Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bilastine
A. Menarini Farmaceutica Internazionale SRL
R06AX29
Bilastine
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5038227000386
ARTWORK PDF 1.5 DATE 30/11/2020 OPERATOR RI016 DRAFT 01 MN_v.08a-2020 PLEASE ENSURE ARTWORK IS CHECKED WITH THIS SETTINGS: PRINT PRODUCTION >> OUTPUT PREVIEW >> OVERPRINT PREVIEW TURNED ON AND COLOR PROFILE SIMULATION SET TO “COATED FOGRA 39” Product: PIL ILAXTEN 20MG Part code: 109R9A Country of destination: UK Production site: MMLS L’AQUILA Pantone colours: BLACK format/dimention: 003F 150X254 MM Font Type: HELVETICA LT STD COND. Font Size: 8 Spacing: 8 Pharmacode: XIIXIIXXX BIANCA/FRONT 109R9A PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ILAXTEN 20 MG TABLETS bilastine 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 ILAXTEN is and what it is used for 2. What you need to know before you take ILAXTEN 3. How to take ILAXTEN 4. Possible side effects 5. How to store ILAXTEN 6. Contents of the pack and other information 1. WHAT ILAXTEN IS AND WHAT IT IS USED FOR ILAXTEN contains the active substance bilastine which is an antihistamine. ILAXTEN is used to relieve the symptoms of hayfever (sneezing, itchy, runny, blocked-up nose and red and watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ILAXTEN 20 MG TABLETS DO NOT TAKE ILAXTEN if you are allergic to bilastine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Ilaxten if you have moderate or severe renal impairment and in additio Read the complete document
OBJECT 1 Ilaxten 20 mg tablets Summary of Product Characteristics Updated 15-May-2021 | A. Menarini Farmaceutica Internazionale SRL • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Ilaxten 20 mg tablets 2. Qualitative and quantitative composition Each tablet contains 20 mg of bilastine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. Oval biconvex scored white tablets (length 10 mm, width 5 mm). 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 Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria. Ilaxten is indicated in adults and adolescents (12 years of age and over). 4.2 Posology and method of administration Posology Adults and adolescents (12 years of age and over) 20 mg bilastine (1 tablet) once daily for the relief of symptoms of allergic rhinoconjunctivitis (SAR and PAR) and urticaria. Read the complete document