Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Doxazosin mesilate
Dexcel-Pharma Ltd
C02CA04
Doxazosin mesilate
4mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050400; GTIN: 5030451003614
WHAT IS IN THIS LEAFLET 1. What Doxadura XL is and what it is used for 2. What you need to know before you take Doxadura XL 3. How to take Doxadura XL 4. Possible side-effects 5. How to store Doxadura XL 6. Contents of the pack and other information 1. WHAT DOXADURA XL IS AND WHAT IT IS USED FOR The active substance in your tablets, doxazosin, belongs to a group of medicines known as alpha-1 antagonists. Doxadura XL is used to treat the following conditions: - High blood pressure. If left uncontrolled, high blood pressure can increase the risk of heart disease or stroke. Doxadura XL works by widening your blood vessels making it easier for your heart to pump blood through them. This helps to lower raised blood pressure and reduce the risk of heart disease. - Symptoms of benign prostatic hyperplasia (BPH). This condition causes enlargement of the prostate gland, which is just underneath the bladder in men. This makes it difficult to pass urine. Doxadura XL works by relaxing muscle around the bladder exit and prostate gland, making it easier to pass urine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXADURA XL DO NOT TAKE DOXADURA XL - if you are allergic to doxazosin, to quinazolines (e.g. prazosin, terazosin) which is the chemical family of medicines to which doxazosin belongs, or any of the other ingredients of this medicine (in section 6). Allergic reactions may be, for example, itching, reddening of the skin or difficulty breathing - if you have low blood pressure (hypotension) or have had a fall in blood pressure on standing up which caused dizziness, light-headedness or fainting (orthostatic hypotension) - if you have or have had any form of obstruction of the digestive tract - if you have benign prostatic hyperplasia (BPH) and additionally suffer from a blockage of your upper urinary tract, chronic urinary infections or bladder stones - if you have an overflowing bladder, almost no production of urine (anuria) or if your kidneys fail to function properly (progressive renal insufficiency) - if you are breast-f Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DoxaduraTM XL 4mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 4 mg doxazosin (as mesilate). For the full list of excipients, see section 6.1. Excipient(s) with known effect Each prolonged-release tablet contains 0.1mg sodium. 3 PHARMACEUTICAL FORM Prolonged-release tablet. White, round, biconvex tablets, with bossing “DL” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. Symptomatic treatment of benign prostatic hyperplasia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The maximum recommended dose is 8 mg doxazosin once daily. _ _ _Essential hypertension _ _Adults _ Most patients treated with Doxadura XL 4 mg prolonged release tablets once daily achieve control of blood pressure. It may take up to four weeks to reach optimal effect. If necessary, the dose can thereafter be increased to 8 mg once daily depending on the clinical response. Doxadura XL 4 mg prolonged release tablets can be used as monotherapy or in combination with another medicinal product e.g. a thiazide diuretic, a beta- adrenoceptor blocking agent, a calcium antagonist or an ACE-inhibitor if either of them alone does not provide sufficient effect. _ _ _Symptomatic treatment of benign prostatic hyperplasia _ _Adults_ Recommended dose is 4 mg once daily. Depending on clinical response, the dosage may be increased to 8 mg doxazosin once daily. Doxazosin may be used in benign prostatic hyperplasia patients who are either hypertensive or normotensive, as the blood pressure reduction in normotensive patients is generally slight. Patients should be closely monitored in the initial phase of the treatment due to the risk of postural adverse events. _Special populations _ _Elderly_ Same dosage recommendations as for adults. _Renal impairment_ Since there is no change in pharmacokinetics in patients with impaired renal function and since there are no signs that doxazosin aggravates Olvassa el a teljes dokumentumot