DOXAZOSIN AUROBINDO 2 Milligram Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

DOXAZOSIN

Disponível em:

Aurobindo Pharma (Malta) Limited

Código ATC:

C02CA04

DCI (Denominação Comum Internacional):

DOXAZOSIN

Dosagem:

2 Milligram

Forma farmacêutica:

Tablets

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Alpha-adrenoreceptor antagonists

Status de autorização:

Authorised

Data de autorização:

2011-03-11

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXAZOSIN AUROBINDO 1 MG TABLETS
DOXAZOSIN AUROBINDO 2 MG TABLETS
DOXAZOSIN AUROBINDO 4 MG TABLETS
Doxazosin
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 Aurobindo is and what it is used for
2.
What you need to know before you take Doxazosin Aurobindo
3.
How to take Doxazosin Aurobindo
4.
Possible side effects
5.
How to store Doxazosin Aurobindo
6.
Contents of the pack and other information
1.
WHAT DOXAZOSIN AUROBINDO IS AND WHAT IT IS USED FOR
Doxazosin belongs to the group known as vasodilators. These substances
cause the blood vessel to widen,
which reduces the blood pressure. Doxazosin can also reduce tension in
the muscle tissues of the prostate
and the urinary tract.
Doxazosin is used to treat:

high blood pressure;

symptoms of an enlarged prostate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXAZOSIN AUROBINDO
DO NOT TAKE DOXAZOSIN AUROBINDO

if you are allergic to doxazosin, other medicines from the same group
(known as quinazolines, such as
e.g. prazosin and terazosin) or any of the other ingredients of this
medicine (listed in section 6);

if you 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

if you have an enlarged prostate gland with one of the following: any
kind of congestion or blockage in
your urinary tract, a longstanding infection of the urinary tract or
you

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxazosin Aurobindo 2mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.42 mg doxazosin mesilate equivalent to 2mg
doxazosin.
Excipients with known effect:
Each Doxazosin Aurobindo 2 mg tablet contains 24 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white coloured, caplet shaped uncoated tablet debossed
with H02 on one side and breakline on other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension. Doxazosin Aurobindo 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
Method of administration:
The tablets should be administered once daily with a sufficient amount
of water. The duration of treatment should be
established by a physician.
Posology:
HYPERTENSION:
Doxazosin is used in a once daily regimen: the initial dose is 1mg, to
minimise the potential for postural hypotension
and/or syncope (see section 4.4). Dosage may then be increased to 2mg
after an additional one or two weeks of therapy
and thereafter, if necessary to 4mg. The majority of patients who
respond to Doxazosin will do so at a dose of 4mg or le
Dosage can be further increased if necessary to 8mg or the maximum
recommended 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 tit