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.
1. Updating of sections 4.2 and 4.4 to include the new recommendation regarding transaminases monitoring:
A blood sample is now recommended to be performed three weeks after start of treatment. 2. Updating of section 4.8 : · to include new adverse events reported during the post-marketing experience : increased gamma glutamyl transferase (GGT), increased alkaline phosphatase (ALP) and hallucinations · to update the frequency of the increases in ASAT and/or ALAT and to reword the whole sentence · To define frequencies for the added adverse reactions based on post-marketing experience according to the current SmPC guideline, dated September 2009.
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Section 4.4 Special warnings and precautions for use
Under "Mania / Hypomania" the reader is referred to Section 4.8 for further information
Under "Increased serum transaminases" caution should be exercised when Valdoxan is administered to patients
with obesity/overweight/non-alcoholic fatty liver disease.
Section 4.8 Undesirable effects
Under "Psychiatric disorders", the following (in red) has been added to the "frequency not known" section:
Under "Skin and subcutaneous tissue disorders" the following has been added: Frequency not known : pruritus
Section 4.9: Overdose: The following changes (in red) have been made:
There is limited experience with agomelatine overdose. Experience with agomelatine in overdose has indicated
that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise have been reported.
Section 4.2- Posology- The words "Valdoxan tablets may be taken with or without food." have been added in.
Section 4.6- Fertility- The words "embryofoetal development and pre- and post natal development" have been deleted
Pregnancy- The words "
Reproduction studies in the rat and the rabbit showed no effect of agomelatine on embryofoetal development and pre- and post natal development. (see section 5.3)." have been inserted. Section 4.9- Overdose- The words "dose up to 2500 mg" have been deleted. The words "Patients have" have been deleted The words "One person having ingested 2450 mg agomelatine," have been inserted.
Section 4.9- Overdose- The words "dose up to 2500 mg" have been deleted.
The words "Patients have" have been deleted The words "One person having ingested 2450 mg agomelatine," have been inserted.