Individual Women, Individual HRT


A combined portfolio of HRT treatment options

Prescribing Information

ELLESTE™ (estradiol +/- norethisterone acetate)
Prescribing Information

Presentation: Elleste Solo™ 1 mg and 2 mg film-coated tablets containing estradiol hemihydrate 1 mg and 2 mg respectively. Elleste Solo™ MX 40 mcg transdermal patch containing 1.25 mg estradiol hemihydrate and Elleste Solo™ MX 80 mcg Transdermal Patch containing 2.5 mg estradiol hemihydrate and delivers 40 and 80 micrograms of estradiol respectively per 24 hours. Elleste Duet™ 1 mg film-coated tablets containing estradiol hemihydrate 1 mg (white tablets) and estradiol hemihydrate 1 mg and norethisterone acetate 1 mg (pale green tablets). Elleste Duet™ 2 mg film-coated tablets containing estradiol hemihydrate 2 mg (orange tablets) and estradiol hemihydrate 2 mg and norethisterone acetate 1 mg (grey tablets). Elleste Duet™ Conti film-coated tablets containing 2 mg estradiol hemihydrate and 1 mg norethisterone acetate.

Indication: Hormone replacement therapy for oestrogen deficiency symptoms in peri- and post-menopausal women (Elleste Solo™; Elleste Duet™; Elleste Solo™ MX 40 patch) and in post-menopausal women with an intact uterus who are at least one-year post menopause (Elleste Duet™ Conti). Prevention of osteoporosis in post-menopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis (Elleste Duet™ Conti; Elleste Duet™ 2 mg; Elleste Solo™ 2 mg; Elleste Solo™ MX 80 patch).

Dosage and Administration: Elleste Solo™ 1 mg and 2 mg film-coated tablets: One tablet daily in hysterectomised women; in women with an intact uterus, progestogen should be added for 12-14 days each cycle. Elleste Solo™ MX 40 and 80 patch: initiate treatment with Elleste Solo™ MX 40 in women with menopausal symptoms. If menstruating regularly, start within five days of bleeding. See SmPC for details of switching from other forms of HRT. Apply one patch twice weekly; in women with an intact uterus, progestogen should be added for 12-14 days during each cycle. The dosage may be increased by using Elleste Solo™ MX 80. Elleste Duet 1 mg film-coated tablets: One white tablet taken daily for 16 days followed by one pale green tablet taken daily for 12 days, then begin a new cycle without a break. Elleste Duet™ 2 mg film-coated tablets: One orange tablet taken daily for 16 days followed by one grey tablet taken daily for 12 days, then begin a new cycle without a break. Elleste Duet™ Conti: One tablet taken daily.

Contra-indications: Pregnancy or breastfeeding. Known, past or suspected breast cancer. Known or suspected oestrogen dependent malignant tumours. Undiagnosed genital bleeding. Untreated endometrial hyperplasia. Active thrombophlebitis. Previous idiopathic or current venous thromboembolism. Known thrombophilic disorders. Active or recent arterial thromboembolic disease. Acute liver disease or history of liver disease as long as LFTs are abnormal. Dubin-Johnson or Rotor Syndromes. Hypersensitivity to the active substances or excipients. Porphyria.

Warnings and Precautions: 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. HRT should only be continued as long as the benefit outweighs the risk. Before initiating or reinstituting HRT, take a complete personal and family medical history and perform appropriate physical examinations. Advise women about what breast changes should be reported. Closely supervise women with the following conditions or a history of them: leiomyoma or endometriosis; history of, or risk factors for, thromboembolic disease; risk factors for oestrogen dependent tumours; hypertension; liver disorders; diabetes mellitus; cholelithiasis; migraine or severe headache; systemic lupus erythematosus; endometrial hyperplasia; epilepsy; asthma; otosclerosis. Discontinue therapy if a contraindication is discovered and in the following conditions: hepatitis, jaundice or deteriorating liver function; significant increase in blood pressure; sudden severe chest pain; sudden breathlessness; unexplained swelling or pain in calf; severe stomach pain; prolonged immobility after surgery or leg injury; new onset migraine-type headache; pregnancy. Risk of endometrial hyperplasia and carcinoma are increased when oestrogens are administered alone for prolonged periods. The risk is reduced with the addition of a progestogen for at least 12 days per cycle in non-hysterectomised women. Investigate breakthrough bleeding. An increased risk of breast cancer has been reported that is dependent on the length of treatment. HRT can increase the density of mammographic images which may affect radiological detection of breast cancer. HRT is associated with an increased relative risk of venous thromboembolism (VTE) or pulmonary embolism (PE). Risk factors include personal or family history of thrombosis, severe obesity, systemic lupus erythematosus, immobilisation, major trauma and major surgery. Consider discontinuing HRT 4-6 weeks before elective surgery requiring immobilisation. Therapy should be discontinued if VTE develops after initiating surgery. There is an increased risk of cardiovascular morbidity during the first year of use of HRT. HRT is associated with an up to 1.5-fold increased risk of stroke. Long term use of oestrogens in women has been associated with an increased risk of ovarian cancer. Oestrogens may cause fluid retention. Women with preexisting hypertriglyceridemia should be followed closely (risk of pancreatitis). Certain endocrine tests may be affected. No evidence for improvement in cognitive function. Increased risk of gallbladder disease. Liver tumours leading to intra-abdominal haemorrhage have been reported. Patients with rare hereditary disorders of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Elleste™ Duet 2 mg film-coated tablets and Elleste™ Solo 2 mg film-coated tablets contain sunset yellow colouring (E110) which can cause allergic reactions. May interact with other medicines. See SmPC for potential interactions.

Side Effects: Common side effects (>1/100): Erythema, itching; uterine bleeding; breast tenderness and enlargement; increase in size of uterine fibroids; nausea; abdominal pain; headache; weight increase/decrease; oedema; change in mood including anxiety and depressive mood; change in libido. Other side effects include: Vaginal candidiasis; vomiting; gallbladder disease; pancreatitis, gallstones; dizziness; migraine; increased blood pressure; leg cramps; alopecia; hirsutism; rash; itching; venous thromboembolism; thrombophlebitis; thrombosis; endometrial neoplasia; dysmenorrhoea; aggravation of endometriosis; changes in cervical eversion, production of mucus and erosion; cystitis-like syndrome; endometrial cancer; breast cancer; bloating; myocardial infarction; stroke; liver tumours; cholestatic jaundice; chloasma; erythema multiforme; erythema nodosum; muscle cramps; vascular purpura; steepening of corneal curvature; visual disturbances; intolerance to contact lenses; sodium and water retention; reduced glucose tolerance; aggravation of porphyria and probable dementia. See SmPC for all side effects.

Marketing Authorisation Numbers and Cost: Elleste Solo™ 1mg: PL 46302/0169; 3 x 28 film-coated tablets £5.06. Elleste Solo™ 2mg: PL 46302/0170; 3 x 28 film-coated tablets £5.06. Elleste Solo™ MX 40 mcg: PL 46302/0167; 8 patches £5.19. Elleste Solo™ MX 80 mcg: PL 46302/0168; 8 patches £5.99. Elleste Duet™ 1mg: PL 46302/0164; 3 x 28 film-coated tablets £9.20. Elleste Duet™ 2mg: PL 46302/0165; 3 x 28 film-coated tablets £9.20. Elleste Duet™ Conti: PL 46302/0166; 3 x 28 film-coated tablets £17.02.

Legal Category: POM.

Marketing Authorisation Holder: Mylan Products Ltd. Further information is available on request from: Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1LT. Tel. 01707 853000 Date of preparation: October 2018 ELL-2018-0047.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Mylan by phone: 0800 121 8267 or by email: ukpharmacovigilance@mylan.com

PRESCRIBING INFORMATION:
Femoston 1/10 mg film-coated tablets
Femoston 2/10 mg film-coated tablets
Refer to the Summary of Product Characteristics for full information.

