Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
DOXAZOSIN MESILATE
Clarendon Pharma Limited
4 Base Milligrams
Tablet Prolonged Release
2005-11-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Doxel 4mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains doxazosin 4mg (as mesilate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet White, round, biconvex tablet embossed with DL on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of hypertension, and may be used as a sole agent to control blood pressure in hypertensive patients. In patients inadequately controlled on single antihypertensive therapy, Doxel 4mg Prolonged Release Tablets may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Doxel 4mg Prolonged Release Tablets can be taken with or without food. The tablets must be swallowed whole with a sufficient amount of liquid. The prolonged-release tablets should not be chewed, divided or crushed _(see section 4.4 “Special warnings and precautions for use”)._ The maximum recommended dose is 8 mg doxazosin once daily. _Arterial hypertension:_ Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg doxazosin once daily. _Elderly_: Same dosage as for adults. The dosage should be kept as low as possible and increments made under close supervision. _Patients with renal impairment_: Since there is no change in pharmacokinetics in patients with impaired renal function, and since there are no signs that doxazosin aggravates existing renal impairment, the usual dose can be used in these patients. _Patients with hepatic impairment_: See section 4.4 ”Special warnings and precautions for use”. _Paediatric use: _Doxel 4m Perskaitykite visą dokumentą