Alendronate Sodium (Page 10 of 12)

Storage

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].

SUPPLEMENTAL PATIENT MATERIAL

Patient Information

Once Weekly

Alendronate Sodium Tablets, USP

Read this information before you start taking alendronate sodium tablets. Also, read the leaflet each time you refill your prescription, just in case anything has changed. This leaflet does not take the place of discussions with your doctor. You and your doctor should discuss alendronate sodium tablets when you start taking your medicine and at regular checkups.

What is the most important information I should know about once weekly alendronate sodium tablets?

  • You must take once weekly alendronate sodium tablets exactly as directed to help make sure it works and to help lower the chance of problems in your esophagus (the tube that connects your mouth and stomach). (See “How should I take once weekly alendronate sodium tablets ?”).
  • If you have chest pain, new or worsening heartburn, or have trouble or pain when you swallow, stop taking alendronate sodium tablets and call your doctor. (See “What are the possible side effects of alendronate sodium tablets?”).

What are alendronate sodium tablets?

Alendronate sodium tablets are prescription medicines for:

  • The treatment or prevention of osteoporosis (thinning of bone) in women after menopause. It reduces the chance of having a hip or spinal fracture (break).
  • Treatment to increase bone mass in men with osteoporosis.
  • Alendronate sodium tablets are for treatment and prevention of osteoporosis.

Improvement in bone density may be observed as early as 3 months after you start taking alendronate sodium tablets even though you won’t see or feel a difference. For alendronate sodium tablets to continue to work, you need to keep taking it.

Alendronate sodium tablets are not hormones.

There is more information about osteoporosis at the end of this leaflet.

Who should not take alendronate sodium tablets?

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 its ingredients. A list of ingredients is at the end of this leaflet.

What should I tell my doctor before using alendronate sodium tablets?

Tell your doctor about all of your medical conditions, including if you:

  • have problems with swallowing
  • have stomach or digestive problems
  • have kidney problems
  • are pregnant or planning to become pregnant. It is not known if alendronate sodium tablets can harm your unborn baby.
  • are breastfeeding. It is not known if alendronate sodium tablets passes into your milk and if it can harm your baby.

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

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 tablets?

  • Choose the day of the week that best fits your schedule.
  • Take 1 dose of alendronate sodium tablets every week on your chosen day after you get up for the day and before taking your first food, drink, or other medicine
  • Take alendronate sodium tablets while you are sitting or standing.
  • Take your alendronate sodium tablets with plain water only as follows:
    • Swallow one tablet with a full glass (6-8 oz) of plain water.

Do not take alendronate sodium tablets with:

Mineral water
Coffee or tea
Juice

Alendronate sodium tablets work only if it is taken on an empty stomach.

Do not chew or suck on a tablet of alendronate sodium.

After taking your 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 until after your first food of the day.

  • It is important that you keep taking alendronate sodium tablets for as long as your doctor says to take it. For alendronate sodium tablets to continue to work, you need to keep taking it.

What should I do if I miss a dose of alendronate sodium tablets or if I take too many?

  • If you miss a dose, take only 1 dose of alendronate sodium tablets on the morning after you remember. Do not take 2 doses on the same day. Continue your usual schedule of 1 dose once a week on your chosen day.
  • If you think you took more than the prescribed dose of alendronate sodium tablets , drink a full glass of milk and call your doctor right away. Do not try to vomit. Do not lie down.

What should I avoid while taking alendronate sodium tablets?

  • Do not eat, drink, or take other medicines or supplements before taking alendronate sodium tablets.
  • Wait for at least 30 minutes after taking alendronate sodium tablets to eat, drink, or take other medicines or supplements.
  • Do not lie down for at least 30 minutes after taking alendronate sodium tablets. Do not lie down until after your first food of the day.

What are the possible side effects of alendronate sodium tablets?

Alendronate sodium tablets may cause problems in your esophagus (the tube that connects the mouth and stomach). (See “What is the most important information I should know about once weekly alendronate sodium tablets?”.) These problems include irritation, inflammation, or ulcers of the esophagus, which may sometimes bleed. This may occur especially if you do not drink a full glass of water with alendronate sodium tablets or if you lie down in less than 30 minutes or before your first food of the day.

  • Stop taking alendronate sodium tablets and call your doctor right away if you get any of these signs of possible serious problems of the esophagus:
    • Chest pain
    • New or worsening heartburn
    • Trouble or pain when swallowing
  • Esophagus problems may get worse if you continue to take alendronate sodium tablets.
  • Mouth sores (ulcers) may occur if the alendronate sodium tablet is chewed or dissolved in the mouth.
  • You may get flu-like symptoms, typically at the start of treatment with alendronate sodium tablets.
  • You may get allergic reactions, such as hives or, in rare cases, swelling of your face, lips, tongue, or throat.
  • Alendronate sodium tablets may cause jaw-bone problems in some people. Jaw-bone problems may include infection, and delayed healing after teeth are pulled.
  • The most common side effect is stomach area (abdominal) pain. Less common side effects are nausea, vomiting, a full or bloated feeling in the stomach, constipation, diarrhea, black or bloody stools (bowel movements), gas, eye pain, rash that may be made worse by sunlight, hair loss, headache, dizziness, a changed sense of taste, joint swelling or swelling in the hands or legs, and bone, muscle, or joint pain.
  • Call your doctor if you develop severe bone, muscle, or joint pain.

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

These are not all the side effects with alendronate sodium tablets. Ask your doctor or pharmacist for more information.

How do I store alendronate sodium tablets?

  • Store at 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59-86°F).
  • Safely discard alendronate sodium tablets that are out-of-date or no longer needed.
  • Keep alendronate sodium tablets and all medicines out of the reach of children.

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