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RAPORSIN XL 4 MG PROLONGED-RELEASE TABLETS

Active substance(s): DOXAZOSIN MESYLATE

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Raporsin XL 4mg
Prolonged-release Tablets
Doxazosin
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.
• The full name of this product is Raporsin XL 4mg
Prolonged-release Tablets but within this leaflet
it will be refered to as Raporsin XL.

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
 ow to take Raporsin XL
3 H
 ossible side effects
4 P
 ow to store Raporsin XL
5 H
 ontents of the pack and other
6 C
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 easily.

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 problems
• 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 treatment.
• 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
concerned.

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 breastfeeding.

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 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. 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 recommendations.

Continued over page

Continued top of next column
AAAI0027

Doxazosin (Raporsin XL) 4mg Prolonged-release tablets PIL - UK

colours/plates:
1. Black

item no: AAAI0027

dimensions: 160 x 420

print proof no: 3

pharmacode:

origination date: 03.06.15

min pt size: 7pts

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 09.07.15

Technical Approval

revised by: DR

date sent: 03.06.15

supplier: Acino Pharma AG

technically app. date: 08.06.15

Non Printing Colours
1.
2.
3.

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.

 ossible side effects
4 P

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 effect.
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
• Prolonged erections, which occurs without sexual
arousal
• Enlarged breasts in men
• Tiredness
• 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.
gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

 ow to store Raporsin XL
5 H

This medicinal product does not require any special
storage conditions.
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.
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 substance is doxazosin (each tablet
contains doxazosin mesilate 4.85mg corresponding
to 4mg doxazosin).
• 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 prolonged-release tablets are white,
round biconvex tablets with embossing “DL”.
The packs contain 28 prolonged-release tablets.

Manufacturers
Actavis UK Ltd
Whiddon Valley
Barnstaple
North Devon
EX32 8NS
United Kingdom

Actavis Nordic A/S
Ørnegårdsvej 16
2820 Gentofte
Denmark
Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland

Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland

This leaflet was last revised in June 2015

If you would like a
leaflet with larger
text, please contact
01271 385257.

Continued top of next column
AAAI0027

Actavis, Barnstaple, EX32 8NS, UK

Doxazosin (Raporsin XL) 4mg Prolonged-release tablets PIL - UK

colours/plates:
1. Black

item no: AAAI0027

dimensions: 160 x 420

print proof no: 3

pharmacode:

origination date: 03.06.15

min pt size: 7pts

3.
4.
5.
6.

originated by: DR
approved for print/date

2.

revision date: 09.07.15

Technical Approval

revised by: DR

date sent: 03.06.15

supplier: Acino Pharma AG

technically app. date: 08.06.15

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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