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Document: Xatral prolonged-release tablet ENG PL change

• Xatral 5 mg prolonged-release tablet PL
• Xatral prolonged-release tablet ENG PL

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Package leaflet: Information for the user

Xatral 5 mg prolonged-release tablets

Alfuzosin hydrochloride

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 Xatral is and what it is used for

2. What you need to know before you take Xatral

3. How to take Xatral

4. Possible side effects

6. Contents of the pack and other information

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 Hyperplasia. 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).

• 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 allergic to alfuzosin hydrochloride or any of the other ingredients of this medicine (listed in section 6).

• If you are taking another alpha-blocker. See section below on “Taking other medicines”.

• If you have something called postural hypotension. This is a drop in blood pressure which usually happens when you stand up. It can make you feel dizzy, lightheaded or faint when you stand or sit up quickly.

• If you have severe liver problems.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Xatral.

Warnings and precautions

Talk to your doctor or pharmacist before taking your medicine if:

• You have a heart disease.

• You have chest pain (angina).

• You are known to have an abnormality of electrocardiogram (ECG ), called “QT prolongation”

• You have had a stroke or short-lasting symtoms similar to stroke, there is a risk of decreased blood flow to parts of the brain.

Some patients, particularly those who are also taking medicine for high blood pressure or medicines for chest pain (angina pectoris) may get dizziness, weakness or sweating within a few hours of taking a dose. If this happens, you should lie down until the symptoms have completely disappeared. Let your doctor know as he may decide to adjust your dose.

Other medicines and Xatral

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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.

Do not take Xatral if you are taking

Talk to 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 the dose of your medicine may be changed.

• You are taking medicines for chest pain (angina).

• You are taking medicines for fungal infections (such as ketoconazole, itraconazole).

• You are taking medicines for HIV (such as ritonavir).

• You are taking medicines for bacterial infections (such as clarithromycin, telithromycin).

• You are taking medicines for treatment of depression (such as nefazodone).

Operations while taking Xatral

• If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking Xatral before the operation. This is because it can be dangerous as it can lower your blood pressure.

• If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Xatral. This is because Xatral may cause complications during the surgery which can be managed if your specialist is prepared in advance.

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.

Xatral contains hydrogenated castor oil.This can cause stomach upset and diarrhoea.

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take

Adults under 65 years

• The recommended dose is one Xatral 5 mg tablet in the morning and one Xatral 5 mg tablet in the evening.

• On the first day you should take only one tablet in the evening just before going to bed.

Adults over 65 years or patients with poor kidney function

• The recommended dose is one Xatral 5 mg tablet in the evening.

• Your doctor may increase the dose depending on your response to the treatment.

Method of administration

Use in children

Xatral is not recommended for children

If you take more Xatral than you should

Contact your local hospital straight away. Tell the doctor how many tablets you have taken. Lie down as much as possibleto 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines,this medicinecan cause side effects, although not everybody gets them. These side effects are most likely to happen at the start of treatment.

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 may affect up to 1 in 10,000 people.

You could notice symptoms of angioedema, such as a red and lumpy skin rash, swelling (on the eyelids, face, lips, mouth and tongue), difficulty breathing or swallowing.

These are symptoms of an allergic reaction. If this happens, stoptaking your tablets and contact a doctor or go to a hospital immediately. This may affect up to 1 in 10,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Feeling dizzy.

• Headache.

• General feeling of being unwell.

• Feeling dizzy or lightheaded when you stand or sit up quickly.

• Feeling sick (nausea).

• Dry mouth.

• Diarrhoea.

• Stomach pain.

• Weakness or tiredness.

Uncommon (may affect up to 1 in 100 people)

• Drowsiness.

• Visual disturbances (changes in your vision or sight).

• Fast heart beat (tachycardia), palpitations (pounding in the chest and irregular heart beat).

• Fainting.

• Lack of control over passing urine.

• Runny nose, itching, sneezing, and stuffy nose.

• Uncomfortable feeling in the stomach and indigestion (dyspepsia).

• Being sick (vomiting).

• Rash and itching.

• Hot flushes.

• Water retention (may cause swollen arms or legs).

• Chest pain.
  
  

Additional side effects(frequency cannot be estimated from the available data) which may occur are:

• Irregular and fast heart beat

• Decrease blood flow to parts of the brain in patients known to have vascular disturbances in the brain

• Decrease in white blood cells. Signs may include more frequent infections, sore throat or mouth ulcers.

• Low numbers of blood platelets. Signs may include bleeding from your gums and nose, bruising, prolonged bleeding from cuts, rash (pinpoint red spots called petechia).

• Abnormal liver function (liver problem). Signs may include yellowing of your skin or the whites of your eyes.

• If you are undergoing eye surgery because of cataract (cloudiness of the lens) and are using or have previously used Xatral, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure. This only occurs during the operation and it is important for the eye specialist to be aware of this possibility as the operation may need to be performed differently (see section “Operations while taking Xatral”).

• Abnormal, often painful, persistent erection of the penis unrelated to sexual activity (priapism).

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 (se details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Xatral

Keep this medicine out of the sight and reach of children.

Do not use this medicineafter the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer used. These measures will help protect the environment.

6. Contents of the pack and other information

What Xatralcontains

• The active substance is alfuzosin hydrochloride. Each tablet contains 5 mg alfuzosin hydrochloride.

• The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, hydrogenated castor oil, povidone, magnesium stearate, hypromellose, propylene glycol, titanium dioxide (E 171), red and yellow iron oxide (E 172).

What Xatrallooks like and contents of the pack

Yellow, round biconvex tablets. Your prolonged-release tablets are available in packs of 28, 56, 60 and 180 tablets in Blister (PVC /aluminium) .

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Xatral

Sweden: Xatral

This leaflet was last revised in 11 July 2014

Detailed information on this medicine is available on the web site of: {name of MS/Agency}