Last Updated on eMC 27-07-2016 View medicine  | Kent Pharmaceuticals Ltd 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 1 - Name of the medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, 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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:23-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐Sections 1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.2, 6.4, 6.5, 6.6 and 10 of the SPC updated in line with the Brand leader SPC Zimovane.

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:24-02-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐

  • Section 4.2: Treatment duration added for transient insomnia (2-5 days) and short term insomnia (2-3 weeks).
  • Section 4.4: Advice added that benzodiazepines are not indicated to treat patients with severe hepatic insufficiency. Advice added for patients with respiratory insufficiency that a lower dose is recommended. Advice added for use in children that the safe and effective dose of Zopiclone has not been established. Advice added that the elderly should be given a reduced dose. Advice added for patients with depression that zopiclone does not constitute a treatment for depression and may even mask its symptoms. A listing of psychiatric and paradoxical reactions has been added.
  • Section 4.8: Information regarding the undesirable effects of this medicine updated. Advice added on how to report adverse side effects.
  • Section 4.9: Information added to the symptoms and management of overdose

Reasons for adding or updating:

  • 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 4.8 - Undesirable Effects

Date of revision of text on the SPC:28-06-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

´╗┐To update sections 4.4, 4.5 and 4.8 of the SPC in line with an RFI which has not yet been fulfilled and the QRD template. Minor typographical errors are also to be amended within section 4.2 and 4.3. As a consequence, the PIL has been updated.

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