July 25, 2014
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Fosavance

(alendronate - cholecalciferol)

DIN (Drug Identification Number)

02276429 FOSAVANCE 70MG/2800UNIT TABLET
02314940 FOSAVANCE 70MG/5600UNIT TABLET

What side effects are possible with Fosavance?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • bloating
  • constipation
  • dizziness
  • diarrhea
  • gas
  • headache
  • heartburn
  • indigestion
  • nausea
  • pain in bones, muscles, or joints (mild to moderate)

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • severe joint, bone, or muscle pain
  • symptoms of low calcium levels such as muscle spasms, and prickling or tingling sensations around the mouth or in the hands or feet
  • vision changes or eye pain

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • new or unusual pain in the hip or thigh
  • signs of a serious allergic reaction (e.g., swelling of face or throat, hives, or difficulty breathing)
  • signs of a severe skin reaction (e.g., high fever; rash; sores; painful blisters on the skin, mouth, or eyes; or skin peeling off)
  • signs of damage to the esophagus (e.g., pain in the esophagus or behind the breastbone, chest pain, difficulty swallowing, pain when swallowing, or new or worsening heartburn)
  • symptoms of a stomach or intestinal ulcer (e.g., nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Fosavance?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

December 19, 2011

Health Canada has issued new restrictions concerning the use of Fosavance® (alendronate - cholecalciferol). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Bone, joint, and muscle problems: Rarely, people taking this medication experience severe bone, joint, or muscle pain. This is usually reversed when the medication is stopped. In addition to this, there is a rare chance of femur (thigh bone) fractures, without any form of trauma. If you have new or unusual pain in the hip or thigh, contact your doctor as soon as possible.

Effects on the esophagus: Alendronate may irritate the lining of the esophagus (the passage from the throat to the stomach). In some cases, these effects have been severe and have required hospitalization. Stop taking the medication and contact your doctor immediately if you suddenly experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn.

To reduce the risk of irritation of the esophagus, swallow this medication with a full glass of plain water first thing in the morning when you get up. Do not lie down until 30 minutes have passed and you have eaten your first meal of the day. Do not chew or suck on the tablet, as this may lead to ulcers in the mouth or throat. Do not take this medication at bedtime or before getting up for the day.

Effects on the stomach and intestines: Rarely, people taking this medication have developed ulcers of the stomach or intestines. Get immediate medical attention if you have symptoms of a stomach or intestinal ulcer, such as nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood.

Jaw problems: Rarely, alendronate may cause jaw problems associated with delayed healing and infection, especially after tooth extractions. If you experience any pain in the jaw, especially after having a tooth removed, contact your doctor immediately.

Low calcium levels or vitamin D deficiency: Your doctor may test you for low calcium levels or vitamin D deficiency before you take alendronate.

Pregnancy: This medication has not been studied for use by pregnant women and therefore should not be taken during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication has not been studied for use by breast-feeding women and therefore should not be taken while breast-feeding.

Children and adolescents: The safety and effectiveness of this medication have not been established for children under 18 years of age.

What other drugs could interact with Fosavance?

There may be an interaction between alendronate - cholecalciferol and any of the following:

  • antacids (wait at least ½ hour after taking this medication to take antacids)
  • antiseizure medications (e.g., carbamazepine, phenytoin)
  • calcium supplements (wait at least ½ hour after taking this medication to take calcium supplements)
  • cholestyramine
  • cimetidine
  • colestipol
  • iron supplements (wait at least ½ hour after taking this medication to take iron supplements)
  • mineral oils
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen and naproxen) used to treat pain and swelling
  • orlistat
  • other medications given by mouth (wait at least ½ hour after taking this medication to take any other medication by mouth)
  • thiazides (e.g., hydrochlorothiazide)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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