Skip to Content



PDF options:  View Fullscreen   Download PDF

PDF Transcript

Raporsin® XL 4mg Prolonged-release Tablets
(doxazosin mesilate)
Your medicine is known by the above name but will be referred to as
Raporsin XL through this
Patient Information Leaflet
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 Raporsin XL is and what it is used for
2) What you need to know before you take Raporsin XL
3) How to take Raporsin XL
4) Possible side effects
5) How to store Raporsin XL
6) Contents of the pack and other information

1) What Raporsin XL is and what it is used for
Raporsin XL is one of a group of medicines called alpha-blockers. It is
used to treat high blood pressure in both male and female patients or the
symptoms caused by enlargement of the prostate gland in male patients.
Raporsin XL can be used to treat high blood pressure (hypertension), by
relaxing blood vessels so that blood passes through them more easily.
This helps to lower blood pressure.
In male patients with an enlarged prostate gland, Raporsin XL is taken to
treat poor and/or frequent passing of urine. This is common in patients
with an enlarged prostate gland. Raporsin XL works by relaxing muscle
around the bladder exit and prostate gland so that urine is passed more

2) What you need to know before you take Raporsin XL
Do not take Raporsin XL if you:
• are allergic to doxazosin, other quinazolines (e.g. prazosin, terazosin)
or any of the other ingredients of this medicine (listed in section 6). An
allergic reaction may include a rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue
• are suffering from benign hyperplasia (an enlarged prostate gland)
together with bladder stones or blockages or infections of the
urinary tract.
• are suffering from benign hyperplasia (an enlarged prostate gland) and
bladder leakage, problems producing urine or worsening kidney
• have any form of obstruction of the digestive tract
• have a history of orthostatic hypotension (a drop in blood pressure
caused by standing or sitting up too quickly).
• have abnormally low blood pressure (only applicable if you are being
treated for enlargement of the prostate gland)
• are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Raporsin XL.
• If you have had a surgical procedure
• At the start of treatment, you may experience faintness or dizziness
caused by low blood pressure, when getting up from sitting or lying
down. If you feel faint or dizzy, you should sit or lie down until you feel
better. Your doctor will monitor your blood pressure at the start of
• If you have acute heart disease such as swelling and/or fluid
accumulation in the lungs (pulmonary oedema) and heart failure.
• Be careful if you have acute heart failure due to a blood clot or build
up of fluid around the heart
• If you have severe liver problems.
• If you are male and use medicines to treat impotence such as
sildenafil, tadalafil and vardenafil as taking these medicines at the same
time with doxazosin may lead to low blood pressure. Your doctor will
advise you with respect to the interval required between taking these
medicines with doxazosin.
• If you are undergoing eye surgery for cataract (cloudiness of the lens)
please inform your eye specialist before the operation that you are
using or have previously used Raporsin XL. This is because Raporsin
XL may cause complications during the surgery which can be managed
if your specialist is prepared in advance.
• If you have your blood or urine tested, remember to tell the doctor or
nurse that you are being treated with Raporsin XL.
Raporsin XL is a modified release tablet. The medicine is contained within
a non absorbable shell that has been specially designed to slowly release
the medicine. Since the empty shell is removed from the body in bowel
movements, you may occasionally observe in the stools, something that
looks like a tablet. This is to be expected and you should not be
Children and adolescents
Raporsin XL is not recommended for use in children or adolescents below
18 years as safety and efficacy have not yet been established.

Other medicines and Raporsin XL
Tell your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines. Your treatment can be affected if
Raporsin XL is taken with certain other medicines.
It is especially important for your doctor to know if you are already being
treated with the following medicines:
• Medicines to treat impotence in men (sildenafil, tadalafil and vardenafil)
taken at the same time as doxazosin may lead to low blood pressure.
• Some patients who take alpha-blocker therapy for the treatment of high
blood pressure or prostate enlargement may experience dizziness or
lightheadedness, 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.
• Other blood pressure lowering medicines - as the blood pressure
lowering effect of these medicines may be increased
• Anti-inflammatory medicines of the NSAID types (Non Steroidal Anti
Inflammatory Drugs) – as they can reduce the effects of Raporsin XL
• Cimetidine, a medicine used in the treatment of stomach ulcers taken at
the same time with doxazosin will increase the effect of doxazosin.
Speak with your doctor about this.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine. Raporsin XL tablets must not be used during
Driving and using machines
Take care if you drive or operate machinery. Your tablets may affect your
ability to drive or operate machinery safely, particularly when you first start
to take them. If affected, do not drive or operate machinery and contact
your doctor immediately.

3) How to take Raporsin XL
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
For oral use.
The tablets must be swallowed whole with a glass of water. Do not
chew, divide or crush the tablets. The tablets can be taken with or
without food.
Raporsin XL can be used if you suffer from high blood pressure as well as
prostatic hyperplasia (enlargement of the prostate gland). It will treat both
conditions at the same time.
Adults including the elderly:
• Treatment of high blood pressure for adult male and female
The recommended dose is 4mg doxazosin (1 prolonged-release tablet)
once a day. If needed, the dosage may be increased to 8mg doxazosin
(2 prolonged-release tablets) once a day. It may take up to 4 weeks to
attain the optimal effect.
• Treatment of symptoms of prostatic hyperplasia (enlargement of
the prostate gland) for adult male patients
The recommended dose is 4mg doxazosin (1 prolonged-release tablet)
once a day. If needed, the dosage may be increased to 8mg doxazosin
(2 prolonged-release tablets) once a day.
• Patients with loss of liver function:
A reduction of the dose may be needed. Always follow the doctors
If you take more Raporsin XL than you should
If you (or someone else) swallow a lot of the tablets at the same time, or if
you think a child has swallowed any of the tablets, contact your nearest
hospital casualty department or your doctor immediately.
If an overdose has been taken there may be signs such as headache,
dizziness, fainting, unconciousness, difficulty breathing, low blood
pressure, palpitations, fast or irregular heart beat or feeling or being sick.
If you forget to take Raporsin XL
If you forget to take a dose, take one as soon as you remember, unless it
is nearly time to take the next one. Do not take a double dose to make
up for a forgotten dose. Take the next dose at the correct time.
If you stop taking Raporsin XL
Continue taking Raporsin XL for as long as recommended by the doctor
and you should not stop taking the Raporsin XL or change the dosage
without checking with your doctor.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4) Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor immediately and stop taking your medicine if you
experience an allergic drug reaction.

