Country: Svíþjóð
Tungumál: sænska
Heimild: Läkemedelsverket (Medical Products Agency)
fexofenadinhydroklorid
Bluefish Pharmaceuticals AB
R06AX26
fexofenadine hydrochloride
180 mg
Filmdragerad tablett
fexofenadinhydroklorid 180 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 7 tabletter; Blister, 10 tabletter; Blister, 15 tabletter; Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 100 tabletter; Blister, 200 (10 x 20) tabletter
Godkänd
2017-09-25
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER FEXOFENADINE BLUEFISH 180MG FILM-COATED TABLETS Fexofenadine hydrochloride 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 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 of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Fexofenadine Bluefish is and what it is used for 2. What you need to know before you take Fexofenadine Bluefish 3. How to take Fexofenadine Bluefish 4. Possible side effects 5. How to store Fexofenadine Bluefish 6. Contents of the pack and other information 1. WHAT FEXOFENADINE BLUEFISH IS AND WHAT IT IS USED FOR Fexofenadine Bluefish contains fexofenadine hydrochloride, which is a non-drowsy antihistamine. Fexofenadine Bluefish 180 mg is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with long term allergic skin reactions (chronic idiopathic urticaria) such as itching, swelling and rashes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEXOFENADINE BLUEFISH DO NOT TAKE FEXOFENADINE BLUEFISH - if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Fexofenadine Bluefish if : - you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat - you are elderly - you have problems with your liver or kidneys. If any of these apply to you, or if you are not sure, tell your doctor before taking Fexofenadine Bluefish. OTHER MEDICINES AND FEXOFENADINE BLUEFISH Tell your doctor or pharmacist if you are taki Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fexofenadine Bluefish 180 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 180 mg fexofenadine hydrochloride, which is equivalent to 168 mg fexofenadine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Yellow, 17 mm x 8 mm capsule-shaped, biconvex, film-coated tablet with a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fexofenadine Bluefish 180 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended dose of fexofenadine hydrochloride for adults is 180 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine. _Paediatric population _ • Children aged 12 years and over The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 180 mg once daily taken before a meal. • Children under 12 years of age The efficacy and safety of fexofenadine hydrochloride 180 mg has not been studied in children under 12 years of age. _Special populations _ Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients. Method of administration Oral use 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There is limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups(see section 4.2). Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, h Lestu allt skjalið