Doxazosin Aurobindo Tablets 1mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOXAZOSIN

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

C02CA04

INN (International Name):

DOXAZOSIN 1 mg

Pharmaceutical form:

TABLET

Composition:

DOXAZOSIN 1 mg

Prescription type:

POM

Therapeutic area:

ANTIHYPERTENSIVES

Authorization status:

Authorised

Authorization date:

2016-08-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXAZOSIN AUROBINDO 1 MG TABLETS
DOXAZOSIN AUROBINDO 2 MG TABLETS
DOXAZOSIN AUROBINDO 4 MG TABLETS
DOXAZOSIN AUROBINDO 8 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 6.1).
•
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Doxazosin Aurobindo 1 mg tablets
Doxazosin Aurobindo 2 mg tablets
Doxazosin Aurobindo 4 mg tablets
Doxazosin Aurobindo 8 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains 1.21 mg doxazosin mesilate equivalent to 1mg
doxazosin.
Each tablet contains 2.42 mg doxazosin mesilate equivalent to 2mg
doxazosin.
Each tablet contains 4.84 mg doxazosin mesilate equivalent to 4mg
doxazosin.
Each tablet contains 9.68 mg doxazosin mesilate equivalent to 8mg
doxazosin.
Excipients with known effect:
Each Doxazosin Aurobindo 1 mg tablet contains 24 mg lactose.
Each Doxazosin Aurobindo 2 mg tablet contains 24 mg lactose.
Each Doxazosin Aurobindo 4 mg tablet contains 48 mg lactose.
Each Doxazosin Aurobindo 8 mg tablet contains 96 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
_ _
_Doxazosin Aurobindo 1mg Tablets: _
White to off white coloured, circular biconvex shaped uncoated tablet
debossed with H on one side and
01 on other side.
_ _
_Doxazosin Aurobindo 2mg Tablets:_
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.
_ _
_Doxazosin Aurobindo 4mg Tablets: _
White to off-white coloured, diamond shaped uncoated tablet debossed
with H03 on one side and
breakline on other side.
The tablet can be divided into equal doses.
_ _
_Doxazosin Aurobindo 8mg Tablets:_
White to off-white coloured, caplet shaped uncoated tablet debossed
with H04 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 antihypertens