Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Solifenacin succinate
Astellas Pharma Co. Limited
G04BD; G04BD08
Solifenacin succinate
1 milligram(s)/millilitre
Oral suspension
oral use
150 ml
Product subject to prescription which may be renewed (B)
Astellas Pharma Europe BV
Urologicals, Drugs for urinary frequency and incontinence
Drugs for urinary frequency and incontinence; solifenacin
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Marketed
2015-10-09
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VESITIRIM 1 MG/ML ORAL SUSPENSION solifenacin succinate 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 Vesitirim is and what it is used for 2. What you need to know before you take Vesitirim 3. How to take Vesitirim 4. Possible side effects 5. How to store Vesitirim 6. Contents of the pack and other information 1. WHAT VESITIRIM IS AND WHAT IT IS USED FOR The active substance of Vesitirim belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder. Vesitirim is used to: - treat the symptoms of a condition called overactive bladder in adults. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time. - treat a condition called neurogenic detrusor overactivity in children aged 2 to 18 years. Neurogenic detrusor overactivity is a condition in which involuntary bladder contractions occur due to a condition that you are born with or injury to the nerves, which control the bladder. If left untreated, neurogenic detrusor overactivity may lead to damage to your bladder and/or kidneys. Vesitirim is used to increase the amount of urine your bladder can hold and reduce urine leakage. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VESITIRIM DO NOT TAKE VES Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 19 October 2023 CRN00DWWV Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vesitirim 1 mg/ml oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vesitirim oral suspension contains 1 mg/ml solifenacin succinate, equivalent to 0.75 mg/ml solifenacin. EXCIPIENTS WITH KNOWN EFFECT: Benzoic acid (E210) 0.015 mg/ml. Methyl parahydroxybenzoate (E218) 1.6 mg/ml. Propylene glycol (E1520) 20 mg/ml. Propyl parahydroxybenzoate (E216) 0.2 mg/ml. This medicine contains 48.4 mg of alcohol (ethanol) per maximum dose of 10ml. Ethanol originates from the natural orange flavour. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension A white to off-white coloured aqueous, homogeneous suspension with an orange flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Overactive bladder in adults_ Vesitirim oral suspension is indicated for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (OAB) syndrome. _Neurogenic detrusor overactivity_ Vesitirim oral suspension is indicated for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 2 to 18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY OVERACTIVE BLADDER Adults, including elderly: The recommended dose is 5 mg (5 ml) solifenacin succinate once daily. If needed, the dose may be increased to 10 mg (10 ml) solifenacin succinate once daily. PAEDIATRIC POPULATION: The efficacy of Vesitirim in children and adolescents with overactive bladder has not been established. Therefore, Vesitirim should not be used for treatment of overactive bladder in children and adolescents under 18 years of age. Currently available data are described in section 5.1 and 5.2. NEUROGENIC DETRUSOR OVERACTIVITY _ _ Health Products Regulatory Authority 19 October 2023 CRN00DWWV Page 2 of 12 Paediatric population (age 2 to 18 years): The recommended dose of Vesitirim oral suspension i Διαβάστε το πλήρες έγγραφο