Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 29/11/2011
SPC Xatral

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 29/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   22-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In order to to comply with the latest Company Core Data Sheet information and to reflect the changes requested as part of the PSUR work-sharing procedure [SE/H/PSUR/0033/001] as some changes were omitted in error, the applicant wishes to update section 4.4 of the SmPC for Xatral to:

 

(a)  Add details that alfuzosin should be used with caution in patients with acute cardiac failure

 

(b)  Add details of QTc prolongation

 

(c)  Add details of risk of cerebral ischemic disorders in patients with symptomatic or asymptomatic pre-existing cerebral circulatory disturbances.

 

(d) Add a sentence about taking care when using Xatral in patients who have a pronounced hypotensive response to another alpha-1-blocker.

 

(e)  Update a sentence relating to coronary insufficiency

 

(f)  Add a new sentence to the end of the paragraph relating to Intraoperative Floppy Iris Syndrome

 

(g) Some PSUR Work-Sharing procedure updates were missed and have now been added.

 
Updated on 19/05/2011 and displayed until 29/11/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC updated following Article 46 Paediatric work-sharing procedure SE/W012/pdWS/001, as follows

Section 4.2 Posology and method of administration
addition of:-

Paediatric population

Efficacy of alfuzosin has not been demonstrated in children aged 2 to 16 years (see section 5.1).  Therefore, alfuzosin is not indicated for use in the paediatric population.

 


Section 5.1
addition of:

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 neurological origin.  Patients were treated with alfuzosin hydrochloride 0.1 mg/kg/day or 0.2 mg/kg/day using adapted paediatric formulations.
Updated on 24/02/2011 and displayed until 19/05/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


(Red denotes additions, Green denotes deletions/replacements)

Section 4.3 Contraindications:

formatting changes only

Section 4.6 Pregnancy and Lactation

formatting change to section title only

Section 4.7 effects on the ability to drive and operate machinery

There are no data available on the effect on driving vehicles.  Adverse reactions such as vertigo, dizziness and asthenia may occur essentially at the beginning of treatment.  This has to be taken into account when driving vehicles and operating machinery.

Section 4.8 Undesirable effects

·          Nervous system disorders

Common: faintness/dizziness, vertigo, malaise, headache

Uncommon: drowsiness, syncope

·          Eye disorders

Uncommon: vision abnormal

Not Unknown: intraoperative floppy iris syndrome

·          Cardiac disorders

Common: hypotension (postural)

Uncommon: tachycardia, palpitations, syncope

Very rare: New onset, aggravation or recurrence of angina pectoris in patients with pre-existing coronary artery disease (see section 4.4.)

Not known: Atrial fibrillation

·        Vascular disorders

Common: hypotension (postural)

Uncommon: flushing

·        Blood and lymphatic system disorders

Not known: neutropenia

·          Respiratory, thoracic and mediastinal disorders

Uncommon: rhinitis

·          Gastro-intestinal disorders

Common: nausea, abdominal pain, diarrhoea, dry mouth

Not known: vomiting

·        Hepatobiliary disorders

Not known: hepatocellular injury, cholestatic liver disease

·          Skin and subcutaneous tissue disorders

Uncommon: rash, pruritus

Very rare: urticaria, angioedema

·        Reproductive system and breast disorders

Not known: priapism

·          General disorders and administration site conditions

Common: asthenia, malaise

Uncommon: flushes, oedema, chest pain

 

Although only reported in isolated cases with alfuzosin, occurrence of priapism can not be excluded as it is generally accepted as being attributable to all other alpha adrenoreceptor blockers.

Section 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.

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

Alfuzosin is not easily dialysable because of its high degree of protein binding.
Updated on 25/02/2009 and displayed until 24/02/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of Ownership from Sanofi-Synthelabo to sanofi-aventis
Updated on 30/01/2009 and displayed until 25/02/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Amendment of section 4.8 with Intraoperative Floppy Iris Syndrome and two hepatic disorders. In addition a number of minor changes to the System Organ Class (SOC) terms, together with corrections to typographical errors.
Updated on 06/01/2009 and displayed until 30/01/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   01-May-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of the following wording to section 5.1;

Pharmacotherapeutic group: alpha-adrenoreceptor antagonists

ATC code: G04CA01
Updated on 21/09/2007 and displayed until 06/01/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of following text under section 4.4:
 
 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 tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
Updated on 19/09/2006 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   04/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
Updated on 15/09/2005 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/06/2003 and displayed until 15/09/2005
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/09/2002 and displayed until 09/06/2003
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/08/2001 and displayed until 27/09/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/08/2001 and displayed until 23/08/2001
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  alfuzosin hydrochloride