Patient Medication Information: uses, side effects, how to take - Ibsrela
What is IBSRELA used for?
- IBSRELA is used in adults (18 years of age and older) to treat a condition called irritable bowel syndrome with constipation (IBS-C).
How does IBSRELA work?
IBSRELA is a medication in a class called an inhibitor of the sodium / hydrogen exchanger 3 (NHE3). It reduces the amount of sodium that your bowels absorb. This increases the release of fluid into the bowels. IBSRELA eases abdominal pain and increases the number of bowel movements. You should notice improvement within the first week of taking IBSRELA.
What are the ingredients in IBSRELA?
Medicinal ingredients: tenapanor (as tenapanor hydrochloride).
Non-medicinal ingredients: colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, propyl gallate, stearic acid, tartaric acid, and the coating agent OPADRY®, which consists of hypromellose, titanium dioxide and triacetin.
IBSRELA comes in the following dosage forms:
As tablets that contain 50 mg of tenapanor.
Do not use IBSRELA if:
- you are allergic to tenapanor hydrochloride or any of the other ingredients in IBSRELA;
- you are allergic to a component of the IBSRELA container;
- you are less than 6 years of age;
- a doctor has told you that you have or you might have a bowel blockage, called a gastrointestinal obstruction.
Serious Warnings and Precautions
Do not give IBSRELA to children who are less than 6 years of age. IBSRELA can cause severe diarrhea in children. This can lead to severe dehydration (loss of large amounts of water and salt in the body). This can seriously harm a child who is less than 6 years of age.
- IBSRELA is not recommended for use in children between 6 years and 18 years of age. It is not known if IBSRELA is safe in children and adolescents between 6 years and 18 years of age. It may harm them.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IBSRELA. Talk about any health conditions or problems you may have, including if you:
Are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if IBSRELA will harm your unborn baby.
- Are breast-feeding or planning to breastfeed, although IBSRELA is not expected to pass into your breast milk and harm your baby. Talk with your doctor about the best way to feed your baby.
Other warnings you should know about:
Diarrhea: IBSRELA can cause diarrhea. It can sometimes be severe. Severe diarrhea can cause dehydration. Stop taking IBSRELA and get immediate medical help 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.
When IBSRELA is co-administered with enalapril you should monitor blood pressure and, if needed, your healthcare professional could ask you to increase the dosage of enalapril.
The following may interact with IBSRELA:
- Enalapril
How to take IBSRELA:
- Take IBSRELA exactly as your doctor tells you to take it.
- Take IBSRELA immediately before breakfast or your first meal of the day. Then, take your next tablet immediately before dinner.
- Swallow the IBSRELA tablet whole.
- Do not crush or chew the tablet.
Usual dose:
Take 1 tablet twice a day.
Overdose:
If you think you, or a person you are caring for, have taken too much IBSRELA, 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 IBSRELA, skip the missed dose. Take your next dose at the usual time. Never take two doses at the same time to make up for a missed dose.
What are possible side effects from using IBSRELA?
These are not all the possible side effects you may have when taking IBSRELA. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Diarrhea (loose, watery stool and passing stools more often)
- An urgent need to pass stool
- Flatulence (passing gas)
- Abdominal bloating or pain
- Abnormal sounds coming from your abdomen
- Inflammation of your nasal passages and throat such as with the common cold
- Dizziness
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 | ||
| UNCOMMON | |||
| Severe diarrhea | √ | ||
| UNKNOWN | |||
| Allergic reaction: skin rash, hives, itching, swelling including of the face, tongue, throat, mouth or lips, difficulty breathing or swallowing, wheezing, chest tightness. | √ | ||
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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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 IBSRELA at room temperature between 15°C and 30°C.
Keep IBSRELA in the bottle that it comes in.
Protect from moisture.
The IBSRELA bottle contains a desiccant canister to help keep your medicine dry. Do not remove the desiccant canister from the bottle.
Keep out of reach and sight of children.
If you want more information about IBSRELA:
- 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://health-products.canada.ca/dpd-bdpp/); the manufacturer’s website (https://www.knighttx.com/), by emailing medinfo@knighttx.com or by calling 1-844-483-5636.
IBSRELA® is a registered trademark of Ardelyx Inc., used under license by Knight Therapeutics Inc.