Patient Medication Information: uses, side effects, how to take - Elmiron
ABOUT THIS MEDICATION
What the medication is used for:
The treatment of inflammation and irritation of the bladder wall (interstitial cystitis).
What it does:
ELMIRON® is thought to adhere to the bladder surface supplementing the defective bladder layer. It is hypothesized that this action improves the symptoms of interstitial cystitis.
When it should not be used:
Do not use ELMIRON® if you are allergic to pentosan
polysulfate sodium, related compounds or any of the other ingredients.
Do not use ELMIRON® if you have a personal history
of eye disease that affects the retina.
What the medicinal ingredient is:
pentosan polysulfate sodium
What the nonmedicinal ingredients are:
gelatin capsule, magnesium stearate, microcrystalline cellulose, and titanium dioxide.
What dosage forms it comes in:
Capsules: 100 mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Do not use ELMIRON® if you have a personal history of eye disease that affects the retina.
Cases of retinal changes (pigmentary maculopathy) have been reported with long-term use of ELMIRON®. This eye disease changes the centre of the retina (called the ‘macula’). This may harm your vision and may lead to a permanent decrease or loss of central vision. Tell your doctor and eye doctor right away if you notice any changes in your vision.
While taking ELMIRON®, regular eye exams that include checking your retina are recommended for detection of pigmentary maculopathy. Your doctor will decide when these eye exams are needed, and if the treatment should be continued.
BEFORE you use ELMIRON® talk to your doctor or pharmacist if:
- You are taking anticoagulant therapy such as coumarin anticoagulants, heparin, tPA, streptokinase, high-dose ASA (acetylsalicylic acid) or anti-inflammatory drugs such as ibuprofen
- You are at increased risk of bleeding due to diseases such as ulcerative GI lesions (sores inside your digestive tract), aneurysms (balloon-like bulges in a blood vessel), or diverticulae (small protrusions of the lining of the intestine into the surrounding muscle).
- You will be undergoing surgery
You are pregnant or breastfeeding
- You have liver problems
- You have a personal or family history of eye problems. Tell your doctor if you notice any changes in your vision.
The safety and effectiveness of ELMIRON® in children and adolescents below the age of 18 years have not been established.
INTERACTIONS WITH THIS MEDICATION
Since ELMIRON® is a weak anticoagulant (blood thinner), tell your doctor or pharmacist if you are taking any other anti-coagulant therapy such as warfarin, high-dose ASA (acetylsalicylic acid), and nonsteroidal anti-inflammatory drugs (NSAIDS).
PROPER USE OF THIS MEDICATION
Usual dose:
The recommended dose of ELMIRON® is 300 mg/day taken as one 100 mg capsule orally three times daily. The capsules should be taken with water at least 1 hour before meals or 2 hours after meals.
Overdose:
Call your doctor or go to the nearest hospital emergency department. Take the labelled medicine bottle with you.
Missed dose:
Take the dose as soon as you remember. If it is almost time for your next dose, skip the dose you missed and take your next dose. Do not double doses to make up for the missed dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
ELMIRON® is usually well tolerated. Reported adverse reactions are infrequent and usually do not require discontinuation of treatment. The most common reactions are associated with digestion, blood, and skin. Common reactions you may experience include nausea and hair loss. Other possible side effects include urticaria (hives), itching, and shortness of breath.
This medication can raise your liver enzymes. This can be confirmed by blood tests ordered by your doctor.
| 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 call your doctor or pharmacis t | ||
| Only if severe | In all cases | |||
| Common | Headache Abdominal pain Diarrhea Rash Abnormal liver function test Blood in stool Nose bleed Gum bleeding | |||
| Uncommon | Dizziness Bruising Allergic reactions | |||
| 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 call your doctor or pharmacis t | ||
| Only if severe | In all cases | |||
| Unknown | Pigmentary Maculopathy (Eye disease that affects the retina): difficulty reading; slow adjustment to low or reduced light, blurry vision, blurry or wavy vision near or in the center of your field of vision | |||
This is not a complete list of side effects. For any unexpected effects while taking ELMIRON®, contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature (15°C to 30°C). Keep out of the reach of children.
REPORTING SUSPECTED 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 3 ways:
- Report online at www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.
- 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 1908C
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.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting
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
For questions, concerns or full Product Monograph go to: http://www.janssen.com/canada
or contact the manufacturer, Janssen Inc., at: 1-800-567-3331or 1-800-387-8781
Janssen Inc.
Toronto, Ontario M3C 1L9
Last revised: October 1, 2020
*Registered trademark of IVAX Research, LLC. Used under license.