Emcyt - Consumer Medicine Information
|Class:||Antineoplastics, Hormones/antineoplastics, Mitotic inhibitors|
|Ingredients:||estramustine sodium phosphate, magnesium stearate, silica (colloidal anhydrous), sodium lauryl sulphate, and talc|
Estramustine Sodium Phosphate
About This Medication
What the Medication Is Used For
EMCYT is used for the treatment of metastatic cancer of the prostate in patients whose disease is not responding to hormone therapy.
What It Does
EMCYT interferes with the growth of tumour cells and may also help to slow down the growth of prostate cancer cells.
When It Should not be Used
Do not take EMCYT if you have any of the following conditions:
- allergic reactions to estramustine sodium phosphate, or estradiol, or nitrogen mustard, or any of the other ingredients in EMCYT
- severe liver disease
- severe heart disease
- active inflammation of veins (thrombophlebitis) or blood clot disorders.
What the Medicinal Ingredient Is
The medicinal ingredient is estramustine sodium phosphate.
What the Important Nonmedicinal Ingredients Are
Nonmedicinal ingredients include magnesium stearate, silica (colloidal anhydrous), sodium lauryl sulphate, and talc.
What Dosage Form It Comes In
EMCYT is available as 140 mg capsules.
Warnings and Precautions
Serious Warnings and Precautions
|EMCYT should be prescribed and used under the supervision of a doctor experienced in the use of cancer drugs.|
BEFORE you use EMCYT talk to your doctor or pharmacist if you:
- Have or had severe liver disease
- Have or had blood clot disorders.
- Have a history of stroke or heart disease
- Have swelling of the legs or heart failure
- Have high blood pressure
- Have bone disease associated with high calcium levels
- Have kidney problems
- Have diabetes
Patients receiving chemotherapy agents, including EMCYT, should not be given live vaccines, or be in contact with any person who has received live vaccines, as this may result in serious infections and death.
A male patient and his female partner must use effective contraceptive methods as EMCYT can cause harm to an unborn child.
Interactions With This Medication
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
Drugs that may interact with EMCYT include:
- tricyclic antidepressants.
- supplements or antacids that contain calcium or milk products.
- ACE-Inhibitors (drugs to treat high blood pressure).
Proper Use of This Medication
The recommended dose of EMCYT is 14 mg for every kg of body weight each day. The total dose is given in 3 or 4 divided doses during the day.
The capsules should be taken on an empty stomach, at least 1 hour before or 2 hours after meals.
The capsules should be swallowed with a glass of water. Do not take with milk, milk products or calcium containing drugs (for example, antacids).
|If you think you have taken too much EMCYT, contact a health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double dose.
Side Effects and What to Do About Them
Side effects may include:
- Nausea, vomiting, diarrhea, stomach upset
- Sleepiness, fatigue
- Muscle weakness
- Erectile dysfunction
- Decreased interest in having sex (low libido)
- Breast enlargement, tenderness or pain
If any of these affects you severely, tell your doctor or pharmacist.
EMCYT can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
Side Effects, how Оften They Happen and What to Do About Them
|Symptom / effect||Talk with your|
|Very Common||Nausea, vomiting, diarrhea, stomach upset||✓|
|Heart failure (symptoms include trouble breathing)||✓|
|Anemia (fatigue, loss of energy, weakness, shortness of breath)||✓|
|Decreased White Blood Cells (infections, fatigue, fever, aches, pains, and flu-like symptoms)||✓|
|Edema (fluid retention, swelling)||✓|
|Liver Disorder (yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite)||✓|
|Common||Heart attack (sudden or sever chest pain)||✓|
|Blood clot (pain, redness, warmth, swelling in the leg)||✓|
|Decreased Platelets (bruising, bleeding, fatigue and weakness)||✓|
|Uncommon||Stroke (sudden or sever headache, confusion, weakness or numbness in arm and leg, and vision problems)||✓|
|Unknown||Allergic reaction / anaphylaxis / angioedema (itching, rash, hives, swelling, tightness in chest, trouble breathing)||✓|
|Cardiac ischemia (decreased oxygen in the heart with symptoms such as chest pressure or pain, shortness of breath)||✓|
|Depression (sad mood)||✓|
|High Blood Pressure (symptoms can include headache, dizziness, blurred vision, nausea, vomiting, chest pain, shortness of breath)||✓|
This is not a complete list of side effects. For any unexpected effects while taking EMCYT, contact your doctor or pharmacist.
How to Store It
Store between 2°- 25°C.
Keep out of reach and sight of children.
Reporting Suspected Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels and the Consumer Side Effects Reporting Form are available at MedEffect.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: www.pfizer.ca
or by contacting the sponsor, Pfizer Canada Inc., Medical Information at 1-800-463-6001