Presentation: Femoston 1/10 mg film-coated tablets containing 1 mg oestradiol (as hemihydrate) or a combination of 1 mg oestradiol (as hemihydrate) and 10 mg dydrogesterone. Femoston 2/10 mg film-coated tablets containing 2 mg oestradiol (as hemihydrate) or a combination of 2 mg oestradiol (as hemihydrate) and 10 mg dydrogesterone.

Indication: Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 months 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 the prevention of osteoporosis.

Dosage and Administration: Given as a continuous sequential HRT without a break. For first 14 days of 28-day cycle, one tablet containing oestradiol taken daily; during the following 14 days one tablet containing oestradiol and dydrogesterone is taken. Can be taken before or after food. For initiation and continuation of treatment of postmenopausal symptoms, use lowest effective dose for shortest duration. Generally start with Femoston 1/10, dosage can be adjusted dependent on clinical response. If complaints linked to oestrogen deficiency are not ameliorated dosage can be increased using Femoston 2/10. Women who are not taking HRT and who are amenorrhoeic, or those who switch from a continuous combined HRT treatment can start on any day. If transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of prior regimen. Paediatric population: No relevant indication.

Contraindications, Warnings etc: Contraindications: Known, past or suspected breast cancer, known or suspected oestrogen-dependent malignant tumours, known or suspected progestogen-dependent neoplasms, undiagnosed genital bleeding, untreated endometrial hyperplasia, venous thromboembolism, known thrombophilic disorders, arterial thromboembolic disease, acute liver disease or a history of liver disease, porphyria, known hypersensitivity to the active substances or to any of the excipients.
Warnings: Before initiating or re-instituting HRT, a complete physical and family medical history should be taken. Carefully supervise if leiomyoma or endometriosis, risk factors for thromboembolic disorders or oestrogen-dependent tumours, hypertension, liver disorders, diabetes mellitus, cholelithiasis, migraine or severe headaches, systemic lupus erythematosus, history of endometrial hyperplasia, epilepsy, asthma and otosclerosis conditions are present or have previously occurred. Therapy should be discontinued in case a contraindication is discovered; breast cancer, endometrial hyperplasia and carcinoma, ovarian cancer, venous thromboembolism, coronary artery disease, ischaemic stroke, renal dysfunction, hypertriglyceridaemia and in the following situations: jaundice or deterioration in liver function, significant increase in blood pressure, new onset of migraine-type headache, pregnancy. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Oestrogen-progestogen combination treatment is not a contraceptive. Drug Interactions: The metabolism of oestrogens and progestogens may be increased by concomitant use of P450 enzymes such as anticonvulsants and anti-infectives. Ritonavir, nelfinavir and herbal preparations containing St. John’s Wort may induce the metabolism of oestrogens and progestogens. Clinically, an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile. Oestrogens may inhibit CYP450 drug-metabolising enzymes via competitive inhibition particularly substances such as tacrolimus and cyclosporine A, fentanyl and theophylline. This may lead to an increased plasma level of the affected substances up to toxic levels. Careful drug monitoring might be indicated and a dosage decrease of tacrolimus, fentanyl, cyclosporine A and theophylline may be necessary.

Pregnancy and Lactation: Not recommended. If pregnancy occurs withdraw treatment immediately.

Ability to Drive and Operate Machinery: No influence on the ability to drive and/or to use machines.

Side Effects: Very Common: Headache, abdominal pain, back pain, breast pain/tenderness. Common: Vaginal candidiasis, depression, nervousness, migraine, dizziness, nausea, vomiting, flatulence, allergic skin reactions (e.g. rash, urticaria, pruritus), menstrual disorders (including postmenopausal spotting, metrorrhagia, menorrhagia, oligo-/amenorrhoea, irregular menstruation, dysmenorrhoea), pelvic pain, cervical discharge, asthenic conditions (asthenia, fatigue, malaise), peripheral oedema, increased weight. Uncommon: Cystitis-like syndrome, increase in size of leiomyoma, hypersensitivity, influence on libido, venous thromboembolism, hypertension, peripheral vascular disease, varicose vein, dyspepsia, abnormal hepatic function, occasionally with jaundice, asthenia or malaise, and abdominal pain, gall bladder disorder, breast enlargement, premenstrual syndrome, decreased weight. Rare: Myocardial infarction, angioedema, vascular purpura. Possible risk factors: Breast cancer, ovarian and endometrial cancer, venous thromboembolism, coronary artery disease and ischaemic stroke. Other adverse reactions: Oestrogen dependent neoplasms both benign and malignant, e.g. endometrial cancer, ovarian cancer, increase in size of progestogen dependent neoplasms, e.g. meningioma, haemolytic anaemia, systemic lupus erythematosus, hypertriglyceridemia, probable dementia over the age of 65, chorea, exacerbation of epilepsy, steepening of corneal curvature, contact lenses intolerance, arterial thromboembolism, pancreatitis (in women with pre-existing hypertriglyceridemia), erythema multiforme, erythema nodosum, chloasma or melasma, which may persist when drug is discontinued, leg cramps, urinary incontinence, fibrocystic breast disease, uterine cervical erosion, aggravated porphyria, total thyroid hormones increased.

Name and Address of Marketing Authorisation Holder: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK.


PL No: Femoston 1/10 mg film-coated tablets PL 46302/0035;
Femoston 2/10 mg film-coated tablets PL 46302/0036.

Basic NHS price: £16.16 (84 tablets).

Legal Category: POM.

Further information is available in the UK from: BGP Products Ltd., Building Q1, Quantum House 60 Norden Road, Maidenhead, Berkshire, SL6 4AY, UK.

Date of Last Revision: 22nd November 2016.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Mylan by phone: 0800 121 8267.

PRESCRIBING INFORMATION:
Femoston-conti 0.5 mg/2.5 mg film-coated tablets
Femoston-conti 1 mg/5 mg film-coated tablets
Refer to the Summary of Product Characteristics for full information.

Presentation: Femoston-conti 0.5 mg/2.5 mg film-coated tablets containing 0.5 mg 17β-estradiol (as hemihydrate) and 2.5 mg dydrogesterone. Femoston-conti 1 mg/5 mg film-coated tablets containing 1 mg 17β-estradiol (as hemihydrate) and 5 mg dydrogesterone.

Indication: Femoston-conti 0.5 mg/2.5 mg and 1 mg/5 mg film film-coated tablets; Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 12 months since last menses. Femoston-conti 1 mg/5 mg film-coated tablets: 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.

Dosage and Administration: Given as a continuous combined HRT for oral use and every day without interruption. Dosage is one tablet per day for a 28 day cycle. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used. Continuous combined treatment may be started depending on the time since menopause and severity of symptoms. Women experiencing a natural menopause should commence treatment not earlier than at least 12 months after their last natural menstrual bleed. For surgically induced menopause, treatment may start immediately. Can be taken before or after food. Paediatric population: No relevant indication.

Contraindications, Warnings etc: Contraindications: Known breast cancer, known oestrogen-dependent malignant tumours, undiagnosed genital bleeding, untreated endometrial hyperplasia, venous thromboembolism, known thrombophilic disorders, arterial thromboembolic disease, acute liver disease or a history of liver disease, porphyria, known hypersensitivity to the active substances or to any of the excipients.
Warnings: Before initiating or re-instituting HRT, a complete physical and family medical history should be taken. Carefully supervise if leiomyoma or endometriosis, risk factors for thromboembolic disorders, oestrogen-dependent tumours, hypertension, liver disorders, diabetes mellitus, cholelithiasis, migraine or severe headaches, systemic lupus erythematosus, history of endometrial hyperplasia, epilepsy, asthma, otosclerosis and meningioma conditions are present or have previously occurred. Therapy should be discontinued in case a contraindication is discovered; breast cancer, endometrial hyperplasia and carcinoma, ovarian cancer, venous thromboembolism, coronary artery disease, ischaemic stroke, renal dysfunction, hypertriglyceridaemia and in the following situations: jaundice or deterioration in liver function, significant increase in blood pressure, new onset of migraine-type headache, pregnancy. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Oestrogen-progestogen combination treatment is not a contraceptive. Drug Interactions: The metabolism of oestrogens and progestogens may be increased by concomitant use of P450 enzymes such as anticonvulsants and anti-infectives. Ritonavir, nelfinavir and herbal preparations containing St. John’s Wort may induce the metabolism of oestrogens and progestogens. Clinically, an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile.

Pregnancy, Lactation and Fertility: Not recommended. If pregnancy occurs withdraw treatment immediately.

Ability to Drive and Operate Machinery: No or negligible influence on the ability to drive and/or to use machines.

Side Effects: Very common: Headache, abdominal pain, back pain, breast pain/tenderness. Common: Vaginal candidiasis, depression, nervousness, migraine, dizziness, nausea, vomiting, abdominal distension (including flatulence), allergic skin reactions (e.g. rash, urticaria, pruritus), menstrual disorders (including postmenopausal spotting, metrorrhagia, menorrhagia, oligo-/amenorrhoea, irregular menstruation, dysmenorrhoea), pelvic pain, cervical discharge, asthenic conditions (asthenia, fatigue, malaise), peripheral oedema, increased weight. Uncommon: Cystitis- like symptoms, increase in size of leiomyoma, hypersensitivity, influence on libido, venous thromboembolism, hypertension, peripheral vascular disease, varicose vein, dyspepsia, abnormal hepatic function occasionally with jaundice, asthenia or malaise, and abdominal pain, gall bladder disorder, breast enlargement, premenstrual syndrome, decreased weight. Rare: Haemolytic anaemia, meningioma, steepening of corneal curvature, contact lenses intolerance, myocardial infarction, stroke, angioedema, vascular purpura, erythema nodosum, chloasma or melasma, which may persist when drug is discontinued, leg cramps. Possible risk factors: Breast cancer, ovarian cancer, endometrial cancer, venous thromboembolism, coronary artery disease and ischaemic stroke. Other adverse reactions: Oestrogen dependent neoplasms both benign and malignant, (e.g. endometrial cancer, ovarian cancer), increase in size of meningioma, systemic lupus erythematosus, hypertriglyceridemia, probable dementia, chorea, exacerbation of epilepsy, arterial thromboembolism, pancreatitis, erythema multiforme, urinary incontinence, fibrocystic breast disease, uterine cervical erosion, aggravated porphyria, thyroid hormones increase.


Name and Address of Marketing Authorisation Holder: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK.

PL No: Femoston-conti 0.5 mg/2.5 mg film-coated tablets PL 46302/0037; Femoston-conti 1 mg/5 mg film-coated tablets PL 46302/0038.

Basic NHS price: £24.43 (84 tablets).

Legal Category: POM.

Further information is available in the UK from: BGP Products Ltd., Building Q1, Quantum House 60 Norden Road, Maidenhead, Berkshire, SL6 4AY, UK.

Date of Last Revision: 26th August 2016.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Mylan by phone: 0800 121 8267.

PRESCRIBING INFORMATION:
Zumenon® 1mg Film-coated Tablets
Zumenon® 2mg Film-coated Tablets

Refer to the Summary of Product Characteristics for full information.

Presentation: Zumenon® 1mg film-coated tablets containing 1 mg estradiol (as hemihydrate), Zumenon® 2mg film-coated tablets containing 2 mg estradiol (as hemihydrate).

Indication: Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 months since last menses. Zumenon 2mg film-coated tablets should be used for the 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.

Dosage and Administration: Given as a continuous oestrogen only HRT for women with or without a uterus, for oral use and every day without interruption. Dosage is one tablet per day continuously without a break between packs. For initiation and continuation of treatment of postmenopausal symptoms, use the lowest effective dose for the shortest duration. Treatment should be started with Zumenon 1mg. Depending on the clinical response, the dosage can be adjusted to individual need and can be increased by using Zumenon 2mg. In women with a uterus, a progestagen should be added to Zumenon for 12-14 days each month to reduce the risk to the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. In women who are not taking hormone replacement therapy and who are amenorrhoeic, are hysterectomised, or women who switch from a continuous combined hormone replacement therapy, treatment may be started on any convenient day. In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen. If the patient has regular menstruation periods, treatment is started on day one of bleeding. Can be taken with or without food.

Contraindications, Warnings etc: Contraindications: Known hypersensitivity to the active substances or to any of the excipients, known, past or suspected breast cancer, known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer), undiagnosed genital bleeding, untreated endometrial hyperplasia, previous or current venous thromboembolism (deep vein 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, porphyria, Non-hysterectomized women without opposing progestogen.
Warnings: Before initiating or re-instituting HRT, a complete physical and family medical history should be taken. Carefully supervise if leiomyoma (uterine fibroids) or endometriosis, risk factors for thromboembolic disorders, oestrogen-dependent tumours (e.g. 1st degree heredity for breast cancer), hypertension, liver disorders, diabetes mellitus, cholelithiasis, migraine or (severe) headache, systemic lupus erythematosus, history of endometrial hyperplasia, epilepsy, asthma, or otosclerosis are present. Therapy should be discontinued in case a contraindication is discovered; jaundice or deterioration in liver function, significant increase in blood pressure, new onset of migraine-type headache, pregnancy. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. If at risk of pregnancy non-hormonal contraceptive methods should be adhered to. Drug Interactions: The metabolism of oestrogens and progestogens may be increased by concomitant use of P450 enzymes such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz). Ritonavir, nelfinavir and herbal preparations containing St. John’s Wort may induce the metabolism of oestrogens and progestogens. Clinically, an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile. Oestrogens may inhibit CYP450 drug-metabolising enzymes via competitive inhibition such as tacrolimus and cyclosporine A, fentanyl and theophylline. This may lead to a plasma increase of the affected substances up to toxic levels. Careful drug monitoring might be indicated and a dosage decrease of tacrolimus, fentanyl, cyclosporin A, and theophylline may be necessary.

Pregnancy and Lactation: Not recommended. If pregnancy occurs withdraw treatment immediately.

Ability to Drive and Operate Machinery: Does not affect the ability to drive or use machines.

Side Effects: Common: Increase and decrease in weight, headache, nausea, abdominal pain, rash, pruritus, leg cramps, metrorrhagia, uterine/vaginal bleeding including spotting, pelvic pain, asthenia. Uncommon: Vaginal candidiasis, hypersensitivity, nervousness, depressed mood, dizziness, visual disturbances, palpitations, venous thromboembolism, hypertension, peripheral vascular disease, varicose vein, dyspepsia, gall bladder disorder, urticaria, erythema nodosum, back pain, change in cervical secretion, menorrhagia, breast pain/tenderness, peripheral oedema, oedema. Rare: Anxiety, increase and decrease in libido, migraine, contact lenses intolerance, bloating, vomiting, hirsutism, acne, muscle cramps, breast enlargement, premenstrual-like symptoms, vaginal discharge, dysmenorrhoea, fatigue. Very rare: Haemolytic anaemia.
Possible risk factors: Breast cancer, ovarian cancer, endometrial cancer, venous thromboembolism, coronary artery disease, ischaemic stroke. Other adverse reactions (frequency unknown): Breast cancer, oestrogen dependent neoplasms benign and malignant, e.g. endometrial cancer, ovarian cancer, increase in size of leiomyoma, probable dementia over the age of 65, chorea, exacerbation of epilepsy, stroke, arterial thromboembolism, i.e. angina and myocardial infarction, venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, pancreatitis (in women with pre-existing hypertriglyceridaemia), gastroesophageal reflux disease, hepatic function abnormal, sometimes with jaundices, angioedema, chloasma, erythema multiforme, vascular purpura, urinary incontinence, fibrocystic breast disease.

Name and Address of Marketing Authorisation Holder: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK.

PL No: Zumenon® 1mg Film-coated Tablets PL 46302/0052;
Zumenon® 2mg Film-coated Tablets PL 46302/0053.

Basic NHS price: £6.89 (84 tablets).

Legal Category: POM.

Further information is available in the UK from: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, UK.

Date of Last Revision: 20th July 2018.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Mylan by phone: 0800 121 8267.

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