Alfuzosin hydrochloride Rowex 10 mg prolonged-release tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
ALFUZOSIN HYDROCHLORIDE
Available from:
Rowex Ltd
ATC code:
G04CA; G04CA01
INN (International Name):
ALFUZOSIN HYDROCHLORIDE
Dosage:
10 milligram(s)
Pharmaceutical form:
Prolonged-release tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Alpha-adrenoreceptor antagonists; alfuzosin
Authorization status:
Not marketed
Authorization number:
PA0711/083/002
Authorization date:
2006-04-28

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alfuzosin hydrochloride Rowex 10 mg Prolonged-Release Tablets

Alfuzosin hydrochloride

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

This medicine has been prescribed for you. 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.

What is in this leaflet:

What Alfuzosin hydrochloride Rowex is and what it is used for

What you need to know before you take Alfuzosin hydrochloride Rowex

How to take Alfuzosin hydrochloride Rowex

Possible side effects

How to store Alfuzosin hydrochloride Rowex

Contents of the pack and other information

1.

What Alfuzosin hydrochloride Rowex is and what it is used for

Alfuzosin hydrochloride Rowex belongs to a group of medicines called alpha-adrenoreceptor antagonists

or alpha-blockers.

It is used to treat moderate to severe symptoms caused by an enlarged prostate gland, a condition that is

also called benign prostatic hyperplasia. Enlarged prostate glands can cause urinary problems such as

frequent and difficult urination, especially at night. Alpha-blockers relax the muscles in the prostate and

bladder neck. This allows urine to flow out of the bladder more easily.

2.

What you need to know before you take Alfuzosin hydrochloride Rowex

Do not take Alfuzosin hydrochloride Rowex

if you are allergic to alfuzosin, other quinazolines (e.g. terazosin, doxazosin, prazosin) or any of the

other ingredients of this medicine (listed in section 6).

if you suffer from conditions that cause a marked drop in blood pressure when standing up.

if you have liver problems.

if you take other medicines that belong to the group of alpha-blockers.

Warnings and precautions

Talk to your doctor or pharmacist before taking Alfuzosin hydrochloride Rowex.

if you have severe kidney problems, since the safety of Alfuzosin hydrochloride Rowex has not been

established in these patients.

if you take medicines to treat high blood pressure. In this case your doctor will check your blood

pressure regularly, especially at the beginning of treatment.

if you experience a sudden drop in blood pressure when you stand up shown by dizziness, weakness

or sweating within a few hours of taking Alfuzosin hydrochloride Rowex. If you experience a drop in

blood pressure you should lie down with your legs and feet up in the air until the symptoms have

completely 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.

if you suffer from a cardiac disease.

if you experienced a marked drop in blood pressure or a hypersensitivity (allergic) reaction in the past

after taking another medicine belonging to the group of alpha-blockers. In this case your doctor will

start treatment with alfuzosin at low doses and will gradually increase the dose.

if you suffer from chest pain (angina) and are treated with a nitrate as this may increase the risk of a

drop in blood pressure. Your doctor will decide whether to treat your angina with a nitrate medicine or

stop treatment with Alfuzosin hydrochloride Rowex, if your angina returns or gets worse.

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 hydrochloride

Rowex. This is because Alfuzosin hydrochloride Rowex may cause complications during the surgery

which can be managed if your specialist is prepared in advance.

Swallow the tablets whole. Do not crush, powder or chew the tablets as too much of the active substance

alfuzosin may reach your body too quickly. This may raise the risk of unwanted effects.

Children and adolescents

Alfuzosin hydrochloride Rowex is not indicated for use in children and adolescent.

Other medicines and Alfuzosin hydrochloride Rowex

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

Alfuzosin hydrochloride Rowex must not be taken if you take other medicines that belong to the group of

alpha-blockers.

