Doxatan 1mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doxazosin mesilate

Available from:

Clonmel Healthcare Ltd

ATC code:

C02CA; C02CA04

INN (International Name):

Doxazosin mesilate

Dosage:

1 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Alpha-adrenoreceptor antagonists; doxazosin

Authorization status:

Marketed

Authorization date:

2000-01-21

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXATAN 1MG, 2MG AND 4MG 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.
IN THIS LEAFLET:
1.
What Doxatan is and what it is used for
2.
What you need to know before you take Doxatan
3.
How to take Doxatan
4.
Possible side effects
5.
How to store Doxatan
6.
Contents of the pack and other information
1. WHAT DOXATAN IS AND WHAT IT IS USED FOR
The active ingredient in your tablets, doxazosin, belongs to a group
of medicines known as
alpha-1 antagonists. Doxatan is used to treat the following
conditions.

High blood pressure (essential hypertension). If left uncontrolled,
high blood pressure can
increase the risk of heart disease or stroke.
Doxatan works by widening your blood vessels making it easier for your
heart to pump blood
through them. This helps to lower raised blood pressure and reduce the
risk of heart disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXATAN
DO NOT TAKE DOXATAN

if you are allergic to doxazosin or any of the other ingredients of
this medicine (listed in
section 6). Allergic reactions may be, for example, itching, reddening
of the skin or
difficulty breathing.

if you know that you are allergic to quinazolines (e.g. prazosin,
terazosin). Quinazolines are
a chemical family of medicines to which doxazosin belongs to.

if you have or have had a fall in blood pressure on standing up which
caused dizziness,
light-headedness or fainting (orthostatic hypotension).

if you have benign prostatic hyperplasia (BPH) and a

Summary of Product characteristics

Health Products Regulatory Authority
21 January 2022
CRN00CQMR
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxatan 1mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg doxazosin (as mesilate).
Excipient with known effect
Each tablet contains 40 mg lactose.
For the full list ofexcipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets.
White, round convex tablet, embossed ‘D1’ on one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxatan 1mg are indicated for the treatment of essentialhypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Unless prescribed otherwise, the following dosage regimen is
recommended:
Start therapy with 1mg of doxazosin once daily. Depending on the
individual patient's blood pressure response, dosage may,
after 1
-
2 weeks, be increased to 2mg of doxazosin once daily, if necessary,
then to 4mg of doxazosin once daily, and
eventually to 8mg of doxazosin once daily.
Average daily dose for maintenance therapy: 2
-
4mg of doxazosin once daily.
Maximum daily dose: 16mg of doxazosin.
_Special populations_
Elderly people and patients with renal impairment:
As the pharmacokinetic properties of doxazosin are unchanged in
elderly patients and those with renal impairment, these
patients can be treated with the usual dose.
However, dosage should be kept as low as possible and increments made
under close supervision.
As doxazosin is highly protein bound, it is not removed by dialysis.
Hepatic impairment:
The doxazosin dose should be titrated particularly carefully in
patients with impaired liver function. No clinical practice
experience is available in patients with serious hepatic dysfunction
(see section 4.4).
Doxazosin tablets can be used as monotherapy or in combination with a
thiazide diuretic, beta-blocking agents when
treatment with these alone has not given the desired effect or is
unsuitable.
Paediatric population
The safety and efficacy of doxazosin mesilate in children and
adolescents have not been establi