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DOXAZOSIN 8MG TABLETS

Active substance(s): DOXAZOSIN MESILATE / DOXAZOSIN MESILATE

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Doxazosin 1 mg tablets
Doxazosin 2 mg tablets
Doxazosin 4 mg tablets
Doxazosin 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 is and
what it is used for
2. What you need to know
before you take Doxazosin
3. How to take Doxazosin
4. Possible side effects
5. How to store Doxazosin
6. Contents of the pack and
other information
1. What Doxazosin 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
DoxazosinDo not take
Doxazosin
• 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 infection of
the urinary tract or you
have bladder stones.
• if you are breast-feeding
• if you have an enlarged
prostate gland (benign
prostatic hyperplasia) and
have low blood pressure.
• if you have overflow
incontinence (you do not
feel the urge to urinate), or
anuria (your body is not
producing any urine) with
or without kidney
problems.
Warnings and precautions
Talk to your doctor or
pharmacist before taking
Doxazosin:
• suffer from serious heart
problems such as e.g.
severely reduced cardiac
function or a restrictive
and painful sensation in
the chest (angina
pectoris);
• are on a strict low-salt diet;
• are using diuretics;
• have kidney or liver
problems.
If you are undergoing eye
surgery because of cataract
(cloudiness of the lens)
please inform your eye
specialist before the
operation that you are using
or have previously used
Doxazosin. This is because
Doxazosin may cause
complications during the
surgery which can be
managed if your specialist is
prepared in advance.
Important information
about Doxazosin
The likelihood of your blood
pressure dropping too fast is
greatest at the start of
treatment or when the dosage
is increased. You may
observe this as dizziness or
more rarely fainting when
changing position. To reduce
the risk of this happening,
your doctor will check your
blood pressure thoroughly at
the start of treatment and
when the dosage is
increased. You should
therefore avoid situations at
the start of treatment in which
dizziness or faintness could
cause injury.
Doxazosin may also affect
the results of some blood and
urine tests. If you are due to
have a blood or urine test
make sure that you tell you
are taking Doxazosin.

Black

Children and adolescents
Doxazosin is not recommended for
use in children or adolescents below
18 years as safety and efficacy have
not yet been established.’
Other medicines and Doxazosin
Tell your doctor or pharmacist if you
are taking or have recently taken or
might take any other medicines.
• Some patients who take
alpha-blocker therapy for the
treatment of high blood pressure
or prostate enlargement may
experience dizziness or
light-headedness, which may be
caused by low blood pressure
upon sitting or standing up quickly.
Certain patients have experienced
these symptoms when taking
drugs for erectile dysfunction
(impotence) with alpha-blockers.
In order to reduce the likelihood
that these symptoms occur, you
should be on a regular daily dose
of your alpha-blocker before you
start drugs for erectile dysfunction.
• Doxazosin may lower your blood
pressure even more if you are
already taking other medicines to
treat high blood pressure such as
terazosin and prazosin;
• nitrates (medicines for heart
problems) such as nitroglycerine
and isosorbide nitrate: these can
exacerbate the hypotensive effect;
• certain painkillers for rheumatism
(known as non-steroidal
anti-inflammatory drugs) such as
naproxen, ibuprofen or any other
anti-inflamatory painkiller: these
can reduce the hypotensive effect;
• medications that could also
possibly affect the liver
metabolism, e.g. cimetidine (a
medicine for stomach problems);
Pregnancy, breast-feeding and
fertility
Ask your doctor or pharmacist for
advice before taking any medicine.
The safety of using doxazosin during
pregnancy has not been established.
If you are pregnant or think you may
be pregnant or are planning to have a
baby, ask your doctor or pharmacist
for advice before taking this
medicine.
Doxazosin should only be used
during pregnancy if your doctor
decides that the benefits for the
mother outweigh the possible risk for
the foetus.
Do not breast feed while taking
Doxazosin.
Driving and using machines
Doxazosin can sometimes cause
dizziness or fainting. In such an
event, you should exercise care
during activities that require
attentiveness, such as driving,
operating machinery and working at
heights. If you are unsure whether
Doxazosin is having a negative effect
on your ability to drive, discuss this
with your doctor.
Doxazosin contains lactose. If you
have been told by your doctor that
you have an intolerance to some
sugars contact your doctor before
taking this medicinal product.
3. How to take Doxazosin
Always take this medicine exactly as
your doctor has told you. You should
check with your doctor or pharmacist
if you are not sure.
The recommended dose is:
HIGH BLOOD PRESSURE
The initial dose is 1mg daily
(= 24 hours) in a single dose. After
1 to 2 weeks, the dose is generally
increased to 2mg in a single daily
dose (= 24 hours). This dose is also
retained for 1 to 2 weeks. If
necessary, the dosage can be further
increased to 4, 8 or 16mg per day,
until the desired reduction in blood
pressure is achieved. The maximum
daily dose is 16mg.
An initial dose should preferably be
taken before going to bed; this means
that any dizziness you may
experience is less of a problem.
ENLARGED PROSTATE
The initial dose is 1 mg daily
(= 24 hours) in a single dose. After
this the usual dose is 2 mg or 4 mg
daily. In some circumstances this
may be increased to a maximum of
8mg daily.
The tablets should be taken as a
single dose each day (= 24 hours).
The tablets must be taken with plenty
of water.
If you take more Doxazosin than
you should
If you have taken more than the
prescribed dose, you should consult
your doctor and/or pharmacist
immediately. If you feel extremely
dizzy or think you might faint, you
should lie down immediately with
your head down.
If you forget to take Doxazosin
If you have forgotten to take a tablet,
then skip it and take the next tablet at
the usual time. You should check with
your doctor or pharmacist if you are
unsure. Do not take a double dose to
make up for a forgotten Dose.
If you stop taking Doxazosin
If you suddenly stop taking
doxazosin, the complaints you
suffered prior to the start of treatment
may recur. It is therefore better not to
stop taking this medication suddenly.
Your doctor will decrease the dosage
gradually. You should always check
with your doctor or pharmacist if you
are unsure.
If you have any further
questions on the use of this
medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Doxazosin
can cause side effects, although
not everybody gets them.
Some side effects could be
serious:

P15XXXXX

Package leaflet:
Information for the user

• hives (urticaria) , hair loss
(alopecia), rash caused by
bleeding under the skin (purpura)
• disorder in passing urine, needing
to pass urine at night, increased
volume of urine passed
• temporary enlargement of the
breasts in men (gynaecomastia).
• feeling tired (fatigue), malaise
(general feeling of being unwell)
• Persistent painful erection of the
penis. Seek urgent medical
advice.
Not known (frequency cannot be
estimated from available data):
• eye problems may occur during
eye surgery for cataract
(cloudiness of the lens of the eye).
See section “Take special care
with Doxazosin”.
• taste disturbances
• little or no semen ejaculated at
sexual climax, cloudy urine
following sexual climax (retrograde
ejaculation)
Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.By
reporting side effects you can help
provide more information on the
safety of this medicine.
5. How to store Doxazosin
Keep this medicine out of the sight
and reach of children.
Do not use this medicine after the
expiry date which is stated on the
blister, , label, bottle and carton after
EXP. The expiry date refers to the
last day of that month.
This medicine does not require any
special storage condition.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment
6. Contents of the pack and other
information
What Doxazosin contains
- The active substance is
doxazosin. Each tablet contains
1/2/4/8 mg doxazosin (as
doxazosin mesilate).
- The other ingredients are:
Cellulose microcrystalline, lactose
anhydrous, sodium starch
glycollate, magnesium stearate
What Doxazosin looks like and
contents of the pack
Doxazosin 1 mg tablets:
White to off-white coloured, circular
biconvex shaped uncoated tablet
debossed with H on one side and
01 on other side.
Doxazosin 2 mg 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
halves.
Doxazosin 4 mg 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
halves.
Doxazosin 8 mg 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
halves.
PVC-PVDC Aluminium blisters:
Pack size: 10, 14, 15, 20, 28, 30, 50,
56, 60, 90, 98, 100 and 140 tablets
HDPE bottle:
Pack size: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
Milpharm Limited
Ares Block, Odyssey Business Park,
West End Road,
Ruislip HA4 6QD.
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
This medicinal product is
authorised in the Member States of
the EEA under the following
names:
Bulgaria:
Doxazosin
Aurobindo 1mg/
2 mg/ 4mg тa
блетки
Czech Republic: Doxazosin
Aurobindo 4mg
tablety
Germany:
Doxazosin
Aurobindo 1mg/
2 mg/ 4mg/ 8mg
Tabletten
Hungary:
Doxazosin
Aurobindo 2 mg/
4 mg tabletta
Ireland:
Doxazosin
Aurobindo 1mg/
2 mg/ 4mg tablets
Italy:
Doxazosin
Aurobindo 2 mg/
4 mg compresse
Poland:
Adadox, 2 mg/4 mg
Doxazosin
Aurobindo, 1 mg
Spain:
DOXAZOSINA
AUROBINDO
2 mg/ 4mg
comprimidos
United Kingdom: Doxazosin 1mg/
2 mg/ 4mg/ 8 mg
tablets
This leaflet was last revised in
12/2016.