Alfuzosin hydrochloride Rowex and some medicines may interfere with each other. These include:

medicines containing ketoconazole or itraconazole (medicines used to treat fungal infections) or

ritonavir (medicine used to treat HIV).

medicines to lower blood pressure.

medicines (nitrates) used to treat the symptoms of chest pain (angina). Please note that taking

Alfuzosin hydrochloride Rowex together with medicines used to treat high blood pressure and nitrates

used e.g. to treat cardiac diseases may lead to low blood pressure.

medicines you receive before an operation (general anaesthetics). Your blood pressure can drop

markedly. If you have to undergo an operation, please tell the doctor that you are taking Alfuzosin

hydrochloride Rowex.

medicines that are known to increase the QT-interval.

Alfuzosin hydrochloride Rowex with food and drink

Alfuzosin hydrochloride Rowex should be taken after a meal.

Pregnancy and breast-feeding

This information is not relevant as Alfuzosin hydrochloride Rowex is only for men.

Driving and using machines

At the beginning of treatment with Alfuzosin hydrochloride Rowex you may feel light-headed, dizzy or

weak. Do not drive or operate machinery or perform any hazardous tasks until you know how your body

responds to the treatment.

Alfuzosin hydrochloride Rowex 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.

3.

How to take Alfuzosin hydrochloride Rowex

Always take Alfuzosin hydrochloride Rowex exactly as your doctor has told you. Check with your doctor

or pharmacist if you are not sure.

The recommended dose for adults, the elderly (over 65 years) and those with mild or moderate kidney

problems is 1 prolonged-release tablet (10 mg alfuzosin) once daily. Take the first tablet at bedtime. Take

the tablets immediately after the same meal each day and swallow them whole with a sufficient amount of

fluid. Do not crush, chew or divide the tablets.

If you take more Alfuzosin hydrochloride Rowex than you should

If you take large amounts of Alfuzosin hydrochloride Rowex your blood pressure may suddenly drop and

you may feel dizzy or even faint. If you begin to feel dizzy, sit or lie down until you feel better. If the

symptoms do not disappear, call your doctor as the drop in blood pressure may have to be treated in

hospital.

If you forget to take Alfuzosin hydrochloride Rowex

Do not take a double dose to make up for a forgotten tablet as this may cause a sudden drop in blood

pressure, especially if you take blood-pressure lowering medicines. Take the next tablet as directed.

If you stop taking Alfuzosin hydrochloride Rowex

You should not interrupt or stop taking Alfuzosin hydrochloride Rowex without speaking to your doctor

first. If you want to stop the treatment or have any further questions on the use of this product, ask your

doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get chest pain, stop taking Alfuzosin hydrochloride Rowex and contact a doctor or go to a

hospital immediately. Sign of chest pain (angina) normally happens if you have had angina before. This

side effect is very rare and may affect up to 1 in 10,000 people.

If you get symptoms such as red lumpy skin rash, swelling (of the face, tongue or throat), difficulty

breathing or swallowing stop taking Alfuzosin hydrochloride Rowex and contact your doctor

immediately. These are symptoms of angioedema, which is a very rare side effect that may affect up to 1

in 10,000 people.

Other side effects that can occur with Alfuzosin hydrochloride Rowex are:

Common (may affect up to 1 in 10 people):

Faintness/dizziness, headache, stomach pain, uncomfortable feeling in the stomach and indigestion

(dyspepsia), feeling sick (nausea), feeling of weakness.

Uncommon (may affect up to 1 in 100 people):

Feeling drowsy, a spinning sensation in the head (vertigo), loss of consciousness resulting from

insufficient blood flow to the brain, faster heartbeat, marked drop in blood pressure when standing up

(especially when starting treatment with too high a dose and when treatment is resumed), runny nose,

diarrhoea, dry mouth, skin rash, itching, water retention (may cause swollen arms, ankles or legs),,

reddening of the face (flushing), chest pain, vomiting.

Not known (frequency cannot be estimated from the available data):

If you must undergo eye surgery because of a cataract and are taking Alfuzosin hydrochloride Rowex

or have taken it in the past, difficulties during surgery may occur (see “Warnings and precautions”).

Very rapid uncoordinated contractions of the heart, abnormal liver function (signs may include yellowing

of your skin or the whites of your eyes), persistent and painful penile erection (priapism), decrease in

white blood cells. Low numbers of blood platelets. Signs may include bleeding from your gums and nose,

bruising, prolonged bleeding from cuts, rash (pinpoint red spots called petechia).

Reporting of 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 HPRA Pharmacovigilance, Earlsfort

Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:

medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store Alfuzosin hydrochloride Rowex

Do not store above 25 °C.

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

Do not use this medicine after the expiry date which is stated on the blister and carton. 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 Alfuzosin hydrochloride Rowex contains

The active substance is alfuzosin hydrochloride.

One prolonged-release tablet contains 10 mg alfuzosin hydrochloride.

The other ingredients are: lactose monohydrate, hypromellose (E 464), povidone K25, magnesium stearate

(E 470 b).

What Alfuzosin hydrochloride Rowex looks like and contents of the pack

Alfuzosin hydrochloride Rowex are white, round, bevelled-edged, uncoated tablets, approximately 10 mm

in diameter.

Alfuzosin hydrochloride Rowex is available in blister packs with 10, 20, 30, 50, 60, 60x1, 90, 100 and 180

prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder

Rowex Ltd., Bantry, Co. Cork, Ireland.

Manufacturers

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria:

Alfuzosin Hexal 10 mg – Retardtabletten

Belgium:

Alfuzosine Sandoz 10 mg Tabletten met

gereguleerde afgifte

Denmark:

Alfuzosin Hexal

Finland:

Alfuzosin Hydrochloride Sandoz 10 mg

depottabletti

Hungary:

Alfuzosin Sandoz Uno 10 mg retard tablets

Ireland:

Alfuzosin hydrochloride Rowex 10 mg Prolonged-Release Tablets

Italy:

Alfuzosina Hexal 10 mg compresse a

rilascio prolungato

Slovakia:

Alfuzosin Sandoz 10mg tablety s predlzenym

uvolnovanim

Spain:

Alfuzosina Bexal 10 mg comprimidos de

liberacion prolongada

Sweden:

Aluzosin Hexal

United Kingdom:

Dazular XL 10 mg Tablets

This leaflet was last revised in 04/2015.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Alfuzosin hydrochloride Rowex 10 mg prolonged-release tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 10 mg alfuzosin hydrochloride.

Excipients with known effect:

Each tablet contains 8 mg Lactose monohydrate.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Prolonged-release tablet.

White, round, bevelled-edge, uncoated tablets, approximately 10mm in diameter.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Treatment of moderate to severe functional symptoms of benign prostatic hyperplasia (BPH).

4.2 Posology and method of administration

The prolonged-release tablet should be swallowed whole with a sufficient amount of fluid.

Adults

1 prolonged-release tablet 10 mg once daily. The first dose should be taken at bedtime. The tablet should be taken

immediately after the same meal each day.

Older people (over 65 years)

As adults. Pharmacokinetic and clinical safety data demonstrate that dose reduction is usually not necessary to elderly

patients.

Reduced renal function

Mild to moderate renal insufficiency (creatinine clearance

30ml/min):

Dose reduction is usually not necessary (see section 5.2).

Severe renal insufficiency (creatinine clearance < 30ml/min):

Alfuzosin hydrochloride Rowex 10 mg should not be given to patients with severely impaired renal function as there

are no clinical safety data available for this patient group (see section 4.4).

Hepatic insufficiency

Alfuzosin hydrochloride Rowex given as 10 mg prolonged release tablets are contraindicated in patients with hepatic

insufficiency. Preparations containing a low dose alfuzosin hydrochloride might be used in patients with mild to

moderate hepatic insufficiency as instructed in the corresponding product information.

Paediatric population

Efficacy of alfuzosin has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore, alfuzosin is

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not indicated for use in the paediatric population.

