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 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
A new paragraph regarding grapefruit and grapefruit juice has been added as a final paragraph to the Concomitant use requiring caution sub-heading under the Interactions linked to amlodipine sub-heading of this section.
What previously was the last paragraph regarding concomitant administration of 240 ml of grapefruit juice in the Concomitant use to be taken into account sub-heading of the Interactions linked to amlodipine sub-heading has been deleted from this section.
Section 4.6 Fertility, Pregnancy and Lactation
The first four sentences of the Fertility sub-heading of this section have been added as new text.
Section 4.8 Undesirable Effects
New adverse reaction details [Rare: Hypoglycaemia (in diabetic patients)] have been added to the Metabolism and Nutrition Disorders frequency grouping for Telmisartan in this section.
A figure 2 (in superscript) has been added to the end of the Rare adverse reaction details of the Hepato-biliary Disorders frequency grouping for Telmisartan. Subsequent details regarding hepatic function abnormal/liver disorder and Japanese patients has been added as supporting text at the end of the Telmisartan disorders frequency grouping list.
The text … (with fatal outcome) has been added to the Rare adverse reaction details of the Skin and Subcutaneous Tissues Disorders frequency grouping for Telmisartan.
The text Peripheral neuropathy has been deleted from the Very Rare adverse reaction details of the Nervous System Disorders frequency grouping for Amlodipine, as has the Uncommon adverse reaction details.
Section 5.3 Preclinical Safety Data
The last but one paragraph of the Telmisartan sub-heading of this section regarding teratogenic effect has been reworded/amended including deletion of the reference to animal studies.
Section 10 Date of Revision of the Text
The date of 14 June 2011 has been added to this section.