Summary of Product Characteristics
last updated on the eMC:
03/02/2012
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 03/02/2012 and displayed until Current
|
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: 22-Sep-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| SPC revised to bring in line with global data sheet, specifically:-
Section 4.3 (contraindications) amended to remove asthma and glaucoma
Section 4.4 (special warnings & precautions) amended to add seizure disorders, narrow angle glaucoma, asthma, bronchitis and COPD. Amendment of warning for patients with renal or hepatic impairment to consult their doctor before using. Addition of warning to avoid concurrent use of other antihistamine containing products. Addition of warning to use with caution in the elderly with confusion.
Section 4.5 (Interactions) Addition of warning to use with caution with MAOIs or within 2 weeks of stopping using an MAOI. Addition of warning to seek medical advice before using with anticholinergic drugs. Addition of potential for interaction with metoprolol and venlafaxine.
Section 4.6 (pregnancy and lactation) Warning revised to advise the product should not be used in pregnancy or whilst breast feeding unless on medical advice.
Section 4.7 (effects on ability to drive) Warning revised to include information on the kind of effects that may affect the ability to drive.
Section 4.8 (undesirable effects) Information now presented in table form by organ class, with inclusion of information on frequency of effects.
Section 4.9 (Overdose) Removal of section regarding mild cases of overdose with antihistamines, and addition of section specific to diphenhydramine
|
|
Updated on 04/01/2011 and displayed until 03/02/2012
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
|
| Date of revision of text on the SPC: 11-Dec-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2 - addition of maximum daily dose
|
|
Updated on 27/07/2009 and displayed until 04/01/2011
|
Reasons for adding or updating:
|
-
Change to section 6.1 - List of Excipients
|
| Date of revision of text on the SPC: 15-Jul-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 6.1, the tablet coating has changed.
|
|
Updated on 12/12/2006 and displayed until 27/07/2009
|
Reasons for adding or updating:
|
-
Change to section 6.1 - List of Excipients
|
| Date of revision of text on the SPC: 10/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 6.1 List of Excipients: Update of the pharmacopoeial reference of hydroxy propylmethylcellulose to hypromellose
|
|
Updated on 17/05/2005 and displayed until 12/12/2006
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
