Alfuzosin HCl 2.5 mg film-coated 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 signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic (hypersensitive) to alfuzosin, other quinazolines (e.g. terazosin, doxazosin) or any of the other ingredients of this medicine (listed in section 6).
• suffer (have suffered) from dizziness, particularly when standing up from a sitting or lying position.
• are also using other alpha1-blockers such as doxazosin and / or other dopamine receptor agonists such as ropinirole.
• have serious liver disease.

Talk to your doctor or pharmacist or nurse before using Alfuzosin HCl

• if you have a condition which affects the coronary arteries (any treatment of a reduction in the supply of blood to the cardiac muscle should be continued); if symptoms of pain in the chest (angina pectoris) recur or become worse, the use of alfuzosin should be stopped.
• if you are known to have an abnormality of electrocardiogram (ECG), called “QT prolongation”
• if you belong to one of the following patient groups:
  • elderly patients
  • patients with an increased sensitivity to alpha1-blockers
  • patients who are treated for high blood pressure
• in some patients, a drop in blood pressure can occur on standing or sitting up within the first few hours of taking the tablet, particularly when sitting or standing up from a lying position. In this case, you should lie down until the symptoms have completely disappeared. This symptom usually occurs at the start of the treatment and is usually of a temporary nature. It is usually possible to continue with the treatment
• 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 Alfuzosin HCl . This is because Alfuzosin HCl may cause complications during the surgery which can be managed if your specialist is prepared in advance
• if you are incontinent (unable to hold urine).
• 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.

Note: the following comments can also apply to the use of medicines some time ago or in the near future.

The medicines mentioned in this section might be known to you by another name, often the trade name. In this section, only the name of the active substance or the category of active substances of the medicine is mentioned and not the trade name. For this reason, you should always take a good look at the packaging or the package insert to see what is the active substance of the medicine you are using.

Interaction means that medicines will have a bearing on each other’s effect and/or side effects when used together. Interaction can occur when these tablets are used with:

• other alpha1-blockers (concomitant use should be avoided)
• antihypertensives (it might be necessary to adjust the dose of these because of the possibility of a drop in blood pressure)
• nitrates (anti-anginal medicines) (it might be necessary to adjust the dose of these because of the possibility of a drop in blood pressure)
• products such as ketoconazole and itraconazole which treat fungal infections or ritonavir which is used for HIV. These products affect the way that alfuzosin works
• medicines for bacterial infections (such as clarithromycin, telithromycin).
• medicines for treatment of depression (such as nefazodone).
• general anaesthetics. If you are to undergo an operation which requires a general anaesthetic you should tell the anaesthetist, as your blood pressure could fall too low.

Tell your doctor or pharmacist if you are using, have recently taken or might take any other medicines.

As Alfuzosin HCl is not used in women, this section does not apply.

The use of Alfuzosin HCl can sometimes result in dizziness or general weakness (see “Possible side effects”). If you suffer from these side effects, do not drive any vehicle and/or operate any machinery which requires you to be alert.

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially ‘sodium-free.’

Alfuzosin HCl is not recommended for children.

The recommended dose is one 2.5 mg tablet three times a day. Your doctor may increase this to four times a day if needed.

In patients with poor kidney function:

The usual dose is two 2.5 mg tablets daily. Take the first tablet in the evening.

In patients with liver problems:

The usual dose is one 2.5 mg tablet daily. Your doctor may increase this to one 2.5 mg tablet twice a day (in the morning and evening).

Adults over 65, patients taking other medicines for high blood pressure, or patients with poor kidney function:

The initial dose is one 2.5 mg tablet twice a day (morning and evening).

If you are starting the treatment, it is best if you take the first tablet before you go to bed.

If you notice that Alfuzosin HCl has too strong or too weak an effect, consult your doctor or pharmacist.

Your doctor or pharmacist will tell you how long you should use Alfuzosin HCl. Alfuzosin HCl is prescribed for a fairly long period of time.

If you (or someone else) have taken too much Alfuzosin HCl, or you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. If you have taken too much Alfuzosin HCl, you might suffer from low blood pressure. Lie down as much as possible, as this will help minimise the side effects.

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten tablet. Take your next dose at the usual time.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: 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.

• The active ingredient of Alfuzosin HCl 2.5 mg is alfuzosin hydrochloride.
• The other ingredients (excipients) are
  Tablet core: Sodium starch glycolate(Type A), cellulose microcrystalline, lactose monohydrate, povidone, magnesium stearate.
  Coating: Hypromellose, macrogol 400, titanium dioxide (E 171).

Film-coated tablet

White to off-white round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘31’ on other side.

Alfuzosin HCl is packed in PVC / PVdC-Aluminium foil blister packs or (HDPE) bottle packs.

Pack sizes:

Blister pack: 15, 30, 50, 60, 90 and 100 film-coated tablets

Bottle pack: 100, 250 and 1000 film-coated tablets

Not all pack sizes may be marketed.

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