SUMMARY CMI

Xatral^® SR

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Xatral SR?

Xatral SR contains the active ingredient alfuzosin hydrochloride. Xatral SR is used to a medical condition in men called Benign Prostatic Hyperplasia or BPH. For more information, see Section 1. Why am I using Xatral SR? in the full CMI.

2. What should I know before I use Xatral SR?

Do not use if you have ever had an allergic reaction to alfuzosin or any of the ingredients listed at the end of the CMI.

Do not use if you have liver disease; you are currently taking another alpha-blocker: prazosin (Minipress), terazosin (Hytrin) and tamsulosin (Flomaxtra); you are currently taking potent CYP3A4 inhibitors (medicines used to treat certain types of infections): ketoconazole (Nizoral), itraconazole (Sporanox) and ritonavir (Norvir); you have a history of feeling dizzy, tired or sweating on standing (orthostatic hypotension).

Talk to your doctor if you have any other medical conditions or take any other medicines.

For more information, see Section 2. What should I know before I use Xatral SR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Xatral SR and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Xatral SR?

• The standard dose for this medicine is one tablet taken after a meal once each day, swallowed whole with a glass of water.
• Do not divide, crush or chew the tablets.

More instructions can be found in Section 4. How do I use Xatral SR? in the full CMI.

5. What should I know while using Xatral SR?

For more information, see Section 5. What should I know while using Xatral SR? in the full CMI.

6. Are there any side effects?

Common side effects may include faintness or dizziness; headaches; sweating or flushes; nausea or vomiting; stomach pain or diarrhoea; dry mouth; tiredness, drowsiness or weakness; inflammation or irritation of the nose; oedema (swelling). Serious side effects may include: irregular heart beat or palpitations; chest pain; yellowing of the skin or eyes; hives or severe skin reactions; bleeding or bruising more easily than normal. Very serious side effects may include: allergy symptoms. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Xatral^® SR (zar-trel)

Active ingredient: Alfuzosin (al-few-zo-sin) hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Xatral SR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Xatral SR.

Where to find information in this leaflet:

1. Why am I using Xatral SR?
2. What should I know before I use Xatral SR?
3. What if I am taking other medicines?
4. How do I use Xatral SR?
5. What should I know while using Xatral SR?
6. Are there any side effects?
7. Product details

1. Why am I using Xatral SR?

Xatral SR contains the active ingredient alfuzosin hydrochloride. It belongs to a group of medicines called alpha1-receptor blockers.

Xatral SR is used to treat a medical condition in men called Benign Prostatic Hyperplasia or BPH.

BPH is a condition where the prostate gland (which is near your bladder) has become bigger making it more difficult for you to pass urine. This can lead to symptoms such as:

• Weak or interrupted stream of urine
• Feeling that you cannot empty your bladder completely
• Delay before you start to pass urine
• Needing to pass urine often, especially at night
• Feeling that you must pass urine right away

Xatral SR works by relaxing the muscles in the prostate gland and increasing the flow of urine.

2. What should I know before I use Xatral SR?

Warnings

Do not use Xatral SR if:

• you are allergic to alfuzosin, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• you have liver disease.
• you are currently taking another alpha-blocker.
  - These include prazosin (Minipress), terazosin (Hytrin) and tamsulosin (Flomaxtra).
• you are currently taking potent CYP3A4 inhibitors (medicines used to treat certain types of infections)
  - These include ketoconazole (Nizoral), itraconazole (Sporanox) and ritonavir (Norvir)
• you have a history of feeling dizzy, tired or sweating on standing (orthostatic hypotension).

Check with your doctor if you:

• have allergies to:
  - any other alpha-blockers, including prazosin (Minipress), terazosin (Hytrin) and tamsulosin (Flomaxtra)
  - any other substances, such as foods, preservatives or dyes.
• have any other medical conditions, especially:
  - angina (a feeling of pain, tightness, heaviness or pressure in the chest)
  - Parkinson's disease
  - multiple sclerosis
  - heart failure
  - prostate cancer
  - high blood pressure
  - heart conditions or heart problems
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Use in people other than adult men

Xatral SR is not intended for use in women.

