Section 4.4 – under sub heading “Other conditions” - addition of examples of potassium sparing products … “such as ACE inhibitors, angiotensin II receptor antagonists or NSAIDs”.
Section 4.4 - under sub heading “Other conditions” – rewording of information relating to checking serum potassium in patients with renal insufficiency.
Section 4.4 - under sub heading “Other conditions” – addition of new text “Women with elevated blood pressure may experience a decrease in blood pressure under treatment with Angeliq due to the aldosterone antagonist activity of drospirenone (see section 5.1). Angeliq should not be used to treat hypertension. Women with hypertension should be treated according to Hypertension Guidelines.”
Section 4.5 – under sub heading “Interaction of Angeliq with other medicinal products” – additional information given – “Based on in vitro inhibition studies and on in vivo interaction studies in female volunteers receiving steady-state doses of 3mg drospirenone per day and omeprazole, simvastatin or midazolam as marker substrate, a clinically relevant interaction of drospirenone with the cytochrome P450 enzyme mediated metabolism of other drugs is unlikely.
Concomitant use of Angeliq and either NSAIDs or ACE inhibitors/angiotensin II receptor antagonists is unlikely to increase serum potassium. However, concomitant use of all these three types of medications together may cause a small increase in serum potassium, which is more pronounced in diabetic women.
Hypertensive women treated with Angeliq and anti-hypertensive medications may experience an additional decrease in blood pressure (see section 4.4).”
Section 4.8 – Table of side effects changed from Harts Body system to MedDRA. Addition of information regarding the number of women in Phase III studies. Rewording of text relating to most commonly reported adverse reactions. New table: deletion of hot flushes, breast engorgement, vasodilatation. Addition of the following side effects: Common – depression. Uncommon – weight decrease, anorexia, eye disorder, visual disturbance, embolism, diarrhoea, constipation, vomiting, flatulence, acne, pruritus, breast carcinoma, endometrial hyperplasia, benign uterine neoplasm, fibrocystic breast, vaginal candidiasis, vaginitis, vaginal dryness. Rare – anaemia, tinnitus, cholelithiasis, myalgia, salpingitis, galactorrhoea. Addition of new text re special populations – “Additional information on special populations:
The following undesirable effects classified as at least possibly related to Angeliq treatment by the investigator, were recorded in 2 clinical studies in hypertensive women.
Metabolism and nutrition disorders: Hyperkalaemia
Cardiac disorders: Cardiac failure, atrial flutter, QT interval prolonged, cardiomegaly
Investigations: Blood aldosterone increased.
The following undesirable effects have been reported in association with HRT products: Erythema nodosum, erythema multiforme, chloasma and haemorrhagic dermatitis.”
Section 5.1 – addition of new text
“Antimineralocorticoid activity
DRSP has aldosterone antagonistic properties that can result in a decrease in blood pressure in hypertensive women. In a double-blind placebo-controlled trial hypertensive postmenopausal women treated with Angeliq (n=123) for 8 weeks experienced a significant decrease in systolic/diastolic blood pressure values (office cuff versus baseline -12/-9 mm Hg, corrected for placebo effect -3/-4 mm Hg; 24h ambulatory blood pressure measurement versus baseline -5/-3 mm Hg, corrected for placebo effect -3/-2 mm Hg).
Angeliq should not be used to treat hypertension. Women with hypertension should be treated according to Hypertension Guidelines.”
Section 5.2 – amendment of sub headings – Hepatic Dysfunction to Hepatic Impairment; Renal Insufficiency to Renal Impairment
Section 10 – date of revision changed to 19 December 2006
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