Trisequens

Per blue FC tab Estradiol 2 mg. Per white FC tab Estradiol 2 mg, norethisterone acetate 1 mg. Per red FC tab Estradiol 1 mg

HRT for oestrogen deficiency symptoms in postmenopausal women w/ at least 6 mth since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are intolerant of or contraindicated for other medicinal products approved for osteoporosis prevention.

1 tab once daily w/o interruption, preferably at the same time of the day starting w/ oestrogen therapy (blue FC tab) over 12 days, followed by 10 days of oestrogen/progestagen therapy (white FC tab) & 6 days of oestrogen therapy (red FC tab). After intake of the last red FC tab, continue treatment w/ the 1st blue FC tab of a new pack on the next day.

May be taken with or without food.

Hypersensitivity. Known, past or suspected breast cancer or oestrogen-dependent malignant tumours (eg, endometrial cancer). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous or current VTE (DVT, pulmonary embolism). Active or previous arterial thromboembolic disease (eg, angina, MI). Known thrombophilic disorders (eg, protein C, protein S or antithrombin deficiency). Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal. Porphyria.

HRT should only be initiated for postmenopausal symptoms that adversely affect quality of life. Careful appraisal of risks & benefits should be undertaken at least annually. Limited evidence regarding risks associated w/ HRT in the treatment of premature menopause. Before initiating or reinstituting HRT, a complete personal & family medical history should be taken. During treatment, periodic check-ups are recommended of a frequency & nature adapted to the individual woman. May recur or be aggravated during treatment w/ Trisequens: leiomyoma (uterine fibroids) or endometriosis; risk factors for thromboembolic disorders; risk factors for oestrogen-dependent tumours (eg, 1st degree heredity for breast cancer); HTN; liver disorders (eg, liver adenoma); DM w/ or w/o vascular involvement; cholelithiasis; migraine or (severe) headache; SLE; history of endometrial hyperplasia; epilepsy; asthma; otosclerosis. Immediate treatment discontinuation in case of jaundice or deterioration in liver function; significant increase in BP; new onset of migraine-type headache; pregnancy. Risk of endometrial hyperplasia & carcinoma; breast cancer; ovarian cancer. Associated w/ risk of developing VTE, more likely in the 1st yr of HRT. Temporarily stopping HRT 4-6 wk earlier is recommended if prolonged immobilisation is to follow elective surgery. Breakthrough bleeding & spotting may occur during the 1st few mth of treatment. Risk of CAD & ischaemic stroke. May cause fluid retention. Closely monitor women w/ pre-existing hypertriglyceridaemia during HRT. Increased thyroid-binding globulin, other binding proteins (ie, corticoid-binding globulin, sex-hormone-binding globulin), & other plasma proteins (angiotensin/renin substrate, α-1-antitrypsin & ceruloplasmin). HRT use does not improve cognitive function. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Not indicated during pregnancy & lactation. Women >65 yr.

Breast pain or tenderness, irregular menstruation or menorrhagia. Genital candidiasis or vaginitis; fluid retention; depression (or depression aggravated); headache, migraine (or migraine aggravated); nausea, abdominal pain/distension/discomfort; back pain, leg cramps; breast oedema or enlargement, uterine fibroids (including aggravated or recurrence); peripheral oedema; increased wt.

Increased metabolism w/ substances known to induce drug-metabolising enzymes (specifically CYP450 enzymes) eg, anticonvulsants (eg, phenobarb, phenytoin, carbamazepine) & anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz); ritonavir, telaprevir & nelfinavir; herbal prep containing St. John's Wort. Increased circulating levels w/ drugs that inhibit the activity of hepatic microsomal drug-metabolising enzymes eg, ketoconazole. Increased blood levels of cyclosporine.

Oestrogens, Progesterones & Related Synthetic Drugs

G03FB05 - norethisterone and estrogen ; Belongs to the class of progestogens and estrogens in sequential preparations.

P₁S₁S₃