4.3 Contraindications

Hypersensitivity to alfuzosin, other quinazolines (e.g. terazosin, doxazosin, prazosin) or to any of the excipients listed

in section 6.1.

Conditions with orthostatic hypotension.

Hepatic insufficiency.

Combination with other alpha-1 receptor blocking agents.

4.4 Special warnings and precautions for use

Alfuzosin hydrochloride Rowex 10 mg should not be administered to patients with severely impaired renal function

(creatinine clearance < 30 ml/min) as there are no clinical safety data available for this patient group.

Alfuzosin hydrochloride Rowex should be given with caution to patients treated with antihypertensive medicinal

products or nitrates. Blood pressure should be monitored regularly, especially at the beginning of treatment.

In some patients postural hypotension may develop, with or without symptoms (dizziness, fatigue, sweating) within a

few hours of administration. This effect is transient, occurs at the beginning of treatment, and does not usually prevent

the continuation of treatment. The patient should be warned of the possible occurrence of such events. In such cases,

the patient should lie down until the symptoms have completely disappeared.

Pronounced drop in blood pressure has been reported in post-marketing surveillance in patients with pre-existing risk

factors (such as underlying cardiac diseases and/or concomitant treatment with anti-hypertensive medication).

The risk of developing hypotension and related adverse reactions may be greater in older people.

Caution should be exercised when alfuzosin is administered to patients who have responded with pronounced

hypotension to other alpha

-blockers.

Treatment should be initiated gradually in patients with hypersensitivity to other

-receptor blockers.

As with all

-receptor blockers, alfuzosin should be used with caution in patients with acute cardiac failure.

In cardiac patients the treatment of coronary insufficiency should continue taking into account that the concomitant

administration of nitrates and alfuzosin may increase the risk of occurrence of hypotension. If angina pectoris recurs or

worsens, treatment with alfuzosin should be discontinued.

The patient should be examined before commencement of therapy with alfuzosin to exclude the presence of other

conditions that can produce similar symptoms to those of BPH.

Patients should be instructed to swallow the tablet whole. Other methods of administration such as crushing, powdering

or chewing the tablet, should be avoided. Incorrect administration may lead to undesirable release and absorption of the

active substance with a risk of early undesirable effects.

The “Intraoperative Floppy Iris Syndrome” (IFIS, a variant of small pupil syndrome) has been observed during cataract

surgery in some patients on or previously treated with

-blockers. Although the risk of this event with alfuzosin

appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or past use of

blockers, as IFIS may lead to increased procedural complications.

Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs

known to increase the QTc interval should be evaluated before and during the administration of alfuzosin.

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This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Contra-indicated combinations:

Alpha-1 receptor blocking agents (see section 4.3).

Combinations requiring caution:

- Alfuzosin blood levels are increased by potent CYP3A4 inhibitors like ketoconazole,

itraconazole and ritonavir.

- Antihypertensive agents (see section 4.4).

- Nitrates (see section 4.4).

Concomitant use with antihypertensive agents or nitrates increases the risk of hypotension.

See also section 4.4.

Administration of general anaesthetics to a patient treated with alfuzosin may lead to blood pressure instability.

No pharmacodynamic or pharmacokinetic interactions have been observed in studies with healthy volunteers between

alfuzosin and the following active substances: warfarin, digoxin, hydrochlorothiazide and atenolol.

Ketoconazole: Repeated 200 mg daily dosing of ketoconazole, for seven days resulted in a 2.1 fold increase in C

The increase in alfuzosin C

and AUC

(last)

following repeated 400 mg daily administration of ketoconazole was 2.3-

fold, and 3.2-fold, respectively.

A 2.5 fold increase in exposure of alfuzosin was seen when administered under fed conditions. (see section 5.2).

4.6 Fertility, pregnancy and lactation

Due to the type of indication this section is not applicable

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Adverse reactions such as vertigo, dizziness and asthenia may occur, especially at the beginning of treatment. This has

to be taken into consideration when driving vehicles and operating machines.

