País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Solifenacin succinate; Tamsulosin hydrochloride
Astellas Pharma Ltd
G04CA53
Solifenacin succinate; Tamsulosin hydrochloride
6mg ; 400microgram
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100; GTIN: 5013346013530
WHAT IS IN THIS LEAFLET 1. What Vesomni is and what it is used for 2. What you need to know before you use Vesomni 3. How to use Vesomni 4. Possible side effects 5. How to store Vesomni 6. Contents of the pack and other information 1. WHAT VESOMNI IS AND WHAT IT IS USED FOR Vesomni is a combination of two different medicines called solifenacin and tamsulosin in one tablet. Solifenacin belongs to a group of medicines called anticholinergics and tamsulosin belongs to a group of medicines called alpha-blockers. Vesomni is used in men to treat both moderate to severe storage symptoms and voiding symptoms of the lower urinary tract which are caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). Vesomni is used when previous treatment with a monoproduct for this condition did not relieve symptoms adequately. As the prostate grows, it can lead to urinary problems (voiding symptoms) such as hesitancy (difficulty to start urinating), difficulty urinating (poor stream), dribbling and feeling of incomplete bladder emptying. At the same time, the bladder is also affected and contracts spontaneously at times you do not want to void. This causes storage symptoms such as changes in bladder sensation, urgency (having a strong, sudden desire to urinate without prior warning), and having to urinate more frequently. Solifenacin reduces the undesired contractions of your bladder and increases the amount of urine that your bladder can hold. Therefore you can wait longer before you have to go to the toilet. Tamsulosin enables urine to pass more readily through the urethra and facilitates urination. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VESOMNI DO NOT USE VESOMNI IF: - you are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6). - you are undergoing kidney dialysis. - you have a severe liver disease. - you suffer from severe kidney disease AND if, at the same time, you are being treated with medicines that may decrease the removal of Vesomni from t Llegiu el document complet
OBJECT 1 VESOMNI 6 MG/0.4 MG MODIFIED RELEASE TABLETS Summary of Product Characteristics Updated 22-May-2018 | Astellas Pharma Ltd 1. Name of the medicinal product Vesomni 6 mg/0.4 mg modified release tablets 2. Qualitative and quantitative composition Each tablet contains a layer of 6 mg solifenacin succinate, corresponding to 4.5 mg solifenacin free base and a layer of 0.4 mg tamsulosin hydrochloride, corresponding to 0.37 mg of tamsulosin free base. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Modified release tablet Each tablet is round, approximately 9 mm in diameter, red film-coated and debossed with “6/0.4”. 4. Clinical particulars 4.1 Therapeutic indications Treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia (BPH) in men who are not adequately responding to treatment with monotherapy. 4.2 Posology and method of administration _Adult males, including older people_ One Vesomni tablet (6 mg/0.4 mg) once daily taken orally with or without food. The maximum daily dose is one Vesomni tablet (6 mg/0.4 mg). The tablet must be swallowed whole, intact without biting or chewing. Do not crush the tablet. _Patients with renal impairment_ The effect of renal impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active substances is well known (see section 5.2). Vesomni can be used in patients with mild to moderate renal impairment (creatinine clearance > 30 mL/min). Patients with severe renal impairment (creatinine clearance ≤ 30 mL/min) should be treated with caution and the maximum daily dose in these patients is one Vesomni tablet (6 mg/0.4 mg) (see section 4.4). _Patients with hepatic impairment_ The effect of hepatic impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active substances is well known (see section 5.2). Vesomn Llegiu el document complet