Doxazosin 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxazosin mesilate

Available from:

Fannin (UK) Ltd

ATC code:

C02CA04

INN (International Name):

Doxazosin mesilate

Dosage:

1mg

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

DOXAZOSIN 1MG, 2MG AND 4MG 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 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 IS AND WHAT IT IS USED FOR
Doxazosin is one of a group of medicines called alpha-blockers. It is
used to treat high blood pressure, 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 vessels so that blood
passes through them more easily. This helps to lower blood pressure.
In patients with an enlarged prostate gland, 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
-
If you have had an allergic (hypersensitive) reaction in the past to
Doxazosin tablets, the active
ingredient doxazosin, other types of quinazolines (such as prazosin or
terazosin) or any of the other
ingredients 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, as safety and efficacy have not
yet been established
-
If y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxazosin Tablets 1mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg 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 1
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