Patient Medication Information: uses, side effects, how to take - Dipentum
What is DIPENTUM® used for?
DIPENTUM is used:
- In patients with a condition called ulcerative colitis who no longer have symptoms. It used as a maintenance treatment to prevent symptoms from returning.
- To treat a condition called acute ulcerative colitis. It is used in patients with mild to moderate ulcerative colitis. It is used with our without other medicines called steroids.
How does DIPENTUM® work?
DIPENTUM acts inside the large intestine to stop inflammation or to prevent it from coming back.
After about a week, you will know that DIPENTUM is working if you have 3 or less stools per day without blood. Ulcerative colitis usually doesn’t go away completely, but using DIPENTUM regularly can lower the risk of symptoms coming back.
What are the ingredients in DIPENTUM®?
Medicinal ingredients: Olsalazine sodium
Non-medicinal ingredients: Black iron oxide, caramel, gelatin, magnesium stearate and titanium dioxide.
DIPENTUM® comes in the following dosage forms:
Capsule, 250 mg
Do not use DIPENTUM® if:
- You are allergic to olsalazine or to any other ingredients in this DIPENTUM.
- You are allergic to medicines called salicylates, such as acetylsalicylic acid (Aspirin)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DIPENTUM®. Talk about any health conditions or problems you may have, including if you:
- Have severe allergies or asthma
- Have kidney problems
- Have liver problems
- Have received the varicella vaccine (for shingles or chicken pox) in the past 6 weeks
Are pregnant or planning to become pregnant
- Are breastfeeding or planning to breastfeed
Other warnings you should know about:
Diarrhea: You may get diarrhea when you start taking DIPENTUM. Talk to your healthcare professional if you experience severe diarrhea. Severe diarrhea means having more than 10 loose, watery stools in a single day.
The diarrhea caused by the medicine is different than the one caused by the disease:
- Diarrhea caused by the medicine: 4 or more loose, watery stools without blood in a single day. It usually goes away by itself.
- Diarrhea caused by the disease: 4 or more stools with blood in a single day.
If your diarrhea becomes more frequent and sometimes contains blood, talk to your healthcare professional, especially if you also experience fever, skin rash, cramps or nausea.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with DIPENTUM®:
- Medicines called salicylates, such as acetylsalicylic acid (Aspirin), used to reduce pain and fever.
- Warfarin, a medicine used thin your blood and prevent blood clots.
- Thioguanine or mercaptopurine, medicine used to treat cancer.
- Varicella vaccine.
How to take DIPENTUM®:
- Take DIPENTUM exactly as your healthcare professional tells you to.
- Take it at regular intervals (i.e. same amount of time between each dose).
Take DIPENTUM with meals.
- Swallow the capsules whole with water.
- Keep taking DIPENTUM every day to prevent your symptoms from coming back.
- Your healthcare professional may decrease your dose for a few days or split it in smaller doses if you get watery diarrhea. Do not change your dose yourself.
- Your healthcare professional may also prescribe to you other medicines called steroids.
- Check with your healthcare professional if you are not sure how to take DIPENTUM.
Usual dose:
Your healthcare professional will tell you how much DIPENTUM to take and how often to take it.
Overdose:
Taking too much DIPENTUM can cause nausea, vomiting and diarrhea.
| If you think you, or a person you are caring for, have taken too much DIPENTUM, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss a dose of DIPENTUM, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. You must never take more than 4 capsules at the same time.
What are possible side effects from using DIPENTUM®?
These are not all the possible side effects you may have when taking DIPENTUM®. If you experience any side effects not listed here, tell your healthcare professional.
- Abdominal pain or cramps
- Bloating
- Blood in stool
- Depression
- Diarrhea
- Dizziness
- Fatigue, drowsiness or lack of energy
- Headache
- Heavy menstrual bleeding
- Impotence
- Losing hair
- Sore mouth
- Insomnia
- Itching
- Joint pain
- Loss of appetite
- Mood swings
- Nausea
- Rash
- Redness of the skin
- Runny nose
- Sensitivity to light
- Tingling, numbness or “pins and needles.”
- Tremors
- Upset stomach
- Urticaria
- Vertigo
- Vomiting
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNKNOWN | |||
| Anaphylactic reaction (severe allergic reaction): swelling, shortness of breath, wheezing, hives, skin rash, chest tightness, cramps, diarrhea, nausea, vomiting, light-headedness, pounding or racing heartbeat | x | ||
| Bronchospasm (tightening of the muscles in the lungs): wheezing, coughing, difficulty breathing | x | ||
| Cardiac disorders (heart problems): chest pain, tightness in the chest, swelling, fatigue, trouble breathing or shortness of breath, palpitations, the feeling that your heart skips beats, pounding or racing heartbeat, light-headedness | x | ||
| Drug-induced hypersensitivity colitis (inflammation of the intestine caused by the medicine): diarrhea that often contains blood, fever, skin rash, abdominal cramps, nausea | x | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Drug-related diarrhea (diarrhea caused by the medicine): 4 or more watery stools per day, without blood | x | ||
| Erythema nodosum (inflammation of the fat layer under the skin): red or purple painful bumps on the skin, on usually on the legs, shins or tights | x | ||
| Hematotoxicity (damage to the blood cells): fever, sore throat, mouth ulcers, bruising, abnormal bleeding, skin rash | x | ||
| Hepatitis (inflammation of the liver): yellowing of the skin, abdominal pain, itching, fever, fatigue, nausea, vomiting | x | ||
| Interstitial lung disease (inflammation and scarring in the lungs): shortness of breath, dry cough, fatigue, chest discomfort | x | ||
| Peripheral neuropathy (damage to the nerves): weakness, uncontrolled movements, tingling and numbness in the extremities, clumsiness | x | ||
| Renal and urinary disorders (disease of the kidneys or bladder): pain or burning when peeing, blood in urine, increased or decreased urine quantity or frequency, swelling, abdominal pain, nausea, vomiting, drowsiness, confusion | x | ||
Serious life-threatening skin reactions (Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)): fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling | x | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| thirsty, urinating less often, less urine or dark urine, hives, red or dry itchy skin, purple or red spots on skin | |||
| Severe diarrhea: 10 or more watery stools in a day | x | ||
| Worsening of symptoms of allergies | x | ||
| Worsening of symptoms of asthma | x | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store in a well closed container at room temperature (15°C to 30°C).
Keep out of reach and sight of children.
If you want more information about DIPENTUM®:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-
- -product-database.html); the manufacturer’s website www.searchlightpharma.com, or by calling 1-855-331-0830.