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BENPH 2MG TABLETS

Active substance(s): TERAZOSIN HYDROCHLORIDE DIHYDRATE

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Benph 1 mg, 2 mg, 5 mg
and 10 mg Tablets
(terazosin)
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 Benph is and what it is used for
2. What you need to know before you
take Benph
3. How to take Benph
4. Possible side effects
5. How to store Benph
6. Contents of the pack and other information

1. What Benph is and what it is
used for
Your medicine contains terazosin, which
belongs to a group of medicines called
alpha-blockers. Benph is given to men
suffering from an enlarged prostate gland (part
of the male sexual organs found just below
the bladder, which can place pressure on the
bladder, causing problems, when passing
water (urine)), as it can relax the muscles
allowing urine to be passed more easily.

2. What you need to know before
you take Benph
Do not take Benph:
• if you are allergic to terazosin or any of the
other ingredients of this medicine (listed in
section 6)
• if you have ever taken a similar medicine to
terazosin (eg. prazosin, alfuzosin, indoramin,
tamsulosin, doxazosin) and you suffered an
allergic reaction
• if you have heart failure which may be
caused by heart valve disease, a blood
clot in the lungs or the membrane
(protective lining) around the heart being
inflamed (pericarditis).

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Warnings and precautions
Talk to your doctor or pharmacist before
taking Benph:
• if you have fallen over or fainted whilst
passing water
• if you have had or are suffering from other
heart conditions eg. heart disease, heart
valve disease, angina, heart failure or stroke
• if you are on a low salt (e.g. sodium) diet or
are very dehydrated (e.g. you may have had
severe diarrhoea or been sick)
• if you have severe liver or kidney problems
• if you have had or are currently suffering from
eye problems due to high blood pressure
• if you have diabetes that requires insulin
treatment
Tell your doctor if any of the above apply to you.

During treatment
When taking this medicine you may experience
a sudden drop in blood pressure when you
stand up, shown by dizziness, weakness or
sweating within a few hours of taking (this may
occur especially after taking the first dose or
during the early stages of treatment or when
treatment is stopped and then restarted). If
you experience a drop in blood pressure you
should lie down with your legs and feet up in
the air until the symptoms have disappeared.
Usually, these effects last for only a short time.
This medicine can cause painful erections,
which may last for hours and continue even
after sex or masturbation (if left untreated
this can cause problems with getting and
maintaining an erection).
If you are undergoing eye surgery because of
cataract (cloudiness of the lens) please inform
your eye specialist before the operation that
you are taking or have previously taken this
medicine. This is because terazosin may cause
complications during the surgery which can
be managed if your specialist is prepared
in advance.

Other medicines and Benph
Tell your doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This includes
medicines obtained without a prescription or
the following:
• medicines to lower blood pressure
(e.g. diltiazem), ACE inhibitors (e.g. ramipril) or
other alpha-blockers (e.g. doxazosin, alfuzosin)
• diuretics (water tablets) e.g. furosemide
• medicine to thin the blood e.g. warfarin
• medicine for erectile dysfunction (impotence)
(e.g. sildenafil, tadalafil, vardenafil)
• anti-inflammatory painkillers e.g.
ibuprofen, diclofenac.
Some patients who take alpha-blocker
therapy for the treatment of 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 medicines
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 medicines for
erectile dysfunction.

Benph with alcohol
Alcohol can increase the effects of this
medicine causing dizziness or fainting.
Do not drink alcohol while taking this
medicine if you are affected.

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Package leaflet: Information for the patient

Pregnancy and breast-feeding
Benph is used to treat a condition found
only in men. It should not be prescribed
to women.
Driving and using machines
Benph may make you feel dizzy, light headed
and drowsy. These side effects are more
likely at the start of treatment, or in the case
of missed doses and where treatment has
been stopped and then restated again. You
may also suffer from blurred vision or other
eyesight changes. Do not drive, operate
machinery or perform any hazardous tasks
for 12 hours when you first start taking your
medicine, or when your doctor increases the
dose you are taking. After this time, make
sure you are not suffering any of these side
effects before carrying out these tasks.
Benph contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.
Benph 5 mg and 10 mg tablets contain
sunset yellow (E110)
Sunset yellow (E110), may cause
allergic reactions.

3. How to take Benph
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
• Swallow the tablets whole with a full glass
of water
• Take with or without food
• Do not chew, break or crush the tablets.

Adults and the elderly (over 65 years
of age) only:
The recommended starting dose is 1 mg of
Benph. Take the very first dose at bedtime as
Benph may make you feel dizzy or faint when
taken for the first time.
Your doctor may adjust your dose depending
on how you respond to the tablets. If your
doctor increases your dose, he or she may
double your dose at intervals of one week or
every two weeks. The usual maintenance dose
is 5 to 10 mg once daily. The maximum daily
dose is 10 mg of Benph.

Use in children and adolescents
(under 18 years):
There is no relevant use in children and
adolescents under 18 years.
If you take more Benph than you should
If you take more Benph than you should
your blood pressure may suddenly drop and
you may feel dizzy or even faint. If you begin
to feel dizzy, lie down until you feel better.
If the symptoms do not disappear, contact
your doctor or nearest hospital casualty
department immediately. Take any remaining
tablets and the container with you.

