| Section 4.1
Add : ‘PANTOLOC Control is indicated for ‘ before ‘short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.’
Section 4.2
Change of heading from ‘Paediatric use’ to ‘Paediatric population’.
Section 4.6
Heading changed from ‘Pregnancy and lactation’ to ‘Fertility, pregnancy and lactation’.
Pregnancy
Final sentence. Change ‘This medicinal product’ to ‘PANTOLOC Control’ before the words ‘should not be used during pregnancy’.
Heading changed from ‘Lactation’ to ‘Breastfeeding’.
Final sentence. Changed ‘This medicine product’ to ‘PANTOLOC Control’ before the words ‘should not be used during breast-feeding’.
Section 4.8
Second paragraph.
Wording changed from ‘Within the following table, undesirable effects are ranked under the following frequency classification:’ to ‘Within the following table, undesirable effects are ranked under the MedDRA frequency classification:’.
Changes in Table 1.
Against:
Blood and lymphatic system disorders –
Agranulocytosis added in rare column, Pancytopenia added in very rare column
Nervous system disorders –
Taste disorders added in rare column
Metabolish and nutrition disorders –
Hypomagnesaemia added in Not Known column
Addition of new line in table
Reproducdtive system and breast disorders –
Gynaecomastia added in Rare column
Section 5.3
First sentence. Change from ‘ ..special hazard to humans...’ for ‘...special hazard to humans.....’.
Section 10
Date change from March 2011 to 7 December 2011
|
