Kliogest

Estradiol 2 mg, norethisterone acetate 1 mg

HRT for oestrogen deficiency symptoms in postmenopausal women w/ >1 yr 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 every 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). Known thrombophilic disorders (eg, protein C, protein S or antithrombin deficiency). Active or previous arterial thromboembolic disease (eg, angina, MI). Acute liver disease or a history of liver disease as long as LFTs 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/ Kliogest: 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. Regularly monitor thyroid function while on HRT in patients who require thyroid hormone replacement therapy. May induce or exacerbate symptoms of angioedema, particularly in women w/ hereditary angioedema. 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. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Not indicated during pregnancy & lactation. Limited experience in treating women >65 yr.

Breast pain or tenderness, vag haemorrhage. 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. May influence some lab tests eg, tests for glucose tolerance or thyroid function. 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

G03FA01 - norethisterone and estrogen ; Belongs to the class of progestogens and estrogens in fixed combinations.

P₁S₁S₃