DOXAND XL

The tablets can be taken with or without food. The tablets must be swallowed whole with a sufficient amount of liquid. The tablets should not be chewed, divided or crushed. The maximum recommended dose is 8 mg doxazosin once daily.

Essential hypertension:

Adults: Usually 4 mg doxazosin once daily. It may take up to four weeks to reach optimal effect. If necessary, the dosage may be increased to 8 mg doxazosin once daily. 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. Doxazosin 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:

Same dosage as for adults. 4).

Patients with hepatic impairment:

Doxazosin should be given with particular caution to patients with evidence of impaired liver function. In patients with severe hepatic impairment clinical experience is lacking and therefore the use of doxazosin is not recommended.

4).

Paediatric population:

Doxazosin is not recommended for use in children and adolescents due to a lack of clinical experience.

4) Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Palpitation, tachycardia Angina pectoris, myocardial infarction Bradycardia, cardiac arrhythmias Vascular disorders Hypotension, postural hypotension Flush Respiratory, thoracic and mediastinal disorders Bronchitis, cough, dyspnea, rhinitis Epistaxis Bronchospasm 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. Gastrointestinal disorders Abdominal pain, dyspepsia, dry mouth, nausea Constipation, diarrhoea, flatulence, vomiting, gastroenteritis Taste disturbances 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

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.

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

Use in 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. Since there is no clinical experience in patients with severe hepatic impairment use in these patients is not recommended.

Use with PDE-5 inhibitors:

Concomitant administration of doxazosin with phosphodiesterase-5-inhibitors (eg sildenafil, tadalafil and vardenafil) should be done with caution as both drugs have vasodilating effects and may lead to symptomatic hypotension in some patients.

To reduce the risk of orthostatic hypotension it is recommended to initiate the treatment with phosphodiesterase-5-inhibitors only if the patient is hemodynamically stabilized on alpha-blocker therapy. Furthermore, it is recommended to initiate phosphodiesterase-5-inhibitor treatment with the lowest possible dose and to respect a 6-hour time interval from intake of doxazosin.

No studies have been conducted with doxazosin prolonged release formulations.

Use in patients undergoing cataract surgery:

The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded.

As IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

Priapism:

Prolonged erections and priapism have been reported with alpha-1 blockers including doxazosin in post marketing experience. If priapism is not treated immediately, it could result in penile tissue damage and permanent loss of potency, therefore the patient should seek immediate medical assistance.

g. 6) 1 - patients with hypotension 2 Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency. 1 For the hypertension indication only 2 For the benign prostatic hyperplasia indication