- Approval Id
- 44b7c881f7bad287
- Drug Name
- ENDOVELLE TABLET 2MG
- Product Name
- ENDOVELLE TABLET 2MG
- Approval Number
- SIN16854P
- Approval Date
- 2023-09-06
- Registrant
- INTEGA PTE LTD
- Licence Holder
- INTEGA PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **4.2 Dosage and method of administration**
_**Method of Administration:**_
For oral use.
_**Dosage Regimen**_
Tablet-taking can be started on any day of the menstrual cycle.
The dosage of Endovelle 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.
The efficacy of Endovelle may be reduced in the event of missed tablets, vomiting and/or diarrhoea (if occurring within 3–4 hours after tablet taking). In the event of missed tablet(s), the woman should take one tablet only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet.
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.
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.
_**Additional information on special populations**_
_Paediatric population_
Endovelle is not indicated in children prior to menarche.
The efficacy of Endovelle 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.
The use of Endovelle 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.
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.
Therefore, the treating physician should weigh the benefits of Endovelle against the possible risks of use in each individual adolescent patient (see sections ‘Special warnings and precautions for use’, ‘Pharmacodynamic properties’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If clinically warranted, BMD may be monitored and the results used in the risk-benefit assessment of use of Endovelle.
_Geriatric population_
There is no relevant indication for the use of Endovelle in the geriatric population.
_Patients with hepatic impairment_
Endovelle is contraindicated in patients with present or past severe hepatic disease (see section Contraindications).
_Patients with renal impairment_
There are no data suggesting the need for a dosage adjustment in patients with renal impairment.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Indication(s)**
Treatment of endometriosis.
- Contraindications
- **4.3 Contraindications**
Endovelle 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 Endovelle, treatment must be discontinued immediately.
- Active venous thromboembolic disorder
- Arterial and cardiovascular disease, present or in history (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease)
- Diabetes mellitus with vascular involvement
- Presence or history of severe hepatic disease as long as liver function values have not returned to normal
- Presence or history of liver tumors (benign or malignant)
- Known or suspected sex hormone-dependent malignancies
- Undiagnosed vaginal bleeding
- Hypersensitivity to the active substance or to any of the excipients
- Atc Code
- G03DB08
- Atc Item Name
- dienogest
- Pharma Manufacturer Name
- INTEGA PTE. LTD.
- Company Detail Path
- /organization/75b0751b6c84fa27/intega-pte-ltd
