DOXADURATM XL

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. 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 existing renal impairment, normal dose can generally be used in these patients.

Hepatic impairment Doxazosin should be administered with caution in patients with signs of minor to moderate hepatic impairment. 4). Paediatric population The safety and efficacy of doxazosin mesilate in children and adolescents have not been established.

Method of administration Doxadura XL 4 mg prolonged release tablets can be taken with or without food. The tablets should be swallowed whole with a sufficient amount of liquid. The patient should not chew, divide or crush the tablet.

Frequencies used are as follows:

Very common ≥ 1/10; Common ≥ 1/100 to < 1/10; Uncommon ≥ 1/1,000 to < 1/100; Rare ≥ 1/10,000 to < 1/1,000; Very rare < 1/10,000; Not known (cannot be estimated from the available data). 4) Ear and labyrinth disorders Common Uncommon Vertigo Tinnitus Cardiac disorders Common Uncommon Very rare Palpitation, tachycardia Angina pectoris, myocardial infarction Bradycardia, cardiac arrhythmias Vascular disorders Common Very rare Hypotension, postural hypotension Flush Respiratory, thoracic and mediastinal disorders Common Uncommon Very rare Bronchitis, cough, dyspnoea, rhinitis Epistaxis Bronchospasm Gastrointestinal disorders Common Uncommon Not known Abdominal pain, dyspepsia, dry mouth, nausea Constipation, diarrhoea, flatulence, vomiting, gastroenteritis Taste disturbances Hepatobiliary disorders Uncommon Very rare Abnormal liver function tests Cholestasis, hepatitis, jaundice Skin and subcutaneous tissue disorders Common Uncommon Very rare Pruritus Skin rash Alopecia, purpura, urticaria Musculoskeletal and connective tissue disorders Common Uncommon Very rare Back pain, myalgia Arthralgia Muscle cramps, muscle weakness Renal and urinary disorders Common Uncommon Very rare Cystitis, urinary incontinence Dysuria, haematuria, micturition frequency Micturition disorder, nocturia, polyuria, increased diuresis Reproductive system and breast disorders Uncommon Impotence Very rare Not known Gynaecomastia, priapism Retrograde ejaculation General disorders and administration site conditions Common Uncommon Very rare Asthenia, chest pain, influenza-like symptoms, peripheral oedema Pain, facial oedema Fatigue, malaise Investigations Uncommon Weight increase Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

Information to be given to the patient:

Patients should be informed that doxazosin tablets should be swallowed whole. Patients should not chew, divide or crush the tablets. For some prolonged-release formulations the active compound is surrounded by an inert, non-absorbable coating that is designed to control the release of the drug over a prolonged period.

After transit through the gastrointestinal tract, the empty tablet shell is excreted. Patients should be advised not to be concerned if they occasionally observe remains in their stools that look like a tablet. g. following surgical resection) could result in incomplete absorption.

In view of the long half-life of doxazosin the clinical significance of this is unclear.

Initiation of therapy:

In relation with the alpha-blocking properties of doxazosin, patients may experience postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness (syncope), particularly with the commencement of therapy.

Therefore, it is prudent medical practice to monitor blood pressure on initiation of therapy to minimise the potential for postural effects. The patient should be cautioned to avoid situations where injury could result should dizziness or weakness occur during the initiation of doxazosin therapy.

Patients with acute cardiac conditions:

As with any other vasodilatory anti-hypertensive agent it is prudent medical practice to advise caution when administering doxazosin to patients with the following acute cardiac conditions: • pulmonary oedema due to aortic or mitral stenosis • heart failure at high output • right-sided heart failure due to pulmonary embolism or pericardial effusion • left ventricular heart failure with low filling pressure Hepatically impaired patients: As with any drug wholly metabolised by the liver, doxazosin should be administered with particular caution to patients with evidence of impaired hepatic function.

g. 6) (for the hypertension indication only) • in patients with hypotension (for the benign prostatic hyperplasia indication only) Doxazosin is contraindicated as monotherapy in patients with either overflow bladder, or anuria with or without progressive renal insufficiency.