Binosto

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Medication Guide provided by your pharmacist before you start taking alendronate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is taken once per week. Choose the day of the week that best fits your schedule and take it on that day each week.

Take this medication by mouth, after getting up for the day and before taking your first food, beverage, or other medication. Do not swallow, chew, or suck on the tablet since this may cause mouth/throat irritation or ulcers. You must dissolve the tablet before you take it. Place the tablet in 4 ounces/120 milliliters plain water (not mineral water or flavored water) at room temperature. After bubbling from the tablet stops, wait at least 5 minutes until it is completely dissolved. Then stir the liquid for about 10 seconds and drink all of it. Stay fully upright (sitting, standing, or walking) for at least 30 minutes and do not lie down until after your first food of the day.

Alendronate works best if taken on an empty stomach. Calcium or iron supplements, vitamins, antacids, coffee, tea, soda, mineral water, calcium-enriched juices, and food can decrease the absorption of alendronate. Wait at least 30 minutes (preferably 1 to 2 hours) after taking the medication before you eat or drink anything except plain water.

Do not take this medication at bedtime or before rising for the day. It may not be absorbed and you may have serious side effects.

Take this medication regularly to get the most benefit from it. Remember to take it on the same day each week. It may help to mark your calendar with a reminder. Talk to your doctor about the risks and benefits of long-term use of this medication.

Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: jaw/ear pain, swelling of joints/hands/ankles/feet, increased or severe bone/joint/muscle pain, symptoms of thigh bone fracture (such as new or unusual hip/thigh/groin pain), symptoms of low calcium levels in the blood (such as muscle spasm/cramps, tingling/numbness in your fingers, toes, or around your mouth), black/tarry stools, vomit that looks like coffee grounds.

This medication may rarely cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking alendronate and talk to your doctor or pharmacist right away: new or worsening heartburn, chest pain, pain or difficulty when swallowing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking alendronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: disorders of the esophagus (such as narrowing, trouble swallowing), trouble standing or sitting upright for at least 30 minutes, low calcium levels, kidney problems, stomach/intestinal disorders (such as heartburn, ulcers).

Some people taking alendronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

This medication contains salt (sodium). Before taking this medication, tell your doctor or pharmacist if you are on a low-salt diet.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking alendronate before your surgery. Follow all instructions about stopping or starting this medication.

This drug is not recommended for use in children. Studies have shown that many children who took this drug had severe side effects such as vomiting, fever, and flu-like symptoms.

Tell your doctor if you are pregnant or plan to become pregnant. Alendronate may stay in your body for many years. You should not become pregnant while using alendronate. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, painful heartburn, pain in the esophagus (chest pain), muscle weakness/cramps, mental/mood changes.

Do not share this medication with others.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice.

Lab and/or medical tests (X-rays, height measurement, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it the next morning after you remember. Then go back to your weekly dosing schedule on your usual day of the week. Do not take two doses on the same day.