Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Desloratadine
Aspire Pharma Ltd
R06AX27
Desloratadine
5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5060209730851
Package leaflet: Information for the user Desloratadine 5mg 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 is and what it is used for 2. What you need to know before you take Desloratadine 3. How to take Desloratadine 4. Possible side effects 5. How to store Desloratadine 6. Contents of the pack and other information 1. What Desloratadine is and what it is used for What Desloratadine is This medicine contains desloratadine which is an antihistamine. How Desloratadine works Desloratadine is an anti-allergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. When Desloratadine should be used Desloratadine relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate and itchy, red or watery eyes. Desloratadine 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. 2. What you need to know before you take Desloratadine Do not take Desloratadine • if you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6), to peanut, to soya or to loratadine. Прочитать полный документ
OBJECT 1 DESLORATADINE 5MG FILM-COATED TABLETS Summary of Product Characteristics Updated 07-Jun-2018 | Aspire Pharma Ltd 1. Name of the medicinal product Desloratadine Gedeon Richter 5 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 5 mg desloratadine (as desloratadine hemisulphate). Excipient with known effect: Each film-coated tablet contains 0.080 mg of soya lecithin. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Yellow, round, biconvex film-coated tablets, of about 6 mm diameter, one side engraved with “R03”. 4. Clinical particulars 4.1 Therapeutic indications Desloratadine 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 of Desloratadine Gedeon Richter 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 5 mg 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 dose can be taken with or without food. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients Прочитать полный документ