RECENTLY LAUNCHELY LAUNCHED V NOW AVA


ED VAGIRUX V


® (estradiol hemihydrate)


AILABLE FRO M YOUR LOCAL PHARMACY AND ALL NATIO


T ONAL WHOLESALERS


VAGIRUX 1 0 micr c


Vagirux is br oagirux is brought to women by Gedeon Richter in a 10 microgra hemihydrate and is indicated for


Refer to Summary of Product Characteristics for further details. agirux


UK Prescribing information – V Vagirux


Product name: Vagirux 10 microgram vaginal tablets. Composition: Each vaginal tablet contains estradiol hemihydrate equivalent


Va Maintenance dose: neO vaginal tablet twice a week. Fo initiar tion a continuand tion o treaf


to 10 microgram estradiol. Indications: rTreatment of vaginal atrophy due to estrogen deficiency in postmenopausal women with or without a uterus. Dosage and administration: Treat vaginal infections prior to starting Vagirux therapy. Start treatment on any convenient day. In women with or without a uterus: Initial dose: One vaginal tablet daily for t weeks.wo


tment of


postmenopausal symptoms, the lowest effective dose for the shortest duration should be used. Systemic exposure to estrogen remains within the normal postmenopausal range following administration of Va


Vagirux vaginal tablet and so it is not


recommended to add a progestogen. Missed dose: A missed dose should be taken as soon as remembered. A double dose should be avoided. Method of administration: Vagirux is administered intravaginally by use of a reusable applicator. Seer. SmPC for full instructions on how to administer . Contraindications: Known, past or suspected breast cance r.r. no K wn or suspected estrogen-dependent malignant tumours (e.g. endometrial cancer). Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism). Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency).Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction).Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal. Porphyria. Hypersensitivity to the active substance or to any of the excipients. Warnings and precautions: HR


the risks and benefits at


examination/follow-up: Before initiating or reinstituting HRT, a complete personal and family medical history should be obtained. Physical (including pelvic and breast) examination should be guided by this and by the contraindica


RT for menopausal symptoms should only be initiated for those that adversely affect quality of life. Assess least annually and continue HR T only as T,


long as benefit outweighs s tha risk. Medical


practices and of a frequency and nature adapted to the individual woman.Women should be advised what changes in their warnings for use. During treatment, periodic check-ups are recommended in accordance with currently accepted screening tions and


breasts should be reported to their doctor or nurse. The pharmacokinetic profile of Vagirux show t there is very low systemic absorption of estradiol during treatment, o h wever, being an HRT product the following need to be considered, especially for long-term or repeated use of this product. 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 trea


estrogen treatment, in particular: leiomyoma (uterine fibroids) or endometriosis; risk factors for thromboembolic disorders; patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during tment, the


systemic lupus erythematosus; history of endometrial hyperplasia; epilepsy; asthma; otosc liver adenoma); diabetes mellitus with or without vascular involvement; cholelithiasis; migraine or (severe) headache; estrogen-dependent tumours, e.g. first-degree heredity for breast cancer; hypertension; liver disorders (e.g.


risk factors for lerosis. Due to the very w lo systemic absorption of estradiol during Va Vagirux treatment, recurrence or aggravation of the above-mentioned conditions is


less likely than with systemic estrogen treatment. Reasons for immediate withdrawal of therapy: Discontinue therapy if 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. Endometrial hyperplasia and carcinoma: Women with an intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who ha


carcinoma is increased when estrogens are administered alone for prolonged the endometrium before initiation of treatment. In women with an intact uterus the risk of endometrial hyperplasia and treated with unopposed estrogens should be examined with special care in order to exclude hyperstimulation/malignancy of ve previously been


products where the systemic exposure to estrogen remains within the normal postmenopausal range, periods. For vaginally administered estrogen


to add a progestagen. During estradiol 10 microgram vaginal tablets treatment, a minor degree of systemic absorption may it is not recommended


occur in some patients, especially during the first two weeks of once-daily administration; however, daily average plasma E2 concentrations remained within the normal postmenopausal range.


