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.
Each tablet of this medicinal product contains 46 mg lactose per tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should take this amount into consideration.
Main Changes to the SPC
Section 4.4 Special warnings and precautions for use
Updated information provided regarding monitoring of patients with renal insufficiency (especially during the concomitant use of potassium-sparing medications).
Addition of information regarding possible decreases in blood pressure when used in hypertensive women. (Angeliq should not be used to treat hypertension.)
Section 4.5 Interaction with other medicaments and other forms of interaction
Additional information:
Updated information regarding the concomitant use of Angeliq and NSAIDs or ACE inhibitors / angiotensin II receptor antagonists.
Section 4.8 Undesirable Effects
Undesirable effects have been tabulated according to the MedDRA System Organ Class affected and the frequency of occurrence.
Updated information regarding the most commonly reported adverse reactions; breast pain, bleeding irregularities and spotting.
Additional possible undesirable effects have been included in the following classes:
Metabolism and nutrition, psychiatric, eye, ear and labyrinth, vascular, gastrointestinal, hepatobiliary, skin and subcutaneous tissue, musculoskeletal and connective tissue, renal and urinary, reproductive system and breast disorders and general disorders and administration site conditions.
Inclusion of additional information regarding use in special populations (hypertensive women).
Inclusion of information regarding other undesirable effects reported in association with HRT products.
Section 5.1 Pharmacodynamic Properties
Inclusion of clinical trial information regarding the anti-mineralocorticoid activity of drospirenone.