P15XXXXX

If any of the following
happens, stop taking this
medicine and tell your doctor
immediately or go to the
casualty department at your
nearest hospital:
• Allergic reactions such as
wheezing, shortness of
breath, extreme dizziness
or collapse, swelling of the
face or throat, or a serious
skin rash with red spots or
blisters (especially
affecting the whole body).
• Chest pain (angina
pectoris), increased or
irregular heartbeat, heart
attack or stroke
(symptoms may include
collapse, numbness or
weakness of the arms or
legs, headache, dizziness
and confusion, visual
disturbance, difficulty
swallowing, slurred
speech, and loss of
speech).
• Yellowing of the skin or
whites of the eyes, caused
by liver problems
(jaundice).
• Unusual bruising or
bleeding caused by low
blood platelets.
• Presence of blood in the
urine
• Hepatitis (liver disease
with nausea, vomiting, loss
of appetite, generally
feeling unwell, fever)
• Cholestasis (blocked flow
of bile - can cause itchy
skin, pale stool, and dark
urine)
These side effects are
uncommon (affects 1 to 10
users in 1,000) or rare
(affects 1 to 10 users in
10,000)
Other side effects:
Very common (affects more
than
1 users in 10)
• dizziness
• headache
Common: (may affect up to
1 in 10 people):
• respiratory tract
infection(nose, throat,
lung)
• urinary tract
infection(symptoms may
include: pain or a burning
sensation when you
urinate or a
• frequent need to urinate),
urinary incontinence
(inability to control passing
urine)
• dizziness, sleepiness
(somnolence), headache
• feeling of dizziness or
“spinning” (vertigo)
• feeling or sensation of
irregular heartbeat
(palpitation), increased
heart rate
• low blood pressure and
low blood pressure as a
result of getting up from a
sitting or lying position
(postural hypotension)
• inflammation of the air
passages within the lungs,
cough, shortage of breath,
nasal stuffiness and/or
runny nose
• abdominal pain,
indigestion, dry mouth,
feeling sick (nausea),
diarrhoea
• itching (pruritus)
• back pain, muscle pain
(myalgia)
• inflammation of the
bladder (cystitis)
• feeling of weakness
(asthenia), chest pain,
influenza like symptoms
• swelling of the ankles, feet
or fingers (peripheral
oedema), feeling tired
(fatigue), malaise
Uncommon: (may affect 1
in 100 people):
• gout, increased appetite,
anorexia (loss of appetite)
• agitation, depression,
anxiety, sleeplessness
(insomnia), nervousness,
tremor
• stroke, reduced sense of
touch or sensation, fainting
• ringing or noise in the ears
(tinnitus)
• flushing
• nosebleed
• constipation, flatulence,
vomiting (being sick),
inflammation of the
gastrointestinal tract,
diarrhoea
• abnormal liver function test
• skin rash
• joint pain
• painful or difficult urination
• difficulty to develop an
erection (impotence)
• pain, swelling of the face
• weight increase.
Very Rare (may affect up to
1 in 10000 people):
• dizziness postural
(dizziness as a result of
getting up from a sitting or
lying position),tingling or
numbness of the hands
and feet (paraesthesia)
• reduced number of white
blood cells(symptoms may
include frequent infections
such as fever, severe
chills, sore throat or mouth
ulcers)
• blurred vision
• reduced heart rate
• hot flushes
• bronchial spasm (difficulty
in breathing, wheezing or
coughing)
• muscle cramps, muscle
weakness
• polyuria (passing large
volumes of urine)
• increased blood levels of
urea and creatin

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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