Doxazosin 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxazosin mesilate

Available from:

Viatris UK Healthcare Ltd

ATC code:

C02CA04

INN (International Name):

Doxazosin mesilate

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050400; GTIN: 5016695300672

Patient Information leaflet

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOXAZOSIN 1 MG, 2 MG AND 4 MG TABLETS
doxazosin mesilate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Doxazosin is and what it is used for
2.
What you need to know before you take Doxazosin
3.
How to take Doxazosin
4.
Possible side effects
5.
How to store Doxazosin
6.
Contents of the pack and other information
1.
WHAT DOXAZOSIN IS AND WHAT IT IS USED FOR
Your medicine belongs to a group of medicines called alpha-blockers.
Doxazosin can treat high blood
pressure (hypertension) by relaxing the blood vessels in the body and
lowering blood pressure. Doxazosin
can also be given to men suffering from an enlarged prostate gland, as
it can relax the muscles allowing urine
to be passed more easily.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXAZOSIN
DO NOT TAKE DOXAZOSIN IF YOU:
-
are allergic to doxazosin, or other types of quinazolines (e.g.
prazosin, terazosin) or any of the other
ingredients of this medicine (listed in section 6).
-
have a history of a condition known as ‘orthostatic hypotension’
which is a form of low blood pressure
that causes you to feel dizzy or light-headed when you stand up from
sitting or lying down
-
have an enlarged prostate gland (benign prostate hyperplasia) and
problems with your bladder, a long
standing infection of the urinary tract or difficulty in passing
urine.
-
have low blood pressure
-
are breast-feeding (see Pregnancy and breast-feeding)
-
have overflow incontinence (you do not feel the urge to urinat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxazosin 4mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Doxazosin 4 mg Tablet contains 4 mg doxazosin as doxazosin
mesilate.
_ _
Excipient with known effect
Each Doxazosin 4 mg Tablet contains 80.1 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
4 mg tablets:
white, capsule shaped, scored tablets marked ‘DX|4’ on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential Hypertension. Treatment of clinical symptoms in benign
prostatic
hyperplasia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In hypertension
Doxazosin tablets are administered once daily. The initial dose is 1
mg. Depending on
the therapeutic response, the dose can be increased to 2 mg after 1
– 2 weeks. If
necessary, the dose can then be doubled at intervals of 1 – 2 weeks.
The maximum
dose is 16 mg doxazosin once daily, but daily doses over 8 mg seldom
give further
reductions in blood pressure.
Doxazosin tablets can be used as monotherapy or in combination with a
thiazide
diuretic or beta-blocking agent when treatment with these alone has
not given the
desired effect or is unsuitable.
In Benign Prostatic Hyperplasia
Doxazosin tablets are administered once daily. The initial dose is 1
mg increasing at 1
– 2 weekly intervals until a satisfactory response is obtained. The
usual effective
dosage is 2 – 4 mg once daily. The maximum daily dose is 8 mg
doxazosin once
daily.
_Use in the elderly and in patients with renal impairment_
Since the pharmacokinetics of doxazosin are unchanged in the elderly
and in patients
with renal insufficiency, the usual dose may be used in these
patients. However,
dosage should be kept as low as possible and increments made under
close
supervision. As doxazosin is highly protein bound it is not removed by
dialysis.
_Use in hepatically impaired patients_
Doxazosin should be administered with particular caution to patients
with evidence of
impaired hepatic function. In patie