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ALENDRONATE SODIUM tablet


  1. An Cause Serious Side Effects Including:
  2. Alendronate Sodium Tablets, Be Sure To Talk To Your Doctor If You:
  3. Especially Tell Your Doctor If You Take:
  4. Alendronate Sodium Tablets?
  5. After Swallowing Alendronate Sodium Tablet, Wait At Least 30 Minutes:
  6. Tablets?
  7. What Are The Ingredients In Alendronate Sodium Tablets?
  8. Alendronate Sodium Tablets Can Cause Serious Side Effects Including:
  9. Alendronate Sodium Tablets Are A Prescription Medicine Used To:
  10. Do Not Take Alendronate Sodium Tablets If You:
  11. Before You Start Alendronate Sodium Tablets, Be Sure To Talk To Your Doctor If You:
  12. How Should I Take Alendronate Sodium Tablets?
  13. After Swallowing Alendronate Sodium Tablets, Wait At Least 30 Minutes:
  14. What Are The Possible Side Effects Of Alendronate Sodium Tablets?
  15. The Most Common Side Effects Of Alendronate Sodium Tablets Are:
  16. How Do I Store Alendronate Sodium Tablets?
  17. Patient Information

An 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 takealendronate sodium tablets 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 takealendronate sodium tabletsexactly as prescribed to help lower your chance of getting esophagus problems. (

    Do not take
    alendronate sodium tablets 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 tabletsor any of their ingredients. A list of ingredients is at the end of this leaflet.


    What should I tell my doctor before taking

Alendronate Sodium Tablets, 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, or plan to become pregnant. It is not known if alendronate sodium tabletscan harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if alendronate sodium 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 tablets work.

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

Alendronate Sodium Tablets? 

  • Take alendronate sodium tabletsexactly as your doctor tells you.
  • Alendronate sodium tabletswork only if taken on an empty stomach.
  • Take alendronate sodium tablets,afteryou get up for the day andbeforetaking your first food, drink, or other medicine.
  • Take alendronate sodium tabletswhile you are sitting or standing.
  • Do not chew or suck on a tablet ofalendronate sodium.
  • Swallow alendronate sodium tablet with a full glass (6 to 8 oz) ofplain wateronly.
  • Do nottake alendronate sodium tabletswith mineral water, coffee, tea, soda, or juice.
  • If you takeAlendronate Daily:
    • Take 1 alendronate tablet one time a day, every dayafteryou get up for the day andbeforetaking your first food, drink, or other medicine.
  • If you takeOnce Weeklyalendronate sodium tablets:
    • Choose the day of the week that best fits your schedule.
    • Take 1 dose of alendronate sodium tabletevery week on your chosen dayafteryou get up for the day andbeforetaking your first food, drink, or other medicine.

After Swallowing Alendronate Sodium Tablet, Wait At Least 30 Minutes: 

  • Before you lie down. You may sit, stand or walk, and do normal activities like reading.
  • Before you take your first food or drink except for plain water.
  • Before you take other medicines, including antacids, calcium, and other supplements and vitamins.

Do not lie down for at least 30 minutes after you takealendronate sodium tablets and after you eat your first food of the day.

If you miss a dose of alendronate sodium tablets, 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, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of
alendronate sodium

Tablets? 


Alendronate sodium tablets may cause serious side effects.

The most common side effects ofalendronate sodium tabletsare:

  • Stomach area (abdominal) pain
  • Heartburn
  • Constipation
  • Diarrhea
  • Upset stomach
  • Pain in your bones, joints, or muscles
  • Nausea

You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat.

Worsening of asthma has been reported.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of alendronate sodium tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store

What Are The Ingredients In Alendronate Sodium Tablets? 


Active ingredient: alendronate monosodium salt trihydrate

Inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.

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

Medication Guides available atwww.northstarrxllc.com/productsor call 1-800-206-7821.

Manufactured for: Northstar Rx LLC
Memphis, TN 38141.

Manufactured by: Aurobindo Pharma Limited
Hyderabad-500 090, India.

M.L.No.: 19/HD/AP/95/F/R

Revised: 12/2017

Alendronate Sodium Tablets Can Cause Serious Side Effects Including: 

  • Esophagus problems
  • Low calcium levels in your blood (hypocalcemia)
  • Bone, joint, or muscle pain
  • Severe jaw bone problems (osteonecrosis)
  • Unusual thigh bone fractures

1. Esophagus problems.

Some people who take alendronate sodium tablets 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 tablets exactly as prescribed to help lower your chance of getting esophagus problems. (

Alendronate Sodium Tablets Are A Prescription Medicine Used To: 

  • Treat or prevent 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.
  • Treat osteoporosis in either men or women who are taking corticosteroid medicines.
  • Treat certain men and women who have Paget s disease of the bone.

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

Do Not Take Alendronate Sodium Tablets 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 tablets or any of their ingredients. A list of ingredients is at the end of this leaflet.

Before You Start Alendronate Sodium Tablets, 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, or plan to become pregnant. It is not known if alendronate sodium tablets can harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if alendronate sodium passes into your milk and may harm your baby.

How Should I Take Alendronate Sodium Tablets? 

  • Take alendronate sodium tablets exactly as your doctor tells you.
  • Alendronate sodium tablets work only if taken on an empty stomach.
  • Take alendronate sodium tablets,afteryou get up for the day andbeforetaking your first food, drink, or other medicine.
  • Take alendronate sodium tablets while you are sitting or standing.
  • Do not chew or suck on a tablet of alendronate sodium.
  • Swallow alendronate sodium tablets with a full glass (6 to 8 oz) ofplain wateronly.
  • Do nottake alendronate sodium tablets with mineral water, coffee, tea, soda, or juice.
  • If you takeAlendronate Daily:
  • Take 1 alendronate tablet one time a day, every dayafteryou get up for the day andbeforetaking your first food, drink, or other medicine.
  • If you takeOnce Weekly Alendronate Sodium Tablets:
  • Choose the day of the week that best fits your schedule.
  • Take 1 dose of alendronate sodium tablets every week on your chosen dayafteryou get up for the day andbeforetaking your first food, drink, or other medicine.

After Swallowing Alendronate Sodium Tablets, Wait At Least 30 Minutes: 

  • Before you lie down. You may sit, stand or walk, and do normal activities like reading.
  • Before you take your first food or drink except for plain water.
  • Before you take other medicines, including antacids, calcium, and other supplements and vitamins.

Do not lie down for at least 30 minutes after you take alendronate sodium tablets and after you eat your first food of the day.

If you miss a dose of alendronate sodium tablets, 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 many alendronate sodium tablets, call your doctor. Do not try to vomit. Do not lie down.

What Are The Possible Side Effects Of Alendronate Sodium Tablets? 

Alendronate sodium tablets may cause serious side effects.

The Most Common Side Effects Of Alendronate Sodium Tablets Are: 

  • Stomach area (abdominal) pain
  • Heartburn
  • Constipation
  • Diarrhea
  • Upset stomach
  • Pain in your bones, joints, or muscles
  • Nausea

You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat.

Worsening of asthma has been reported.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of alendronate sodium tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Do I Store Alendronate Sodium Tablets? 

  • Store alendronate sodium tablets at room temperature, 20 to 25 C (68 to 77 F).
  • Keep alendronate sodium tablets in a tightly closed container.

Keep alendronate sodium tablets and all medicines out of the reach of children.

General information about the safe and effective use of alendronate sodium tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use alendronate sodium tablets for a condition for which they were not prescribed. Do not give alendronate sodium tablets to other people, even if they have the same symptoms you have. They may harm them.

This Medication Guide summarizes the most important information about alendronate sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about alendronate sodium tablets that is written for health professionals. For more information, call 1-888-838-2872, Medical Information.

Patient Information 


SeeFDA-approved patient labeling (Medication Guide).

Instruct patients to read the Medication Guide before starting therapy with alendronate sodium 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 sodium 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 sodium[seeClinical Pharmacology (12.3)].

Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal ulceration.

Instruct patients to swallow each tablet of alendronate sodium with a full glass of water (6 to 8 ounces) to facilitate delivery to the stomach and thus reduce the potential for esophageal irritation.

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

Instruct patients not to take alendronate sodium 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 sodium and consult their physician.

If patients miss a dose of once weekly alendronate sodium, 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.

Medication Guides available atwww.northstarrxllc.com/productsor call 1-800-206-7821.

Manufactured for: Northstar Rx LLC
Memphis, TN 38141.

Manufactured by: Aurobindo Pharma Limited
Hyderabad-500 090, India.

M.L.No.: 19/HD/AP/95/F/R

Revised: 12/2017



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