- Approval Id
- 655de0012b75d32b
- Drug Name
- ACTIVELLE TABLET
- Product Name
- ACTIVELLE TABLET
- Approval Number
- SIN10960P
- Approval Date
- 1999-06-01
- 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>
Activelle<sup>®</sup> is a continuous combined HRT product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day.</p>
<p>For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>) should be used.</p>
<p>A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for symptom relief.</p>
<p>In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Activelle<sup>®</sup> may be started on any convenient day. In women in transition from a sequential HRT regimen, treatment should start right after their withdrawal bleeding has ended.</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 may increase the likelihood of breakthrough bleeding and spotting.</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 with more than 1 year since last menses.</p>
<p>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.</p>
<p>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 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 previous 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>Known hypersensitivity to the active substances or to any of the excipients</li>
<li>Porphyria</li>
</ul>
- Atc Code
- G03FA01
- Atc Item Name
- norethisterone and estrogen
- Pharma Manufacturer Name
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/novo-nordisk-pharma-singapore-pte-ltd