4.8 Undesirable effects

The most commonly reported event is dizziness, which occurs in approximately 5% of treated patients.

The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and

absolute frequency. Frequencies are defined as very common (

1/10); common (> 1/100 to < 1/10); uncommon (>

1/1000 to < 1/100); rare (> 1/10 000 to

< 1/1000); very rare (< 1/10 000); not known (cannot be estimated from the available data)

Blood and lymphatic system disorders

Not known: Neutropenia, thrombocytopenia

Nervous system disorders

Common: Headache, faintness/dizziness.

Uncommon: Vertigo, drowsiness.

Eye disorders

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Not known: Intraoperative Floppy Iris Syndrome (see section 4.4).

Cardiac disorders

Uncommon: Syncope (initially above all with too high a dose or if treatment is started again after a short interruption of

therapy), postural hypotension (see section 4.4) (initially above all with too high a dose or if treatment is started again

after a short interruption of therapy), tachycardia.

Very rare: Angina pectoris predominantly in patients with pre-existing coronary artery disease (see section 4.4).

Not known: Atrial fibrillation

Respiratory, thoracic and mediastinal disorders

Uncommon: Rhinitis.

Gastrointestinal disorders

Common: Nausea, abdominal pain, dyspepsia.

Uncommon: Diarrhoea, dry mouth, vomiting.

Hepatobiliary disorders

Not known: Hepatocellular injury, cholestatic liver disease.

Skin and subcutaneous tissue disorders

Uncommon: Rash (urticaria, exanthema), pruritus.

Very rare: Angioedema.

Reproductive system and breast disorders

Not known: Priapism

General disorders and administration site conditions

Common: Asthenia.

Uncommon: Oedema, chest pains, hot flushes.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: http://www.hpra.ie/; E-mail: medsafety@hpra.ie.

4.9 Overdose

In case of overdosage, the patient should be hospitalized, kept in the supine position, and conventional treatment of

hypotension such as addition of fluids and vasopressor drugs should take place.

In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on

vascular muscle fibres.

Alfuzosin is highly protein-bound, therefore, dialysis may not be of benefit.

Active charcoal should be administered following possible gastric lavage.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in benign prostate hypertrophy, alpha-adrenoreceptor antagonists.

ATC code: G04C A01

Mechanism of action

Alfuzosin, which is a racemate, is an orally acting quinazoline derivative, which selectively blocks post-synaptic alpha-

1 receptors. In vitro studies have confirmed the selectivity of the substance on alpha-1 receptors in the trigone of the

urine bladder, the urethra and the prostate gland. The clinical symptoms in BPH are not only related to the size of the

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prostate, but also to sympathomimetic nerve impulses, which by stimulating the post-synaptic alpha receptors increase

the tension of the smooth muscle of the lower urinary tract. Treatment with alfuzosin relaxes this smooth muscle, thus

improving the urinary flow.

Clinical efficacy and safety

Clinical evidence of uroselectivity has been demonstrated by clinical efficacy and a good safety profile in men treated

with alfuzosin, including the elderly and patients with hypertension. Alfuzosin may cause moderate anti-hypertensive

effects.

In man, alfuzosin improves the voiding parameters by reducing urethral tone and bladder outlet resistance, and thus

facilitates bladder emptying.

A lower frequency of acute urinary retention has been observed in patients treated with alfuzosin than in untreated

patients.

In placebo-controlled studies of BPH patients, alfuzosin has:

- significantly increased maximum urinary flow (Q

) in patients with Q

< 15 ml/s by an average of 30 %. This

improvement was observed from the first dose;

- significantly reduced the detrusor pressure and increased the volume producing a strong desire to void,

- significantly reduced the residual urine volume.

These urodynamic effects lead to an improvement of Lower Urinary Tract Symptoms (LUTS), i.e. filling (irritative) as

well as voiding (obstructive) symptoms, which has been clearly demonstrated.

Paediatric population

Alfuzosin is not indicated for use in the paediatric population (see section 4.2).

