Endometrin - Consumer Medicine Information
|Condition:||Amenorrhea, Progesterone Insufficiency|
|Form:||Vaginal (e.g., douche, pessary, etc.), Tablets|
|Ingredients:||Progesteronelactose, monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicone dioxide.|
Progesterone Effervescent Vaginal Tablets, 100 mg
About This Medication
What the Medication is Used For
Endometrin is used as a progesterone supplement in women undergoing treatment for in vitro fertilization (IVF).
What It Does
Progesterone is one of the hormones essential for helping you to become and to stay pregnant.
When It Should not be Used
Do not use Endometrin if you:
- are allergic to progesterone or any of the other ingredients in Endometrin
- have severe liver disease
- have or have had blood clots in the leg, lungs, eyes, or elsewhere in the body, or thrombophlebitis (inflammation of the veins)
- have breast cancer, suspected breast cancer or genital track cancer
- have Acute Porphyria (a blood disease),
- have known missed abortion or ectopic pregnancy (the fertilized egg attaches somewhere other than the uterus).
- undiagnosed vaginal bleeding.
What the medicinal ingredient is
The medicinal ingredient is progesterone.
What the Important Nonmedicinal Ingredients Are
The important nonmedicinal ingredients are: lactose monohydrate, polyvinylpyrrolidone, adipic acid, sodium bicarbonate, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and colloidal silicone dioxide.
What Dosage Forms It Comes In
Each Endometrin vaginal tablet is a white to off-white oblong-shaped tablet debossed with “FPI” on one side and “100” on the other side. Each Endometrin® (progesterone) vaginal tablet 100 mg, is packed individually in a sealed foil pouch. These pouches are available in cartons packed with 21 vaginal tablets and 21 disposable vaginal applicators.
Warnings and Precautions
Before starting treatment you and your partner should be assessed by a doctor for causes of infertility. Before using Endometrin, talk to your doctor if you have or have had the following condition:
- a history of breast disease (e.g., breast lumps) or a family history of breast cancer or genital track cancer
- high blood pressure
- heart or kidney disease
- history of depression
- migraine headache
- a history of seizures/epilepsy
- a history of blood clots, heart attack or stroke
- unusual vaginal bleeding without a known reason
- a history of liver disease or jaundice
- breast feeding
- water retention
Interactions With This Medication
Tell your doctor or pharmacist if you are taking, or have been taking, any other medicines, even medicines you buy without a prescription, and natural health products. Certain drugs may interact with progesterone. Endometrin is not recommended for use with other vaginal products (such as those to treat vaginal yeast infection).
Proper Use of This Medicaton
Use Endometrin exactly as prescribed by your doctor.
One tablet inserted into the vagina 2 to 3 times a day.
How to use Endometrin
- Unwrap the applicator.
- Put one tablet in the space provided at the end of the applicator. The tablet should fit snugly and not fall out.
- While you are standing, sitting, or when lying on your back with your knees bent, gently place the thin end of the applicator well into the vagina.
- Push the plunger to release the tablet.
- Remove the applicator and throw it away in the trash.
Call your doctor if you use too much Endometrin, or contact poison control centre.
If you forget a dose of Endometrin, take the dose as soon as you remember, but do not use more than your daily dose.
Side Effects and What to Do About Them
Sex steroids may also increase the risk of vision impairment. Talk to your doctor if you are 35 years of age or older, and smoking to prevent complications. Endometrin should be stopped and contact your doctor immediately if you experience sudden severe headache, impaired vision and stroke
The sudden discontinuation of Endometrin may cause increased anxiety, moodiness and increased risk of seizures. If depression worsens Endometrin should be discontinued.
Common side effects with Endometrin include: abdominal pain, nausea, swollen ovaries (ovarian hyperstimulation syndrome), abdominal bloating, headache, uterine cramping, vaginal bleeding, vomiting, urinary infections, constipation and tiredness. A side effect associated with IVF includes post procedural pain such as pain post-oocyte retrieval (pelvic pain after surgery).
Less common side effects include vaginal irritation such as genital itching, vaginal burning sensation, vaginal discomfort and discharge, and swelling of the limbs.
Other reported side effects similar to other drugs containing progesterone include breast tenderness, mood swings, irritability and drowsiness.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your doctor or pharmacist||Stop taking drug and talk to your doctor or pharmacist|
|Only if severe||In all cases|
|Common||Mild OHSS (Ovarian Hyperstimulation Syndrome) |
Fluid retention in abdomen
|Pelvic Pain After Surgery||✓|
|Less Common||Vaginal Irritation |
Vaginal burning sensation
|Swelling of the Limbs||✓|
Similar symptoms as above but more severe
This is not a complete list of side effects. For any unexpected effects while taking Endometrin, contact your doctor or pharmacist.
How to Store It
Store Endometrin at room temperature, 20-25º C. Excursions permitted to 15-30 º C.
Reporting Suspected Side Effects
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at : 1- 866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789 or,
- Mail to: Canada Vigilance Program
Postal Locator 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effect, please contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found by contacting Ferring Inc. at 1-866-373-1333.