Summary of Product Characteristics
last updated on the eMC:
01/11/2011
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 01/11/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 27-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| The following paragraphs have been added with new precautions derived from clinical experience.
Baseline tests are unnecessary in children unless a complicating condition is known or clinically suspected.
Rifadin capsules may produce a reddish coloration of the urine, sweat, sputum and tears, and the patient should be forewarned of this. Soft contact lenses have been permanently stained (see section 4.8).
All patients with abnormalities should have follow up examinations, including laboratory testing, if necessary.
|
|
Updated on 21/12/2010 and displayed until 01/11/2011
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.3 - Contraindications
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 05-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
SPC updated with following changes:
Section 1: re-formatted
Section 2: following text added: For a full list of excipients, see section 6.1.
Section 3: text ammended to: Capsule, hard-The gelatine capsule is composed of a red half and a blue half.
Section 4.3: content remians the same but text has been re-worded and re-formatted to,
Section 4.7: wording changed from non stated to - No studies on the effects on the ability to drive and use machines have been performed.
Section 5.1: ATC code added: J04AB02 Antimycobacterials, antibiotics
Section 6.6: wording ammended from non stated to No special requirements.
Section 10: date changed t o 05/11/2010
|
|
Updated on 29/06/2009 and displayed until 21/12/2010
|
Reasons for adding or updating:
|
-
Change to section 5.2 - Pharmacokinetic Properties
|
| Date of revision of text on the SPC: 13-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Addition of: -
Rifampicin is readily absorbed from the gastrointestinal tract. Peak serum concentrations of the order of 10 µg/ml occur about 2 to 4 hours after a dose of 10 mg/kg body weight on an empty stomach.
Absorption of rifampicin is reduced when the drug is ingested with food.
The pharmacokinetics (oral and intravenous) in children are similar to adults.
|
|
Updated on 06/01/2009 and displayed until 29/06/2009
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 01-Jul-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Removal of bottles as alternative pack
|
|
Updated on 25/09/2008 and displayed until 06/01/2009
|
Reasons for adding or updating:
|
-
New individual SPC (was previously included in combined SPC)
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
