Xatral XL 10 mg Prolonged-Release Tablets

XATRAL XL 10 mg belongs to a group of medicines called alpha-blockers. XATRAL XL 10 mg can be used to treat the symptoms of benign prostatic hyperplasia (BPH). 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 urine 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 widen and so makes it easier to pass water.

In a few patients with benign prostatic hyperplasia, the prostate gland gets so big that it stops the flow of urine completely. This is called acute urinary retention (AUR). This is very painful and you may need a short stay in hospital.

• A thin, flexible tube (catheter) is passed into the bladder. This drains the urine and relieves the pain.
• During this time, XATRAL XL 10 mg may be used to help the urine to flow again. This has only been shown to help in men aged over 65.

Do not take XATRAL XL 10 mg and tell your doctor if:

• You are allergic (hypersensitive) to alfuzosin hydrochloride or any of the other ingredients of XATRAL XL 10 mg (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You are taking other alpha-blockers to treat BPH or to treat your blood pressure (see Other medicines and XATRAL XL 10 mg).
• You have, or have ever had, something called orthostatic hypotension. This is a drop in blood pressure which usually happens when you stand up quickly. It can make you feel dizzy, light-headed or faint when you stand or sit up quickly.
• You have liver problems.
• You have serious kidney problems (see Warnings and precautions).
• You are 18 years old or younger.
• You are taking medicines known as potent CYP3A4 inhibitors such as itraconazole, ketoconazole, protease inhibitors, clarithromycin, telithromycin and nefazodone, since it can increase the blood levels of XATRAL XL 10 mg (see Other medicines and XATRAL XL 10 mg).

Warnings and precautions:

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

• You have chest pain (angina) or are taking medicine for angina.
• You are taking medicines for high blood pressure. Your doctor should monitor your blood pressure regularly while you are taking this medicine. Some patients, with pre-existing risk factors (such as cardiac disease and/or are taking medicine for high blood pressure or medicines for chest pain) may experience 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. This is particularly important at the start of your treatment as the symptoms may get less severe with continued treatment. The risk of developing these side effects may be greater in elderly patients.
• You have a known problem with the way your heart beats (QT prolongation).
• You are undergoing eye surgery because of cataracts (cloudiness of the lens). Please inform your eye specialist before the operation that you are using or have previously used XATRAL XL 10 mg. This is because XATRAL XL 10 mg may cause complications during the surgery which can be managed if your specialist is prepared in advance.
• In the past, you have had a large fall in blood pressure while taking an alpha-blocker such as doxazosin and tamsulosin. This could include previous use of XATRAL XL 10 mg (see Other medicines and XATRAL XL 10 mg).

In case of an erection (often painful), unrelated to sexual activity, that persists longer than 4 hours you should contact your doctor or go to a hospital immediately because you may need treatment (see POSSIBLE SIDE EFFECTS).

If you are not sure of any of the above, please talk to your doctor or pharmacist before taking XATRAL XL 10 mg.

Do not share medicines prescribed for you with any other person. Always take XATRAL XL 10 mg exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are unsure.

The usual dose is as follows:

For benign prostate hyperplasia:

One XATRAL XL 10 mg tablet once a day.

For acute urinary retention:

• XATRAL XL 10 mg will be given to you by your doctor on the day you have the catheter inserted.
• You should continue taking XATRAL XL 10 mg once a day.

Swallow the tablets whole with plenty of water. Do not break, crush or chew the prolonged release tablets – this can affect the release of your medicine into the body. Take the tablet after a meal.

If you take more XATRAL XL 10 mg tablets than you should:

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre, 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 (see section 4 - POSSIBLE SIDE EFFECTS).

If you forget to take XATRAL XL 10 mg:

Do not take a double dose to make up for the forgotten individual doses.

If you stop taking XATRAL XL 10 mg:

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.

XATRAL XL 10 mg can have side effects. Stop taking XATRAL XL 10 mg and see a doctor or go to a hospital straight away if:

• You get swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean that you have an allergic reaction to XATRAL XL 10 mg.
• You have chest pain (angina).
• You have an abnormal, often painful, erection of the penis not related to sexual activity, lasting for longer than 4 hours. This condition can lead to permanent impotence if not properly treated.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days. Also, tell them if you notice any side effects not listed in this leaflet (see Reporting of side effects).

Frequent side effects:

• feeling dizzy or faint
• headache
• feeling sick (nausea)
• stomach pain
• weakness or tiredness (asthenia).

Less frequent side effects:

• feeling dizzy, light-headed or faint when you stand or sit up quickly (postural hypotension)
• a fast heartbeat (tachycardia) and pounding in the chest and uneven heartbeat (palpitations)
• runny, itchy, stuffy nose and sneezing (rhinitis)
• chest pain (angina)
• drowsiness
• diarrhoea and being sick (vomiting)
• dry mouth
• rash and itching
• flushing
• water retention (may cause swollen arms or legs)
• general feeling of being unwell (malaise)
• abnormal vision.

Additional side effects (frequency not known) which may occur are:

• Abnormal liver function (liver problem). Signs may include yellowing of your skin or the whites of your eyes.
• Occasionally, problems have arisen during cataract surgery in patients taking XATRAL XL 10 mg. If you are due to have eye surgery because of cataracts, it is important that you tell the specialist before the operation that you are using or have used XATRAL XL 10 mg (see Warnings and precautions).
• 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).

Not all side effects reported for XATRAL XL 10 mg are included in this leaflet. Should your general health worsen or if you experience any untoward effect while taking XATRAL XL 10 mg please consult your healthcare provider for advice.

Reporting of side effects:

If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can report side effects directly to Sanofi’s Pharmacovigilance Unit at Email: [email protected] or Tel: 011 256 3700. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of XATRAL XL 10 mg.

Store at or below 25 °C. Protect from moisture. Keep tablets in the blister strips until required for use. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Do not take this medicine after the month shown on the pack.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).