Loading…
PROGYNOVA TS 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 for estrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause. • 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Progynova TS 100 is an oestrogen-only patch applied to the skin once weekly. 4) should be used. Treatment to control menopausal symptoms should be initiated with the lowest Progynova TS patch dose. If considered necessary, a higher dosed patch should be used.
Once treatment is established the lowest effective dose patch necessary for relief of symptoms should be used. For prevention of postmenopausal osteoporosis Progynova TS 50 is recommended. Women receiving Progynova TS 100 for postmenopausal symptoms can continue at this dose.
In women with an intact uterus, a progestogen should be added to Progynova TS 100 for at least 12-14 days each month. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.
For continuous use:
The patches should be applied once weekly on a continuous basis, each used patch being removed after 7 days and a fresh patch applied to a different site.
For cyclical use:
The patches may also be prescribed on a cyclical basis. Where this is the preferred option, the patches should be applied weekly for 3 consecutive weeks followed by a 7 day interval, without a patch being applied, before the next course.
How to start Progynova TS 100 Women who do not take oestrogens or women who change from a continuous combined HRT product may start treatment at any time. Patients changing from a continuous sequential HRT regimen, should begin the day following completion of the prior regimen.
Patients changing from a cyclic HRT regimen should begin the day after the treatment-free period. Missed or lost patch In the event that a patch falls off before 7 days are up, it may be reapplied. If necessary, a new patch should be applied for the remainder of the 7-day dosing interval.
If the patient forgets to replace a patch, this should be done as soon as possible after she remembers it. The next patch has to be used after the normal 7-day interval. After several days without replacement of a new patch there is an increased likelihood of breakthrough bleeding and spotting.
Method of administration Following removal of the protective liner the adhesive side of Progynova TS patches should be placed on a clean, dry area of the skin of the trunk or buttocks. Progynova TS patches should not be applied to the breasts.
During the first few months of treatment, breakthrough bleeding, spotting and breast tenderness or enlargement can occur. These are usually temporary and normally disappear after continued treatment. The table below lists adverse drug reactions recorded in clinical studies as well as adverse drug reactions reported post-marketing.
Adverse drug reactions were recorded in 3 phase III clinical studies (n = 611 women at risk) and were included in the table when considered at least possibly related to treatment with 50 μg/day estradiol or 100 μg/day estradiol, respectively, following transdermal application.
The experience of adverse drug reactions is overall expected in 76% of the patients. Adverse drug reactions appearing in > 10% of patients in clinical trials were application site reactions and breast pain. Organ system Adverse events reported in clinical trials Adverse events reported post marketing Common (≥ 1/100, < 1/10) Uncommon (≥ 1/1000, < 1/100) BODY AS A WHOLE Pain.
Fatigue, abnormal laboratory test1, asthenia1, fever1, flu syndrome1, malaise1. CARDIOVASCULAR SYSTEM - Migraine, palpitations, superficial phlebitis1, hypertension1. Cerebral ischaemic events DIGESTIVE SYSTEM Flatulence, nausea. Increased appetite, constipation, dyspepsia1, diarrhoea1, rectal disorder1.
Abdominal pain, bloating (abdominal distension), cholestatic jaundice IMMUNE SYSTEM DISORDER Exacerbation of hereditary angioedema METABOLIC and NUTRITIONAL DISORDER Oedema, weight gain. Hypercholesteremia1 HAEMATOLOGICAL and LYMPHATIC SYSTEM - Purpura1.
MUSCULOSKELETAL SYSTEM - Joint disorder, muscle cramps. RESPIRATORY SYSTEM - Dyspnoea1, rhinitis1. NERVOUS SYSTEM Depression, dizziness, nervousness, lethargy, headache, increased sweating, hot flushes. Anxiety, insomnia, apathy, emotional lability, impaired concentration, paraesthesia, libido changed, euphoria1, tremor1, agitation1.
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 risks 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) o Diabetes mellitus with or without vascular involvement o Cholelithiasis o Migraine or (severe) headache o Systemic lupus erythematosus o A history of endometrial hyperplasia (see below) o Epilepsy o Asthma o Otosclerosis o Hereditary angioedema Reasons for immediate withdrawal of therapy: Therapy should be discontinued in case a contraindication is discovered and in the following situations: o Jaundice or deterioration in liver function o Significant increase in blood pressure o New onset of migraine-type headache o Pregnancy 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.
g. g. g. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Estradiol in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The sites of application should be rotated, with an interval of at least one week between applications to a particular site. The area selected should not be oily, damaged or irritated. The waistline should be avoided since tight clothing may rub the patch off.
The patch should be applied immediately after opening the pouch and removing the protective liner. The patch should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges.
The patch should be changed once weekly. If the patch is applied correctly, the patient can bath or shower as usual. The patch might, however, become detached from the skin in very hot bath water or in the sauna. Additional information on special populations Paediatric population Progynova TS 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 TS has not been specifically studied in patients with hepatic impairment. 3). 4). Patients with renal impairment Progynova TS has not been specifically studied in renally impaired patients.
SKIN and APPENDAGES Application site pruritus, rash. Acne, alopecia, dry skin, benign breast neoplasm, breast enlargement, breast tenderness, nail disorder1, skin nodule1, hirsutism1 Contact dermatitis, eczema, breast pain UROGENITAL SYSTEM Menstrual disorder, vaginal discharge, disorder of vulva/vagina.
Increased urinary frequency/urgency, benign endometrial neoplasm, endometrial hyperplasia, urinary incontinence1, Uterine fibroids Organ system Adverse events reported in clinical trials Adverse events reported post marketing Common (≥ 1/100, < 1/10) Uncommon (≥ 1/1000, < 1/100) cystitis1, urine discoloration1, haematuria1, uterine disorder1.
SPECIAL SENSES Abnormal vision1, dry eye1 1 have been reported in single cases. Given the small study population (n=611) it cannot be determined based on these results if the events are uncommon or rare. 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 (MWS) are presented.
8 *2Taken 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.
0 *1 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. US WHI studies - additional risk of breast cancer after 5 years’ use Endometrial cancer risk Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1000 women with a 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 […]
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 prevent the excess risk associated with oestrogen-only HRT.
625 mg and patches >50 μg/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 likely in the first year of HRT […]