Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
oxibutyninhydroklorid
2care4 ApS
G04BD04
oxibutyninhydroklorid
5 mg
Tablett
oxibutyninhydroklorid 5 mg Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagt
Förpacknings: Blister, 98 tabletter; Blister, 105 tabletter; Blister, 252 tabletter
Avregistrerad
2017-06-28
PACKAGE LEAFLET: INFORMATION FOR THE USER OXYBUTYNIN ACCORD 2.5 AND 5MG TABLETS OXYBUTYNIN 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, 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 are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Oxybutynin Accord is and what it is used for 2. What you need to know before you take Oxybutynin Accord 3. How to take Oxybutynin Accord 4. Possible side effects 5. How to store Oxybutynin Accord 6. Contents of the pack and other information 1. WHAT OXYBUTYNIN ACCORD IS AND WHAT IT IS USED FOR Oxybutynin Accord contains a medicine called Oxybutynin hydrochloride. This belongs to two groups of medicines called “anticholinergics and “antispasmodics”. It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps control the release of water (urine). Oxybutynin Accord can be used to treat: Adults: Frequent and severe urinary urgency or Loss of control in passing urine (urge incontinence) caused by damage to the nervous system. Children over 5 years: - Loss of control in passing water (urinary incontinence). - Increased need or urgency to pass urine (frequent and excessive urination). - Night time bedwetting in children when other treatments have not worked. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYBUTYNIN ACCORD DO NOT TAKE OXYBUTYNIN ACCORD AND TELL YOUR DOCTOR IF: - You are allergic to Oxybutynin or any of the other ingredients of this medicine (listed in Section 6). - You have a rare condition called “Myasthenia gravis” that makes the muscles in the body become weak and tire easily. - You Läs hela dokumentet
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oxybutynin Accord 2.5mg tablets Oxybutynin Accord 5mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mg tablet contains 2.5mg Oxybutynin hydrochloride Excipient(s) with known effect: Contains 53.25 mg Lactose monohydrate per tablet. For the full list of excipient, see section 6.1. Each 5 mg tablet contains 5mg Oxybutynin hydrochloride Excipient(s) with known effect: Contains 106.50 mg Lactose monohydrate per tablet. For the full list of excipient, see section 6.1. 3 PHARMACEUTICAL FORM Tablets 2.5 MG: White to off white, odourless, 5mm round biconvex, uncoated tablets with inscription “BS” on one side and plain on the other side. 5 MG: White to off white, odourless, 7.9mm round biconvex, uncoated tablets with inscription “B” and “R” on either side of score line on one side and plain on the other side. The 5 mg tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS Treatment of frequency, urgency or urge incontinence as may occur in bladder overactivity whether due to neurogenic bladder disorders (detrusor hyperreflexia) or idiopathic detrusor overactivity. PAEDIATRIC POPULATION Oxybutynin hydrochloride is indicated for children over 5 years for: - Urinary incontinence, urgency and frequency in overactive bladder conditions caused by idiopathic overactive bladder or neurogenic bladder dysfunction (detrusor over activity). - Nocturnal enuresis associated with detrusor over activity, in conjunction with non-drug therapy, when other treatment not been successful. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The dosage should be adapted individually. Unless otherwise specified, the following recommendations apply: Page 2 of 8 Adults: The initial starting dose is 2.5 mg three times daily. Thereafter, the lowest effective dose should be selected. The daily dose may vary between 5mg two or three times daily (10 and 15 mg per day) and maximum dose is 5mg four times dail Läs hela dokumentet