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Indications:

Hormone replacement therapy (HRT) of estrogen deficiency symptoms in postmenopausal women. - Prevention of osteoporosis in postmenopausal women with increased risk of osteoporotic fracture and with intolerance or cons-indication to other treatments indicated for the prevention of osteoporosis. (See also section warnings and precautions for use). - The experience of this treatment in women aged over 65 years is limited.

Contraindications:

Hypersensitivity to any of the active ingredients or to any of the excipients; - Breast cancer known or suspected or history of breast cancer; - Malignant neoplasms known or suspected estrogen-dependent (eg endometrial cancer); - Genital hemorrhage undiagnosed - Untreated endometrial hyperplasia; - Previous history of venous thrombo-embolism or idiopathic venous thrombo-embolism in evolution (deep vein thrombosis, pulmonary embolism); - Accident recent arterial thromboembolic events or developments (eg angina, myocardial infarction); - Acute liver disease or a history of liver disease, until normalization of liver tests; - Porphyria. - Due to the presence of lactose, the drug-cons is indicated for congenital galactosemia, malabsorption of glucose and galactose or lactase deficiency. - Pregnancy: this medicine 1 mg / 0,025 mg is not indicated during pregnancy. The discovery of a pregnancy during treatment this medicine 1 mg / 0,025 mg requires immediate discontinuation of treatment. Clinical data on a limited number of exposed pregnancies do not show any adverse effect of gestodene on the fetus. To date, most epidemiological studies have not shown teratogenic or fetotoxic in pregnant women inadvertently exposed to the associations of estrogen and progestin. - Breastfeeding: this medicine 1 mg / 0,025 mg is not indicated during lactation.

Adverse reactions:

* Breast pain, tenderness or enlargement. * Breakthrough bleeding and spotting. * Vaginal thrush. * Headache/migraine. * Gut disturbances, such as nausea, abdominal pain, flatulence, indigestion. * Leg cramps. * Weight changes. * Depression. * Anxiety. * Dizziness. * Changes in sex drive. * Rise in blood pressure. * Excessive fluid retention in the body tissues, resulting in swelling (oedema). * Skin reactions such as rash and itch. * Steepening of corneal curvature which may make contact lenses uncomfortable. * Disturbance in liver function. * Irregular brown patches on the skin, usually of the face (chloasma). * Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above).

Interactions:

The metabolism of estrogens and progestogens may be increased by concurrent use of inducers of drug metabolizing enzymes, especially the isozymes of cytochrome P450, such as anticonvulsants (phenobarbital, phenytoin, carbamazepine, for example) and anti-infectives (rifampicin, rifabutin, nevirapine, efavirenz, for example). - Ritonavir and nelfinavir, although known as potent enzyme inhibitors, have paradoxically inducing properties when used in combination with steroid hormones. - Preparations containing herbal St. John’s wort (Hypericum perforatum) may increase the metabolism this medicine 1 mg / 0,025 mg. - The increased metabolism of estrogens and progestins may decrease the therapeutic effect and changes in the uterine bleeding profile.

Warnings:

