Alendronate, cholecalciferol.
Each tablet of APO-ALENDRONATE / VITAMIN D3 (70 mg/140 mcg) contains 70 mg of alendronate and 140 mcg of cholecalciferol (5600 IU of vitamin D3).
Excipients/Inactive Ingredients: Butylated hydroxytoluene, colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, mannitol, microcrystalline cellulose.
Alendronate sodium: Alendronate sodium is a member of a class of non-hormonal drugs called bisphosphonates.
The alendronate sodium component of APO-ALENDRONATE / VITAMIN D3 not only prevents the loss of bone but actually helps to rebuild bone that may have been lost and increases the bone mass. This makes bone stronger and less likely to fracture. Thus, APO-ALENDRONATE / VITAMIN D3 reverses the progression of osteoporosis.
Cholecalciferol: Cholecalciferol is the natural form of vitamin D.
Vitamin D is an essential nutrient, required for calcium absorption and healthy bones. The main source is through exposure to sunlight, which makes vitamin D in the skin. In addition, as people age, their skin becomes less able to make vitamin D. Very few foods are natural sources of vitamin D. Some foods (for example, milk, select brands of orange juice and breakfast cereals) are fortified with vitamin D.
Too little vitamin D leads to inadequate calcium absorption and low phosphate - the minerals that make bones strong. Even if eating a diet rich in calcium or taking a calcium supplement, the body cannot absorb calcium properly unless there is enough vitamin D. Too little vitamin D may lead to bone loss and osteoporosis, and severe vitamin D deficiency may cause muscle weakness which can lead to falls, and greater risk of fracture. Vitamin D supplements reduce these risks and their consequences.
APO-ALENDRONATE / VITAMIN D3 is indicated for treatment of osteoporosis in post-menopausal women and in men. Since it is not known how long APO-ALENDRONATE / VITAMIN D3 should be continued for osteoporosis, the need to stay on this medication should be discussed with the doctor regularly to determine if treatment with APO-ALENDRONATE / VITAMIN D3 is still appropriate.
APO-ALENDRONATE / VITAMIN D3 alone should not be used to treat vitamin D deficiency.
If over the age of 70, home bound, or suffering from a long-term illness, vitamin D may need to be received in addition to that provided in APO-ALENDRONATE / VITAMIN D3.
APO-ALENDRONATE / VITAMIN D3 does not contain calcium. The doctor may recommend calcium supplements.
In addition, the doctor may recommend one or more of the following lifestyle changes: Stop smoking. Smoking appears to increase the rate at which bone is lost and, therefore, may increase the risk of fracture.
Exercise. Like muscles, bones need exercise to stay strong and healthy. Consult the doctor before beginning any exercise program.
Eat a balanced diet. The doctor can advise whether to modify the diet or to take any dietary supplements.
Reduce the use of alcohol.
USUAL DOSE: These are the important things that must be done to help make sure the patient will benefit from APO-ALENDRONATE / VITAMIN D3: 1. Choose the day of the week that best fits the schedule. Every week, take one APO-ALENDRONATE / VITAMIN D3 tablet on the chosen day.
2. After getting up for the day and before taking the first food, beverage, or other medication, swallow the APO-ALENDRONATE / VITAMIN D3 tablet with a full glass (200-250 mL) of plain water only.
Do NOT take APO-ALENDRONATE / VITAMIN D3 with: Mineral water; Coffee or tea; Juice.
Although it has not been tested, because of high mineral content, "hard water" may decrease absorption of APO-ALENDRONATE / VITAMIN D3. If the normal drinking water is classified as "hard water", the patient should consider taking this medication with distilled water (i.e., not mineral water).
Do NOT chew or suck on a tablet of APO-ALENDRONATE / VITAMIN D3.
3. After swallowing the APO-ALENDRONATE / VITAMIN D3 tablet, do not lie down - stay fully upright (sitting, standing or walking) for at least 30 minutes and do not lie down until after the first food of the day.
4. Do NOT take APO-ALENDRONATE / VITAMIN D3 at bedtime or before getting up for the day.
The previous actions will help the APO-ALENDRONATE / VITAMIN D3 tablet reach the stomach quickly and help reduce the potential for irritation of the esophagus.
