Doxazosin 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxazosin mesilate

Available from:

Sandoz 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

Patient Information leaflet

1
0035-0036/O/PIL/003/I
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXAZOSIN 2MG AND 4MG TABLETS
(Doxazosin mesilate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE:
•
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 illnessare 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 Tablet is and what itis used for
2.
What you need to know before you take Doxazosin Tablet
3.
How to take Doxazosin Tablet
4.
Possible side effects
5.
How to store Doxazosin Tablets
6.
Content of the pack and other information
1. WHAT DOXAZOSIN TABLET IS AND WHAT IT IS USED FOR
Doxazosin belongs to a group of medicines called alpha-blockers. It is
used to treat high
blood pressure (hypertension), or the symptoms caused by enlargement
of the prostate
gland in men.
Doxazosin can be used to treat high blood pressure (hypertension), by
relaxing blood
vesselsso that blood passes through them more easily. This helps to
lower blood pressure.
In patients with an enlarged prostate glands, Doxazosin is taken to
treat poor and/or
frequent passing of urine. This is common in patients with an enlarged
prostate gland.
Doxazosin works by relaxing muscle around the bladder exit and
prostate gland so urine
is passed more easily.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXAZOSIN TABLET
DO NOT TAKE DOXAZOSIN TABLET
•
If you are allergic to doxazosin, other types of quinazolines (such as
prazosin or
terazosin), or any of the other ingredients of this medicine (listed
in section 6). This may
have been itching, reddening of the skin or difficulty in breathing.
•
If you are breast-feeding.
•
If you are under 18 years of age.
•
If you have an enlarged prostate gland (benign prosta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxazosin 4mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxazosin mesilate
4.85mg equivalent to 4mg doxazosin
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets
Doxazosin 4mg: round, white, flat bevelled edge tablets, diameter
9mm,plain on one
side and marked ‘DXN 4’ on the other side.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
_Hypertension:_ Doxazosin tablets are medicated for the treatment of
hypertension and
can be used as the sole agent to control blood pressure in the
majority of patients. In
patients inadequately controlled on single antihypertensive therapy,
Doxazosin tablets
may be used in combination with a thiazide diuretic, beta-
adrenoceptor blocking
agent, calcium antagonist or an angiotensin-converting enzyme
inhibitor.
_Benign prostatic hyperplasia:_ Doxazosin tablets are indicated for
the treatment of
urinary outflow obstruction and symptoms associated with benign
prostatic
hyperplasia (BPH). Doxazosin may be used in BPH patients who are
either
hypertensive or normotensive.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Doxazosin may be administered in the morning or the evening.
POSOLOGY
_HYPERTENSION:_ Doxazosin tablets are used in a once daily regimen:
the initial dose is
1mgto minimise the potential for postural hypotension and/or syncope
(see section
4.4). Dosage may then be increased after one or two weeks of therapy
to 2mg and
thereafter, if necessary to 4mg. The majority of patients who respond
to Doxazosin
tablets will do so at a dose of 4mg or less. Dosage can be further
increased if
necessary to 8mg or the maximum recommended dose of 16mg.
_BENIGN PROSTATIC HYPERPLASIA:_ The initial dosage of Doxazosin
tablets 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 response dosage
may then be
increased to 2mg and thereafter to 4mg and up to the maximum
recommended dose of
8mg.The