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ENDOMETRIN VAGINAL TABLETS 100 MG [SIN15005P]

Active ingredients: ENDOMETRIN VAGINAL TABLETS 100 MG

Last updated 26 October 2025

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Product Info
Instructions for Use

Product Info

ENDOMETRIN VAGINAL TABLETS 100 MG

[SIN15005P]

Product information

Active Ingredient and Strength

PROGESTERONE, MICRONIZED - 100 MG

Dosage Form

TABLET, EFFERVESCENT

Manufacturer and Country

SEVER PHARMA SOLUTIONS AB - SWEDEN

Registration Number

SIN15005P

Licence Holder

FERRING PHARMACEUTICALS PRIVATE LIMITED

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

G03DA04

THERAPEUTIC INDICATIONS
ENDOMETRIN® is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.

POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The dose of ENDOMETRIN® is 100 mg administered vaginally two or three times daily starting at oocyte retrieval and continuing for up to 10 weeks total duration (or 12 weeks of gestation).

Specific populations may derive greater benefits from BID or TID dosing regimen and the clinician can tailor treatment to the patient (see “Clinical efficacy and safety” section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Serum progesterone levels may be measured 7 days post fertilization and used to guide therapy.

Paediatric population
There is no relevant use of ENDOMETRIN® in the paediatric population.

Elderly
No clinical data have been collected in patients over age 65.

Use in special populations
There is no experience with use of ENDOMETRIN® in patients with impaired liver or renal function.

Method of Administration
ENDOMETRIN® is to be placed directly into the vagina by the applicator provided.

Instructions for Use

  1. Unwrap the applicator.

  2. Put one tablet in the space provided at the end of the applicator. The tablet should fit securely and not fall out.

  3. The applicator with the tablet may be inserted into the vagina while you are standing, sitting, or when lying on your back with your knees bent. Gently insert the thin end of the applicator well into the vagina.

  4. Push the plunger to release the tablet.

Remove the applicator and rinse it thoroughly in warm running water, wipe dry with a soft tissue and keep the applicator for subsequent use.

Endometrin Dosage Image 1



CONTRAINDICATIONS
ENDOMETRIN® should not be used in individuals with any of the following conditions:

  • Hypersensitivity to the active substance or to any of the excipients listed in section QUALITATIVE AND QUANTITATIVE COMPOSITION – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

  • Undiagnosed vaginal bleeding

  • Known missed abortion or ectopic pregnancy

  • Severe hepatic dysfunction or disease

  • Known or suspected breast or genital tract cancer

  • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events

  • Porphyria