Doxazosin 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxazosin mesilate

Available from:

Ennogen Pharma Ltd

ATC code:

C02CA04

INN (International Name):

Doxazosin mesilate

Dosage:

8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050400; GTIN: 05060313370578

Patient Information leaflet

Doxazosin 1mg, 2mg, 4mg and 8mg Tablets
(doxazosin mesilate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, pharmacist or nurse.
!
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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET
1.
What Doxazosin Tablets are and what they are
used for
2.
What you need to know before you take
Doxazosin Tablets
3.
How to take Doxazosin Tablets
4.
Possible side effects
5.
How to store Doxazosin Tablets
6.
Contents of the pack and other information
1.
WHAT DOXAZOSIN TABLETS ARE AND
WHAT THEY ARE USED FOR
Doxazosin Tablets contain the active substance
doxazosin (as mesilate). Doxazosin is one of a group
of medicines called alpha-blockers.
It is used to treat:
!
High blood pressure
!
Symptoms caused by the enlargement of the
prostate gland in men.
In patients taking this medicine to treat high blood
pressure (hypertension), it works by relaxing blood
vessels so that blood passes through them more
easily. This helps to lower blood pressure.
In patients with an enlargement of the prostate gland,
this medicine is taken to treat poor and/or frequent
passing of urine. This medicine works by relaxing the
muscle around the bladder exit and prostate gland so
the urine is passed more easily.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DOXAZOSIN TABLETS
DO NOT TAKE DOXAZOSIN TABLETS IF:
!
You are allergic to doxazosin,
related quinazolines (such as
prazosin and terazosin) or any
of the other ingredients of this
medicine (listed in section 6)
!
You are breast-feeding
!
You have an enlarged prostate
gland (benign prostatic
hyperplasia) and have low bloo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxazosin Tablets 8mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8mg doxazosin (as mesilate).
Excipient(s) with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, odourless biconvex uncoated tablets with D and 8
on
either side of the score line and plain on the other.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Doxazosin Tablets are indicated for management of hypertension, as the
sole
agent, or in combination with a thiazide diuretic, ACE inhibitor,
beta-blocker
or calcium antagonist, and for the treatment of urinary outflow
obstruction and
symptoms associated with benign prostatic hyperplasia (BPH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doxazosin may be administered in the morning or evening.
Adults and the elderly:
_Hypertension: _Doxazosin Tablets should be taken once a day.
Initial dosage is 1mg to minimise the potential
for postural hypotension and/or syncope (see
section 4.4). This may be increased after 1-2
weeks to 2mg daily, and thereafter to 4mg
daily, if necessary. The majority of patients
who respond to doxazosin will do so at a
dose of 4mg or less. Dosage can be further
increased if necessary to 8mg or to a
maximum daily dose of 16mg.
_Benign prostatic hyperplasia: _The recommended initial dosage of
Doxazosin
is 1mg given once daily to minimise the
potential for postural hypotension and/or
syncope (see section 4.4). Depending on the
individual patient’s urodynamics and BPH
symptomatology, dosage may then be
increased to 2mg and thereafter to 4mg and up
to the maximum recommended dose of 8mg.
The recommended titration interval is 1-2
weeks. The usual recommended dose is 2-4mg
daily.
Paediatric population:
The safety and efficacy of doxazosin mesilate (Doxazosin Tablets) in
children
and adolescents have not be