RAPORSIN XL Prolonged-release tablet Ref.[49967] Active ingredients: Doxazosin

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.

Raporsin XL, prolonged-release tablets can be used as sole agent or in combination with another medicinal product e.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

Same dosage as for adults.

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.

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. (See section 4.4).

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.

Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures should be performed if thought appropriate in individual cases. Since doxazosin is highly protein bound, dialysis is not indicated.

4 years.

This medicinal product does not require any special storage conditions.

PVC/PVDC/aluminium blister.

Pack sizes: 10, 28, 30, 50, 90, 98 and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

No special requirements.