In the indication of treatment of menopausal symptoms, HRT should be initiated if the disturbances are perceived as affecting the patient’s quality of life. In all cases, a reassessment of risk / benefit ratio must be done at least once a year. - The HRT can be continued as long as the benefit outweighs the risk. - Clinical examination and monitoring: . Before you start or restart a hormone replacement therapy (HRT), it is necessary to undertake clinical and gynecological examination (including the collection of personal and family medical history), taking into account the cons and precautions to employment. Throughout the duration of treatment, regular reviews will be conducted, their nature and their frequency is adapted to each patient. . Women should be informed of the type of breast abnormalities that may occur during treatment, these conditions should be reported to the attending physician (see "Breast cancer" below). The examinations, including mammography, should be charged according to current recommendations, and tailored to each patient. - Conditions requiring supervision: If one of the following conditions, have occurred previously, and / or worsened during pregnancy or previous hormone treatment, the patient should be closely monitored. The following conditions may recur or worsen during treatment with this medicine 1 mg / 0,025 mg tablet, in particular: . leiomyoma (uterine fibroids) or endometriosis; . history or presence of risk factors for thromboembolism (see below); . Risk factors for estrogen-dependent tumors, eg 1st degree heredity for breast cancer; . hypertension; . liver disorders (eg liver adenoma); . diabetes with or without vascular . cholelithiasis; . migraine or severe headache; . lupus erythematosus; . history of endometrial hyperplasia (see below); . epilepsy . asthma . otosclerosis. - Immediate stoppage of treatment: Treatment should be stopped immediately in case of occurrence of a cons-indication or in the following cases: . jaundice or impaired liver function; . significant increase in blood pressure; . migraine headache unusual type; . pregnancy. - Endometrial hyperplasia: . The risk of endometrial hyperplasia and endometrial cancer increases in case of prolonged administration of estrogen alone (see side effects section). Among non-hysterectomized women, the association of a progestin for at least 12 days per cycle greatly reduces this risk. . Break-through bleeding and spotting may occur during the first months of treatment. The occurrence of irregular bleeding months after starting treatment or persistent bleeding after discontinuation of treatment should be seek an underlying disease. This may require an endometrial biopsy to rule out malignancy. - Breast cancer . A randomized placebo-controlled, the Women’s Health Initiative Study (WHI) "and epidemiological studies, including the" Million Women Study (MWS), have shown an increased risk of developing breast cancer among women treated for several years by estrogen alone, the progestagen combined HRT, or tibolone (see side effects section). . For all HRT, the increased risk becomes significant after a few years of use and increases with duration of treatment. The risk declines upon discontinuation of treatment gradually disappear in a few years (more than 5 years). . In the MWS, the combination of a progestin to conjugated equine estrogens (CEE) or with estradiol (E2) increased the relative risk of breast cancer, regardless of the sequence of administration (continuous or sequential) and type of progestin. It has not been demonstrated to influence the route of administration on the risk of breast cancer. . In the WHI study, breast cancers reported with conjugated equine estrogens and medroxyprogesterone acetate (CEE + MPA) were associated with continuous slightly larger and more frequently accompanied by local lymph node metastases than those reported with placebo. . HRT, especially combined treatments of estrogen-progestin increased breast density on mammography, which could hinder the diagnosis of breast cancer. - Accidents thrombo-embolic events: . HRT is associated with an increased relative risk of venous thromboembolic events (deep vein thrombosis or pulmonary embolism). A randomized controlled trial and epidemiological studies have highlighted a risk two to three times higher among users of HRT compared to nonusers. Among nonusers, the incidence of thrombo-embolic events over a period of five years is estimated at 3 per 1000 women aged 50-59 years and 8 per 1000 women aged 60-69 years. In healthy women using HRT for 5 years, the number of additional cases is estimated at between 2 and 6 (best estimate = 4) per 1000 women aged 50-59 years and between 5 and 15 (best estimate = 9) per 1000 women aged 60-69 years. This event occurs more during the first year of treatment. . The recognized risk factors of thrombo-embolic events are: personal or family history, severe obesity (BMI/u003e 30 kg / m²), systemic lupus erythematosus (SLE). However, there is no consensus on the possible role of varicose veins on the venous thromboembolic risk. . Patients with a history of venous thrombosis or with recurrent thrombotic disease known to have an increased risk of venous thromboembolic events. HRT may increase this risk. The personal or family history of thrombo-embolism or recurrent spontaneous abortions should be sought to eliminate any underlying thrombophilia. In these patients, the use