Section 4.3 has been updated regarding disease which may cause tissue hypoxia (includes decompressed heart failure).
Section 4.4 has been updated with information on lactic acidosis - additional cautionary information relating to situations where renal function may become impaired; update to clarify when precaution should be taken and when the product is contraindicated in patients with reduced renal function and those with heart failure; update to information on use of iodinated contrast agent as this can lead to renal failure (consequential update to sections 4.5 and 4.6).
Section 5.3 has been updated to include additional information for juvenile toxicity study.
Section 6.5 has been updated to include a new pack size (90 x 1 tablets).
Section 8 has been updated to include a new pack size (90 x 1 tablets).
Section 8 has been updated to include the following new licence numbers:
- Synjardy 5 mg/850 mg (EU/1/15/1003/037)
- Synjardy 5 mg/1000 mg (EU/1/15/1003/038)
- Synjardy 12.5 mg/850 mg (EU/1/15/1003/039)
- Synjardy 12.5 mg/1000 mg (EU/1/15/1003/040)
Section 10 has been updated to align with the date of Positive Opinion (22 October 2015).
In addition minor editorial corrections/updates have been made to sections 4.2, 4.4, 4.9, 5.1 and 5.2.
Following a recent update of the European SPC template, the four strengths have also been consolidated into one SPC. As a consequence sections 1, 2, 3, 6.1 and 8 have been revised.