- Approval Id
- ed9daa1f53a8732a
- Drug Name
- VIENOMET TABLETS 2MG
- Product Name
- VIENOMET TABLETS 2MG
- Approval Number
- SIN16681P
- Approval Date
- 2023-01-25
- Registrant
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
- Licence Holder
- ABBOTT LABORATORIES (SINGAPORE) PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><em>Method of administration:</em><br>
For oral use.<br>
<u>Posology</u><br>
Tablet-taking can be started on any day of the menstrual cycle.</p>
<p>"There is no experience with Dienogest 2mg tablets treatment >15 months in patients with endometriosis"</p>
<p>The dosage of Dienogest tablets 2mg is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.</p>
<p>If a short acting, e.g. oral, hormonal treatment was prescribed before starting treatment with dienogest, treatment may be started on the first day of menstrual bleeding after cessation of treatment.</p>
<p>If a long-acting, i.e. injectable, hormonal treatment was administered before starting treatment with dienogest, then dienogest may be started once metabolism/excretion of the previously administered drug is expected to complete.</p>
<p><u><em>Management of missed tablets:</em></u></p>
<p>The efficacy of Dienogest tablets 2mg may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occurring within 3–4 hours after tablet taking). In the event of one or more missed tablets, the woman should take one tablet only, as soon as she remembers, and should then continue the next day at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by one tablet.</p>
<p><u><em><strong>Additional information on special populations</strong></em></u></p>
<p><u><em>Paediatric population:</em></u></p>
<p>Dienogest tablets 2mg is not indicated in children prior to menarche.</p>
<p>The efficacy of Dienogest tablets 2mg has been demonstrated in the treatment of endometriosis – associated pelvic pain in adolescent patients (12–18 years), with an overall favorable safety and tolerability profile.</p>
<p>The use of Dienogest tablets 2mg in adolescents over a treatment period of 12 months was associated with a mean decrease in Bone Mineral Density (BMD) in the lumbar spine of 1.2 %. After cessation of treatment, BMD increased again in these patients.</p>
<p>Loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if BMD decrease in this population will reduce peak bone mass and increase the risk for fracture in later life.</p>
<p>Therefore, the treating physician should weigh the benefits of Dienogest 2mg against the possible risks of use in each individual adolescent patient (see sections ‘Special warnings and precautions for use’, ‘Pharmacodynamic properties’ – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). If clinically warranted, BMD may be monitored, and the results used in the risk-benefit assessment of use of Dienogest tablets 2mg.</p>
<p><em><u>Geriatric population:</u></em></p>
<p>There is no relevant indication for use of Dienogest tablets 2mg in the Geriatric population.</p>
<p><em>Patients with hepatic impairment:</em></p>
<p>Dienogest tablets 2mg is contraindicated in patients with present or past severe hepatic disease (see section 4.3).</p>
<p><em><u>Patients with renal impairment:</u></em></p>
<p>There are no data suggesting the need for a dosage adjustment in patients with renal impairment.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Treatment of endometriosis.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Dienogest tablets 2mg should not be used in the presence of any of the conditions listed below, which are partially derived from information on other progestogen-only preparations. Should any of the conditions appear during the use of Dienogest tablets 2mg, treatment must be discontinued immediately.</p>
<ul>
<li>Active venous thromboembolic disorder</li>
<li>Arterial and cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease)</li>
<li>Diabetes mellitus with vascular involvement</li>
<li>Presence or history of severe hepatic disease as long as liver function values have not returned to normal</li>
<li>Presence or history of liver tumors (benign or malignant)</li>
<li>Known or suspected sex hormone-dependent malignancies</li>
<li>Undiagnosed vaginal bleeding</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>
</ul>
- Atc Code
- G03DB08
- Atc Item Name
- dienogest
- Pharma Manufacturer Name
- ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
