloratadine Mylan is and what it is used for 2. What you need to know before you take Desloratadine Mylan 3. How to take Desloratadine Mylan 4. Possible side effects 5. How to store Desloratadine Mylan 6. Contents of the pack and other information 1. WHAT DESLORATADINE MYLAN IS AND WHAT IT IS USED FOR Desloratadine Mylan is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. Desloratadine Mylan is indicated for adults and adolescents (12 years of age and older) to: relieve symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. Desloratadine Mylan is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESLORATADINE MYLAN DO NOT TAKE DESLORATADINE MYLAN: - if you are allergic to desloratadine, to any of the other ingredients of this medicine (listed Læs hele dokumentet
OBJECT 1 DESLORATADINE MYLAN 5 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 07-Jun-2018 | Generics UK T/A Mylan 1. Name of the medicinal product Desloratadine Mylan 5 mg film-coated tablets 2. Qualitative and quantitative composition Each tablet contains 5 mg of desloratadine. Excipient with known effect Each tablet contains 4.4 micrograms of Sunset Yellow Aluminium Lake (E110). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablets A blue, film-coated, round, biconvex, bevelled edge tablet marked “DE 5” on one side of the tablet and “M” on the reverse. 4. Clinical particulars 4.1 Therapeutic indications Desloratadine Mylan is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1). - urticaria (see section 5.1). 4.2 Posology and method of administration Posology _Adults and adolescents (12 years of age and over)_ The recommended dose is one tablet once a day. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods. _Paediatric population_ There is limited clinical trial efficacy experience with the use of desloratadine in adolescents 12 through 17 years of age (see sections 4.8 and 5.1). The safety and efficacy of desloratadine film-coated tablets in children below the age of 12 years have not been established. No data are available. Method of administration Oral use. The tablets can be taken with or without food. 4.3 Contraindications Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1 or Læs hele dokumentet