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DOXAZOSIN TABLETS 4MG

Active substance(s): DOXAZOSIN MESILATE

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Artwork No.

260517/4

Colours Used

Customer

Ennogen

Black

Description

Doxazosin Leaflet

Keyline

Market

UK

Language

English

Size

160 x 420 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.

5

Date

27-10-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Doxazosin 1mg, 2mg, 4mg and 8mg Tablets
(Doxazosin mesilate)

Quality Control (QC)

Production

If you forget to take Doxazosin Tablets:
Do not worry. If you forget to take a tablet, leave
that dose out completely. Then go back to your
usual schedule. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Doxazosin Tablets:
It is important to keep taking your tablets. Do not
change the dose or stop taking the tablets without
first checking with your doctor. Do not wait until
your tablets are finished before seeing your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

!
Temporary enlargement of the
breasts in men (gynecomastia)

Feeling tired (fatigue), malaise
!
(general feeling of being unwell).

Not known (frequency cannot be
estimated from the available data):
Eye problems may occur during eye
!
surgery for cataracts (cloudiness of
the lens of the eye). See section 2,
“Warnings and precautions”
Little or no semen ejaculated at sexual climax,
!
cloudy urine following sexual climax (retrograde
ejaculation).

Read all of this leaflet carefully before you start
Other medicines and Doxazosin Tablets:
taking this medicine because it contains
Tell your doctor or pharmacist if you are taking,
4. POSSIBLE SIDE EFFECTS
important information for you.
have recently taken or might take any other
Reporting of side effects
!
Keep this leaflet. You may need to read it
medicines.
If you get any side effects, talk to your doctor,
Like
all
medicines,
this
medicine
can
cause
side
again.
pharmacist or nurse. This includes any possible
effects, although not everybody gets them.
!
!
Some patients who take alpha-blocker therapy
If you have further questions, ask your doctor,
side effects not listed in this leaflet. You can also
for the treatment of high blood pressure or
pharmacist or nurse.
report side effects directly via the Yellow Card
If any of the following happens, stop taking this
!
prostate enlargement may experience
This medicine has been prescribed for you
Scheme at: http://www.mhra.gov.uk/yellowcard
medicine
and
tell
your
doctor
immediately
or
dizziness or light-headedness, which may be
only. Do not pass it on to others. It may harm
By reporting side effects you can help provide
go to the nearest hospital casualty department:
caused by low blood pressure upon sitting or
them, even if their signs of illness are the same
!
more information on the safety of this medicine.
Allergic
reaction
such
as
wheezing,
shortness
standing up quickly. Certain patients have
as yours.
of breath, extreme dizziness or collapse,
If you get any side effects, talk to your doctor,
experienced these symptoms when taking
!
swelling of the face or throat, or a serious skin
5. HOW TO STORE DOXAZOSIN TABLETS
pharmacist or nurse. This includes any possible
drugs for erectile dysfunction (impotence) with
rash with red spots or blisters (especially
side effects not listed in this leaflet. See section
alpha-blockers. In order to reduce the likelihood
Keep this medicine out of the sight and reach of
affecting the whole body)
4.
that these symptoms occur, you should be on a
!
children.
Chest pain (angina pectoris), increased or
regular daily dose of your alpha-blocker before
Do not use this medicine after the expiry date
irregular
heartbeat,
heart
attack
or
stroke
What is in this leaflet:
you start taking drugs for erectile dysfunction
which is stated on the carton or blister.
(symptoms may include collapse, numbness or
1. What Doxazosin Tablets are and what they
!
Doxazosin Tablets may lower your blood
The expiry date refers to the last day of that month.
weakness
of
the
arms
or
legs,
headache,
are used for
pressure even more if you are already taking
Do not store above 25°C. Store in the original
dizziness and confusion, visual disturbance,
other medicines to treat high blood pressure
2. What you need to know before you take
package.
difficulty
swallowing,
slurred
speech
and
loss
of
such as terazosin and prazosin
Doxazosin Tablets
speech)
Do not use this medicine if you notice any defects
Nitrates (medicines for heart problems) such as
!
3. How to take Doxazosin Tablets
!
Yellowing
of
the
skin
or
whites
of
the
eyes
