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LARBEX XL 4MG PROLONGED-RELEASE TABLETS

Active substance(s): DOXAZOSIN MESILATE

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LARBEX XL 4 mg
PROLONGED-RELEASE TABLETS
Doxazosin

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 or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet

1.What Larbex XL is and what it is used for
2.What you need to know before you take
Larbex XL
3.How to take Larbex XL
4.Possible side effects
5. How to store Larbex XL
6. Contents of the pack and other information

Version:

3

07 October 2015

1

The name of your medicine is Larbex XL
4 mg prolonged-release tablets. It belongs to
a class of medicines called “alpha blockers.” It
can be used to treat high blood pressure or a
condition called “Benign Prostatic
Hyperplasia” (enlargement of the prostate).
If you suffer from high blood pressure, this
can increase your risk of developing heart
disease or having a stroke. Larbex XL lowers
your blood pressure by relaxing your blood
vessels which makes it easier for your heart
to pump blood through them.
If you suffer from “Benign Prostatic
Hyperplasia” (enlargement of the prostate)
you may experience problems passing urine.
In men the prostate gland is just below the
bladder. If enlarged, it can make it more
difficult for urine to flow out of your bladder.
Larbex XL works by relaxing muscles around
the bladder and prostate gland making it
easier to pass urine.

231-30-87074-Y LEA DOXAZOSIN (LARBEX) 4mg TAB TUK
2

TEVA UK Ref:

What Larbex XL is and what it is
used for

What you need to know before you
take Larbex XL

Do not take Larbex XL:
• If you are allergic to doxazosin or other
similar medicines which are in the same
chemical class (e.g. prazosin, terazosin) or
any of the other ingredients of this
medicine (listed in section 6)
• If you have a orthostatic hypotension (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 suffer from Benign Prostatic
Hyperplasia and have:
• low blood pressure
• an obstruction to your upper urinary tract
(tubes running between your kidneys and
your bladder).
• chronic urinary tract infection
• bladder stones
• If you have or have had a narrowing or
blockage in your oesophagus (tube leading
from your mouth to your stomach) or
intestine or elsewhere in the digestive tract
• If you are breast-feeding
• Larbex XL should not be your only
medicine in the treatment of
• overflow incontinence (leakage of urine
even when you feel no urge to urinate)
• if you have kidney problems or you
produce little or no urine
Warnings and precautions
• Talk to your doctor or pharmacist before
taking Larbex XL
• If you have previously had surgery to
remove a section of your intestine (gut)
• Your medicine may make you feel dizzy and
light headed, especially at the start of
treatment or if you start treatment again
after a break. Rarely this can result in loss
of consciousness. If affected you should not
drive, operate machinery or participate in
any other dangerous activity that requires
your full attention.
• If you have heart problems (e.g. heart
failure) or if the valves in your heart do not
work properly
• If you have liver problems (and especially if
you are taking other medicines which are
known to be broken down by the liver (e.g.
cimetidine)). Check with your doctor or
pharmacist if unsure.
• Larbex XL 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 your doctor that you are taking
Larbex XL

• If you are diabetic and have a condition
called “Diabetic Autonomic Neuropathy.”
Check with your doctor if unsure
• If you are taking certain medicines used to
treat erectile dysfunction (male erection
problems) such as sildenafil, tadalafil and
vardenafil
• 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 Larbex XL. This is because
Larbex XL may cause complications during
the surgery which can be managed if your
specialist is prepared in advance.
• It is normal if occasionally you see remains
in your stool that look like a tablet
Children and adolescents
Larbex XL is not recommended for use in
children or adolescents below 18 years as
safety and efficasy have not yet been
established.
Other medicines and Larbex XL
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines
• Other medicines used to treat high blood
pressure.
• Non-steroidal anti-inflammatory drugs
(NSAIDs) used for pain relief (e.g. ibuprofen
and diclofenac sodium)
• Medicines containing estrogens such as the
oral contraceptive pill
• Nasal decongestants or cough and cold
preparations containing nasal
decongestants (e.g. ephedrine and
phenylephrine)
• Medicines used in hospital to stimulate
your heart (e.g. dopamine, ephedrine,
epinephrine, metaraminol or methoxamine)
• Medicines which are known to be broken
down by the liver (e.g. cimetidine). Check
with your doctor or pharmacist if unsure
• 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) such as
sildenafil, tadalafil and vardenafil 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.
Larbex XL with food and drink
Food does not affect the way that your
medicine works. It can be taken with food or
on an empty stomach.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
baby, ask your doctor or pharmacist for
advice before taking this medicine.
If you are pregnant or trying to become
pregnant Larbex XL should only be used if
your doctor considers it to be absolutely
necessary. The effects on your baby are not
known.
Larbex XL must not be used if you are
breast-feeding as it may accumulate in your
breast milk and harm your baby.
Driving and using machines
Larbex XL can make you feel light headed
and dizzy, especially at the start of treatment
or if you restart your medicine after a break. It
can also cause drowsiness. If affected you
should not drive or operate machinery or
participate in any other dangerous activity
that requires your full attention.

