Alendronate & Cholecalciferol

Alendronate/cholecalciferol is a prescription medication used to treat and prevent osteoporosis in men and women. It is a single tablet containing 2 medications. Alendronate belongs to a group of medications called bisphosphonates, which work by preventing bone breakdown and increasing bone density. Cholecalciferol, a form of vitamin D, is important for calcium absorption and bone health.

This medication comes in tablet form and is usually taken once a week. Always take alendronate/cholecalciferol on an empty stomach.

Common side effects include stomach pain, heartburn, and constipation.

Alendronate/cholecalciferol is a prescription medicine used to:

• treat osteoporosis in women after menopause
• increase bone mass in men with osteoporosis

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Alendronate/cholecalciferol 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

Esophagus problems. Some people who take alendronate/cholecalciferol 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/cholecalciferol exactly as prescribed to help lower your chance of getting esophagus problems.
• Stop taking alendronate/cholecalciferol and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

Low calcium levels in your blood (hypocalcemia). Alendronate/cholecalciferol may lower the calcium levels in your blood. If you have low blood calcium before you start taking alendronate/cholecalciferol, it may get worse during treatment. Your low blood calcium must be treated before you take alendronate/cholecalciferol. 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 alendronate/cholecalciferol. Take calcium and vitamin D as your doctor tells you to.

Bone, joint, or muscle pain. Some people who take alendronate/cholecalciferol develop severe bone, joint, or muscle pain.

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

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

Alendronate/cholecalciferol may cause serious side effects.

• See "Drug Precautions".

The most common side effects include:

• stomach area (abdominal) pain
• heartburn
• constipation
• diarrhea
• upset stomach
• bone, joint, or muscle pain
• nausea

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

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/cholecalciferol. 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.

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

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/cholecalciferol 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if alendronate/cholecalciferol passes into your milk and may harm your baby.