Alfuzosin Hydrochloride 2.5mg Tablets
Out of date information, search anotherRef:0265/290414/1/F
Xatral ® 2.5mg Tablets
(alfuzosin hydrochloride)
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Xatral 2.5mg Tablets but will be referred to as Xatral throughout this leaflet.
In this leaflet:
^ What Xatral is and what it is used for Before you take Xatral ^ How to take Xatral ^ Possible side effects ^ How to store Xatral Further information
^ What Xatral is and what it is used for
The name of your tablets is Xatral. This belongs to a group of medicines called alpha-blockers.
Xatral 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.
Do not take Xatral 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 Xatral
* 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 Xatral before the operation.
Your doctor may decide to stop you having Xatral 24 hours before the operation.
This is because it can be dangerous as it can lower your blood pressure. Taking Xatral with food and drink
* You may feel dizzy and weak while taking Xatral. If this happens do not drink any alcohol.
Driving and using machines
You may feel dizzy and weak while taking Xatral. If this happens do not drive or operate any tools or machines.
Important information about some of the ingredients of Xatral
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product
[4 Before you take Xatral
Do not take Xatral if:
* You are allergic (hypersensitive) to alfuzosin or any of the other ingredients of Xatral (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 serious 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 Xatral
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 Xatral in the past. This is because Xatral may cause complications during your operation. This can be managed if your eye specialist knows before carrying out the operation.
* You have circulatory problems affecting the brain as there is a risk of impaired brain function due to low blood flow.
* You have heart problems, or if your heart suddenly stopped pumping efficiently (acute cardiac failure)
* You have hereditary problems with the way your heart beats (congenital QTc prolongation)
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 Xatral can affect the way some other medicines work. Some
medicines can also have an effect on the way that Xatral works.
How to take Xatral
Always take Xatral 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 Xatral tablet three times a day.
If you are over 65 or are being treated for high blood pressure
* You should start on one Xatral tablet in the morning and one tablet in the evening.
If you have kidney problems
* You should start on one Xatral tablet twice a day. This may be changed depending upon how you respond.
If you have liver problems
* You should start on one Xatral tablet a day. This may be changed to two tablets a day, depending upon how you respond.
If you take more Xatral 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 Xatral
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 Xatral
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.
(alfuzosin hydrochloride)
Patient Information Leaflet (continued)
Possible side effects
Like all medicines, Xatral 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).
* Fainting
,5 How to store Xatral
Expiry date
Do not use this medicine after the expiry date shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep his medicine, if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Storing your medicine
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30°C.
Store in the original package.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.
Q Further Information
What Xatral contains
Each tablet contains 2.5mg alfuzosin hydrochloride as the active ingredient. Xatral also contains microcrystalline cellulose, lactose, povidone, sodium starch glycollate, macrogol, magnesium stearate, titanium dioxide (E171), hypromellose.
What Xatral looks like and contents of the pack
They are white round film coated tablets, marked Xatral 2.5 on one side and plain on the other.
They are available in blister packs of 30, 60 & 90 tablets.
Manufacturer and Licence Holder:
Xatral is manufactured by Sanofi Winthrop Industrie, Tours, France and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM
Very rare side effects (affects less than 1 in 10,000 people)
* Itchy, lumpy rash also called hives or nettle rash (urticaria).
Other side effects (frequency not known) which may occur are:
* A painful erection of the penis, unrelated to sexual activity, that will not go away.
* Liver problems. Signs may include yellowing of the skin or whites of your eyes
* Intraoperative Floppy Iris Syndrome (IFIS). If you are having an operation on your eyes becuase of cataracts (where the lens of the eye is cloudy) and are already taking or have taken Xatral 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 our differently (see section ‘Take special care with Xatral').
* You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia).
* Being sick (vomiting).
* Abnormal heart rhythm
* Impaired brain function due to low blood flow in patients with existing circulatory problems affecting the brain
* Increased risk of bleeding (including nose bleeds and/or bleeding gums) and bruising. This could be a blood problem called ‘thrombocytopenia' which is reduced number of platelets in the blood.
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 www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
PL Number: 15184/0265 Xatral 2.5mg Tablets
Xatral is a registered trademark of Sanofi-Synthelabo.
Revision date: 29/04/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Alfuzosin hydrochloride 2.5mg Tablets but will be referred to as Alfuzosin hydrochloride throughout this leaflet.
In this leaflet:
^ What Alfuzosin hydrochloride is and what it is used for ^ Before you take Alfuzosin hydrochloride ^ How to take Alfuzosin hydrochloride Possible side effects How to store Alfuzosin hydrochloride Further information
What Alfuzosin hydrochloride is and what it is used for
The name of your tablets is Alfuzosin hydrochloride. This belongs to a group of medicines called alpha-blockers.
