RAPORSIN XL

Posology The maximum recommended dose is 8 mg doxazosin once daily.

Essential hypertension:

Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg doxazosin once daily. It may take up to 4 weeks to reach optimal effect. g. a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.

Symptomatic treatment of prostatic hyperplasia:

Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage may be increased to 8 mg doxazosin once daily. Raporsin XL, prolonged-release tablets may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.

In hypertensive patients both conditions are treated concomitantly.

Elderly patients:

In common with other drugs of this class, 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. Raporsin XL is not dialysable.

g. cimetidine). As with any drug metabolised wholly by the liver, Raporsin XL should be used with care in patients with significant existing hepatic dysfunction. 2).

Paediatric population:

The safety and efficacy of Raporsin XL, prolonged-release tablets is children and adolescents have not been established. Method of administration Oral use. Raporsin XL, 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.

In clinical trials, the most common reactions associated with Doxazosin were of a postural type (rarely associated with fainting) or non-specific. The following undesirable effects have been observed and reported during treatment with doxazosin with the following frequencies: 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) and not known (cannot be estimated from the available data).

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

Doxazosin is not appropriate for first-line treatment for essential hypertension. It may be used as monotherapy in patients who have failed to respond to or have contraindications to other agents. Alternatively, use should be limited to second- or third-line treatment in combination with other antihypertensives.

Information to be given to the patient:

Patients should be informed that doxazosin tablets should be swallowed whole. 2). For some prolonged-release formulations the active compound is surrounded by an inert, non absorbable coating that is specially 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.

Postural Hypotension/Syncope 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. When instituting therapy with any effective alpha-blocker, the patient should be advised how to avoid symptoms resulting from postural hypotension and what measures to take should they develop.

The patient should be cautioned to avoid situations where injury could result should dizziness or weakness occur during the initiation of doxazosin therapy, such as driving or operating machinery. Priapism Prolonged erections and priapism have been reported with alpha-1 blockers including doxazosin in post marketing experience.

1. • Patients with a history of orthostatic hypotension • Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones. 6) • Patients with hypotension (For benign prostatic hyperplasia indication only) Doxazosin is contraindicated as monotherapy in patients with benign prostatic hyperplasia causing overflow bladder, anuria or progressive renal insufficiency.