Patient Medication Information: uses, side effects, how to take - Trulance
What is TRULANCE used for?
TRULANCE is used in adults to treat:
- a condition called irritable bowel syndrome with constipation (IBS-C).
- a type of constipation called chronic idiopathic constipation (CIC).
How does TRULANCE work?
TRULANCE is a medicine in a class of medicines called guanylate cyclase type C (GC-C) agonists. TRULANCE treats constipation by increasing the release of fluid into the bowels. This makes bowel movements softer and helps them occur more often. It also reduces abdominal pain by acting on nerves in the intestines. You may notice improvement of your bowel symptoms within the first week of treatment.
What are the ingredients in TRULANCE?
Medicinal ingredients: plecanatide
Non-medicinal ingredients: magnesium stearate and microcrystalline cellulose
TRULANCE comes in the following dosage form:
3 mg oral tablets
Do not use TRULANCE if:
- you are allergic to plecanatide or any of the other ingredients in TRULANCE.
- you are allergic to a component of the TRULANCE container.
- you are less than 6 years of age.
- a doctor has told you that you have bowel blockage (intestinal obstruction).
Serious Warnings and Precautions
|
TRULANCE must not be used in children under 6 years of age. It is not recommended for use in children and adolescents between 6 and 18 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRULANCE. Talk about any health conditions or problems you may have, including if you:
are pregnant or are planning to become pregnant.
- are breastfeeding or are planning to breastfeed.
Other warnings you should know about:
TRULANCE can cause diarrhea. It can sometimes be severe. Severe diarrhea can cause dehydration. Stop taking TRULANCE and contact your doctor right away if you get severe diarrhea (persistent watery stools).
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take TRULANCE:
- Take TRULANCE exactly as your doctor tells you to take it.
- Take one tablet by mouth once a day.
TRULANCE can be taken with or without food.
- Swallow the TRULANCE tablet whole.
- If you take TRULANCE with food and then have diarrhea or abdominal cramping, you should avoid high-fat, high-calorie meals near the time you take TRULANCE.
- Adults who cannot swallow TRULANCE tablets whole may crush the TRULANCE tablet and mix it with applesauce. TRULANCE can also be dissolved in water. It can also be taken with water through a nasogastric or gastric feeding tube.
- It is not known if TRULANCE is safe and effective when crushed and mixed with foods other than applesauce or when dissolved in liquids other than water. Therefore, if crushed, it should be taken with applesauce. If dissolved, it should be dissolved in water. Follow specific instructions for taking TRULANCE in applesauce, or in water or through a nasogastric or gastric feeding tube, below.
Taking TRULANCE in applesauce:
- Crush the TRULANCE tablet in a clean container until it is a powder.
- Mix it with 1 teaspoon of room temperature applesauce.
- Swallow all of the TRULANCE and applesauce mixture right away.
- Do not keep the TRULANCE and applesauce mixture for future use.
Taking TRULANCE in water:
- Place the TRULANCE tablet in a clean cup.
- Pour 30 mL (1 ounce) of room temperature water into the cup.
- Gently swirl the TRULANCE tablet and water for at least 10 seconds to mix. The TRULANCE tablet will fall apart in the water.
- Swallow all of the TRULANCE tablet and water mixture right away.
- Do not keep the mixture for future use.
- If you see any part of the tablet left in the cup, add another 30 mL of water to the cup, swirl for at least 10 seconds and swallow it right away.
Taking TRULANCE through a nasogastric or gastric feeding tube (with water):
- Gather the supplies you will need to take your TRULANCE dose. Your doctor should tell you what size catheter tipped syringe you will need for your dose. Ask your doctor if you have any questions about how to give TRULANCE the right way.
- Place the TRULANCE tablet in a clean cup.
- Add 30 mL (1 ounce) of room temperature water.
- Gently swirl the TRULANCE tablet and water for at least 15 seconds to mix. The TRULANCE tablet will fall apart in the water.
- Flush the nasogastric or gastric feeding tube with 30 mL (1 ounce) of water.
- Draw up the TRULANCE tablet and water mixture into a catheter tipped syringe and give right away through the nasogastric or gastric feeding tube. Do not keep the mixture for future use.
- If you see any part of the tablet left in the cup, add another 30 mL of water to the cup, swirl for at least 15 seconds and use the same catheter tipped syringe to give the mixture through the nasogastric or gastric feeding tube.
- Using the same or another catheter tipped syringe, flush the nasogastric or gastric feeding tube with at least 10 mL of water.
Usual adult dose:
Take one tablet once a day with or without food.
Overdose:
| If you think you have taken too much TRULANCE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you missed a dose, skip the missed dose that day. Take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
What are possible side effects from using TRULANCE?
These are not all the possible side effects you may feel when taking TRULANCE. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Diarrhea (loose, watery stools and passing stools more often)
- Dizziness
- Headache
- Nausea
- Common cold
- Back pain
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 | ||
| COMMON | |||
| Upper Respiratory Tract Infection such as | ✓ | ||
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 | ||
| bronchitis,laryngitis or sinusitis: cough, sneezing, runny nose, sore throat, fever, fatigue | |||
| Urinary Tract Infection (infection in urinary system including kidneys, ureters, bladder and urethra): blood in urine, cloudy urine, frequent urination, pain or burning sensation while urinating, pain in the pelvis, strong smelling urine | ✓ | ||
| Influenza (viral infection of your respiratory system) : sudden fever, chills, body aches, cough, sore throat | ✓ | ||
| UNCOMMON | |||
| Severe diarrhea | ✓ | ||
| UNKNOWN | |||
| Allergic Reactions: skin itching, hives, rash | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to 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 TRULANCE bottles and blister packs at room temperature (15-30°C).
- The TRULANCE bottle comes with a desiccant to help keep your medicine dry. Do not remove the desiccant from the bottle.
- Protect from moisture.
- Keep out of reach and sight of children.
If you want more information about TRULANCE:
- 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.html); the manufacturer’s website www.bauschhealth.ca, or by calling 1-800-361-4261.