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BENESTAN 2.5MG TABLETS

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Assessed against the UK PIL dated November 2008

Mock up

By Amy Stock at 4:40 pm, Sep 10, 2009

Benestan 2.5mg Tablets/
Alfuzosin Hydrochloride 2.5mg Tablets
(Alfuzosin hydrochloride)

Your medicine is known by either of the above names, but will be referred
to as Benestan throughout this:

Patient Information Leaflet
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 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.
In this leaflet:
1) What Benestan is and what it is used for
2) Before you take Benestan.
3) How to take Benestan.
4) Possible side effects.
5) How to store Benestan.
6) Further information.

1) What Benestan is and what it is used for
The name of your tablets is Benestan. This belongs to a group of
medicines called alpha-blockers.
Benestan can be used to treat the symptoms of Benign Prostatic
Hypertrophy. This is when the prostate gland enlarges (hyperplasia), but
the growth is not cancerous (it is benign). It can cause problems in passing
water (urine). This happens mainly in older men.
• The prostate gland lies underneath the bladder. It surrounds the urethra.
This is the tube that takes your water to the outside of the body.
• If the prostate gets bigger, it presses on the urethra making it smaller.
This makes it difficult to pass water.
• Your tablets work by relaxing the prostate gland muscle. This allows the
urethra to get bigger and so makes it easier to pass water.

2) Before you take Benestan
Do not take Benestan if:
• You are allergic (hypersensitive) to alfuzosin or any of the other
ingredients of Benestan (see Section 6). Signs of an allergic reaction
include: a rash, swallowing or breathing problems, swelling of your lips,
throat, or tongue.
• You are taking another alpha-blocker See section below on ‘Taking other
medicines’.
• You have something called orthostatic hypotension. This is a drop in
blood pressure which usually happens when you stand up. It can make
you feel dizzy, light-headed or faint when you stand or sit up quickly.
• You have liver problems.
If you are not sure if any of these apply to you, do not take and talk to your
doctor
Take special care with Benestan
Check with your doctor or pharmacist before taking your medicine if:
▲ You have chest pain (angina).
▲ You have a long-term infection in your urinary tract (including your
kidney, bladder and urethra), had difficulty when passing water or had
small crystals (stones) forming in the water.
• If you are going to have an operation on the eye called 'Cataract
(cloudiness of the eye'), tell your eye specialist you are using or have
used Benestan in the past. This is because Benestan may cause
complications during your operation. This can be managed if your eye
specialist knows before carrying out the operation.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines including medicines obtained without a
prescription.
This is because Benestan can affect the way some other medicines work.
Some medicines can also have an effect on the way that Benestan works.
Do not take Benestan if you are taking:
• Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin,
tamsulosin, or phenoxybenzamine.
Check with your doctor or pharmacist before taking your medicine if:
• In the past, you have had a large fall in blood pressure while taking an
alpha-blocker (this could include previous use of alfuzosin. See
paragraph immediately above for examples of other alpha-blockers).
• You are taking a medicine for high blood pressure, as you may get dizzy,
weak or start sweating within a few hours of taking this medicine. If this
happens, lie down until the symptoms have completely gone.
Tell your doctor as he or she may decide to change the dose of your
medicine.
Check with your doctor if you are taking any of the following:
• Medicines for chest pain (angina)
• Medicines for fungal infections (such as ketoconazole or itraconazole)
and HIV (such as ritonavir).
Operations and tests while taking Benestan
• If you are being treated for high blood pressure, your doctor should
measure your blood pressure regularly, especially at the start of
treatment.
• If you are going to have an operation that needs a general anaesthetic,
tell your doctor you are taking Benestan before the operation.
Your doctor may decide to stop you having Benestan 24 hours before the
operation. This is because it can be dangerous as it can lower your blood
pressure.
Taking Benestan with food and drink
• You may feel dizzy and weak while taking Benestan. If this happens do
not drink any alcohol.
Driving and using machines
You may feel dizzy and weak while taking Benestan. If this happens do not
drive or operate any tools or machines.
Important information about some of the ingredients of Benestan
If you have been told by your doctor that you have an intolerance to some
sugars contact your doctor before taking this medicinal product

3) How to take Benestan
Always take Benestan exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
• Swallow your tablets whole with plenty of water.
• Do not break, crush or chew your tablets.
This can affect the release of your medicine into the body.
• Take this medicine after a meal.
The usual dose is one Benestan tablet three times a day.
If you are over 65 or are being treated for high blood pressure
• You should start on one Benestan tablet in the morning and one tablet in
the evening.
If you have kidney problems
• You should start on one Benestan tablet twice a day. This may be
changed depending upon how you respond.

