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DOXZOGEN XL 4 MG PROLONGED-RELEASE TABLETS

Active substance(s): DOXAZOSIN MESYLATE

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Rare (may affect up to 1 in 1,000 people)
• swelling of the voice box (larynx) causing a hoarse voice
• low blood sugar
Very rare (affects less than 1 user in 10,000)
• blood changes
• an increase in blood of creatinine levels and urea
• low white blood cells which may cause infections
• agitation
• nervousness
• blurred vision
• aggravated wheezing and coughing (bronchospasm)
• condition in which the flow of the bile from the liver is
blocked (cholestasis)
• yellowing of skin or the eyes (jaundice)
• passing more urine than normal
• disorder in passing urine
• needing to pass urine at night
• enlargement of breasts in men
• persistent painful erection
• sensation of tingling, pricking or numbness of
skin (paraesthesia)
• dizziness on standing. This is more likely to happen at
the beginning of treatment
• hair loss
• hives
• bruising because of bleeding into the skin (purpura)
• muscle cramps
• muscle weakness
• hot flushes
• fatigue
• generally feeling unwell
• low body temperature in the elderly
Not known (frequency cannot be estimated from the
available data)
• eye problems during eye surgery for cataract which
is a condition with cloudiness of the lens of the eye
(intraoperative floppy iris syndrome (IFIS)
• abnormal ejaculation
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Doxzogen XL 4 mg ProlongedRelease Tablets
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 and carton.

Doxzogen XL 4 mg Prolonged-Release Tablets
can also be given to men suffering from an
enlarged prostate gland, as it can relax the
muscles allowing urine to be passed more easily.

TBC

• decreased feeling or sensitivity, especially in the skin
• passing blood in the urine (haematuria)
• failure or inability to get and maintain erection
• pain
• painful urination
• abnormal sensitivity or intolerance of your eyes to light
• increase in tear flow
• weight gain
•reduced blood flow to your arms and feet

2. What you need to know before you
take Doxzogen XL 4 mg ProlongedRelease Tablets

This medicinal product does not require any special
storage conditions.
Do not throw any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.
6. Contents of the pack and
other information

Package leaflet: Information for the user

DOXZOGEN XL 4 mg
PROLONGED-RELEASE
TABLETS
(doxazosin)

What Doxzogen XL 4 mg Prolonged-Release Tablets
contains: The active substance is 4 mg of doxazosin
as doxazosin mesilate. The other ingredients are
macrogol, microcrystalline cellulose, povidone,
butylhydroxytoluene (E321), alpha-tocopherol,
anhydrous colloidal silica, sodium stearyl fumarate,
methacrylic acid copolymer and titanium dioxide (E171).
What Doxzogen XL 4 mg Prolonged-Release Tablets
looks like and contents of the pack:
Doxzogen XL Prolonged-Release Tablets are white,
round, biconvex tablets with bossing 'DL'.
PVC/PVDC/ aluminium blisters:
Pack sizes: 10, 28, 20, 30, 50, 56, 60, 90, 98, 100, 140
(10 x 14) tablets
Calendar packs of 28 and 98
Unit dose 50 x 1
HDPE tablet container:
Pack sizes: 100, 250 tablets
Not all packs sizes may be marketed
Marketing Authorisation Holder: Generics [UK] Limited,
Station Close, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer:
Gerard Laboratories, Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland
Mylan Hungary Kft., H-2900 Komárom, Mylan utca 1,
Hungary
This leaflet was last revised in 12/2013.

365521
00000000

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 side effects, talk to you doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1. What Doxzogen XL 4 mg Prolonged-Release
Tablets is and what it is used for
2. What you need to know before you take
Doxzogen XL 4 mg Prolonged-Release Tablets
3. How to take Doxzogen XL 4 mg ProlongedRelease Tablets
4. Possible side effects
5. How to store Doxzogen XL 4 mg ProlongedRelease Tablets
6. Contents of the pack and other information
1. What Doxzogen XL 4 mg ProlongedRelease Tablet is and what it is used for
Your medicine is in the form of a 'prolongedrelease' tablet. It contains Doxazosin, which
belongs to a group of medicines called
alpha-blockers. Doxzogen XL 4 mg ProlongedRelease Tablets can treat high blood pressure
(hypertension) by relaxing the blood vessels in
the body and lowering blood pressure.

