Patient Medication Information: uses, side effects, how to take - Amitiza
What is AMITIZA® used for?
AMITIZA® is used to treat chronic idiopathic constipation (CIC), (long-term constipation with an unknown cause), in adults, 18 years and older.
How does AMITIZA® work?
AMITIZA® is a drug that increases the secretion of fluids into the bowels.
By increasing intestinal fluid secretion, AMITIZA®:
- Softens the stool.
- Eases the passage of stool.
- Reduces straining.
- Increases the number of bowel movements.
What are the ingredients in AMITIZA®?
Medicinal ingredients: lubiprostone
Non-medicinal ingredients: Medium-chain triglycerides, gelatin, sorbitol, black ink, and purified water; Black ink composition: Propylene glycol, black iron oxide, polyvinyl acetate phthalate, and polyethylene glycol. May contain trace levels of lecithin.
AMITIZA® comes in the following dosage form:
Soft capsule 24 mcg
Do not use AMITIZA® if:
- You have known or suspected mechanical bowel obstruction (e.g., partial or complete blockage of the bowel caused by disease, inflammation, twisted tissue, foreign bodies or other cause).
- You are allergic (hypersensitive) to lubiprostone or to any ingredient of the capsule (See: What are the ingredients in AMITIZA®?)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AMITIZA®. Talk about any health conditions or problems you may have, including if:
- You have liver problems.
- The cause of your constipation is due to a bowel obstruction.
You are pregnant or planning to become pregnant. AMITIZA® is not recommended during pregnancy. Women of child-bearing potential should use contraception. Discuss with your healthcare professional if the potential benefit justifies the potential risk to the fetus.
- You are breastfeeding or planning to breastfeed.
Talk to your healthcare professional if the following occurs while taking AMITIZA®:
- You develop severe or persistent diarrhea. Stop taking AMITIZA® and contact your healthcare professional.
You develop persistent nausea. Taking AMITIZA® with food and water may help reduce the nausea.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
No drug interaction studies have been done with AMITIZA® and no interactions are expected with this product.
How to take AMITIZA®:
Usual adult dose, as prescribed by your healthcare professional: Take one capsule twice daily with food and water. Swallow capsules whole; do not break apart or chew. Your healthcare professional may lower the dose if you have liver problems.
Overdose:
Missed Dose:
If you miss a dose, you should take the missing dose of AMITIZA® as soon as possible. You should not take two capsules to make up for the missed dose. All doses should be taken at least 5 hours apart.
What are possible side effects from using AMITIZA®?
The most commonly observed side effects for AMITIZA® include nausea, diarrhea, abdominal pain/discomfort, dry mouth, gas, headache, dizziness, difficulty breathing (dyspnea), flushing, palpitations (irregular heartbeat), and sweating.
This is not a complete list of side effects. For any unexpected side effects while taking AMITIZA®, contact your healthcare professional.
If you think you have taken too much AMITIZA®, contact your healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report: Online at MedEffect; By calling 1-866-234-2345 (toll-free); By completing a Consumer Side Effect Reporting Form and sending it 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 at 15-30◦C. Protect from light and extreme temperatures. Do not freeze.
Keep out of the reach and sight of children.
If you want more information about AMITIZA®:
- 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; the manufacturer’s website (http://www.AMITIZA.com), or by calling 1-866-295-4636.
This information is current up to the last revision date shown below. More current information may be available from the manufacturer.