Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Oxybutynin
Orion Pharma (UK
G04BD04
Oxybutynin
3.9mg/24hour
Transdermal patch
Transdermal
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5024091001215
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 KENTERA. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Kentera is and what it is used for 2. Before you use Kentera 3. How to use Kentera 4. Possible side effects 5. How to store Kentera 6. Further 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. BEFORE YOU USE KENTERA DO NOT USE KENTERA: - If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera. - 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. TAKE SPECIAL CARE WITH KENTERA: If you have any of the following: - Liver problems - Kidney problems - Difficulty urinating - Intestinal blockage - Bloody stools - Generalized muscle weakness - Painful swallowing Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever and heat stroke if you are exposed to high environmental temperatures. Kentera is no Läs hela dokumentet
OBJECT 1 KENTERA OXYBUTYNIN TRANSDERMAL PATCH Summary of Product Characteristics Updated 04-Aug-2014 | Orion Pharma (UK) Limited 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 a 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 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 recommended dose is one 3.9 mg transdermal patch applied twice weekly (every 3 to 4 days). There is no experience in children 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients. Kentera is contraindicated in patients with urinary retention, severe gastro-intestinal condition, myasthenia gravis or narrow-angle glaucoma and in patients who are at risk for these conditions. 4.4 Special warnings and precautions for use Kentera should be used with caution in patients with hepatic or renal impairment. The use of Kentera in patients with hepatic impairment should be carefully monitored. Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Kentera. If urinary tract infection is present, an appropriate antibacterial therapy should be started. _Urinary retention: _Anticholinergic products should be administered with caution to patients with clini Läs hela dokumentet