Consumer Information for: PROSTIN E2 TABLETS
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
PROSTIN® E2 Tablets is used to induce labour in pregnant women at the end or near the end of pregnancy.
What it does
PROSTIN® E2 Tablets is an oxytocic agent, it effect on uterine smooth muscle leads to the cervix ripening (opening of the uterus) and results in labour induction.
When it should not be used
PROSTIN® E2 Tablets should not be used if:
- You cannot be given Oxytocic drugs or unable to have prolonged contractions of the uterus;
- You have unexplained vaginal bleeding during pregnancy;
- You are unable to have vaginal delivery;
- When drugs used to stimulate labour are not required or when prolonged contraction of the uterus may be harmful to the baby’s safety or stability of the uterus;
- You are allergic to prostaglandins or any of the other ingredients in the PROSTINE E2 tablets;
- You have no engagement of the baby head (baby’s head down into the pelvic), or abnormal position of the placenta or umbilical cord, or fetal malpresentation (baby in the difficult position for the birth process).
- You have or have had untreated pelvic inflammatory disease
- You are having heart, lung, kidney, or liver disease, PROSTIN E2 Tablet should not be used together with other oxytocics
What the medicinal ingredient is
Dinoprostone
What the non-medicinal ingredients are
Corn starch, colloidal silicon dioxide, lactose anhydrous, magnesium stearate powder; food grade, microcrystalline cellulose.
What dosage form it comes in
PROSTIN® E2 Tablets are in glass bottles containing 10 tablets each.
Warnings and precautions
PROSTIN® E2 Tablets should be given to you only by
doctor experienced in using the drug.
BEFORE you use PROSTIN® E2 Tablets talk to your
doctor if:
- you are 35 year of age and over with complications during pregnancy;
- You have had blood clotting problem after giving birth (post-partum)
- You have or have had a seizure
- You have asthma or glaucoma
- You have heart, liver, kidney probleme
Interactions with this medication
Before receiving PROSTIN E2 Tablets, tell your doctor if you are taking others drugs including non-prescription and natural health products.
Proper use of this medication
Usual Dose
The recommended dose of PROSTIN® E2 Tablets is 0.5 mg (one tablet) followed in one hour by a second dose of 0.5 mg (one tablet). All subsequent doses should be given hourly. The lowest effective dose should be used. All doses should be taken with a small amount of water.
Overdose
Missed Dose
N/A
Side effects and what to do about them
In studies the most commonly reported adverse reactions were
vomiting, with or without nausea and diarrhea (21% at dose
0.5 – 3.0 mg).
Other adverse reactions include Fetal heart changes (6.5%),
uterine hypertonus (3.1%), and fetal distress syndrome.
This is not a complete list of side effects. For any
unexpected effects while taking PROSTIN® E2 Tablets,
contact your doctor or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Abnormal labour affecting fetus | ✔ | ||
| Fetal distress syndrome | ✔ | ||
| Uerine hypertonus | ✔ | ||
| Uncommon | |||
| Nausea, vomiting | ✔ | ||
| diarrhea | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking PROSTIN® E2 Tablets, contact your doctor or pharmacist.
How to store
Store in a refrigerator at a temperature lower than 4°C
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three 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 0701D
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, 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 at: http://www.pfizer.ca
This leaflet was prepared by Pfizer Canada Inc.
Last revised: 05 September 2012
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