Do not give Xatral SR to a child or adolescent. There is no experience with its use in children or adolescents under 18 years old.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Xatral SR and affect how it works. These include:

• medicines to lower blood pressure
• other alpha-blockers, including prazosin (Minipress), terazosin (Hytrin) and tamsulosin (Flomaxtra)
• non-selective alpha-blockers, including phentolamine (Regitine), labetalol (Trandate) and phenoxybenzamine (Dibenyline)
• nitrates (medicines which aid the dilation of constricted blood vessels)
• potent CYP3A4 inhibitors (medicines used to treat certain types of infections) such as ketoconazole (Nizoral), itraconazole (Sporanox) and ritonavir (Norvir)
• general anaesthetics (medicines used to put you to sleep during an operation or procedure)
• medicines used to treat a fast or irregular heart beat e.g. amiodarone, quinidine, disopyramide.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Xatral SR.

4. How do I use Xatral SR?

How much to take

• The standard dose for this medicine is one tablet taken once each day.
• Your doctor may have prescribed a different dose.
• Follow the instructions provided and use Xatral SR until your doctor tells you to stop.

When to take / use Xatral SR

• Take Xatral SR after a meal, at about the same time each day.

Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.

How to take Xatral SR

• Swallow the tablets whole with a full glass of water.

Do not divide, crush or chew the tablets. If they are broken or crushed they will not work over 24 hours as they are supposed to and it may increase the risk of side effects.

If you forget to use Xatral SR

Xatral SR should be used regularly at the same time each day.

If it is almost time for your next dose (within 12 hours), skip the dose you missed and take your next dose when you are meant to.

Otherwise, it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you use too much Xatral SR

If you take too much Xatral SR, you may feel light-headed, dizzy, tired, drowsy or sweaty.

If you think that you have used too much Xatral SR, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Xatral SR?

Things you should do

• 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 Xatral SR.

This is because Xatral SR may cause complications during the surgery which can be managed if your specialist is prepared in advance.

• If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.

In most cases, Xatral SR will need to be stopped before surgery.

Remind any doctor, dentist or pharmacist you visit that you are using Xatral SR.

Things you should not do

• Do not stop using this medicine suddenly; if you need to stop taking Xatral SR your doctor will slowly reduce the dose over a number of days or weeks
• Do not lower the dosage, without checking with your doctor or pharmacist.
• Do not divide, crush or chew the tablets.
• Do not take more than the recommended dose unless your doctor or pharmacist tells you to.
• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Things to be careful of

Xatral SR may cause dizziness, light-headedness and fainting, especially if you get up too quickly. This is also more likely to occur if you have just started Xatral SR or the dose has just been increased. Therefore:

• get up slowly after you have been sitting or lying down
• if you feel dizzy or light-headed, lie down so that you do not faint. Then sit up for a few moments before standing to prevent the dizziness from returning

If the symptoms continue, tell your doctor or pharmacist

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Xatral SR affects you.

Xatral SR may cause light-headedness, tiredness or weakness in some people, especially after the first dose or after a dose increase.

Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if you feel dizzy.

Drinking alcohol

Tell your doctor if you drink alcohol.

The effects of alcohol (dizziness or light-headedness) could be made worse while taking Xatral SR. It is recommended that you do not drink alcohol while taking it.

Looking after your medicine

• Keep your tablets in the blister pack until it is time to take them.
• If you take the tablets out of the blister pack they may not keep well.

Follow the instructions on the carton on how to take care of your medicine properly.

Store it in a cool dry place—below 25°C—away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Very serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Xatral SR contains

Do not take this medicine if you are allergic to any of these ingredients.

What Xatral SR looks like

Xatral SR is three layered biconvex tablets: two of the layers are yellow with a white layer in-between. It is a sustained release preparation.

A blister pack contains 30 or 60 tablets.
(Aust R 81900).

Who distributes Xatral SR

Xatral SR is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared in November 2020

^®Registered Trademark

xatral-sr-ccdsv13-cmiv8-nov20

Published by MIMS February 2021

1 Name of Medicine

Alfuzosin hydrochloride.

2 Qualitative and Quantitative Composition

Xatral (alfuzosin hydrochloride) is an orally active quinazoline derivative.
Each tablet contains 10 mg of alfuzosin hydrochloride as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Modified release tablet.
Three-layered, round biconvex, prolonged release tablet containing the active ingredient in a white matrix layer between two inactive yellow layers.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of the functional symptoms of benign prostatic hyperplasia.

4.2 Dose and Method of Administration

The recommended dose is one 10 mg tablet daily to be taken immediately after the meal. The tablets should be swallowed whole.