Do not take Doxzogen XL 4 mg ProlongedRelease Tablets:
• if you are allergic to doxazosin, or any of the other
ingredients of this medicine (listed in section 6) or
other quinazolines (e.g. prazosin, terazosin)
• have a history of a condition known as 'orthostatic
hypotension' which is a form of low pressure that
causes you to feel dizzy or light-headed when you
stand up from sitting or lying down
• if you have or have had constipation
• if you have low pressure
• if you have benign prostate hyperplasia and
simultaneous regular infections of the upper
urinary tract, impeded urinary flow or
bladder stones
• during breast-feeding (see Pregnancy
and lactation)
• 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
• if you have kidney problems such as bladder
stones, difficulty passing urine or suffer from
frequent urine infections.
Warnings and precautions
• Talk to you doctor or pharmacist before taking
Doxzogen XL 4 mg Prolonged-Release Tablets:if
you have heart disease or a heart condition
• if you have liver problems
• if you have diabetes
• if you need a blood test as Doxzogen XL 4 mg
Prolonged-Release Tablets can affect some
test results.
Tell your doctor if any of the above apply to you.
When you start to take Doxzogen XL 4 mg
Prolonged-Release Tablets you may experience
faintness or dizziness caused by low blood pressure,
when getting up from sitting down. If you feel faint
or dizzy, you should sit or lie down until you feel
better and avoid situations where you might fall or
hurt yourself. Your doctor may want to measure your
blood pressure regularly at the start of therapy to
reduce the possibility of these effects happening.

Other medicines and Doxzogen XL 4 mg
Prolonged-Release Tablets:
Tell your doctor or pharmacist if you are already
taking, have recently taken or might take any
other medicines:
• other medicines to lower blood pressure
• painkillers called non-steroidal antiinflammatory medicine (NSAIDs) eg. Ibuprofen
• medicines containing estrogen
• medicines containing dopamine, metaraminol,
methoxamine, adrenaline (epinephrine),
cough and cold remedies as they may contain
Ephedrine, Phenylephrine.
• Medicines (PDE-5 inhibitors, e.g. sildenafil,
tadalafil, vardenafil) used in the treatment of
sexual dysfunction characterised by the
inability to develop or maintain an erection
(erectile dysfunction).
Some patients who take alpha-blocker therapy
for the treatment of high blood pressure or
prostrate 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 the drug 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 the
drugs for erectile dysfunction.
Doxzogen XL 4 mg Prolonged-Release Tablets
with food and drink:
Doxzogen XL 4 mg Prolonged-Release Tablets
can be taken with or without food.
Pregnancy and breast-feeding:
Do not take Doxzogen XL 4 mg Prolonged-Release
Tablets if you are pregnant or breast-feeding.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist before taking this medicine.

Driving and using machines:
Do not drive or operate machinery if you feel
less alert while taking this medicine. This is more
likely at the start of treatment or if the doctor
increases your dose.

If you forget to take Doxzogen XL 4 mg ProlongedRelease Tablets:
Take it as soon as you remember. If it is almost time for
your next dose though, do not double the dose, just
carry on as before.

3. How to take Doxzogen XL 4 mg
Prolonged-Release Tablets

If you stop taking Doxzogen XL 4 mg ProlongedRelease tablets:
Do not suddenly stop taking your medicine as this may
cause serious changes in your blood pressure.