in the tablets such as chipped or broken tablets,
nitroglycerine and isosorbide mononitrate:
4. Possible side effects
caused by liver problems (jaundice)
take them to your pharmacist for advice before
these can exacerbate the hypotensive effect
5. How to store Doxazosin Tablets
!
Unusual
bruising
or
bleeding
caused
by
low
taking them.
Medications that could also possibly affect the
!
6. Contents of the pack and other information
blood platelets
Do not throw away any medicines via wastewater
liver metabolism, e.g. cimetidine (a medicine
!
Presence
of
blood
in
the
urine
or household waste. Ask your pharmacist how to
for stomach problems).
1. WHAT DOXAZOSIN TABLETS ARE AND
!
Hepatitis (liver disease with nausea, vomiting,
throw away medicines you no longer use. These
WHAT THEY ARE USED FOR
loss
of
appetite,
generally
feeling
unwell,
fever)
measures will help protect the environment.
Doxazosin Tablets with food and drink:
!
Cholestasis (blocked flow of bile - can cause
Swallow each tablet whole with a glass of water.
The name of your medicine is Doxazosin Tablets.
itchy skin, pale stool and dark urine)
6. CONTENTS OF THE PACK AND OTHER
You can take these tablets with or without food.
Doxazosin is one of a group of medicines called
!
Leukopenia (reduced number of white blood
INFORMATION
alpha-blockers.
cells. Symptoms may include frequent
Pregnancy and breast-feeding:
It is used to treat:
infections such as fever, severe chills, sore
What Doxazosin Tablets contain:
If you are pregnant do not take Doxazosin Tablets
High blood pressure
!
throat or mouth ulcers)
Each tablet contains 1mg, 2mg, 4mg or 8mg of the
without consulting your doctor first. The safety of
Symptoms caused by the enlargement of the
!
!
Persistent painful erection of of the penis. Seek
active ingredient doxazosin (as mesilate).
this medicine is not sufficiently established in
prostate gland in men.
urgent medical advice.
The tablets also contain microcrystalline cellulose
pregnancy. You must not take Doxazosin Tablets if
(E460), sodium lauryl sulphate, lactose
you are breast-feeding.
In patients taking this medicine to treat high blood
Common (may affect up to 1 in 10 people):
monohydrate (see section 2), sodium starch
Doxazosin should only be used during pregnancy if
pressure (hypertension), it works by relaxing blood
!
Respiratory
tract
infection
(nose,
throat,
lung)
glycollate, colloidal silicon dioxide and magnesium
your doctor decides that the benefits for the mother
vessels so that blood passes through them more
!
Urinary tract infection (symptoms may include:
stearate.
outweigh the possible risk for the foetus.
easily. This helps to lower blood pressure.
pain or a burning sensation when you urinate)
Doxazosin 2mg and 4mg tablets also contain
!
Urinary incontinence (inability to control
sunset yellow (E110) (see section 2).
Driving and using machines:
In patients with an enlargement of the prostate
passing
urine)
Take care if you drive or operate machinery. Your
gland, this medicine is taken to treat poor and/or
!
Dizziness, sleepiness (somnolence), headache
What Doxazosin Tablets look like and contents
tablets may affect your ability to drive or operate
frequent passing of urine.
!
Feeling
of
dizziness
or
“spinning”
(vertigo)
of the pack:
machinery safely, particularly when you first start to
This medicine works by relaxing muscle around the
!
Low blood pressure and low blood pressure as
Doxazosin 1mg Tablets are white to off-white,
bladder exit and prostate gland so the urine is
take them. They may make you feel weak or dizzy.
a
result
of
getting
up
from
a
sitting
or
lying
odourless biconvex uncoated tablets with D and 1
passed more easily.
If you are affected, do not drive or operate
position (postural hypotension)
on either side of the score line and plain on the
machinery and contact your doctor immediately.
!
Inflammation
of
the
air
passages
within
the
other.
2. WHAT YOU NEED TO KNOW BEFORE YOU
lungs, cough, shortage of breath, nasal
TAKE DOXAZOSIN TABLETS
Doxazosin Tablets contain lactose:
stuffiness and/or runny nose
Doxazosin 2mg Tablets are light orange to pink,
If you have been told by your doctor that you have
!
Abdominal pain, indigestion, dry mouth, feeling
odourless biconvex uncoated tablets with D and 2
Do not take Doxazosin Tablets if:
an intolerance to some sugars, contact your doctor
sick
(nausea)
on either side of the score line and plain on the
before taking this medicinal product.
You are allergic to doxazosin, related
!
!
Itching (pruritus)
other.
quinazolines e.g. prazosin or terazosin, or any
!
Back
pain,
muscle
pain
(myalgia)
