Alendronate and cholecalciferol

You should not take this medicine if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

Do not take this medicine tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

To make sure alendronate and cholecalciferol is safe for you, tell your doctor if you have:

• low blood calcium (hypocalcemia);

• a cancer such as sarcoidosis, leukemia, lymphoma;

• a vitamin D deficiency;

• kidney disease; or

• an ulcer in your stomach or esophagus.

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use alendronate and cholecalciferol, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

Talk with your doctor about the risks and benefits of using this medication.

It is not known whether alendronate and cholecalciferol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether alendronate and cholecalciferol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate and cholecalciferol.

Alendronate and cholecalciferol combination is used to treat osteoporosis (thinning of the bone) in women after menopause. alendronate and cholecalciferol may also be used to increase bone mass in men who have osteoporosis.

alendronate and cholecalciferol is available only with your doctor's prescription.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach before breakfast.
• Take at least 30 minutes before the first food, drink, or drugs of the day.
• Do not lie down for at least 30 minutes after taking alendronate and cholecalciferol.
• Take with a full glass of water.
• Take with plain water only. Avoid taking with mineral water, milk, or other drinks.
• Swallow whole. Do not chew, break, or crush.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Do not take it later in the day.
• Take the missed dose on the next morning after you think about it and then go back to your normal time.
• Do not take 2 doses on the same day.

Osteoporosis: Treatment of osteoporosis in postmenopausal females; increase bone mass in males with osteoporosis

Limitations of use: Not for use in the treatment of vitamin D deficiency.

CrCl ≥35 mL/minute: No dosage adjustment necessary.

Clcr <35 mL/minute: Use is not recommended.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture and light. Keep sealed in blister container or original bottle (with desiccant) until use.

Bone mineral density (BMD) should be evaluated 1 to 2 years after initiating therapy and every 2 years thereafter (NOF [Cosman, 2014]); annual measurements of height and weight, assessment of chronic back pain; serum calcium and 25(OH)D; may consider monitoring biochemical markers of bone turnover

Animal reproduction studies have not been conducted with this combination. The Canadian labeling recommends avoiding use in pregnant women. See individual agents.

Applies to alendronate / cholecalciferol: oral tablet

Along with its needed effects, alendronate / cholecalciferol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alendronate / cholecalciferol:

• Chest pain, discomfort, or burning
• difficulty with swallowing
• heartburn
• muscle or bone pain
• pain with swallowing
• vomiting blood

• Abdominal or stomach cramps
• blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chills
• confusion
• convulsions
• cough
• diarrhea
• difficulty with breathing
• fever
• irregular heartbeats
• itching
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• numbness and tingling around the mouth, fingertips, or feet
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• shortness of breath
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the neck
• tremor
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

• Burning upper abdominal or stomach pain
• difficulty with moving
• heavy jaw feeling
• loosening of a tooth
• loss of appetite
• muscle aching or cramping
• muscle pains or stiffness
• pain or burning in the throat
• pain, swelling, or numbness in the mouth or jaw
• severe bone, joint, or muscle pain
• stomach bloating, burning, cramping, or pain
• swollen joints
• weight loss

Some side effects of alendronate / cholecalciferol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• constipation
• excess air or gas in the stomach or intestines
• full feeling
• headache
• indigestion
• passing gas
• pressure in the stomach
• stomach discomfort, upset, or pain
• swelling of the abdominal or stomach area

• Blurred vision or other change in vision
• decreased vision
• eye pain
• eye redness
• eye tenderness
• flushing or redness of the skin
• increased tearing
• rash
• redness of the eye
• sensitivity of the eye to light
• severe eye pain
• tearing
• unusually warm skin

• Dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• hair loss
• hives or welts
• lack or loss of strength
• sensation of spinning
• thinning of the hair

In case of overdosage, dialysis to remove this drug would not be beneficial.