OSPHENA
As listed in the register: OSPHENA
60 mg · tablet
- Prescription only
- Urinary and reproductive system, hormones
- Active substance
- Ospemifene
- Made by
- Duchesnay Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Osphena). It describes the substance, not this exact product.
OSPHENA is an estrogen receptor agonist/antagonist with tissue selective effects.
Its biological actions are mediated through binding to estrogen receptors.
In vitro experiments with human liver microsomes indicated that ospemifene primarily undergoes metabolism via CYP3A4, CYP2C9, and CYP2C19.
Following an oral administration of ospemifene, approximately 75% and 7% of the dose were excreted in feces and urine, respectively.
After a single oral administration of OSPHENA 60 mg tablet in postmenopausal women with a high fat/high calorie (860 kcal) meal, C max was reached at approximately 2.5 hours (range: 1 to 6 hours) post-dose.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-02-14
Safety of the active substance
From the US prescribing label for the same active substance (Osphena). It describes the substance, not this exact product.
WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS WARNING: ENDOMETRIAL CANCER and CARDIOVASCULAR DISORDERS See full prescribing information for complete boxed warning.
- OSPHENA is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding.
- Estrogen-dependent neoplasia.
- Active DVT, PE, or a history of these conditions.
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions.
The most common adverse reactions (≥1 percent) with OSPHENA are: hot flush, vaginal discharge, muscle spasms, headache, hyperhidrosis, vaginal hemorrhage, night sweats.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
Spain1 matching products
Netherlands1 matching products
Details
| Made by | Duchesnay Inc |
|---|---|
| Active substance | Ospemifene |
| Used in | Urinary and reproductive system, hormones |
| Strength | 60 mg |
| Form | tablet |
| Classification | G03XC05 · Urinary and reproductive system, hormones |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02518112 |
| DPD drug code | 100744 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.