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CARDOZIN XL 4 MG PROLONGED-RELEASE TABLETS

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PATIENT INFORMATION LEAFLET

Cardozin XL 4mg Prolonged-release Tablets
(doxazosin)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. Do NOT pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Taking other medicines
In this leaflet:
Please inform your doctor or pharmacist if you are taking
1. What Cardozin XL 4mg is and what it is used for
or have recently taken any other medicines. This includes
2. Before you take Cardozin XL 4mg
medicines that can be bought without a prescription.
3. How to take Cardozin XL 4mg
4. Possible side effects
It is especially important that you tell your doctor if you
5. How to store Cardozin XL 4mg
are taking or have recently taken any of the following:
6. Further information
• medicines to lower your blood pressure (e.g.
1. WHAT CARDOZIN XL 4MG IS AND WHAT IT IS
USED FOR
Cardozin XL contains the active substance doxazosin
(as doxazosin mesilate) which is one of a group of
medicines called alpha-blockers.
Cardozin XL is used to treat
• high blood pressure, or
• the symptoms caused by enlargement of the
prostate gland in men (e.g. poor and/or frequent
passing of urine)
In patients taking Cardozin XL 4mg to treat high blood
pressure (hypertension), doxazosin works by relaxing
the blood vessels so that blood passes through them
more easily. This helps to lower blood pressure.
In patients with enlargement of the prostate gland,
Cardozin XL 4mg is taken to treat poor and/or frequent
passing of urine. This is common in patients with
enlargement of the prostate gland. Doxazosin works by
relaxing muscle around the bladder exit and prostate
gland so urine is passed more easily.
2. BEFORE YOU TAKE CARDOZIN XL 4MG
Do not take Cardozin XL 4mg:
• if you are allergic (hypersensitive) to doxazosin or
any of the other ingredients of Cardozin XL
• if you know that you are sensitive to quinazolines
(e.g. prazosin, terazosin) which is the chemical
family of medicines to which doxazosin belongs
• if you have or ever have had low blood pressure
which makes you feel faint or dizzy when you stand
up after sitting or lying down (postural or orthostatic
hypotension)
• if you have an enlarged prostate gland and have any
kind of congestion or blockage in your urinary tract,
a chronic infection of the urinary tract or have
bladder stones
• if you have a serious kidney disorder (anuria or
progressive renal insufficiency)
• if you suffer from a loss of bladder control (bladder
overflow)
• if you have or have ever had any form of obstruction
of the digestive tract
• if you are being given this medicine to treat an
enlarged prostate gland and have low blood pressure
• if you are breast-feeding.
Take special care with Cardozin XL 4mg:
Talk to your doctor if any of the following apply to you:
• you have problems with your heart or a history of
heart disease
• you have liver disease
• you have had surgery to remove part of your gastrointestinal tract.
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 Cardozin XL 4mg. This is because
Cardozin XL 4mg may cause complications during the
surgery which can be managed if your specialist is
prepared in advance.

fosinopril and lisinopril) as Cardozin XL 4mg can
increase their effect
• certain medicines used to treat erectile problems
(e.g. sildenafil, tadalafil and vardenafil).
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 alphablocker before you start drugs for erectile dysfunction.
Taking Cardozin XL 4mg with food and drink
Cardozin XL 4mg can be taken with or without food. The
tablets should be swallowed whole with a glass of water.
Pregnancy and breast-feeding
Pregnancy
Do not take Cardozin XL 4mg if you are pregnant unless
your doctor tells you to. If you become pregnant whilst
taking this medicine you should contact your doctor as
soon as possible.
Breast-feeding
You must not breast-feed whilst you are taking
Cardozin XL 4mg.
Driving and using machines
Cardozin XL 4mg can affect your judgement and
concentration, especially when you start taking your
tablets. Make sure that you are not affected before
you drive or operate machinery.
3. HOW TO TAKE CARDOZIN XL 4MG
Always take this medicine exactly as your doctor told
you. Do not take more than the doctor told you to.
Read and follow the instructions on the pharmacist’s
label. You should check with your doctor or pharmacist
if you are unsure of how to take your medicine.
Your tablets should be swallowed whole with a glass
of water. Do not chew, crush or divide them. The
tablets can be taken at any time of the day and before,
during or after meals. Choose a time that is convenient
for you and take your tablet at this time each day.
The usual dose of Cardozin XL 4mg is one tablet (4mg)
taken as a single dose each day.
Your doctor may wish to increase your dose to 8mg per
day. This is the maximum daily dose of Cardozin XL 4mg.
Cardozin XL 4mg is not recommended for patients
under the age of 18 years.
It is important that you continue to take Cardozin XL
4mg for as long as your doctor recommends. Do not
change the dose or stop taking your tablets unless your
doctor tells you to.

