BINOSTO Important Safety Information
BINOSTO® (alendronate sodium) effervescent tablets for oral solution 70mg is a prescription medicine used to:
- Treat thinning of your bones (osteoporosis) in women after menopause. BINOSTO helps reduce the chance of having a hip or spinal fracture (break).
- Increase bone mass in men who have osteoporosis
It is not known how long BINOSTO works for the treatment of osteoporosis. You should see your doctor regularly to determine if BINOSTO is still right for you.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT BINOSTO EFFERVESCENT TABLET?
BINOSTO Effervescent Tablet can cause serious side effects, including:
- Esophagus Problems: Some people who take BINOSTO may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed
- It is important to take BINOSTO exactly as prescribed to help lower the chance of getting esophagus problems. BINOSTO should be taken after getting up for the day and 30 minutes before taking the first food, drink, or other medicine.
- Stop taking BINOSTO and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when swallowing.
- Low calcium levels in the blood (hypocalcemia): BINOSTO may lower the calcium levels in your blood. If you have low blood calcium before you start taking BINOSTO, it may get worse during treatment. Your Low blood calcium must be treated before taking BINOSTO. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as: Spasms, twitches, or cramps in your muscles or Numbness or tingling in your fingers, toes, or around your mouth.
- Bone, joint, or muscle pain: Some people who take BINOSTO develop severe bone, joint, or muscle pain.
- Severe jaw bone problems (osteonecrosis): Severe jaw bone problems may happen when you take BINOSTO. Your doctor should examine your mouth before starting BINOSTO. Your doctor may tell you to see your dentist before starting BINOSTO. It is important to practice good mouth care during treatment with BINOSTO
- Unusual thigh bone fractures: Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in the hip, groin, or thigh
Call your doctor right away if you have any of these side effects.
Do not take BINOSTO if you:
- Have certain problems with their esophagus, the tube that connects your mouth with your stomach
- Cannot stand or sit upright for at least 30 minutes
- Have trouble swallowing liquids
- Have low levels of calcium in their blood
- Become pregnant or suspect that you are pregnant or planning to become pregnant
- Are allergic to BINOSTO or any of its ingredients
Tell your doctor about all of your medical conditions, including if you have problems with swallowing, stomach or digestive problems, low blood calcium, plan to have dental surgery or teeth removed, kidney problems, trouble absorbing minerals in your stomach or intestines (malabsorption syndrome), been told to lower your salt intake, are pregnant, planning to become pregnant or suspect that you are pregnant, or are breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements, especially if you take calcium, antacids, aspirin, nonsteroidal anti-inflammatory (NSAID) medicines.
BINOSTO contains a high amount of salt in each tablet. Avoid eating foods with a high amount of salt if your doctor has told you to limit how much salt you eat.
Common side effects of BINOSTO are stomach area (abdominal) pain, heartburn, constipation, diarrhea, wind, upset stomach, pain in bones, joints or muscles and nausea. You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat.
If you would like more information, talk with your healthcare provider. You may report side effects to ASCEND Therapeutics® US, LLC at 1-877-204-1013
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Medication Guide for more details at www.binosto.com.