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 2 - Qualitative and quantitative composition
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:06-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections 2, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1 and 6.6 of the SPC have been updated.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:31-05-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section:-7 Marketing authorisation holder
Section:-10 Date of revision of the tex

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:17-12-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10: Change in the date of revision.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:20-09-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 of Marketing Authorisation Holder has been changed from Goldshield Pharmaceuticals Limited to Mercury Pharmaceuticals Ltd.

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:20-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3: A warning about use in hepatic failure, hypokalaemia and the risk of rhabdomyolysis has been added.

Section 4.4: Warnings about cllchicine toxicity and interaction with triazolobenzodiazepines, such as triazolam, and midazolam has been added.
A special precautions about hypersenstivity,  QT prolongation, Skin and soft tissue infections of mild to moderate severity, HMG-CoA reductase inhibitors, Oral hypoglycaemic agents/Insulin, Oral anticoagulants, anti-microbial therapy, interactions with antibiotics, cross resistance between clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin has been added.

Section 4.5: Many new interactions have been added.

Section 4.6: the following statement has been added: Therefore, use during pregnancy is not advised without carefully weighing the benefits against risk. Clarithromycin is excreted into human breast milk.

Section 4.7:
The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.

Section 4.8: A few more side-effects have been added.

Section 4.9: the following statements have been added:
Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum levels are not expected to be appreciably affected by haemodialysis or peritoneal dialysis.
In the case of overdosage, clarithromycin IV (powder for solution for injection) should be discontinued and all other appropriate supportive measures should be instituted.

Reasons for adding or updating:

  • New SPC for new product

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

Legal Category:POM

Black Triangle (CHM): NO