- Approval Id
- 6d651a7a3ab1e44f
- Drug Name
- ELLA TABLET 30MG
- Product Name
- ELLA TABLET 30MG
- Approval Number
- SIN13979P
- Approval Date
- 2011-06-21
- Registrant
- HYPHENS PHARMA PTE. LTD.
- Licence Holder
- HYPHENS PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **4.2 Posology and method of administration**
Posology
The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.
The tablet can be taken with or without food.
If vomiting occurs within 3 hours of Ella intake, another tablet should be taken.
Ella can be taken at any moment during the menstrual cycle.
Pregnancy should be excluded before Ella is administered.
_Special populations_
_Renal or hepatic impairment:_
In the absence of specific studies, no specific dose recommendations for Ella can be made.
_Severe hepatic impairment:_
In the absence of specific studies, Ella is not recommended.
_Children and adolescents:_
A limited number of women under 18 years were included in clinical trials of Ella.
Method of administration
Oral use.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
- Contraindications
- **4.3 Contraindications**
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
Pregnancy.
- Atc Code
- G03AD02
- Atc Item Name
- ulipristal
- Pharma Manufacturer Name
- HYPHENS PHARMA PTE. LTD.
- Company Detail Path
- /organization/hyphens-pharma-pte-ltd-singapore
