Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Doxazosin mesilate
Zentiva Pharma UK Ltd
C02CA04
Doxazosin mesilate
4mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050400; GTIN: 5000283652731
2020 06 Type IA IN MAH address change in UK ZN1614 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SLOCINX XL 4 MG PROLONGED-RELEASE TABLETS DOXAZOSIN 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 Slocinx XL is and what it is used for 2. What you need to know before you take Slocinx XL 3. How to take Slocinx XL 4. Possible side effects 5. How to store Slocinx XL 6. Contents of the pack and other information 1. WHAT SLOCINX XL IS AND WHAT IT IS USED FOR The name of this product is Slocinx XL 4 mg prolonged-release tablets (referred to as Slocinx XL throughout this leaflet). It contains the active substance doxazosin mesilate and is one of a group of medicines called alpha-blockers. It can be used to treat: _ _ High blood pressure (hypertension) by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure. _ _ In patients with an enlarged prostate gland Slocinx XL is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate. Slocinx XL works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SLOCINX XL DO NOT TAKE SLOCINX XL AND TELL YOUR DOCTOR IF _ _ you are allergic to doxazosin, other types of quinazolines (such as prazosin or terazosin), or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include itching, reddening of the Прочитать полный документ
1 NAME OF THE MEDICINAL PRODUCT Slocinx XL 4 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 4 mg doxazosin (as doxazosin mesilate). Excipients with known effect: Each film-coated tablet contains 0.10 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet White round biconvex tablets marked “DL” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hypertension_: Slocinx XL is indicated for the treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. In patients inadequately controlled on single antihypertensive therapy, Slocinx XL may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor. _Benign prostatic hyperplasia_: Slocinx XL is indicated for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). Slocinx XL may be used in BPH patients who are either hypertensive or normotensive. While the blood pressure changes in normotensive patients with BPH are not usually clinically significant, patients with hypertension and BPH have had both conditions effectively treated with doxazosin monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Hypertension and benign prostatic hyperplasia _ The initial dose of Slocinx XL is 4 mg doxazosin once daily. Over 50% of patients with mild to moderate severity hypertension will be controlled on Slocinx XL 4 mg once daily. Optimal effect of Slocinx XL may take up to 4 weeks. If necessary, the dosage may be increased following this period to 8 mg once daily according to patient response. The maximum recommended dose of Slocinx XL is 8 mg once daily. Slocinx XL 4 mg can be used as sole agent to control blood pressure in the majority of patients. In patients inadequately controlled on single antihypertensive therapy, Slocinx XL 4 mg may be u Прочитать полный документ