Besavar XL 10mg Tablets

• 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 symptoms 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).

1. What Besavar XL is and what it is used for
2. What you need to know before you take Besavar XL
3. How to take Besavar XL
4. Possible side effects
5. How to store Besavar XL
6. Contents of the pack and other information

• are allergic (hypersensitive) to alfuzosin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• are taking another alpha-blockers (see section below on 'Other Medicines and Besavar XL')
• 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, light-headed or faint when you stand or sit up quickly
• You have severe liver problems

• You have chest pain (angina)
• You have a condition where your kidneys are hardly working at all
• You have kidney problems
• 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 Besavar XL. This is because Besavar XL may cause complications during the surgery which can be managed if your specialist is prepared in advance
• You are allergic (hypersensitive) to other alpha blockers such as doxazosin, tamsulosin
• You are taking medicines for high blood pressure. Your doctor should monitor your blood pressure regularly while you are taking this medicine. This is particularly important at the start of your treatment.
• 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)
• You are over 65. This is due to the increased risk of developing hypotension and related adverse reactions in elderly patients
• You ever get painful erections of the penis, unrelated to sexual activity that will not go away, before or during treatment.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Besavar XL.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Besavar XL and some other medicines can affect the way each other work.

• Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin, or phenoxybenzamine.

• 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.

Or if 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.
• medicines such as glyceryl trinitrate for chest pain (angina)
• medicines for fungal infections (such as itraconazole).
• medicines for HIV (such as ritonavir).
• medicines for bacterial infections (such as clarithromycin, telithromycin).
• medicines for treatment of depression (such as nefazodone).
• ketoconazole tablets (used to treat Cushing’s syndrome - when the body produces an excess of cortisol).

• 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 Besavar XL before the operation.
  Your doctor may decide to stop you having Besavar XL 24 hours before the operation.

This is because it can be dangerous as it can lower your blood pressure.

• Take Besavar XL after a meal.
• You may feel dizzy and weak while taking Besavar XL. If this happens do not drink any alcohol.

You may feel dizzy and weak while taking Besavar XL. If this happens do not drive or operate any tools or machines.

This can cause stomach upset and diarrhoea.

• Swallow the 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.

Benign Prostatic Hyperplasia

• The usual dose is one Besavar XL tablet once a day.

Acute Urinary Retention

• Besavar XL will be given to you by your doctor on the day you have the catheter inserted.
• You should continue taking Besavar XL once a day.
• You should stop taking Besavar XL the day after the catheter is removed (3-4 days in total).

Children

• Alfuzosin is not recommended for use in children under 16 years of age.

Contact your local hospital Accident and Emergency department straight away. Tell the doctor or nurse 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.

Do not take a double dose to make up for a forgotten tablet. Miss it out and then go on as before.

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.

• 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 you are having an allergic reaction to Besavar XL tablets.
• You have chest pain (angina). This usually only happens if you have had angina before. This side effect is very rare.
• You have a painful erection of the penis, not related to sexual activity, which will not go away. This side effect has only been reported in a very small number of people taking Besavar XL.

Common side effects (affects less than 1 in 10 people)

• Feeling dizzy or faint
• Headache
• Feeling sick (nausea)
• Stomach pain
• Weakness or tiredness

Uncommon side effects (affects less than 1 in 100 people)

• Feeling dizzy light-headed or faint when you stand or sit up quickly (postural hypotension)
• A fast heart beat (tachycardia) and pounding in the chest and uneven heartbeat (palpitations)
• Chest pain
• Drowsiness
• Diarrhoea
• Dry mouth
• Rash and itching
• Flushes
• Water retention (may cause swollen arms or legs)
• General feeling of being unwell

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 alfuzosin. 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, Besavar XL.
• 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).
• Increased risk of bleeding (including nose bleeds and/or bleeding gums) and bruising. This could be a problem called ‘thrombocytopenia’ which is a reduced number of platelets in the blood.

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 via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Each tablet contains 10mg of alfuzosin hydrochloride as the active substance.

The other ingredients are ethyl cellulose, hydrogenated castor oil, hypromellose, yellow ferric oxide (E172), magnesium stearate, microcrystalline cellulose, povidone, colloidal hydrated silica and mannitol.

Besavar XL 10mg tablets are round, biconvex, three layer tablets: one white layer between two yellow layers. They are supplied in blister packs of 30 tablets.