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AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: +44 (0)1582 836 836
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

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: 23/02/2011
SPC Avloclor Tablets

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 23/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   06-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SPC Changes

 

Avloclor 250mg

 

Section 2

Sentence added at end of section, reads as,

 

“For a full list of excipients, see section 6.1.”

 

Section 4.4

Fourth paragraph added, reads as,

 

“A small number of cases of diffuse parenchymal lung disease have been identified in patients taking chloroquine. A response after therapy with steroids has been observed in some of these cases.”

 

Section 4.8

New sub paragraph added after “Muscular” paragraph, reads as

 

“Respiratory: diffuse parenchymal lung disease.”

 

 

Section 10

6th July 2010

 
Updated on 14/06/2010 and displayed until 23/02/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes to SPC: Avloclor

 

Section 1
Revised text, now reads, “Avloclor 250 mg Tablets”

 

Section 10

29th March 2010
Updated on 06/08/2009 and displayed until 14/06/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5

Update to section to include poor bioavailability of certain anti-malaria drugs, Chloroquinine included, associated with concomitant therapy with antacids/adsorbents:

Change of text in first and second paragraph (note the text has been moved in the section)

If the patient is taking amiodarone then chloroquine and hydroxychloroquine may increase the risk of cardiac arrhythmias including ventricular arrhythmias, bradycardias and cardiac conduction defect. Concurrent use is contraindicated.

Antacids (aluminium, calcium and magnesium salts) and adsorbents (e.g. kaolin) may reduce the absorption of chloroquine, so should be taken well separated from Avloclor (at least four hours apart).

Section 10

Revision date of text: 28 July 2009
Updated on 20/06/2005 and displayed until 06/08/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 12/06/2003 and displayed until 20/06/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 09/11/2001 and displayed until 12/06/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 12/10/2001 and displayed until 09/11/2001
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 24/08/2001 and displayed until 12/10/2001
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 06/09/1999 and displayed until 24/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  chloroquine phosphate