RAPORSIN

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

DOXAZOSIN

Disponível em:

Actavis Group PTC ehf

Código ATC:

C02CA04

DCI (Denominação Comum Internacional):

DOXAZOSIN

Dosagem:

8 Milligram

Forma farmacêutica:

Tablet Prolonged Release

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

doxazosin

Status de autorização:

Marketed

Data de autorização:

2011-09-09

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE
USER
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 RAPORSIN IS AND WHAT IT IS USED
FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RAPORSIN
3 HOW TO TAKE RAPORSIN
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE RAPORSIN
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT RAPORSIN IS AND WHAT IT IS
USED FOR
Your doctor may have prescribed Raporsin
because you have high blood pressure, which can
increase your risk of heart disease or stroke if it is
not treated. The active substance in the tablets,
doxazosin, belongs to a group of medicines
known as alpha-1 antagonists. These medicines
work 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.
You may also have been given Raporsin to treat
the symptoms of benign prostate enlargement
(benign prostatic hyperplasia, BPH). This
condition means that the prostate, which is
directly underneath the bladder in men, is
enlarged. This makes it more difficult to empty
your bladder. Raporsin works by relaxing muscles
around the bladder exit and the prostate gland,
making it easier to empty your bladder.
Doxazosin, which is in Raporsin prolonged-
release tablets, may also be approved to
treat other diseases that are not listed in this
leaflet. Ask your doctor, pharmacist or another
healthcare professional if you have any further
questions and always follow their instructions.
2 WHAT YOU NEED TO KNOW BEFORE
YOU TA

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Raporsin 8mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 8 mg doxazosin (as mesilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round, biconvex tablets with DH embossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension.
Symptomatic treatment of benign prostatic hyperplasia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The maximum recommended dose is 8 mg doxazosin once daily.
Essential hypertension
_Adults and elderly:_
The standard dose is 4 mg doxazosin once daily. If necessary, the dose
can be increased to 8 mg once daily. It may take
up to four weeks to achieve an optimal effect.
Raporsin 8 mg can be used in combination with thiazide diuretics,
beta-adrenoceptor blocking agents, calcium
antagonists or ACE inhibitors.
Symptomatic treatment of prostatic hyperplasia
_Adults and elderly_
The standard dose is 4 mg doxazosin once daily. If necessary, the dose
can be increased to 8 mg once daily.
Doxazosin can be used in both normotensive and hypertensive patients
with benign prostatic hyperplasia. The fall in
blood pressure in normotensive patients is generally insignificant.
The patient must be closely monitored during the
initial phase of the treatment due to the risk of postural side
effects.
Dose response studies have not been performed for doxazosin
prolonged-release tablets, which means that an increased
effect has not yet been shown with an increased dose (up to 8 mg).
_Patients with renal impairment_
As there is no change in the pharmacokinetics of doxazosin in patients
with impaired renal function, and as there are no
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