Summary of Product Characteristics
last updated on the eMC:
18/10/2011
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 18/10/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
|
| Date of revision of text on the SPC: 14-Oct-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2 - Maximum duration of use amended to 5 days.
|
|
Updated on 04/01/2011 and displayed until 18/10/2011
|
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 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.3 – Contra-indications to concomitant use of other sympathomimetic decongestants, phaeochromosytoma and closed angle glaucoma added.
Section 4.4 – Special warnings and precautions added for enlarged prostate gland, occlusive vascular disease and cardiovascular disease. Addition of advice to consult a physician before taking if suffering from chronic cough or asthma, or if cough lasts more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache.
Addition of alcohol warning.
Section 4.5 – Addition of table detailing nature of drug interactions.
Section 4.8 – Addition of table listing undesirable effects by ingredient and body system.
Section 4.9 – Revision of section relating to phenylephrine and addition of section relating to guaifenesin.
Section 10 - New revision date
|
|
Updated on 21/08/2007 and displayed until 04/01/2011
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|