repeated use of local vaginally administered estrogen is uncertain. Treatment should be reviewed at least annually, with Endometrial safety of long-term (more than one year) or


special consideration given to any symptoms of endometrial hyperplasia or carcinoma. If estrogen replacement therapy is prescribed for longer than one year r,, another physical (including gynaecological) examination should be performed. I bleedingf or spotting appears at any time during therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy. The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment


tment. Unopposed estrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis; caution is advised when using this product in women who ha


endometriosis, especially if they are known to have residual endometriosis. The following risks have been associated with ve undergone hysterectomy because of


repeated use of this product. Breast cancer: The overall evidence suggests an increased risk of breast cancer in women the estrogen remains within the normal postmenopausal range. However, they should be considered in case of long term or ginally administered estrogen products for which the systemic exposure to


systemic Tc HRT and apply to a lesser extent for va taking combined estrogen-progestagen and possibly also estrogen-only systemic HRT, c T, that is dependent on the duration of


AGIRUX 10 microgram vaginal tablet e


al tablet


postmenopausal women with or without a uterus. For commercial matters please contact Harpreet Sawhney (Commercial Manager) on: harpreet.sawhney@gedeonrichter


the treatment of vaginal atrophy due to estrogen d e


r.eu chter.eu and +44 (0) 795 7 705415.


taking HRT. The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment.


t. Ovarian cancer: Ovarian cancer is much rarer than breast cancer from a large meta-analysis suggests a slightly increased risk in women taking estrogen-onl y systemic


ancerr.. Epidemiological evidence c HRT


apparent within 5 years of use and diminishes over time after stopping. Venous thro mboembolism: Systemic Rc H T is associated with a 1.3- to 3-fold risk of developing venous thromboembolism (VTE), i.e. deep embolism. The occurrence o f such an event is more likely in the first year of HRT th thrombophilic states have an increased risk of VTE and HRT may add to this risk. HR Generally recognised risk fac tors for VTE include use of estrogens, older age, major surger obesity (BMI >30 kg/m2), pregnanc


mboembolism:


p vein thrombosis or pulmonary han later. Patients with known


RT is contraindicated in such pa


gery, prolonged immobilisa tients.


egnancy/postpartum period, systemic lupus erythematosus (SLE) and cancer r.. There is no


consensus about the possible role of varicose veins in VTE. As in all postoperative patients, prophylactic measures need be considered to prevent VTE following surgery. If prolonged immobilisation is to follow electi ve surgery temporarily stopping HR


RT 4 to 6 weeks earlier is r ecommended.


combination of defects) HR T is contraindicated. Women already on chronic anticoagulant consideration of the benefit- risk of use of HRT. f


c c ecommended. Treatment should not be restarted until the wo man is completely mobilised. In


women with no personal histo ry of VTE but with a first degree relative with a history of thro mbosis at young age, screening may be offered after careful co unselling regarding its limitations. If a thrombophilic defect is identified which segregates with thrombosis in family members


rs or if the defect is ‘severe’ (e.g., antithrombin, protein S, or protein C deficiencies or a treatment


require careful T. I VTE develops after initiating therapy, treatment must be discontinued.


Patients should be told to con tact their doctors immediately when they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea). Coronary artery disease (CAD): Randomised controlled data found no increased risk of CAD in hysterectomised women using systemic estrogen-only therapy. Ischaemic stroke: Systemic estrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke. The relative risk does not change with


overall risk of stroke in women who use HR age or time


therefore patients with cardiac ed c


ime since menopause. Howeverr,, as the baseline risk of stroke is strongly age-dependent, the n who use HRT increases with age. Other conditions: Estrogens may cause fluid retention, and or


T renal reased, dysfunction should be carefully observed. Women with pre-existing


hypertriglyceridaemia should be follow losely during estrogen replacement or hormone replacement therapy; rare cases of large increases of plasma triglycerides