If you have taken more Cardozin XL 4mg than you
should, contact your doctor immediately or go to the
nearest casualty department. Remember to take the
pack and any remaining tablets with you.
If you forget to take your Cardozin XL 4mg:
Take your next dose at the normal time. Do not take
the missed dose or a double dose to make up for the
one you missed.
If you stop taking Cardozin XL 4mg:
Keep taking your tablets until your doctor tells you to stop.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Cardozin XL can cause side effects,
although not everybody gets them.
Tell your doctor immediately if:
• You get any swelling of the face, tongue or throat,
intense itching, skin rashes, difficulty in swallowing
and/or breathing. This may be the sign of a serious
allergic reaction.
• You feel pain in your chest, shoulder and/or arms
and tightening of your chest (angina) or any other
effects on your heart (including a rapid or irregular
heartbeat).
• You develop severe fatigue, loss of appetite or if
your skin or eyes look yellow (signs of jaundice).
You may feel faint or dizzy when standing up from a
sitting or lying position especially at the beginning of
your treatment or if you restart your treatment after a
break. If this happens do not worry but make sure that
you do not drive, operate machinery or carry out any
activity which might be dangerous should you feel
faint. If these symptoms persist or become a problem
please contact your doctor.
The following side effects have been reported. Tell
your doctor or pharmacist if you get any troublesome
symptoms which you think might be side effects.
Common (probably affecting less than one person in 10
but more than one person in 100):
• chest pain
• feeling your heartbeat
• low blood pressure with
racing or pounding
or without dizziness
(palpitations)
when you get up from a • urinary incontinence or
sitting or lying position
pain on urination
• shortness of breath
(urinary tract infection
• swelling or irritation
or cystitis)
inside the nose (rhinitis) • bronchitis
• giddiness
• muscle pain
• general feeling of being • itching
unwell and weakness
• swelling of the hands
• dizziness
and feet
• abdominal pain
• headache
• dry mouth
• nausea (feeling sick)
• back pain
• cough
• sleepiness
• indigestion.
Uncommon (probably affecting less than one person in
100 but more than one person in 1,000):
• heart attack
• allergic reactions
• angina (tightening and
(hypersensitivity)
pain in the chest and
• difficulty with urinating
shoulder)
• changes in the results of
• change in frequency of
tests for liver function
urination
• eating disorders
• blood in the urine
(anorexia)
• impotence
• joint pain
• gout (causing gout pain) • pain
• insensitivity to touch,
• anxiety
pain, heat or cold
• ringing in the ears
• depression
(tinnitus)
• skin rash
• trouble sleeping
• shaking (tremor)
• weight increase
• increased appetite
• nose bleeds
• fainting
• vomiting (being sick)
• diarrhoea
• constipation
• flatulence (‘wind’)
• swelling of the face.
• stroke

Very rare (probably affecting less than one person in
10,000):
• an increase or slowing • bile disorders (which
may appear as dark
of the heart rate
urine, pale or fatty
• hepatitis (liver
stools, intense itching
inflammation)
or jaundice)
• a reduction in white
• a reduction in platelets
cells in the blood
in the blood
(leukopenia) which
(thrombocytopenia),
makes getting an
which may appear as
infection more likely
bruising or easy
• increase in urea and
bleeding
creatinine levels in the
blood (which indicates • increased desire or
need to urinate
changes in the way the
• an increase in breast
kidneys are working)
size in men
• painful persistent
• ‘nettle rash’
erection of the penis
• muscle cramps or
• hair loss
weakness
• agitation
• nervousness
• blurred vision
• pins and needles
• tiredness
• tightening of the chest • flushing.
The following side effects have been observed in
patients taking doxazosin but the frequency is not
known:
• eye problems
• difficulty with
(especially in patients
ejaculation
with cataracts)
• taste disturbances.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. HOW TO STORE CARDOZIN XL 4MG
Keep out of the sight and reach of children.
Do not use Cardozin XL 4mg after the expiry date
which is printed on the carton after the word “EXP”.
This medicine does not require any special storage
conditions.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines which are no longer required.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Cardozin XL 4mg contains:
• This medicine contains the active substance
doxazosin (as doxazosin mesilate).
• The other ingredients in the tablet core are
macrogol, microcrystalline cellulose, povidone,
butylhydroxytoluene (E-321), α-tocopherol, silica
colloidal anhydrous and sodium stearyl fumarate.
The other ingredients in the tablet coat are
methacrylic copolymer, silica colloidal anhydrous,
macrogol and titanium dioxide (E-171).
What Cardozin XL 4mg looks like and contents of the
pack:
Cardozin XL 4mg is in the form of prolonged-release
tablets. These tablets are white, round and biconvex
with the embossing ‘DL’.
Cardozin XL 4mg is available in blister packs of 10, 28,
30, 56, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Arrow Generics Limited, Unit 2, Eastman Way,
Stevenage, Hertfordshire, SG1 4SZ, United Kingdom.
Manufacturer:
Arrow Pharm (Malta) Limited, 62 Hal Far Industrial
Estate, Birzebbugia, BBG3000, Malta.
This leaflet was last approved in 03/2012.

L3024/5

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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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