If you get a skin rash, swelling of the face, lips, tongue, throat,
difficulty breathing or swallowing, stop taking Raporsin XL and
contact your doctor immediately. You may need urgent medical
attention or hospitalisation.
Contact your doctor immediately if you develop a heart attack. This is
a very serious but uncommon side effect.
Contact your doctor immediately if you develop hepatitis (liver
disease with nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itching, yellowing of the skin and eyes, and dark
coloured urine) or jaundice (yellowing of the skin and whites of the
eyes) or narrowing of the airways. This is a very serious but rare side
Common (may affect up to 1 in 10 people):
• Respiratory tract infection
• Urinary tract infection
• Dizziness and weakness and rarely fainting
• Headache
• Drowsiness
• Imbalance when getting upright quickly
• Palpitations (greater awareness of the heart beat) or faster heart beat
• Low blood pressure
• Dizziness/spinning sensation especially when you stand up abruptly
• Bronchitis
• Cough
• Shortness of breath
• Runny or blocked nose, sneezing, facial pressure or pain
• Abdominal pain (stomach pain and discomfort)
• Indigestion and heartburn
• Dry mouth
• Nausea
• Itching
• Back pain
• Muscle pain
• Inflammation of the urinary bladder (cystitis)
• Involuntary leakage of urine
• Chest pain
• Weakness and loss of strength
• Water retention in legs
• Influenza- like symptoms
Uncommon (may affect up to 1 in 100 people):
• Loss of appetite
• Gout
• Increased appetite
• Generalised fear
• Anxiety
• Mental state characterised by extreme sadness (depression)
• Difficulty in sleeping
• Stroke (inability to move one or more limbs on one side of the body,
inability to understand or formulate speech, or inability to see one side
of the visual field)
• Reduced sense of touch
• Loss of consciousness
• Fainting
• Tremor
• Involuntary shakiness
• Ringing or buzzing in the ears
• Pain in the centre of the chest (angina pectoris)
• Constipation
• Nose bleed
• Wind
• Vomiting
• Diarrhoea
• Abnomal liver function tests (detected by a blood test)
• Stomach flu
• Skin rash
• Joint pain
• Blood in the urine
• Pain when passing urine
• Urinating more frequently
• Reduced sexual potency in men (impotence)
• Pain
• Swelling of the face
• Weight increase
Very rare (may affect up to 1 in 10,000 people):
• Reduction in white blood cells (may cause more infections (such as
fever, severe chills, sore throat or mouth ulcers) or platelets (may cause
more bruising or bleeding) in the blood
• Excitement or restlessness (agitation)
• Nervousness
• Numbness
• Posture-related dizziness
• Blurred vision
• Slower heart beat
• Irregular heart beat
• Narrowing of the airways e.g. asthma (may cause difficulty breathing,
wheezing, or coughing)
• Failure in the flow of bile
• Sudden blush
• Hair loss, baldness (alopecia)
• Itchy skin rash
• Red or purple discolouring to the skin (purpura)

Muscle cramps
Muscle weakness
Tingling or pins and needles
Frequent urination at night
Producing more urine than normal
Problems passing urine
Persistent painful erections of the penis, seek urgent medical advice
Enlarged breasts in men
Feeling of general discomfort and illness (malaise)

Not known (frequency cannot be estimated from the available data)
• Intraoperative floppy iris syndrome (IFIS) which can develop during
operation for cataract
• Taste disturbances
• Retrograde ejaculation - occurs when semen is redirected to the urinary
bladder instead of normally being ejaculated via the urethra
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:
By reporting side effects you can help provide more information on the
safety of this medicine.

5) How to store Raporsin XL
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton and blister label. The expiry date refers to the last day of the
• This medicinal product does not require any special storage conditions.
• 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 Raporsin XL contains:
The active ingredient is doxazosin. Each prolonged-release tablet
contains 4mg of doxazosin (as mesilate).
The other ingredients are: polyethylene oxide, microcrystalline cellulose,
povidone K 29-32, butylhydroxytoluene (E321), all-rac-alphatocopherol,
colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid-ethyl
acrylate copolymer, macrogol 1300-1600 and titanium dioxide (E171).
What Raporsin XL looks like and contents of the pack
Raporsin XL 4 mg Prolonged-release Tablets are white, round, biconvex
tablets marked with “DL” on one side.
They are available in blister packs containing 30 tablets.
PL 10383/2219

Raporsin XL 4mg Prolonged-release Tablets

Who makes and repackages your medicine?
Your medicine is manufactured by Actavis UK Ltd., Whiddon Valley,
Barnstaple, N Devon, EX32 8NS, UK
Actavis Nordic A/S, Ørnegårdsvey 16, DK-2820 Gentofte, Denmark
Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur,
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 29.06.2017
Raporsin® is a registered trademark of Actavis Group PTC ehf, Iceland.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

+ 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.