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ALENDRONATE SODIUM solution


  1. Alendronate Sodium Oral Solution Can Cause Serious Side Effects Including:
  2. Alendronate Sodium Oral Solution Is A Prescription Medicine Used To:
  3. Do Not Take Alendronate Sodium Oral Solution If You:
  4. Before You Start Alendronate Sodium Oral Solution, Be Sure To Talk To Your Doctor If You:
  5. Especially Tell Your Doctor If You Take:
  6. How Should I Take Once Weekly Alendronate Sodium Oral Solution?
  7. What Are The Possible Side Effects Of Alendronate Sodium Oral Solution?
  8. Patient Information
  9. Distributed By:

Alendronate Sodium Oral Solution Can Cause Serious Side Effects Including: 

1.
Esophagus problems
2.
Low calcium levels in your blood (hypocalcemia)
3.
Bone, joint, or muscle pain
4.
Severe jaw bone problems (osteonecrosis)
5.
Unusual thigh bone fractures

1. Esophagus problems.

Some people who take Alendronate Sodium Oral Solution 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 that you take Alendronate Sodium Oral Solution exactly as prescribed to help lower your chance of getting esophagus problems. (

Alendronate Sodium Oral Solution Is A Prescription Medicine Used To: 

Treat osteoporosis in women after menopause. It helps reduce the chance of having a hip or spinal fracture (break).
Increase bone mass in men with osteoporosis.

It is not known how long alendronate works for the treatment and prevention of osteoporosis. You should

Do Not Take Alendronate Sodium Oral Solution If You: 

Have certain problems with your esophagus, the tube that connects your mouth with your stomach
Cannot stand or sit upright for at least 30 minutes
Have low levels of calcium in your blood
Are allergic to Alendronate Sodium Oral Solution or any of its ingredients. A list of ingredients is at the end of this leaflet.

Before You Start Alendronate Sodium Oral Solution, Be Sure To Talk To Your Doctor If You: 

Have problems with swallowing
Have stomach or digestive problems
Have low blood calcium
Plan to have dental surgery or teeth removed
Have kidney problems
Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
Are pregnant, trying to become pregnant or suspect that you are pregnant.If you become pregnant while taking Alendronate Sodium Oral Solution, stop taking it and contact your doctor.It is not known if Alendronate Sodium Oral Solution can harm your unborn baby.
Are breast-feeding or plan to breast-feed. It is not known if Alendronate Sodium Oral Solution passes into your milk and may harm your baby.

Especially Tell Your Doctor If You Take: 

antacids
aspirin
Nonsteroidal Anti-Inflammatory (NSAID) medicines

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how Alendronate Sodium Oral Solution works.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

How Should I Take Once Weekly Alendronate Sodium Oral Solution? 

Take Alendronate Sodium Oral Solution exactly as your doctor tells you.
Alendronate Sodium Oral Solution works only if taken on an empty stomach.
Take Alendronate Sodium Oral Solution after you get up for the day and before taking your first food, drink, or other medicine.
Take Alendronate Sodium Oral Solution while you are sitting or standing.
Do nottake Alendronate Sodium Oral Solution with mineral water, coffee, tea, soda, or juice.
Choose the day of the week that best fits your schedule.
Take 1 dose of Alendronate Sodium Oral Solution every week on your chosen dayafteryou get up for the day andbeforetaking your first food, drink, or other medicine.

Do not lie down for at least 30 minutes after you take Alendronate Sodium Oral Solution and after you eat your first food of the day.

If you miss a dose of Alendronate Sodium Oral Solution, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.

If you take too much Alendronate Sodium Oral Solution, call your doctor. Do not try to vomit. Do not lie down.

What Are The Possible Side Effects Of Alendronate Sodium Oral Solution? 

Alendronate Sodium Oral Solution may cause serious side effects.

Store Alendronate Sodium Oral Solution at 20 to 25 C (68 to 77 F). [

Active ingredient: alendronate sodium

Inactive ingredients: citric acid (anhydrous), methylparaben, propylparaben, purified water, raspberry blend, saccharin sodium and sodium citrate

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instruct patients to read the Medication Guide before starting therapy with alendronate and to reread it each time the prescription is renewed.

17.1 Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D, if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist.

17.2 Dosing Instructions

Instruct patients that the expected benefits of alendronate may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing with orange juice or coffee has been shown to markedly reduce the absorption of alendronate[seeClinical Pharmacology (12.3)].

Instruct patients to drink at least 2 ounces (a quarter of a cup) of water after taking alendronate oral solution, to facilitate gastric emptying.

Instruct patients not to lie down for at least 30 minutesanduntil after their first food of the day.

Instruct patients not to take alendronate at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems.

Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking alendronate and consult their physician.

If patients miss a dose of once weekly alendronate, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

Distributed By: 


TAGI Pharma, Inc.
722 Progressive Lane, Room 205
South Beloit, IL 61080

10005270/06
Revised September 2019



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