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Zentiva
One Onslow Street, Guildford, Surrey, GU1 4YS
Telephone: +44 (0) 1483505515
Fax: +44 (0) 1483 554831
Medical Information Direct Line: +44 (0) 1483 554101
Medical Information e-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Fax: +44 (0) 1483 554831

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: 07/03/2012
SPC Ciprofibrate 100mg 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 07/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   25-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change in the shape of the tablet form from "capsule-shaped" to "round, with the marking "S170" on one side and a breakline on the other
Updated on 04/05/2011 and displayed until 07/03/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 Name of Medicinal product

Modalim Tablets 100 mg
Ciprofibrate 100mg Tablets

Section 4.1 Therapeutic indications

Modalim Ciprofibrate tablets are recommended for the treatment ......

Section 4.2 Posology and administration

Modalim Ciprofibrate should not be used in severe renal impairment.
 
and

Modalim Ciprofibrate tablets are for oral administration only
Updated on 12/01/2011 and displayed until 04/05/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   06-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Correction of formatting error
Updated on 05/01/2011 and displayed until 12/01/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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
Date of revision of text on the SPC:   06-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 & 4.9 of the SPC in line with the agreed Core Safety Profile for ciprofibrate following completion of the PSUR worksharing procedure

Updated on 15/09/2009 and displayed until 05/01/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  ciprofibrate