Doxazosin 2mg and 4mg Tablets also contain
of the other ingredients of this medicine (listed
!
Inflammation of the bladder (cystitis)
Doxazosin 4mg Tablets are light orange to pink,
sunset yellow (E110):
in section 6)
!
Feeling
of
weakness
(asthenia),
chest
pain,
odourless biconvex uncoated tablets with D and 4
This may cause allergic reactions.
!
You are breast-feeding
influenza like symptoms
on either side of the score line and plain on the
!
You have a history of blood pressure dropping
!
Swelling
of
the
ankles,
feet
or
fingers
other.
3. HOW TO TAKE DOXAZOSIN TABLETS
on standing up
(peripheral oedema).
You have any form of obstruction of the urinary
!
Doxazosin 8mg Tablets are white to off-white,
Always take Doxazosin Tablets exactly as your
tract
Uncommon (may affect up to 1 in 100 people):
odourless biconvex uncoated tablets with D and 8
doctor has told you.
!
You are suffering from benign hyperplasia (an
!
Gout,
increased
appetite,
anorexia
(loss
of
on either side of the score line and plain on the
You should check with your doctor or pharmacist if
enlarged prostate gland) together with bladder
appetite)
other.
you are not sure. Doxazosin Tablets are normally
stones or blockages or infections of the urinary
!
Agitation,
depression,
anxiety,
sleeplessness
taken once a day.
tract
(insomnia), nervousness, tremor
Doxazosin Tablets are available in packs of 28, 30
!
You are suffering from bladder leakage,
!
Stroke,
reduced
sense
of
touch
or
sensation,
and 56.
The usual dose of Doxazosin Tablets is:
problems producing urine or worsening kidney
fainting
Not all pack sizes may be marketed.
Adults and the elderly:
problems.
!
Ringing or noise in the ears (tinnitus)
For high blood pressure:
!
Nose bleed
Marketing Authorisation Holder
!
The initial dose is 1mg taken at bedtime
Warnings and precautions
!
Constipation, flatulence, vomiting (being sick),
Ennogen Pharma Limited
!
Your doctor may increase your dose after 1 or 2
Talk to your doctor, pharmacist or nurse before
inflammation of the gastrointestinal tract,
Unit G4, Riverside Industrial Estate
weeks to 2mg daily and then again if
taking this medicine if:
diarrhoea
Riverside Way, Dartford, DA1 5BS
!
necessary, to 4mg daily
You have kidney or liver problems
!
Abnormal
liver
function
test
United Kingdom.
!
!
In some cases, the dose may be further
You suffer from serious heart problems such as
!
Skin rash
increased to 8mg daily or to the maximum dose
severely reduced cardiac function or a
!
Joint pain
Manufacturer
of 16mg daily if necessary.
restrictive and painful sensation in the chest
!
Painful or difficult urination
Dragenopharm, Apotheker Puschl Gmbh & Co KG
(angina pectoris)
!
Difficulty
to
develop
an
erection
(impotence)
Göllstraße 1, 84529 Tittmoning, Germany
!
To relieve the symptoms of an enlarged
You have a tendency to faint or dizziness
!
Pain, swelling of the face
prostate gland:
(hypotension)
!
Weight increase
This leaflet was last revised in October 2017.
!
!
The initial dose is 1mg once daily taken at
You suffer from an accumulation of fluid on the
!
Need to urinate more often than usual
bedtime
lungs.
(micturition frequency).
!
Your doctor may increase your dosage at 1-2
If you are undergoing eye surgery because of
cataracts (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.
Dizziness, weakness and in rare cases fainting
may occur, especially when you first start taking
this medicine. You should therefore be careful at
the beginning of treatment, and avoid situations
that could lead to injury if these symptoms occur.
Doxazosin mesilate (Doxazosin Tablets) is not
recommended for use in children or adolescents
below 18 years as safety and efficacy have not
been established.

weekly intervals to 2mg and then again to 4mg
Rare (may affect up to 1 in 1,000 people):
up to a maximum of 8mg daily
!
Muscle cramps, muscle weakness
!
The usual recommended dose is 2mg to 4mg
!
Polyuria (passing large volumes of urine).
daily.
Use in children
Doxazosin Tablets are not recommended for
children.
The score line is only there to help you break the
tablet if you have difficulty swallowing it whole.
If you take more Doxazosin Tablets 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.

Very rare (may affect up to 1 in 10,000 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)
!
Blurred vision
!
Reduced heart rate
!
Hot flushes
!
Bronchial spasm (difficulty in breathing,
wheezing or coughing)
!
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

+ Expand Transcript

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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