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Alfuzosin Hydrochloride 2.5mg Tablets

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


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Assessed against the UK PIL dated November 2008

Benestan 2.5mg Tablets/ Alfuzosin Hydrochloride 2.5mg Tablets

(Alfuzosin hydrochloride)

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.


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

Patient Information Leaflet

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.

APPROVED


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


Assessed against the UK PIL dated November 2008


-Mock up

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.

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

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/    |POM|

Alfuzosin hydrochloride 2.5mg Tablets

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.


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.

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.

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).