Estrogens increase thyroid bi nding globulin (TBG) leading to increased circulating total thyroid hormone, T4 levels or T3 levels. T3 resin uptake is dec reased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, concentrations


are


alpha-1-antitrypsin, cerulopla smin).The minimal systemic absorption of estradiol with local vaginal administration is likely to result in less pronounced effects on plasma binding proteins than with systemic treatment. HR T does not improve cognitive function. There is some evid ence from the WHI trial of increased risk of probable dementia in women who start using systemic continuous combined in the treatment of premature


unchanged. ged. Other smin).


d or estrogen-only RT


menopause is limited. Due to the low level of absolute risk in younger women, the balance of HRT after the age of 65. Evidence regarding the risks associated with HRT


benefits and risks for these w omen may be more favourable than in older women. Intravaginal applicator may cause minor local trauma, especially in women with serious vaginal atrophy. Undesirable effects: More than 1100 patients have been treated with estradiol 10 micrograms vaginal tablets in clinical trials, including over 497 patients treated up to 52 weeks. Estrogen-related adverse even ts such as breast pain, peripheral oedema and postmenopausal bleedings have been reported with estradiol 10 micrograms vaginal tablets at very low rates, similar to placebo, but if they occurr,, they are most likely present only at


the beginning of the treatment. Common (≥1/100 to <1/10): Headache; abdominal pain; vaginal


haemorrhage, vaginal discharge or vaginal discomfort. Uncommon (≥1/1,000 to <1/100):Vulvovaginal mycotic infection; hot flush.; hypertension; nausea; rash; weight increased. Post-marketing experience: the following have been spontaneously reported for patients being trea


eated with estradiol 25 micrograms vaginal tablets and are considered possibly related to


treatment. These spontaneo us-reported adverse reactions are Very rare (<1/10,000 patient years): Breast cancer; endometrial cancer; generalised hypersensitivity reactions (e.g. anaphylactic reaction/shock); fluid retention; insomnia; migraine aggravated; deep v enous thrombosis; diarrhoea; urticaria; rash erythematous; rash pruritic; genital pruritus; endometrial hyperplasia; vagin


a; er arian cancer £11.34 Legal Classification: PO


r,, venous thromboembolism and ischaemic stroke. Packs and NHS Price: Vagirux 24 vaginal tablet pack - OM. MA Number: PL 04854/0184Marketing Authorisation Holder: Gedeon Richter Plc, Gyömró´


Va ó´


út 19-21, 1103 Budapest , Hungar ngary Further information is available from: Gedeon Richter UK Ltd, 127 Shirland Road, London W9 P.


2EP Tel: +44 (0) 207 604 8806. Date of preparation of PI: Septe


Email: medinfo.uk@gedeonrichter.eu Date of Authorisation: 20 August 2020 r.eu ember 2020. Job number: UK--2000010.


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Y Google Play or Apple App Store. . Adverse events should also be reported to Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or drugsafety


Yellow Card in the


Adverse events should also be reported to Gedeon Richter (UK) Ltd on +44 (0) 207 604 8806 or drugsafety.uk@gedeonrichter eur..eu UK--2000 ber 2020


blood estrogen increased. Oth er adverse reactions reported in association with systemic estrogen/progestagen treatment: Gall bladder disease; chloasm a; erythema multiforme; erythema nodosum; vascular purpura; probable dementia over the a of 65. Consult summary of p ovarian cancer


nal irritation; vaginal pain; vaginismus; vaginal ulceration; drug ineffective; weight increased; c


product characteristics for detailed information on breast cancer, endometrial cancer, ge


plasma proteins may


respectively. Free or biologically active hormone be


increased (angiotensinogen/renin


iglycerides leading to pancreatitis have been reported with estrogen therapy in this condition. nding


substrate, tion, T,, which becomes


am vaginal tablet contai ning estradiol deficiency in


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