of HRT is cons-indicated until a precise evaluation of thrombophilic factors is undertaken or that anticoagulant therapy is initiated. In women already treated with anticoagulants, the benefit / risk of HRT should be assessed carefully. . The risk of venous thromboembolic events may be temporarily increased with prolonged immobilisation, major trauma or major surgery. To prevent any risk VTE postoperatively, the usual prophylactic measures should be strictly enforced. In case of a prolonged or in cases of elective surgery, particularly abdominal or orthopedic surgery to lower limbs, a temporary interruption of therapy should be considered 4-6 weeks before surgery. The treatment will be reinstated when the patient has regained normal mobility. . The occurrence of thromboembolic events requires discontinuation of HRT. Upon the occurrence of signs suggestive of thrombosis such as painful swelling of a leg, sudden pain in your chest and dyspnea, patients are advised to consult their doctor immediately. - Coronary heart disease: The randomized controlled trials have shown no evidence of cardiovascular benefit in continuing treatment involving combined conjugated equine estrogens and medroxyprogesterone acetate (MPA). Two large clinical trials: WHI and HERS (Heart and Estrogen / progestin Replacement Study) showed a possible increased risk of cardiovascular disease during the first year of use, and no overall benefit. Few data from randomized controlled studies are available on the effects on cardiovascular morbidity and mortality from other HRT. Thus, it is unclear whether these results also apply to these specialties. - Stroke: A large randomized clinical trial (WHI) showed an increased risk of ischemic stroke (secondary endpoint) in healthy women receiving a combination treatment involving continuous conjugated oestrogens and medroxyprogesterone acetate. Among nonusers, the incidence of stroke over a period of five years is estimated 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years. Among women receiving combination of conjugated equine estrogens and medroxyprogesterone acetate for 5 years, the number of additional cases is estimated between 0 and 3 (best estimate = 1) per 1000 women aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 women aged 60-69 years. The effect on the risk of stroke in other specialties listed in the HRT is unknown. - Ovarian cancer: Some epidemiological studies have shown that prolonged use (at least 5-10 years) of estrogen alone in hysterectomized women was associated with an increased risk of ovarian cancer. The effect of prolonged use of HRT estroprogestative is not known. - Other precautions: . Estrogens may cause fluid retention, patients with renal or heart must be closely monitored. Patients with ESRD should also be closely monitored because of possible increase of circulating levels of active ingredients of this medicine. . Women with pre-existing hypertriglyceridaemia should be closely monitored during hormone replacement therapy. . Rare cases of substantial increase in triglycerides leading to pancreatitis have been reported with estrogen therapy. . During treatment with estrogen, increased plasma levels of TBG (thyroid binding globulin) is observed, it leads to elevated plasma levels of thyroid hormones measured by total GDP (protein-bound iodine), total T4 [Column or measured by RIA (radioimmunoassay-assay)] and total T3 (measured by RIA). The binding of T3 resin is decreased, reflecting the increase in TBG. Concentrations of free fractions of T4 and T3 remain unchanged. The other serum binding proteins such as CBG (corticosteroid binding globulin) and SHBG (sex hormone binding globulin) can be increased resulting in, respectively, an increase of circulating levels of glucocorticoids and sex steroids. The concentrations of free fractions or active hormones remain unchanged. Other plasma proteins may also be increased (angiotensinogen / renin substrate, alpha 1-antitrypsin, ceruloplasmin). . It has not been demonstrated to improve cognitive function in the HRT. The results of the WHI study suggest an increased risk of probable dementia in women who start treatment with continuous combined CEE and MPA after 65 years. The effects in younger women or other HRT are not known. . Due to the presence of lactose, the drug-cons is indicated for congenital galactosemia, malabsorption of glucose and galactose or lactose deficiency. - Combinations requiring precautions: inducers of drug metabolizing enzymes, especially the isozymes of cytochrome P450, such as anticonvulsants (phenobarbital, phenytoin, carbamazepine, for example) and anti-infective drugs (rifampicin, rifabutin, nevirapine, efavirenz, for example), ritonavir and nelfinavir; Wort (Hypericum perforatum).

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Consultants Corner

Yaser Habrawi , F.R.C.S.Ed

Yaser Habrawi , F.R.C.S.Ed Consultant Ophthalmologist

Dr . Dirar Abboud

Dr . Dirar Abboud Hepatologist – Gastroenterologist

Dr. Tahsin Martini

Dr. Tahsin Martini Degree status: M.D. in Ophthalmology

Dr. Hani Najjar

Dr. Hani Najjar Pediatrics, Neurology

Dr. Faisal Dibsi

Dr. Faisal Dibsi Specialist of Otolaryngology - Head and Neck Surgery

Dr. Talal Sabouni

Dr. Talal Sabouni UROLOGY AND KIDNEY TRANSPLANT

Samir Moussa M.D.

Samir Moussa M.D. ENT Specialist

Dr. Samer Al-Jneidy

Dr. Samer Al-Jneidy Pediatrician
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