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If you forget to take Benph
If you forget to take Benph, do not take a
double dose to make up for a forgotten dose
as this may cause a sudden drop in blood
pressure, especially if you take blood pressure
lowering medicines, just carry on as before.
If for any reason, you have stopped taking
Benph for several days, do not continue your
treatment using the same dose. Contact your
doctor as you may need to start taking your
medicine at a lower strength than you have
been used to taking.
If you stop taking Benph
Do not suddenly stop taking your medicine as
this may cause serious changes in your blood
pressure. 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.

If you experience any of the following,
stop taking Benph and tell you doctor
immediately or go to the nearest hospital
emergency department:
Very rare (may affect up to 1 in 10,000 people):
• itchy skin or a rash, difficulty breathing,
feeling wheezy, or swelling of the face,
mouth or throat,
• fast and uneven heartbeat, which may make
you feel tired, dizzy and short of breath
(atrial fibrillation)
Tell your doctor if you suffer from a painful,
prolonged erection which continues even
after sex or masturbation. This is a rare side
effect in men but can lead to permanent
impotence (failure to get and maintain an
erection) if not treated.
Benph can make you feel dizzy or faint which
is more likely after your first dose. You may
also notice your heart beating faster before
you feel faint. Your first dose is best taken at
bedtime to help avoid these side effects.

Other possible side effects:
Common (may affect up to 1 in 10 people):
• feeling dizzy, light-headed or weak
• sleepiness
• feeling nervous
• constipation, diarrhoea, feeling or being sick
• swelling of the ankles or hands
• itchy skin or skin rash
• uneven or rapid heart beat
• breathlessness
• headache
• impotence
• chest pain
• tingling or numbness in the hands and feet
• fainting on standing
• blurred vision or decreased vision (lazy eye)
• pain in the extremities (hands and feet)
• back pain
• feeling weak
• nose bleeds, sinusitis or blocked nose
Uncommon (may affect up to 1 in 100 people):
• depression
• weight gain
• loss of sexual desire
• fainting
Rare (may affect up to 1 in 1,000 people):
• bladder (urinary tract) infection or loss of
control of passing water (incontinence),
mostly in women who have been through
the menopause
Very rare (may affect up to 1 in 10,000 people):
• unusual bruising or bleeding of the skin
Not known (frequency cannot be estimated
from the available data): anxiety, difficulty
sleeping, abnormal vision, infection causing
redness and swelling of the thin layer
covering the front of the eye (conjunctivitis),
ringing in the ears, spinning sensation,
irregular heart beat, bronchitis, flu symptoms,
sore throat, cold symptoms, cough, dry
mouth, indigestion, wind, swelling of the face,
sweating, stomach, neck and shoulder pain,
gout, painful joints or muscles, changes in
urinary frequency, fever, dilation of the blood
vessels which may cause redness of the skin.

If you are undergoing eye surgery because
of cataract and you are taking or have taken
this medicine in the past, there may be
complications during the surgery (please see
“Warnings and precautions”).
The use of this medicine may affect the results
of some blood tests. Always tell your doctor
that you are taking this medicine.

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.

5. How to store Benph
Keep this medicine out of the sight and reach
of children.
Do not store above 30°C.
Do not use this medicine after the expiry date
which is stated on the blister and carton after
EXP. The expiry date refers to the last day of
that month.
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 Benph contains
• The active substance is terazosin
hydrochloride dihydrate (equivalent to 1 mg,
2 mg, 5 mg and 10 mg of terazosin).
• The other ingredients are talc, magnesium
stearate, povidone, pregelatinised starch,
lactose monohydrate (see section 2.
“Important information about some of the
ingredients of Benph”). In addition, the 2mg
tablet contains quinoline yellow (E104). The
5 mg and 10 mg tablets contain sunset yellow
(E110) (see section 2 “Benph 5 mg and 10 mg
tablets contain sunset yellow [E110]”).
What Benph looks like and contents of
the pack
The 1mg tablets are white, round, flat
bevel-edged tablets imprinted ‘E’ and ‘451’ on
one side.
The 2 mg tablets are yellow, round, flat
bevel-edged tablets imprinted ‘E’ and ‘452’ on
one side.
The 5 mg tablets are light orange, round, flat
bevel-edged tablets imprinted ‘E’ and ‘453’ on
one side.
The 10 mg tablets are orange, round, flat
bevel-edged tablets imprinted ‘E’ and ‘454’ on
one side.
They are available in PVC/PVDC/ aluminium
blister packs of:
1 mg: 7, 10, 14, 20, 28, 50 and 100 tablets *
2 mg: 7, 10, 14, 20, 28, 50, 84, 98 and 100 tablets *
5 mg: 14, 20, 28, 30, 50, 84, 98 and 100 tablets *
10 mg: 28, 50, 84, 98 and 100 tablets *
* Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer
Gerard Laboratories,
35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
EGIS Pharmaceuticals PLC, H-1165 Budapest
Bökényföldi út. 118-120., Hungary

This medicinal product is authorised in
the Member States of the EEA under the
following names:
Italy:
Terazosina Mylan Generics
2 mg, 5 mg compresse
Portugal:
Terazosina Mylan 1 mg,
2 mg, 5mg comprimidos
United Kingdom: Benph 1 mg, 2 mg, 5 mg,
10 mg Tablets
This leaflet was last revised in: August 2015

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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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