4.3 Contraindications

Xatral SR must not be administered to patients with known hypersensitivity to alfuzosin hydrochloride or any other ingredient in this product, to patients with a history of orthostatic hypotension or hepatic insufficiency.
Xatral SR is contraindicated in combination with other alpha-blockers.
Concomitant administration of Xatral SR with potent CYP3A4 inhibitors is contraindicated (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

Xatral SR should be administered carefully to patients with known hypersensitivity to α₁-blockers.
In certain subjects, in particular elderly patients and patients receiving antihypertensive medications, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until symptoms have completely disappeared. These effects are usually transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. Pronounced drop in blood pressure has been reported in postmarketing surveillance in patients with pre-existing risk factors (such as underlying cardiac diseases and/or concomitant treatment with antihypertensive medication). The risk of developing hypotension and related adverse reactions may be greater in elderly patients. The patients should be warned about the possible occurrence of such events.
Xatral SR should be administered carefully to patients being treated with antihypertensives. Blood pressure should be monitored regularly, especially at the beginning of treatment.
Xatral SR should be administered carefully to patients who have had a pronounced hypotensive response to another α₁-blocker.
Care should be taken when alfuzosin is administered to patients with symptomatic orthostatic hypotension or in patients on antihypertensive medication or nitrates.
Use with caution in patients with acquired or congenital QT prolongation or who are taking medications that prolong the QT interval.
Alfuzosin, like other alpha adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Patients should be advised about the seriousness of this condition as it can lead to permanent impotence if not properly treated.
Xatral SR should not be prescribed alone in coronary patients: specific treatment for coronary insufficiency should be continued. If the angina reappears or worsens, Xatral SR should be discontinued.
Patients with Parkinson's disease, multiple sclerosis, unstable angina or severe heart failure were excluded from phase II studies. As a result, the safety of Xatral SR in these patients has not been formally assessed.
Carcinoma of the prostate should be excluded in any patients for whom alfuzosin therapy is being considered for presumed BPH.
Patients should be warned that the tablet should be swallowed whole. Any other mode of administration, such as crushing, chewing, grinding or pounding to powder should be avoided. These actions may lead to inappropriate release and absorption of the drug and therefore possible unwanted adverse effects.

Cataract surgery.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following combinations are contraindicated:
Use with other α₁-blockers, e.g. prazosin, terazosin, doxazosin, tamsulosin.
Concomitant use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir since alfuzosin blood levels are increased (see Section 5.2 Pharmacokinetic Properties, Metabolic interactions).
The following combinations are to be avoided:
Nonselective α₁-blockers: phentolamine, labetalol and phenoxybenzamine.
The following combinations are to be taken into account:
Combination with general anaesthetics: the administration to patients treated with alfuzosin may lead to blood pressure instability. Alfuzosin treatment should be stopped 24 hours prior to surgery.
Concomitant use with antihypertensives (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant use with nitrates.
Grapefruit juice contains one or more components that inhibit cytochrome CYP3A4. It is not known how combined exposure of any medications metabolised by CYP3A4 (such as modern α₁-blockers), herbal remedies (particularly St. John's wort, milk thistle) and grapefruit juice may influence the overall efficacy and unwanted side effects of these medications, therefore, caution should be exercised.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

There are no data available on the use of Xatral SR and its effect on driving vehicles, however, adverse effects such as vertigo, dizziness and asthenia may occur, essentially at the beginning of treatment, and this should be taken into account when driving vehicles and operating machinery.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials data.

Body as a whole.

Blood and lymphatic system disorders.

CNS and psychiatric disorders.

Cardiovascular disorders.

Eye disorders.

Gastrointestinal disorders.

Hepatobiliary disorders.

Respiratory system disorders.

Skin and appendages disorders.

Reproductive system and breast disorders.

Note.

Reporting suspected adverse effects.

4.9 Overdose

In case of overdosage, the patient should be hospitalised, kept in the supine position, and conventional treatment of hypotension should take place.
Alfuzosin in not easily dialyzable because of its high degree of protein binding.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: alpha-adrenoreceptor antagonists, ATC code: G04CA01.

Mechanism of action.

Clinical trials.

Benign prostatic hyperplasia.

Acute urinary retention.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Metabolic interactions.

Pharmacokinetics in special populations.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ethylcellulose, hydrogenated castor oil, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, mannitol.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Available in a polyvinyl chloride (PVC)/Aluminum foil blister pack of 30 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Alfuzosin hydrochloride is a white to off white crystalline powder. It is freely soluble in water.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes