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
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
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
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
Adverse events should also be reported to Mylan by phone: 0800 121 8267.