- Approval Id
- cb2839b3e196d08f
- Drug Name
- VAGIFEM® VAGINAL TABLET 10MCG
- Product Name
- VAGIFEM® VAGINAL TABLET 10MCG
- Approval Number
- SIN14877P
- Approval Date
- 2015-10-21
- 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>
Vagifem® is administered intravaginally as a local oestrogen therapy by use of an applicator.</p>
<p>Initial dose: One vaginal tablet daily for two weeks.<br>
Maintenance dose: One vaginal tablet twice a week.<br>
Treatment may be started on any convenient day.</p>
<p>If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.</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>For oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains <strong>within</strong> the normal postmenopausal range, such as Vagifem®, it is not recommended to add a progestagen (but see section 4.4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Vagifem® may be used in women with or without an intact uterus.</p>
<p>Vaginal infections should be treated before start of the Vagifem® therapy.</p>
<p><u>Administration:</u></p>
<ol>
<li>Open the blister pack at the plunger end.</li>
<li>Insert the applicator in the vagina until resistance is met (8–10 cm).</li>
<li>Release the tablet by pressing the plunger.</li>
<li>Withdraw the applicator and discard.</li>
</ol>
- Route Of Administration
- VAGINAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong><br>
Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
The experience of treating women older than 65 years is limited.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<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 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>Known hypersensitivity to the active substances or to any of the excipients</li>
<li>Porphyria.</li>
</ul>
- Atc Code
- G03CA03
- Atc Item Name
- estradiol
- Pharma Manufacturer Name
- NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
