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PROGYNOVA is a brand name for Estradiol (also known as Oestradiol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in peri- and postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. See also…
Verbatim from this product's MHRA label. Tap a section to expand.
• Posology Progynova is an oestrogen-only product. One tablet of Progynova 2 mg to be taken daily. It does not matter at what time of day the woman takes her tablet, but once she has selected a particular time she should keep to it every day.
Treatment is continuous, which means that the next pack follows immediately without a break. 4) should be used. Treatment to control menopausal symptoms should be initiated with Progynova 1 mg. If considered necessary, Progynova 2 mg should be used.
Once treatment is established the lowest effective dose necessary for relief of symptoms should be used. For prevention of postmenopausal osteoporosis one tablet of Progynova 2 mg is to be taken daily. In women with an intact uterus, a progestogen should be added to Progynova for at least 12 - 14 days each month/28 day cycle.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women. • How to start Progynova 2 mg If the woman has an intact uterus and is still menstruating, a combination regimen with Progynova and a progestogen, commencing with the oestrogen phase, should begin on the first day of bleeding.
6). In women transferring from a continuous combined HRT product, treatment with Progynova may be started on any day. In women transferring from cyclic or continuous sequential HRT regimens, the woman should complete the cycle and then change to Progynova without a break in therapy.
• Missed or lost tablets If the woman forgets to take a tablet at the usual time, she may take it within the following 12 hours. If the woman is more than 12 hours late the forgotten tablet should not be taken and the remaining tablets taken at the usual time on the right days.
A missed dose may lead to breakthrough bleeding or spotting. Paediatric population Progynova is not indicated for use in children and adolescents. Geriatric patients There are no data suggesting a need for dosage adjustment in elderly patients.
Patients with hepatic impairment Progynova has not been specifically studied in patients with hepatic impairment. 3). 4). Patients with renal impairment Progynova has not been specifically studied in renally impaired patients. Method of administration The tablets can be taken with or without food.
The following undesirable effects have been reported in users of Progynova and other oral HRT preparations. Neoplasms benign, malignant and unspecified Breast cancer*, Endometrial cancer* Immune system disorders Hypersensitivity reaction, Exacerbation of hereditary angioedema.
4) Musculoskeletal and connective tissue disorders Muscle cramps, Leg pain Renal and urinary disorders Cystitis-like symptom Reproductive system and breast disorders Increased size of uterine fibroids, Vaginal candidosis, Uterine cervical erosions, Changes in vaginal bleeding pattern and abnormal bleeding or flow, Breakthrough bleeding, Spotting (bleeding irregularities usually subside during continued treatment), Dysmenorrhoea, Changes in vaginal secretion, Premenstrual-like syndrome, Breast secretion, Breast tenderness, enlargement or pain.
General disorders and administration site conditions Oedema * Please see further information below. Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestogen therapy for more than 5 years.
• The increased risk in users of oestrogen-only therapy is lower than that seen in users of oestrogen-progestogen combinations. 4). • Absolute risk estimations based on results of the largest randomised placebo-controlled trial (WHI study) and the largest meta-analysis of prospective epidemiological studies are presented.
0 a Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2).
Note:
Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately. 8 *Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2) Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
• For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risk and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
• Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.
Medical examination/follow-up: • Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.
During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below).
g mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. Conditions which need supervision: • If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
g. g. liver adenoma) - Diabetes mellitus with or without vascular involvement - Cholelithiasis - Migraine or (severe) headache - Systemic lupus erythematosus - A history of endometrial hyperplasia (see below) - Epilepsy - Asthma - Otosclerosis - Hereditary angioedema.
Reasons for immediate withdrawal of therapy:
Therapy should be discontinued in case a contraindication is discovered and in the following situations: - Jaundice or deterioration in liver function - Significant increase in blood pressure - New onset of migraine-type headache - Pregnancy.
g. g. g. 1 - Porphyria
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The tablets should be swallowed whole with a glass of water or milk. The tablets should be taken at the same time each day.
5) +4 (0 - 9) a WHI study in women with no uterus, which did not show an increased in risk of breast cancer. b When the analysis was restricted to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than in non-users.
Endometrial cancer risk Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1000 women with an uterus not using HRT. 4). Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from between 5 and 55 extra cases diagnosed in every 1000 women between the ages of 50 and 65.
Adding a progestogen to oestrogen-only therapy for at least 12 days per cycle can prevent this increased risk. 2)). 4). 56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of using HT (see […]
Endometrial hyperplasia and carcinoma • In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods. 8). After stopping treatment risk may remain elevated for at least 10 years.
• The addition of a progestogen cyclically for at least 12 days per month/28 day cycle or continuous combined oestrogen-progestogen therapy in non- hysterectomised women prevents the excess risk associated with oestrogen-only HRT. 625 mg and patches > 50 micrograms/day the endometrial safety of added progestogens has not been demonstrated.
• Break-through bleeding and spotting may occur during the first months of treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
• Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore, the addition of progestogens to oestrogen replacement therapy should be considered in women who have undergone hysterectomy because of endometriosis, if they are known to have residual endometriosis.
Breast cancer The overall evidence shows an increased risk of breast cancer in women taking combined oestrogen-progestogen or oestrogen-only HRT, that is dependent on the duration of taking HRT. 8). Oestrogen-only therapy • The WHI trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only HRT.
8). • Results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.
• HRT, especially oestrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer. Ovarian cancer • Ovarian cancer is much rarer than breast cancer.
• Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen- progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
8). e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more […]