Doxazosin 1mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download Bijsluiter (PIL)
01-04-2018
Download Productkenmerken (SPC)
04-11-2019

Werkstoffen:

Doxazosin mesilate

Beschikbaar vanaf:

Mawdsley-Brooks & Company Ltd

ATC-code:

C02CA04

INN (Algemene Internationale Benaming):

Doxazosin mesilate

Dosering:

1mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02050400

Bijsluiter

                                DOXADURA 1 MG TABLETS
DOXADURA 2 MG TABLETS
DOXADURA 4 MG TABLETS
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.
• DOXADURA is a treatment for high blood pressure, or
the symptoms caused by enlargement of the prostate
gland in men.
• 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.
• You
should
take
DOXADURA
regularly
to
get
the
maximum benefit, even if you are feeling well.
• Most
people
do
not
have
serious
problems
when
taking DOXADURA but side effects can occur.
If you experience swelling of the face, tongue or
windpipe, see your doctor immediately. If you get
any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
• Taking other medicines may sometimes cause
problems. Check with your doctor or pharmacist
before taking this or any other medicines.
• If you are, or are trying to become pregnant,
do not take DOXADURA and tell your doctor or
pharmacist.
WHAT IS IN THIS LEAFLET:
1. WHAT DOXADURA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DOXADURA
3. HOW TO TAKE DOXADURA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DOXADURA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The name of your medicine is DOXADURA 1 mg Tablets,
DOXADURA 2 mg Tablets, DOXADURA 4 mg Tablets
(referred to as DOXADURA throughout this leaflet).
1. WHAT DOXADURA IS AND WHAT IT IS USED FOR
Doxazosin is one of a group of medicines called alpha-
blockers.
DOXADURA tablets are used to treat high blood pressure
(hypertension) or the symptoms caused by enlargement
of the prostate gland in men.
In
patients
taking
DOXADURA
to
treat
high
blood
pressure (hypertension) DOXADURA works by relaxing
blood vessels so that blood passes through them m
                                
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Productkenmerken

                                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
                                
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