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.
Section 2 - Addition of text in red Each tablet contains 10 mg pravastatin sodium.
Each tablet contains 64.45 mg of lactose monohydrate.
Each tablet contains 20 mg pravastatin sodium.
Each tablet contains 128.9 mg of lactose monohydrate.
Each tablet contains 40 mg pravastatin sodium.
Each tablet contains 257.8 mg of lactose monohydrate.
Section 4.2 - Amendment to text in red Children and adolescents (8-18 years of age):
Children and adolescents (8-18 years of age):
For adolescents (14-18 years of age), the recommended dose range is 10-40 mg once daily. In children (8-13 years of age), the maximum recommended dose is 10 - 20 mg once daily, as doses greater than 20 mg have not been studied in this population (for children and adolescent females of child-bearing potential, see also section 4.6; for results of the study see section 5.1).
Section 10 - Change to date of revision of text
July 2010
Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8). Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Dizziness, headache, sleep disturbance, insomnia, nightmares
The following adverse events have been reported with some statins:
· Memory loss
· Sexual dysfunction
· Depression
· Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4)