Last Updated on eMC 14-09-2016 View medicine  | Concordia International - formerly AMCo Contact details

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.

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:08-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 of the SPC has been updated

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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:27-02-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section:-4.1 Therapeutic indications
Section:-4.2 Posology and method of administration
Section:-4.3 Contraindications
Section:-4.4 Special warnings and precautions for use
Section:-4.8 Undesirable effects
Section:-10. Date of revision of the text

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:30-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 of the SPC on MArketing Authorisation Holder has been changed from Antigen International Ltd. to Mercury Pharma International Ltd.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC:31-03-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section4.4: Warnings about use in the folliwing patients has been added:
-The elderly and patients in poor general condition.
- Patients with partial or complete heart block., patients in later stages of Pregnancy.

Warning about the use of certain local anaesthetic procedures may be associated with serious adverse reactions, regardless of the local anaesthetic drug used, especially relateed to the procedure has been added.

Reasons for adding or updating:

  • 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
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data

Date of revision of text on the SPC:20-10-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4: clinicians should be trained appropriately has been added.
Administrsation of large volume of local anaesthetic may be required has been added.
New warnings on the use of this injectables has been added. Warnings on its use as a retrobulbar injection have been added.

Section 4.5: Interaction between Bupivacaine and anti-arrhythmic drugs has been added.

Section 4.6: A ststement on bupivacaine entering mother's milk has been added.

Section 4.7: A warning about bupivicaine impairing alertness and mental function and co-ordination has been added.

Section 4.8: Symptoms have been arranged according to SOc and frequency has been added.
New symptoms have been added.
Acute systemic toxicity, central nervous system toxicity and cardiovascular system toxicity has been added.

Section 4.9: Some data from overdosage has been removed from this section and has been added in section 4.8.

Section 5.1: ATC COde and some more properties have been added.

Section5.2: Statement on diminished clearance in neonates and volume of distribution , placental transfer has been added.

Section 5.3: Bupivacaine is a well established ingredients has been added.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO