Yosprala® is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.

Important Safety Information about Yosprala

You should take Yosprala (aspirin and omeprazole) exactly as prescribed, at the lowest dose possible and for the shortest time needed. Do not stop taking Yosprala without talking with your doctor. Stopping Yosprala suddenly could increase your risk of having a heart attack or stroke.

Do not take Yosprala if you are allergic to aspirin, omeprazole, or any of the ingredients in Yosprala. Do not take Yosprala if have a medical condition with severe shortness of breath, chest tightness or pain, coughing or wheezing (asthma), sneezing, runny nose or itchy nose (rhinitis), and growths inside of your nose or sinuses (nasal polyps). Do not take Yosprala if you are allergic to any non-steroidal anti-inflammatory drug.

Do not take Yosprala if you are taking a medicine that contains rilpivirine such as EDURANT®, COMPLERA®, or ODEFSEY®.

Yosprala should not be used in children.

Tell your doctor if you have unexpected bleeding, if you bleed more than usual, or if your bleeding lasts longer than is normal for you, such as increased bruising or more frequent nose bleeds after taking Yosprala.

Tell your doctor if you have stomach problems while taking or after you stop taking Yosprala. Stop taking Yosprala and call your doctor right away if you have any of the following signs or symptoms: black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds, or severe nausea, vomiting, or stomach pain.

Avoid heavy alcohol use (3 or more drinks daily) during treatment with Yosprala.

Yosprala contains aspirin and omeprazole. Before taking Yosprala, tell your doctor if you take:

  • aspirin, or any prescription or over-the-counter medicines containing aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)
  • clopidogrel bisulphate (PLAVIX®). You should not take clopidogrel bisulphate (PLAVIX®) if you take Yosprala.
  • ticagrelor (BRILINTA®). If your doctor prescribes Yosprala for you, you should not take Yosprala that contains the 325/40 mg strength dose.

Kidney problems may happen at any time during treatment with Yosprala. Call your doctor if you have a decrease in the amount that you urinate, have blood in your urine, changes in urination, swelling, skin rash or itching, or your breath smells like ammonia.

Yosprala can cause diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor if you have watery stools or stomach pain that does not go away. You may or may not have a fever.

Bone fractures (hip, wrist, or spine) in people who take multiple daily doses of proton pump inhibitor (PPI)-containing medicines like Yosprala for a long period of time (a year or longer) may occur.

Certain types of lupus erythematosus may happen or get worse in people who already have lupus and who take PPI medicines, including Yosprala. Call your doctor right away if you have joint pain or a rash on your cheeks or arms that gets worse in the sun.

Liver problems may happen during treatment with Yosprala. Tell your doctor if you have signs or symptoms of liver problems, including: yellowing of your skin or your eyes, stomach-area (abdominal) pain and swelling, itchy skin, and dark (tea-colored) urine.

Low vitamin B12 levels in your body can happen in people who have taken a PPI medicine, such as omeprazole, for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B12 levels, including: shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness.

Low magnesium levels in your body can happen in people who have taken Yosprala for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including: seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

If you are pregnant, planning to become pregnant, or nursing, talk to your doctor before taking Yosprala. Breastfeeding is not recommended during treatment with Yosprala.

Tell your doctor about all the medicines you take, including prescription and non-prescription drugs, anti-cancer drugs, vitamins, and herbal supplements. Yosprala may affect how other medicines work, and other medicines may affect how Yosprala works. This can cause serious side effects.

Especially tell your doctor if you are taking:

  • a medicine that contains rilpivirine (EDURANT®, COMPLERA®, ODEFSEY®)
  • clopidogrel bisulphate (PLAVIX®)
  • ticagrelor (BRILINTA®)
  • John’s Wort (Hypericum perforatum)
  • methotrexate (OTREXUP, RASUVO, TREXALL)

Yosprala is not interchangeable with the individual components of aspirin and omeprazole.

The most common side effects of Yosprala include: indigestion or heartburn and stomach-area pain, nausea, diarrhea, growths (polyps) in your stomach, and chest pain behind the breastbone, for example, with eating.

The risk information provided here is not comprehensive. To learn more, talk about Yosprala with your pharmacist or other health care providers. The product information can be found at www.Yosprala.com or 1-866-207-6592.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs. To report suspected adverse events contact Aralez Pharmaceuticals at 1-866-207-6592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, please visit www.yosprala.com

This product information is intended only for residents of the United States.