What Endometrin is used for and how to use it
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Endometrin - Consumer Medicine Information

Manufacture: Ferring Pharmaceuticals
Country: Canada
Condition: Amenorrhea, Progesterone Insufficiency
Class: Progestins
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
  • diabetes
  • 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
  • asthma
  • smoking

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.

Usual Dose

One tablet inserted into the vagina 2 to 3 times a day.

How to use Endometrin

  1. Unwrap the applicator.
  2. Put one tablet in the space provided at the end of the applicator. The tablet should fit snugly and not fall out.
  3. 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.
  4. Push the plunger to release the tablet.
  5. Remove the applicator and throw it away in the trash.

Overdose

Call your doctor if you use too much Endometrin, or contact poison control centre.

Missed Dose

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 / effectTalk with your doctor or pharmacistStop taking drug and talk to your doctor or pharmacist
Only if severeIn all cases
CommonMild OHSS (Ovarian Hyperstimulation Syndrome)
Weight Gain,
Bloating,
Fluid retention in abdomen
Nausea
Vomiting
Pelvic pain
Pelvic Pain After Surgery
Abdominal pain
Nausea
Abdominal bloating
Headache
Uterine Cramping
Vaginal Bleeding
Vomiting
Urinary Infection
Constipation
Tiredness
Breast Tenderness
Mood Swings
Irritability
Drowsiness
Less CommonVaginal Irritation
Genital itching
Vaginal burning sensation
Vaginal discomfort
Discharge
Swelling of the Limbs
UncommonSevere OHSS
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
    Health Canada 
    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.

More Information

This document plus the full product monograph, prepared for health professionals can be found by contacting Ferring Inc. at 1-866-373-1333.