Alfuzosin hydrochloride 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.
Before you take Alfuzosin hydrochloride
Do not take Alfuzosin hydrochloride if:
* You are allergic (hypersensitive) to alfuzosin or any of the other ingredients of Alfuzosin hydrochloride (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 serious 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 Alfuzosin hydrochloride
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 Alfuzosin hydrochloride in the past. This is because Alfuzosin hydrochloride may cause complications during your operation. This can be managed if your eye specialist knows before carrying out the operation.
* You have circulatory problems affecting the brain as there is a risk of impaired brain function due to low blood flow.
* You have heart problems, or if your heart suddenly stopped pumping efficiently (acute cardiac failure)
* You have hereditary problems with the way your heart beats (congenital QTc prolongation)
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 Alfuzosin hydrochloride can affect the way some other medicines work. Some medicines can also have an effect on the way that Alfuzosin hydrochloride works.
Do not take Alfuzosin hydrochloride 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 Alfuzosin hydrochloride
* 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 Alfuzosin hydrochloride before the operation.
Your doctor may decide to stop you having Alfuzosin hydrochloride 24 hours before the operation.
This is because it can be dangerous as it can lower your blood pressure.
Taking Alfuzosin hydrochloride with food and drink
* You may feel dizzy and weak while taking Alfuzosin hydrochloride. If this happens do not drink any alcohol.
Driving and using machines
You may feel dizzy and weak while taking Alfuzosin hydrochloride. If this happens do not drive or operate any tools or machines.
Important information about some of the ingredients of Alfuzosin hydrochloride
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product
^ How to take Alfuzosin hydrochloride
Always take Alfuzosin hydrochloride 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 Alfuzosin hydrochloride tablet three times a day.
If you are over 65 or are being treated for high blood pressure
* You should start on one Alfuzosin hydrochloride tablet in the morning and one tablet in the evening.
If you have kidney problems
* You should start on one Alfuzosin hydrochloride tablet twice a day. This may be changed depending upon how you respond.
If you have liver problems
* You should start on one Alfuzosin hydrochloride tablet a day. This may be changed to two tablets a day, depending upon how you respond.
If you take more Alfuzosin hydrochloride 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 Alfuzosin hydrochloride
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 Alfuzosin hydrochloride
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.
POM
Patient Information Leaflet (continued)
If you have any further questions on the use of this product, ask your doctor or pharmacist.
^ Possible side effects
Like all medicines, Alfuzosin hydrochloride 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).
* Fainting
Very rare side effects (affects less than 1 in 10,000 people)
* Itchy, lumpy rash also called hives or nettle rash (urticaria).
Other side effects (frequency not known) which may occur are:
* A painful erection of the penis, unrelated to sexual activity, that will not go away.
* Liver problems. Signs may include yellowing of the skin or whites of your eyes
* Intraoperative Floppy Iris Syndrome (IFIS). If you are having an operation on your eyes becuase of cataracts (where the lens of the eye is cloudy) and are already taking or have taken Alfuzosin hydrochloride 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 our differently (see section ‘Take special care with Alfuzosin hydrochloride').
* You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia).
* Being sick (vomiting).
* Abnormal heart rhythm
* Impaired brain function due to low blood flow in patients with existing circulatory problems affecting the brain
* Increased risk of bleeding (including nose bleeds and/or bleeding gums) and bruising. This could be a blood problem called ‘thrombocytopenia' which is a reduced number of platelets in the blood.
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 www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
How to store Alfuzosin hydrochloride
Expiry date
Do not use this medicine after the expiry date shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep his medicine, if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Storing your medicine
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 30°C.
Store in the original package.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). He/she will have additional information about this medicine and will be able to advise you.
Further information
What Alfuzosin hydrochloride contains
Each tablet contains 2.5mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride also contains microcrystalline cellulose, lactose, povidone, sodium starch glycollate, macrogol, magnesium stearate, titanium dioxide (E171), hypromellose.
What Alfuzosin hydrochloride looks like and contents of the pack
They are white round film coated tablets, marked Xatral 2.5 on one side and plain on the other.
They are available in blister packs of 30, 60 & 90 tablets.
Manufacturer and Licence Holder:
Alfuzosin hydrochloride is manufactured by Sanofi Winthrop Industrie, Tours, France and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL Number: 15184/0265 Alfuzosin hydrochloride 2.5mg Tablets
Revision date: 22/04/14