Details for: IBSRELA
Company: KNIGHT THERAPEUTICS INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02498049 | IBSRELA | TENAPANOR (TENAPANOR HYDROCHLORIDE) | 50 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is 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).
What it does
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.
When it should not be used
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.
What the medicinal ingredient is
Medicinal ingredients: tenapanor (as tenapanor hydrochloride).
What the non-medicinal ingredients are
Non-medicinal ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, propyl gallate, stearic acid, tartaric acid, titanium dioxide and triacetin.
What dosage form it comes in
As tablets that contain 50 mg of tenapanor.
Warnings and precautions
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. It is not known if IBSRELA passes into your breast milk. Talk with your doctor about the best way to feed your baby.
Other warnings you should know about:
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
How to take IBSRELA:
- Take IBSRELA exactly as your doctor tells you to take it.
- Swallow the IBSRELA tablet whole.
- Do not crush or chew the tablet.
Interactions with this medication
Proper use of this medication
Usual Adult Dose
Take 1 tablet twice a day. Take IBSRELA immediately before breakfast or your first meal of the day. Then take your next tablet immediately before dinner.
Overdose
If you think you have taken too much IBSRELA, contact your 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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking IBSRELA. If you experience any side effects not listed here, contact 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
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Severe diarrhea | ✔ | ||
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.
How to store
- 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 packet to help keep your medicine dry. Do not remove the desiccant packet from the bottle.
Keep out of reach and sight of children.
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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
More information
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website, by emailing medinfo@gudknight.com, or by calling 1-844-483-5636.
IBSRELATM is a trademark of Ardelyx Inc., used under license by Knight Therapeutics Inc.
Last Revised April 15, 2020.