3

How to take Larbex XL

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Your medicine may be used to treat high
blood pressure or Benign Prostatic
Hyperplasia (enlargement of the prostate).
The dose for each condition is the same.
Tablets should be swallowed whole with a
sufficient amount of fluid. They should not be
chewed or crushed. They should be taken at
the same time each day.
The recommended dose is
Adults (including Older people)
The usual dose of Larbex XL is one tablet
daily although your doctor may increase your
dose to the maximum of two tablets each day.
Use in children and adolescents
Larbex XL is not recommended for use in
children.
Patients with hepatic impairment
If you have liver problems your doctor will
monitor you closely during treatment. Larbex
XL is not recommended for use in patients
with severe liver problems.

TEVA UK Ref:

231-30-87074-Y LEA DOXAZOSIN (LARBEX) 4mg TAB TUK
Version:

3

07 October 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Skin rash
Painful joints
Gout
Failure/inability to achieve penile erection
(impotence)
• Unusual results from liver function tests
(blood tests completed by your doctor to
monitor the health of your liver)
• Anxiety, depression,sleeplessness
• Pain
Rare: may affect up to 1 in 1, 000 people
• Redness of the face
Very rare: may affect up to 1 in 10, 000 people
• Disturbances of heart rhythm, slow
heartbeat
• Changes to the blood including lower levels
of white blood cells and platelets
• Feeling dizzy or light-headed when you
stand up from sitting or lying down
(dizziness postural)
• Sensation of tingling or numbness
(paraesthesia)
• Blurred vision
• Disorder in passing urine, needing to pass
urine at night, increased volume of urine
passed, increase in the number of times of
passing urine
• Loss of hair from the head or body
• Purpura (the appearance of red or purple
discolorations on the skin that do not
blanch on applying pressure)
• Nettle rash which can cover a lot of your
body, hives (urticaria)
• Muscle cramps
• Muscle weakness
4 Possible side effects
• Debility
• General feeling of being unwell
Like all medicines, this medicine can cause
• Swelling of the face
side effects, although not everybody gets
• Enlargement of the breasts in men
them.
• Nervousness
Your medicine may make you feel dizzy and
• Agitation (excitement, restlessness)
light headed, especially at the start of
treatment or if you start treatment again after Not known: frequency cannot be estimated
from the available data
a break Rarely this can result in loss of
• Certain complications during cataract
consciousness.
(cloudiness of the eye lens) operation
Stop taking doxazosin and seek emergency
(Intraoperative floppy iris syndrome, see
medical attention or notify your doctor
also “Warnings and precautions”)
straight away if one of the following serious
• Abnormal taste
side effects occurs:
• Ejaculation problems.
• Swelling of the face, hands, lips, feet,
tongue or throat, difficulty swallowing or
Reporting of side effects
breathing (allergic drug reaction)(this side
If you get any side effects, talk to your doctor
effect is uncommon)
or pharmacist or nurse. This includes any
• Chest pain and/or shortness of breath
possible side effects not listed in this leaflet.
(symptoms of a heart attack or angina
You can also report side effects directly via
pectoris) (this side effect is uncommon)
the Yellow Card Scheme at:
• Stroke (e.g. weakness or numbness down
www.mhra.gov.uk/yellowcard
one side of the body)(this side effect is
By reporting side effects you can help provide
uncommon)
more information on the safety of this
• Difficulty breathing caused by sudden
medicine.
constriction of the bronchi (bronchospasm)
(this side effect is very rare)
5 How to store Larbex XL
• Obstruction to the normal flow of bile
(cholestasis) which may cause jaundice
Keep this medicine out of the sight and reach
(yellowing of the skin or whites of the
of children.
eyes), inflammation of the liver (hepatitis)
Do not use this medicine after the expiry date
(this side effect is very rare)
which is stated on the carton and blister after
• Persistent painful erection of the penis
EXP. The expiry date refers to the last day of
(priapism) (this side effect is very rare).
that month.
The following side effects have been reported
The medicinal product does not require any
at the approximate frequencies shown:
special storage conditions.
Common: may affect up to 1 in 10 people
Do not throw away any medicines via
• Rapid heart beat, feeling your heartbeat
wastewater or household waste. Ask your
(palpitations)
pharmacist how to throw away medicines
• Dizziness
you no longer use. These measures will help
• Headache
protect the environment.
• Sleepiness
If you take more Larbex XL than you should
If you (or someone else) swallow a lot of
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately. An overdose is likely to
cause headache, dizziness, unconsciousness,
difficulty breathing, low blood pressure,
palpitations (awareness of your own
heartbeat), an abnormally fast heart beat,
heart rhythm disturbances, nausea and
vomiting and may cause low levels of
glucose and potassium in your blood. Please
take this leaflet, any remaining tablets and
the container with you to the hospital or
doctor so that they know which tablets were
consumed.
If you forget to take Larbex XL
If you miss a dose you should take the
missed tablet as soon as you remember.
However, if it is nearly time for your next
dose then you should skip the missed dose
and continue taking your tablets as per
normal. Do not take a double dose to make
up for a forgotten tablet.
If you stop taking Larbex XL
Keep taking your medicine according to your
doctor’s instructions. You should not stop
taking your medicine without discussing it
with your doctor first.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

