WHAT IS THE MOST IMPORTANT SAFETY INFORMATION I SHOULD KNOW?
MYCAPSSA can cause problems with the gallbladder. Tell your healthcare provider if you have any of these symptoms: sudden pain in your upper right stomach (abdomen) or right shoulder or between your shoulder blades; yellowing of your skin or the whites of your eyes; fever with chills; or nausea.
MYCAPSSA may affect your blood sugar, thyroid hormone, or vitamin B12 levels. Tell your healthcare provider if you have any problems or conditions related to these. Your healthcare provider may monitor these levels during your treatment with MYCAPSSA.
Tell your healthcare provider if you have an irregular heartbeat.
WHO SHOULD NOT USE MYCAPSSA?
MYCAPSSA can cause a serious allergic reaction including anaphylactic shock. Stop taking MYCAPSSA right away and get emergency help if you have any of these symptoms: swelling of your tongue, throat, lips, eyes or face; trouble swallowing or breathing; severe itching of the skin with rash or raised bumps; feeling faint; chest pain; or rapid heartbeat.
Do not use MYCAPSSA if you are allergic to octreotide or any other ingredients in MYCAPSSA. If you need to know the ingredients, ask your healthcare provider or pharmacist.
If you have certain other medical conditions, you should use MYCAPSSA with caution. Tell your healthcare provider about all your medical conditions, especially the following: pregnancy or breastfeeding; liver disease; kidney disease; or difficulty in emptying bladder completely.
Women taking an oral contraceptive should use an alternative non-hormonal method of contraception or a back-up method when taking MYCAPSSA. Tell your healthcare provider about all the medicines you take. MYCAPSSA may affect the way other medicines work, and other medicines may affect how MYCAPSSA works.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF MYCAPSSA?
The most common side effects are headache, joint pain, nausea, weakness, diarrhea, and sweating a lot.
Please contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Keep MYCAPSSA and all medicines out of the reach of children.
HOW SHOULD I TAKE MYCAPSSA?
Do not take MYCAPSSA with food. MYCAPSSA should be taken with a glass of water on an empty stomach. Take MYCAPSSA at least 1 hour before a meal or at least 2 hours after a meal (for example, you could take your morning dose 1 hour before breakfast and your evening dose at bedtime).
Please see full Prescribing Information, including Medication Guide.