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
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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| 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
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| 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 syrup 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.
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Updated on 29/06/2009 and displayed until 01/11/2011
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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| 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
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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.
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Updated on 25/09/2008 and displayed until 29/06/2009
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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