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

1. Low calcium levels in your blood (hypocalcemia).

Reclast may lower the calcium levels in your blood. If you have low blood calcium before you start taking Reclast, it may get worse during treatment. Your low blood calcium must be treated before you take Reclast. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium, such as:

• Spasms, twitches, or cramps in your muscles
  
• Numbness or tingling in your fingers, toes, or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take Reclast. Take calcium and vitamin D as your doctor tells you to.

2. Severe kidney problems.

Severe kidney problems may happen when you take Reclast. Severe kidney problems may lead to hospitalization or kidney dialysis and can be life-threatening. Your risk of kidney problems is higher if you:

• already have kidney problems
  
• take a diuretic or “water pill”
  
• do not have enough water in your body (dehydrated) before or after you receive Reclast
  
• are of advanced age since the risk increases as you get older
  
• take any medicines known to harm your kidneys

You should drink at least 2 glasses of fluid within a few hours before receiving Reclast to reduce the risk of kidney problems.

3. Severe jaw bone problems (osteonecrosis).

Severe jaw bone problems may happen when you take Reclast. Your doctor should examine your mouth before you start Reclast. Your doctor may tell you to see your dentist before you start Reclast. It is important for you to practice good mouth care during treatment with Reclast.

4. Unusual thigh bone fractures.

Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

5. Bone, joint, or muscle pain.

Some people who take bisphosphonates develop severe bone, joint, or muscle pain.

Call your doctor right away if you have any of these side effects.

• Treat or prevent osteoporosis in women after menopause. Reclast helps reduce the chance of having a hip or spinal fracture (break).
• Increase bone mass in men with osteoporosis.
• Treat or prevent osteoporosis in either men or women who will be taking corticosteroid medicines for at least one year.
• Treat certain men and women who have Paget’s disease of the bone.

• Have low levels of calcium in your blood.
  
• Have kidney problems.
  
• Are allergic to zoledronic acid or any of its ingredients. A list of ingredients is at the end of this leaflet.

• Have low blood calcium.
• Have kidney problems.
• Had parathyroid or thyroid surgery (glands in your neck).
• Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome) or have had parts of your intestine removed
• Have asthma (wheezing) from taking aspirin.
• Plan to have dental surgery or teeth removed.
• Are pregnant, or plan to become pregnant. Reclast should not be used if you are pregnant. It is not known if Reclast can harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if Reclast passes into your milk and may harm your baby. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how Reclast works.

• An antibiotic. Certain antibiotic medicines called aminoglycosides may increase the effect of Reclast in lowering your blood calcium for a long period of time.
• A diuretic or “water pill”.
• Non-steroidal anti-inflammatory medicines (NSAIDS).

• Your doctor will tell you how often you will receive Reclast.
• Reclast is given by infusion into your vein (intravenously). Your infusion should last at least 15 minutes.
• Before you receive Reclast, drink at least 2 glasses of fluid (such as water) within a few hours as directed by your doctor.
• You may eat before your treatment with Reclast.
• If you miss a dose of Reclast, call your doctor or healthcare provider to schedule your next dose.

• See “What is the most important information I should know about Reclast?”

• Fever
  
• Pain in your bones, joints or muscles
  
• Pain in your arms and legs
  
• Headache
  
• Flu-like illness (fever, chills, bone, joint, or muscle pain, fatigue)
  
• Nausea
• Vomiting
• Diarrhea