- Approval Id
- 4e0eab45c42371f2
- Drug Name
- ESTROFEM TABLET 1 MG
- Product Name
- ESTROFEM TABLET 1 MG
- Approval Number
- SIN09922P
- Approval Date
- 1998-07-31
- Registrant
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
- Licence Holder
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
Estrofem® is an oestrogen-only product for hormonal replacement. Estrofem® is administered orally, one tablet daily without interruption, and should not be administered to women with an intact uterus unless combined with a suitable progestagen for at least 12–14 days every month/28 day cycle. For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>A switch to a higher dose or a lower dose of Estrofem® could be indicated if the response after three months is insufficient for satisfactory symptom relief or if the tolerability is not satisfactory.<br>
Prevention of bone mineral content loss is normally achieved with 1–2 mg estradiol daily, therefore higher doses are not usually used for long term prophylaxis of osteoporosis.</p>
<p>In women without a uterus, Estrofem® may be started on any convenient day.<br>
In women with a uterus who present amenorrhoea and are being transferred from a sequential HRT, Estrofem® may be initiated on day 5 of bleeding and only in combination with a progestagen for at least 12–14 days; if transferred from a continuous-combined HRT, Estrofem® along with a progestin, may be started on any convenient day. The progestagen type and dose should provide sufficient inhibition of the oestrogen induced endometrial proliferation (see also section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose for women with a uterus may increase the likelihood of breakthrough bleeding and spotting. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women.<br>
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.<br>
Estrofem® is particularly for women who have been hysterectomised and therefore do not require combined oestrogen/progestagen therapy.<br>
The experience of treating women older than 65 years is limited.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Known, past or suspected breast cancer</li>
<li>Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)</li>
<li>Undiagnosed genital bleeding</li>
<li>Untreated endometrial hyperplasia</li>
<li>Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)</li>
<li>Known thrombophilic disease disorders (e.g. protein C, protein S or antithrombin deficiency (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>))</li>
<li>Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)</li>
<li>Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal</li>
<li>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em></li>
<li>Porphyria.</li>
</ul>
- Atc Code
- G03CA03
- Atc Item Name
- estradiol
- Pharma Manufacturer Name
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/novo-nordisk-pharma-singapore-pte-ltd