By Amy Stock at 4:41 pm, Sep 10, 2009

Assessed against the UK PIL dated November 2008

Mock up

If you have liver problems
• You should start on one Benestan tablet a day. This may be changed to
two tablets a day, depending upon how you respond.

Another side effect that can happen is a painful erection of the penis,
unrelated to sexual activity, that will not go away. The chance of this
happening is very small.

If you take more Benestan than you should
Contact your local hospital Accident and Emergency department straight
away. Tell the doctor how many tablets you have taken.
Lie down as much as possible to help stop the side effects. Do not try to
drive to the hospital yourself.

Other side effects (frequently not known) which may occur are:
• Liver problems. Signs may include yellowing of your skin or the whites of
your eyes.
• Intraoperative Floppy Iris Syndrome (IFIS). If you are having an
operation on your eyes because of cataracts (where the lens of the eye
is cloudy) and are already taking or have taken Benestan in the past, the
pupil may dilate poorly and the Iris (the coloured part of the eye) may
become floppy during the procedure. This only happens during the
operation and it is important for the eye specialist to be aware of this as
the operation may need to be carried out differently (see section 'Take
special care with Benestan’).
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

If you forget to take Benestan
Do not take a double dose to make up for a forgotten tablet. Miss it out and
then go on as before.
If you stop taking Benestan
Keep taking your tablets, even if your symptoms improve. Only stop if your
doctor tells you to. The symptoms are better controlled if you continue
taking the same dose of this medicine.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4) Possible side effects
Like all medicines, Benestan can cause side effects, although not
everybody gets them. These side effects are most likely to happen at the
start of treatment.
Chest pain (angina)
Normally, this only happens if you have had angina before. If you get
chest pain stop taking your tablets and contact a doctor or go to a
hospital immediately.
This happens in less than 1 in 10,000 people.
Allergic reactions
You could notice symptoms of angioedema, such as a red and lumpy skin
rash, swelling (on the eyelids, face, lips, mouth and tongue), difficulty in
breathing or swallowing. These are symptoms of an allergic reaction. If
this happens, stop taking your tablets and contact a doctor or go to a
hospital immediately. This happens in less than 1 in 10,000 people.
Other side effects include:
Common (affects less than 1 in 10 people)
• Feeling dizzy or faint.
• Headache.
• Feeling sick (nausea).
• Stomach pain.
• Weakness or tiredness.
• General feeling of being unwell.
• Feeling dizzy, lightheaded, or faint when you stand or sit up quickly
(postural hypotension).
• Diarrhoea.
• Dry mouth.
Uncommon (affects less than 1 in 100 people)
• Fast heart beat (tachycardia) and palpitations (pounding in the chest and
uneven heartbeat).
• Chest pain.
• Drowsiness.
• Rash and itching.
• Flushes.
• Water retention (may cause swollen arms or legs).
• Lack of control over passing water.
• Runny nose, itching, sneezing, and stuffy nose.
• Visual disturbances (changes in your vision or sight).
Very rare side effects (affects less than 1 in 10,000 people)
• Itchy, lumpy rash also called hives or nettle rash (urticaria).

5) How to store Benestan
• Keep out of the reach and sight of children.
• Do not use Benestan after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
• Benestan 2.5mg Tablets should be stored in a dry place below 30°C
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
• If your doctor tells you to stop taking the tablets, please take them back
to the pharmacist for safe disposal. Only keep the tablets if your doctor
tells you to.
• If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
6) Further information
What Benestan contains
• The active substance is 2.5 mg alfuzosin hydrochloride. Each tablet
contains the active ingredient alfuzosin hydrochloride.
• The other ingredients are lactose, microcrystalline cellulose, povidone,
sodium starch glycollate, magnesium stearate, methylhydroxypropyl
cellulose, polyethylene glycol 400 and titanium dioxide (E171).
What Benestan looks like and contents of the pack
White, film-coated, round tablets coded ‘ALZ’ on one side and ‘2.5’on the
reverse.
Your tablets are available in packs of 60 and 90 tablets.
PL 10383/0804

Benestan 2.5mg Tablets/
Alfuzosin hydrochloride 2.5mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured Sanofi Winthrop Industrie 30-38, Ave
Gustave Eiffel, 37001 Tours, France Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd, 28 Sarum
Complex, Uxbridge, Middlesex UB8 2RZ.
Leaflet date: 01.07.2009.

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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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