• Feeling of spinning or rotation of
surroundings (vertigo)
• Respiratory problems (stuffy nose, cough,
respiratory tract (throat, bronchi, lungs)
infections)
• Stomach problems (sickness, stomach
pain, dry mouth, upset stomach,
indigestion)Urinary infections, urinary
incontinence (inability to control passing
urine)
• Itching
• Muscle pain, back pain
• Low blood pressure
• Postural hypotension (a form of low blood
pressure that causes you to feel dizzy or
light-headed when you stand up from
sitting or lying down)
• Loss of strength
• Flu-like symptoms
• Swelling of the feet and ankles
Uncommon: may affect up to 1 in 100 people
• Increased appetite or loss of appetite,
weight gain
• Decreased sense of touch
• Fainting
• Nose bleeds,
• Ringing in the ears,
• Tremor (shaking)
• Stomach problems (constipation, wind,
inflammation of the stomach and intestines
(gastroenteritis) which can cause diarrhoea
and vomiting)
• Urinary problems (pain or discomfort on
passing urine, needing to pass urine more
often than usual, blood in urine)






6

Contents of the pack and other
information

What Larbex XL contains
• The active substance is doxazosin. Each
prolonged-release tablet contains 4 mg
doxazosin (as doxazosin mesilate).
• The other ingredients are: polyethylene
oxide, microcrystalline cellulose, povidone,
butylhydroxytoluene, α-tocopherol,
colloidal anhydrous silica, sodium stearyl
fumarate.
• The other ingredients in the tablet coating
are: methacrylic acid – ethyl acrylate
copolymer, colloidal anhydrous silica,
macrogol, titanium dioxide (E171).
What Larbex XL looks like and contents of
the pack:
Larbex XL are white, round biconvex,
film-coated, prolonged-release tablets with
bossing “DL” on one side.
They are available in blister packs containing
14, 15, 28, 30, 50 x 1, 60, 90, 100 tablets. Not
all pack sizes may be marketed.
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne, BN22 9AG &
Company Responsible for Manufacture:
Pharmachemie B.V., Swensweg 5, PO Box 552,
2003 RN Haarlem, Netherlands.
This leaflet was last revised September 2015
PL 00289/1147

87074-Y

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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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