Efficacy of alfuzosin hydrochloride was not demonstrated in the two studies conducted in 197 patients 2 to 16 years of

age with elevated detrusor leak point pressure (LPP 40 cm H2O) of neurologic origin. Patients were treated with

alfuzosin hydrochloride 0.1 mg/kg/day or 0.2 mg/kg/day using adapted paediatric formulations.

5.2 Pharmacokinetic properties

Alfuzosin shows linear pharmacokinetics in the therapeutic dosage range. The kinetic profile is characterised by large

interindividual fluctuations in plasma concentrations.

Absorption

The mean relative bioavailability of Alfuzosin hydrochloride Rowex compared to the immediate release formulation is

104% in healthy volunteers. The maximum plasma concentration is achieved 9 hours after the administration. The

apparent elimination half-life is 9 hours. Studies have shown consistent pharmacokinetics when the product is

administered after a meal. Under fed conditions, mean C

and C

values are 14 (5.6) and 3 (1.6) ng/ml

respectively. Mean AUC

0-24

is 194 (75) ng * h/ml.

Distribution

Plasma protein binding is approximately 90 %. The volume of distribution of alfuzosin in healthy volunteers is 2.5 l/kg.

It has been shown to preferentially distribute in the prostate in comparison to plasma.

Elimination

The kinetic profile is characterised by large inter-individual fluctuations (sevenfold) in plasma concentrations. Mean

plasma half-life of alfuzosin is approximately 5 hours (1-10 hours). Alfuzosin is extensively metabolised in the liver

(several routes), metabolites are eliminated via renal excretion and probably also via biliary excretion. Of an oral dose,

75-91 % is excreted in the faeces; 35 % as unchanged substance and the rest as metabolites, indicating some degree of

biliary excretion. About 10 % of the dose is excreted in urine as unchanged substance. None of the metabolites has any

pharmacological activity.

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Renal or hepatic impairment

Volume of distribution and clearance increase with reduced renal function, possibly owing to a decreased degree of

protein binding. The half-life, however, is unchanged. This change in the pharmacokinetic profile is not considered

clinically relevant. Therefore, this does not necessitate a dosing adjustment in patients with mild to moderate renal

insufficiency. Due to a lack of clinical safety data for patients with severe renal insufficiency, Alfuzosin hydrochloride

Rowex 10 mg prolonged-release tablets should not be administered to this patient group (see sections 4.2 and 4.4). In

patients with severe hepatic insufficiency the half-life is prolonged. The peak plasma concentration is doubled, and the

bioavailability increases in relation to that in young, healthy volunteers. Alfuzosin hydrochloride Rowex 10 mg

prolonged-release tablets are contraindicated in hepatic insufficiency (see section 4.3).

Elderly patients

Immediate-release tablets: Oral absorption is more rapid, and bioavailability (AUC) is greater in elderly (>75 years)

than in younger subjects.

Prolonged-release tablets: Compared to healthy middle-aged volunteers, the peak plasma concentration (Cmax) and

bioavailability (AUC) are not increased in elderly patients.

The elimination half-life (t½) remains unchanged.

5.3 Preclinical safety data

Nonclinical studies showed that alfuzosin increases plateau potential and prolongs action potential duration (APD) and

QT interval

clinically relevant

concentrations.

However

clinical

investigations

showed that

alfuzosin is

associated with a clinically relevant prolongation of the QT interval in practice. Furthermore, there has been no signal

of Torsades de Pointes in extensive post-marketing experience with alfuzosin.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Hypromellose

Povidone K25

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

PVC/PVDC-aluminium blister.

10, 20, 30, 50, 60, 60x1, 90, 100 and 180 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

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No special requirements.

7 MARKETING AUTHORISATION HOLDER

Rowex Ltd

Bantry

Co. Cork

8 MARKETING AUTHORISATION NUMBER

PA 0711/083/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 28

April 2006

Date of last renewal: 4

June 2009

10 DATE OF REVISION OF THE TEXT

June 2015

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