Package leaflet: Information for the user

Bundisarin XL 10 mg prolonged release tablets

Alfuzosin hydrochloride

Read all of this leaflet carefully before you start using 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, please ask your doctor, pharmacist or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Bundisarin XL is and what it is used for

2.    What you need to know before you take Bundisarin XL prolonged release tablets

3.    How to take Bundisarin XL prolonged release tablets

4.    Possible side effects

5.    How to store Bundisarin XL prolonged release tablets

6.    Contents of the pack and other information

1.    What Bundisarin XL is and what it is used for

Bundisarin XL belongs to a group of medicines called alpha-1-blockers.

Bundisarin XL is used to treat moderate to severe symptoms of Benign Prostate Hyperplasia. This is a condition where the prostate gland enlarges (hyperplasia), but the growth in itself is not cancerous (benign). It occurs most often in older men.

The prostate gland is situated under the bladder surrounding the urethra (the tube that takes your urine to the outside of the body). With age, the prostate gland may grow and press the urethra making it smaller. This may cause problems with urination such as frequent urination and difficulty in passing urine.

Bundisarin XL works by relaxing the prostate gland muscle. This reduces the narrowing of the urethra and so makes it easier to pass urine.

2.    What you need to know before you take Bundisarin XL prolonged release tablets Do not take Bundisarin XL

•    If you are allergic to alfuzosin hydrochloride or to any one of the other ingredients of this medicine (listed in Section 6). Symptoms of an allergic reaction include: a rash, swelling of your lips, throat, or tongue, difficulty in swallowing or breathing.

•    If you are allergic to alfuzosin-equivalent substances (such as terazosin, doxazosin).

•    If you have, or have had in the past, low blood pressure when standing up from a sitting or lying position (the medical term for this is orthostatic hypotension). It can make you feel dizzy, light-headed or faint when you stand or sit up quickly.

•    If you have liver problems.

•    If you are already taking another alpha-1-blocker (such as terazosin, doxazosin). See the section below on ‘Other medicines and Bundisarin XL’. In case of doubt please ask your pharmacist or doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bundisarin XL:

•    If you are taking other medicines to treat high blood pressure then your doctor will check your blood pressure regularly, especially at the beginning of treatment.

•    If you experience dizziness, weakness or sweating within a few hours after you have taken Bundisarin XL then you should lie down with your legs and feet raised up in the air until the symptoms have disappeared. Usually, these effects last for only a short time and occur at the start of the treatment. Normally, there is no need to stop treatment (see Section 4).

•    If you have experienced a marked drop in blood pressure in the past after taking another medicine belonging to the group of alpha-blockers. In this case your doctor will start treatment with Bundisarin XL at low doses and will gradually increase the dose.

•    If you have a condition where your kidneys are hardly working at all (severe kidney problems).

•    If you are suffering from acute heart failure (insufficient pumping power of the heart).

•    If you suffer from chest pain (angina) and are being treated with a nitrate (medicines that widen the tubes that circulate the blood in your body and make it easier for blood to flow), as this may increase the risk of a drop in blood pressure. You should discuss with your doctor whether to continue or stop your treatment with Bundisarin XL, especially when the chest pain recurs or worsens.

•    If you have an eye surgery for cataract (cloudiness of the eye) planned, tell your eye specialist that you are using Bundisarin XL or have previously been treated with an alpha-blocker. This is because Bundisarin XL may cause complications during your operation which can be managed if your eye specialist is aware of this information before carrying out the operation.

•    If you suffer from a defect in heart rhythm or you are taking medicines which may cause a defect in heart rhythm (the medical term for this defect is QTc prolongation). In this case your doctor should evaluate you before and during the period of administration of Bundisarin XL.

•    If you are over 65. This is due to the increased risk of developing low blood pressure (hypotension) and related side effects in older people.

Other medicines and Bundisarin XL

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

medicines.

•    Do not use Bundisarin XL at the same time as other alpha-blockers such as doxazosin, prazosin, terazosin or tamsulosin (see the section “Do not take Bundisarin XL tablets”).

•    If you are taking a medicine for high blood pressure (antihypertensive) or medicines used to treat chest pain (nitrates) at the same time, 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. (See section: “Warnings and precautions”).

•    If you are going to have an operation that needs a general anaesthetic, tell your doctor that you are taking Bundisarin XL before the operation. Your doctor may decide to stop

Bundisarin XL 24 hours before the operation. This is because it can be dangerous as this medicine can lower your blood pressure.

The effect and side effects of Bundisarin XL can be increased by certain medicines used for fungal infections (such as ketoconazole, itraconazole), certain antibiotics (such as clarithromycin, erythromycin) and medicine used to treat HIV (such as ritonavir).

Bundisarin XL with food, drink and alcohol

• You may feel dizzy and weak while taking Bundisarin XL. If this happens do not drink any alcohol.

