When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
The SmPC has been updated to harmonise the text according to the article 30 referral. This has resulted in a rewrite of the full SPC. As part of the module 3 harmonisation we have switched from the heritage oval tablets to the small round tablets
4.4. Special warnings and special precautions for use
Temporary suspension of atorvastatin may be appropriate during fusidic acid therapy (see Section 4.5)
4.5. Interactions with other medicinal products and other forms of interaction
Erythromycin, clarithromycin: Erythromycin and clarithromycin are known.At atorvastatin doses exceeding 40mg, clinical monitoring, including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped (see Section 4.4), until the clarithromycin treatment course is completed and CPK has returned to baseline values.
Itraconazole: Concomitant administration At atorvastatin doses exceeding 40 mg, clinical monitoring including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped (see Section 4.4), until the itraconazole treatment course is completed and CPK has returned to baseline values.
Fusidic Acid: Although interaction studies with atorvastatin and fusidic acid have not been conducted, severe muscle problems such as rhabdomyolysis have been reported in post-marketing experience with this combination. Patients should be closely monitored, including measurement of serum creatine phosphokinase (CPK) and temporary suspension of atorvastatin treatment may be appropriate.
Section1: The name of the product has been updated to include the pharmaceutical form.
Section 4.4 and 5.1 – additional of SPARCL data and information
Section 4.4 and 4.5 – inclusion of information about drug-drug interactions with atorvastatin
Section 4.8 – Update Adverse Drug Reaction information after the completion of the MRP renewal
4.1 - update to existing primary prevention indication
4.2 - addition of dosing information relating to primary prevention studies
5.1 - addition of CARDS primary prevention study description
- modification of existing ASCOT study description wording
- addition of MIRACL acute coronary syndrome study description
Update to section 4.2 of the SmPC for Lipitor Tablets (all strengths) to include the paediatric dosing information below: