Alfuzosin Hydrochloride 2.5mg 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 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 is and what it is used for
2. What you need to know before you take alfuzosin
3. How to take alfuzosin
4. Possible side effects
5. How to store alfuzosin
6. Contents of the pack and other information

The name of your medicine is Alfuzosin Hydrochloride 2.5mg Tablets (called alfuzosin throughout this leaflet). This belongs to a group of medicines, alpha-blockers.

Alfuzosin 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). 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.

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.

• 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 water and relieves the pain.
• During this time, alfuzosin may be used to help the water to flow again. This has only been shown to help in men aged over 65.

• 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 other alpha-blockers. See section below on ‘Other Medicines and Alfuzosin ’.
• 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.
• have liver problems
• You are taking Ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, nirmatrelvir. See section “Other medicines and Alfuzosin”.

If you are not sure if any of these apply to you do not take Alfusozin and talk to your doctor.

• You have chest pain (angina)
• You have a condition where your kidneys are hardly working at all
• 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 alfuzosin.

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 alfuzosin can affect the way some other medicines work. Also some medicines can affect the way alfuzosin works.

Do not take this medicine, and tell your doctor, if you are taking:

• Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin, or phenoxybenzamine.
• Ritonavir (a medicine used for treatment of Chronic Hepatitis C infection) alone or as a combination drug with ombitasvir/paritaprevir. These medicines will lead to more quantity of alfuzosin in blood due to decrease of liver function to remove alfuzosin from the body.

Tell 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.
• You are taking medicines such as glyceryl trinitrate for chest pain (angina)
• You are taking medicines for fungal infections (such as 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).
• You are taking 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 on the eye because of cataract (cloudiness of the eye), tell your eye specialist you are using or have used alfuzosin in the past. This is because alfuzosin may cause complications during your operation. This can be managed if your eye specialist knows before carrying out the operation.
• If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking alfuzosin before the operation. Your doctor may decide to stop you having alfuzosin 24 hours before the operation.
  This is because it can be dangerous as it can lower your blood pressure.

You may feel dizzy and weak whilst taking alfuzosin. If this happens do not drink any alcohol.

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

Alfuzosin 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 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium free’.

• Swallow the tablets whole
• The first dose should be taken just before bedtime
• The actual dose of alfuzosin depends on your needs and the condition being treated but the usual doses are listed below

Adults (under 65 years of age)

• The usual dose is one tablet three times a day
• Your doctor may increase this to a maximum of four tablets each day if needed

Elderly (over 65 years of age), patients with high blood pressure or patients with kidney problems

• The usual dose is one tablet in the morning and one tablet in the evening.

Children

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

Patients with liver problems

• The usual dose is one tablet per day
• Your doctor may increase this to one tablet in the morning and one tablet in the evening

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.

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.

Common affects less than 1 in 10 people)

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

Uncommon (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), 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)
• Runny nose, itching, sneezing, and stuffy nose
• General feeling of being unwell
• Problems with your vision

Very rare (affects less than 1 in 10, 000 people)

• Itchy, lumpy rash also called hives or nettle rash (urticaria).

Other (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
• If you are having an operation on your eyes because of cataracts (where the lens of the eye is cloudy) and are already taking or have taken alfuzosin 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 out differently (see section “Take special care with Alfuzosin”).
• 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 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 2.5mg of alfuzosin hydrochloride as the active substance.

The other ingredients are, microcrystalline cellulose, lactose, povidone, sodium starch glycollate, magnesium stearate, methylhydroxypropylcellulose, polyethylene glycol 400, titanium dioxide suspension (E171).

Alfuzosin Hydrochloride 2.5mg tablets are white film-coated tablets marked “ALZ” on one side and “2,5” on other side. They are supplied in blister packs of 60 tablets.

or