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Adults including the elderly:
The recommended starting dose is one Doxzogen
XL 4 mg Prolonged-Release Tablet once a day. If
necessary, your doctor may increase this dose to
the maximum of two tablets once a day.
To treat hypertension, your doctor may give you
another medicine to take along with Doxzogen XL
4 mg Prolonged-Release Tablets. Doxzogen XL 4 mg
Prolonged-Release Tablets is unlikely to affect your
blood pressure unless you suffer from hypertension.
Your prolonged release tablets have been
specially designed to slowly release the medicine
from the tablet shell. The shell does not break
down but passes through your body. The empty
tablet will be passed out in your stools. Do not
worry if sometimes you notice the tablet shell in
your stools.
Use in children and adolescents
Doxzogen XL 4 mg Prolonged-Release Tablet is
not recommended for use in paediatric patients
under the age of 18 years due to missing data on
its efficacy and safety.
Use in patients with liver problems
Your doctor may reduce your dose or monitor
your progress closely. Doxazosin XL 4 mg
Prolonged-Release Tablet is not recommended
for use in patients with severe liver problems.
Method of administration
• Swallow the tablets whole with a full glass
of water
• Take with or without food
• Do not chew, break or crush the tablets
If you take more Doxzogen XL 4 mg ProlongedRelease Tablets than you should:
Contact your doctor or nearest hospital casualty
department immediately. Take any remaining
tablets and the container with you.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like most medicines, this medicine can sometimes cause
side effects, although not everybody gets them.
STOP taking Doxzogen XL 4 mg Prolonged-Release
Tablets and call an ambulance if you experience any of
the following:
• heart attack (uncommon)
• collapse, numbness or weakness of arms or, legs,
headache, dizziness and confusion, visual disturbance,
difficulty swallowing, or problems speaking such
as slurred speech and loss of speech which may be
symptoms of stroke (uncommon)
• swelling of the face, tongue or throat, which may be the
result of an allergic reaction to this medicine (uncommon)
• angina pectoris (common)
• increased, decreased or irregular heartbeat (common,
very rare)
• a liver disease causing dark urine, pale stools, yellowing
of the skin, nausea, fever (hepatitis) (very rare)
Other side effects:
Common (may affect up to 1 in 10 people)
• dizziness
• sleepiness
• flu like symptoms
• indigestion
• breathlessness
• swelling of the feet and hands
• runny and blocked nose
• palpitations
• delayed ejaculation
• headache
• chest pain
• infection of the kidney or bladder (urinary tract infection)
• (nose, throat and, lungs)infection (respiratory
tract infection)
• spinning sensation (vertigo)
• unusual weakness
• low blood pressure

• feeling sick
• light-headedness when
standing up
• back pain
• muscle pain
• abdominal pain
• dry mouth
• inflammation of the airways
(bronchitis)
• coughing
• itching
• bladder infection
• inability to control passing urine (urinary incontinence)
• difficulty in focusing or blurred vision
(accommodation disturbances)
• apathy
• swelling of different parts of the body (oedema)

TBC

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 Doxzogen XL 4 mg
Prolonged-Release Tablets. This is because Doxzogen
XL 4 mg Prolonged-Release Tablets may cause
complications during the surgery which can be
managed if your specialist is prepared in advance.

Uncommon (may effect up to 1 to 100 people)
• swelling of the face and body
• feeling faint
• being sick
• cold fingers and toes (peripheral ischaemia)
• sore swollen throat
• low blood potassium
• feeling thirsty
• painful, swollen joints due to accumulation of uric
acid (gout)
• nightmares
• loss of memory
• mood changes
• tremor
• muscle stiffness
• ringing in the ears
• loss of bladder control or less frequent urge to pass urine
• joint pain
• increase in appetite
• changes in taste
• allergic drug reaction
• difficulty in sleeping
• loss of appetite
• feeling nervous
• diarrhoea
• paleness
• fever or shivering
• constipation
• wind
• inflammation of the stomach and intestines
(gastroenteritis)
• abnormal liver function tests
• skin rash
• depression

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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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