Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Doxazosin mesilate
Kent Pharma (UK) Ltd
C02CA04
Doxazosin mesilate
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050400
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. IF YOU FORGET TO TAKE DOXAZOSIN If you forget to take a tablet, leave that dose out completely. Then go back to your usual schedule. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. In case of doubt you should always consult your pharmacist or doctor. IF YOU STOP TAKING DOXAZOSIN You should continue to take these tablets for as long as your doctor tells you to. If the use of this medication is suddenly stopped, the symptoms that existed before the start of the treatment may reoccur. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP TAKING THE TABLETS AND TELL YOUR DOCTOR IMMEDIATELY or go to the casualty department at your nearest hospital if you experience any of the following effects: • allergic reactions, this can be recognized by e.g. rash and/or itch • swelling of the face due to fluid accumulation (facial oedema). These are very serious but uncommon side effects. You may need urgent medical attention or hospitalisation. COMMON (may affect up to 1 in 10 people) • infection of the respiratory tract • infection of the urinary tract • headache • dizziness • sleepiness • low blood pressure (hypotension), faintness or dizziness caused by low blood pressure when getting up from a sitting or lying position (postural hypotension) • sensation that one's self or the surroundings are moving or spinning (vertigo) • palpitations, rapid heart rate (tachycardia) • inflammation of the airway (bronchitis), cough, shortness of breath, runny nose (rhinitis) • abdominal pain, pain or discomfort in the upper abdomen (dyspepsia), dry mouth, feeling sick • severe itching (pruritus) • back pain, muscle pain • bladder infection (cystitis), uri Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Doxazosin Tablets 1mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg doxazosin (as mesilate). Excipient(s) with known effect Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, odourless biconvex uncoated tablets with D and 1 on either side of the score line and plain on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Doxazosin Tablets are indicated for management of hypertension, as the sole agent, or in combination with a thiazide diuretic, ACE inhibitor, beta-blocker or calcium antagonist, and for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doxazosin may be administered in the morning or evening. Adults and the elderly: _Hypertension: _Doxazosin Tablets should be taken once a day. Initial dosage is 1mg to minimise the potential for postural hypotension and/or syncope (see section 4.4). This may be increased after 1-2 weeks to 2mg daily, and thereafter to 4mg daily, if necessary. The majority of patients who respond to doxazosin will do so at a dose of 4mg or less. Dosage can be further increased if necessary to 8mg or to a maximum daily dose of 16mg. _Benign prostatic hyperplasia: _The recommended initial dosage of Doxazosin is 1mg given once daily to minimise the potential for postural hypotension and/or syncope (see section 4.4). Depending on the individual patient’s urodynamics and BPH symptomatology, dosage may then be increased to 2mg and thereafter to 4mg and up to the maximum recommended dose of 8mg. The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4mg daily. Paediatric population: The safety and efficacy of doxazosin mesilate (Doxazosin Tablets) in children and adolescents have not be Lue koko asiakirja