Pregnancy, breast-feeding and fertility

This section does not apply as Bundisarin XL is only used by men.

Driving and using machines

You may feel dizzy and weak while taking Bundisarin XL. Do not drive or operate any tools or machines until you know how your body responds to the treatment.

3. How to take Bundisarin XL prolonged release tablets

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

•    Swallow your tablets whole with plenty a fluid (for instance a glass of water).

•    Do not break, crush or chew your tablets. This can affect the release of your medicine into the body.

•    The first dose of this medicine should be taken just before going to bed.

•    Take this medicine just after eating food (immediately after the same meal each day i.e. at the same time each day). Do not take it on an empty stomach.

Adults:

The recommended dose is one Bundisarin XL 10 mg prolonged release tablet once a day. Older patients (> 65 years):

The recommended dose is one Bundisarin XL10 mg prolonged release tablet once a day. The dose does not need to be adjusted for the older people (over 65 years).

Patients with mild to moderate kidney problems

Your dose does not need to be adjusted for mild to moderate kidney problems.

If you take more Bundisarin XL than you should

Contact your doctor or your local hospital Accident and Emergency Department straight away.

Take this leaflet or some tablets with you so your doctor will know what you have taken. 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.

If you forget to take Bundisarin XL

Do not take a double dose to make up for a forgotten tablet as this may cause a sudden drop in blood pressure. Skip the missed dose and take the next tablet as directed.

If you stop taking Bundisarin XL

You should not interrupt or stop taking Bundisarin XL without speaking to your doctor first. Take your tablets as directed and for as long as directed. Do not stop taking them even if you feel better, as otherwise the symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

The following side-effects may occur:

Very serious side effects

Reported very rarely (may affect up to 1 in 10,000 people)

•    Rapid swelling of the eyelids, face, lips, mouth and tongue, difficulty in breathing or swallowing, rashes, hives and itching. These are symptoms of a very serious allergic reaction. (The medical term for these symptoms is Angioedema).

•    Feeling of tightness, heaviness, discomfort, or crushing pain that is felt behind the breastbone and may spread to the arms, neck and jaw. (These may be manifestations of Angina). Normally, this only happens if you have had angina before.

If any of the above mentioned side effects occur, stop taking Bundisarin XL and tell your doctor immediately or go to the Emergency department at your nearest hospital.

Other side effects include:

Common (may affect up to 1 in 10 people)

•    Feeling dizzy, light headed, or faint when you stand or sit up quickly.

•    Headache

•    Feeling sick (nausea)

•    Stomach pain

•    Weakness or tiredness (Asthenia)

Uncommon (may affect up to 1 in 100 people)

•    Fast heart beat (tachycardia) and awareness of heart beat (palpitations)

•    Chest pain

•    Drowsiness

•    Being sick (vomiting)

•    Loose stools (diarrhoea)

•    Dryness of mouth

•    Rashes and hives

•    Flushing

•    Water retention (may cause swollen arms or legs)

•    General feeling of being unwell

•    Vision Abnormal

•    Inability to retain urine (urine incontinence)

•    Runny nose

Very rare side effects (may affect up to 1 in 10,000 people)

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

Side effects where frequency is not known (frequency cannot be estimated from the available data)

•    During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery.

•    Prolonged and painful erection of the penis, unrelated to sexual activity (these may be manifestations of a medical condition called priapism)

•    Yellowing of skin and whites of eyes with decreased appetite and stomach pain (these may be manifestations of a liver problem)

•    You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (Neutropenia).

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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. By reporting side effects you can help provide more

information on the safety of this medicine.

5. How to store Bundisarin XL prolonged release tablets

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

This medicinal product does not require any special storage conditions.

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

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

6. Contents of the pack and other information

What Bundisarin XL prolonged release tablets contain

The active substance is alfuzosin hydrochloride.

Each prolonged release tablet contains 10 mg of alfuzosin hydrochloride.

The other ingredients are:

hypromellose (E464), hydrogenated vegetable oil, povidone (E1201), calcium hydrogen phosphate (E341), carbomer, silica colloidal anhydrous (E551), magnesium stearate (E470b), propylene glycol (E1520), titanium dioxide (E 171).

The tablet has a prolonged effect which means that after taking the active substance is not released immediately but gradually from the tablet and therefore acts longer.

What Bundisarin XL prolonged release tablets look like and contents of the pack

Bundisarin XL 10 mg prolonged release tablets are white to off-white, round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘47’ on the other side.

Bundisarin XL10 mg prolonged release tablets are available in Alu / Alu blister pack, and HDPE tablet container with a silica gel desiccant.

Pack size:

Alu / Alu blister pack: 10, 14, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets HDPE container pack: 30 and 1000 tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland

Manufacturer:

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,

Hal Far, Birzebbugia, BBG 3000Malta

This leaflet was last revised in 08/2014