Larbex XL 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxazosin mesilate

Available from:

Teva UK Ltd

ATC code:

C02CA04

INN (International Name):

Doxazosin mesilate

Dosage:

4mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050400; GTIN: 5017007049616

Patient Information leaflet

BLACK
PANTONE® GREEN C
TEMPLATE
ZINC Ref:
EAS3528B LEA DOXAZOSIN (LARBEX) 4MG TAB TUK

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Larbex XL 4mg Prolonged-release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 4 mg doxazosin (as mesilate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round biconvex film-coated tablets with bossing "DL" on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension. Doxazosin is not appropriate for first-line
treatment.
It may be used as a 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.
Symptomatic treatment of benign prostatic hyperplasia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
Larbex XL can be used as a 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.
Larbex XL 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. As with any other medication of
this
type it is prudent medical practice to monitor the patient during the
initial
period of therapy.
_ _
Older people:
Same dosage as for adults.
_ _
Patients with renal impairment:
Since there is no significant variation in pharmacokinetics in
patients with
impaired renal function the usual adult dose of doxazosin tablets is
recommend