CARDURA XL

Posology Hypertension and benign prostatic hyperplasia:

The initial dose of Cardura XL is 4mg once daily. Over 50% of patients with mild to moderate severity hypertension will be controlled on Cardura XL 4mg once daily. Optimal effect of Cardura XL may take up to 4 weeks. If necessary, the dosage may be increased following this period to 8mg once daily according to patient response.

The maximum recommended dose of Cardura XL is 8mg once daily.

Paediatric population:

The safety and efficacy of Cardura XL in children and adolescents have not been established.

Elderly patients:

Normal adult dosage.

Hepatic/Renal function Patients with renal impairment:

Since there is no change in pharmacokinetics in patients with impaired renal function the usual adult dose of Cardura XL is recommended. Doxazosin is not dialysable. 2). Method of administration Cardura XL can be taken with or without food.

The tablets should be swallowed whole with a sufficient amount of liquid. 4).

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

4) Ear and labyrinth disorders Vertigo Tinnitus Cardiac Palpitation, Angina Bradycardia, disorders tachycardia pectoris, myocardial infarction cardiac arrhythmias Vascular disorders Hypotension, postural hypotension Flush Respiratory, thoracic and mediastinal disorders Bronchitis, cough, dyspnea, rhinitis Epistaxis Bronchospasm Gastrointestinal disorders Abdominal pain, dyspepsia, dry mouth, nausea Constipation, diarrhoea, flatulence, vomiting, gastroenteritis Gastrointestina l obstruction Hepato-biliary disorders Abnormal liver function tests Cholestasis, hepatitis, jaundice Skin and subcutaneous tissue disorders Pruritus Skin rash Alopecia, purpura, urticaria Musculoskeletal , connective tissue and bone disorders Back pain, myalgia Arthralgia Muscle cramps, muscle weakness Renal and urinary disorders Cystitis, urinary incontinence Dysuria, hematuria, micturition frequency Micturition disorder, nocturia, polyuria, increased diuresis Reproductive system and breast disorders Impotence Gynecomastia, priapism Retrograde ejaculation General disorders and administration site conditions Asthenia, chest pain, influenza-like symptoms, peripheral edema Pain, facial oedema Fatigue, malaise Investigations 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 Cardura XL tablets should be swallowed whole. 2). In Cardura XL, the active compound is surrounded by an inert, non-absorbable shell that has been 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 that they should not 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 Cardura XL therapy.

Use in 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 - high-output cardiac failure - right-sided heart failure due to pulmonary embolism or pericardial effusion - left ventricular heart failure with low filling pressure.

1. 2) Patients with a history of orthostatic hypotension 3) Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones. 4) Patients with a history of gastro-intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro- intestinal tract.

5) Patients with hypotension (For benign prostatic hyperplasia indication only) Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.