Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
oxybutynin
Teva B.V.
G04BD04
oxybutynin
Urologicals
Urinary Incontinence, Urge
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.
Revision: 21
Authorised
2004-06-15
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INFORMATION FOR THE USER KENTERA 3.9 MG / 24 HOURS TRANSDERMAL PATCH oxybutynin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have 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 Kentera is and what it is used for 2. What you need to know before you use Kentera 3. How to use Kentera 4. Possible side effects 5. How to store Kentera 6. Contents of the pack and other information 1. WHAT KENTERA IS AND WHAT IT IS USED FOR Kentera is used in adults to control the symptoms of urge incontinence and/or increased urinary frequency and urgency. Kentera works by allowing the bladder to expand and accommodate more urine. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KENTERA DO NOT USE KENTERA - if you are allergic to oxybutynin or any of the other ingredients of this medicine (listed in section 6). - if you have a rare condition called myasthenia gravis that makes the muscles in the body become weak and tire easily. - if you experience incomplete bladder emptying during urination, the use of oxybutynin may increase this problem. You should discuss this problem with your doctor before using Kentera. - if you have digestion problems caused by reduced emptying of the stomach after a meal you should consult your doctor before using Kentera. - if you have glaucoma or a family history of glaucoma, tell your doctor. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Kentera if you have any of the following. - Liver problems - Kidney problems - Difficulty urinating - Intestinal blockage - Bloody stools - Generaliz Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kentera 3.9 mg / 24 hours transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch contains 36 mg of oxybutynin. The area of the patch is 39 cm 2 , releasing a nominal 3.9 mg of oxybutynin per 24 hours. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal patch The patch is a clear plastic with an adhesive backing, protected by a release liner that is to be removed prior to application. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days). _Elderly _ Based on clinical trial experience no dose adjustment is considered necessary in this population. Nonetheless Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics (see section 4.4). _Paediatric population _ The safety and efficacy of Kentera in the paediatric population has not been established. Kentera is not recommended for use in the paediatric population. Currently available data are described in section 4.8 but no recommendation on a posology can be made. Method of administration The patch should be applied to dry, intact skin on the abdomen, hip, or buttock immediately after removal from the protective sachet. A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days. The patch must not be divided or cut into pieces. Patches that are damaged should not be used. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3 Kentera is contraindicated in patients with urinary retention, severe gastro-intestinal Прочетете целия документ