5. After swallowing the APO-ALENDRONATE / VITAMIN D3 tablet, wait at least 30 minutes before taking the first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. APO-ALENDRONATE / VITAMIN D3 is effective only if taken when the stomach is empty.
6. If difficulty or pain upon swallowing, chest pain, or new or worsening heartburn develop, stop taking APO-ALENDRONATE / VITAMIN D3 immediately and call the doctor.
7. It is important to continue taking APO-ALENDRONATE / VITAMIN D3 for as long as the doctor prescribes it. APO-ALENDRONATE / VITAMIN D3 can treat osteoporosis only if continuously taken.
It is important to take APO-ALENDRONATE / VITAMIN D3 over the long-term to continue to help rebuild bone that may have been lost. It is, therefore, important to follow the doctor's instructions for taking APO-ALENDRONATE / VITAMIN D3 without skipping doses or varying from the prescribed treatment schedule. It is also important to continue to follow the doctor's advice on lifestyle changes.
MISSED DOSE: If a dose is missed, just take one APO-ALENDRONATE / VITAMIN D3 tablet in the morning after remembering. Do NOT take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on the chosen day.
If too many tablets are taken, drink a full glass of milk and contact the doctor immediately. Do not induce vomiting. Do not lie down.
If the patient thinks he/she has taken too much APO-ALENDRONATE / VITAMIN D3, the patient should contact the healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
The patient should NOT take APO-ALENDRONATE / VITAMIN D3 if he/she: has certain disorders of the esophagus; is unable to stand or sit upright for at least 30 minutes; is allergic to any of its ingredients; has low blood calcium; has SEVERE kidney disease. If having any doubts if this applies, speak to the doctor.
BEFORE using APO-ALENDRONATE / VITAMIN D3, the patient should talk to the doctor or pharmacist if he/she: Has cancer, gum disease, poor oral hygiene, or diabetes; gets chemotherapy or radiotherapy; takes corticosteroids or immunosuppressive drugs; takes angiogenesis inhibitors that slow down the growth of new blood vessels and are used mostly to treat cancer (e.g. bevacizumab); is or has been a smoker; is a heavy alcohol user.
If any of the previously mentioned are applicable, have a dental check-up before starting APO-ALENDRONATE / VITAMIN D3.
Has or has had any medical problems including known kidney disease; has or has had any dental problems; has any allergies; has any swallowing or digestive problems.
Osteonecrosis of the external auditory canal: Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infection.
Warning on the possible risk of atypical thigh bone (femur) fractures; Optimal duration of use of bisphosphates for treatment and prevention of osteoporosis is uncertain.
Digestive problems: Some patients may experience digestive problems while taking APO-ALENDRONATE / VITAMIN D3, which may be severe, including irritation or ulceration of the esophagus, which can cause chest pain, heartburn or difficulty or pain upon swallowing. These reactions may occur especially if patients do not drink the recommended amount of water with APO-ALENDRONATE / VITAMIN D3 and/or if they lie down in less than 30 minutes or before their first food of the day.
The patient should talk to the doctor: If he/she has ear pain and/or discharge from the ear while taking APO-ALENDRONATE / VITAMIN D3 as these could be signs of bone damage in the ear.
Effect on ability to drive or operate machinery: There have been side effects reported with APO-ALENDRONATE / VITAMIN D3 that may affect the ability to drive or operate machinery. Individual responses to APO-ALENDRONATE / VITAMIN D3 may vary.
Use in Pregnancy & Lactation: Do not take APO-ALENDRONATE / VITAMIN D3 if pregnant or breast-feeding.
Use in Children: APO-ALENDRONATE / VITAMIN D3 is not indicated for anyone under 18 years of age and should not be given to them.
Use in the Elderly: APO-ALENDRONATE / VITAMIN D3 works equally well in, and is equally well tolerated by, patients older and younger than 65 years of age.
Do not take APO-ALENDRONATE / VITAMIN D3 if pregnant or breast-feeding.
APO-ALENDRONATE / VITAMIN D
3 may have unintended or undesirable effects.
Digestive problems such as nausea, vomiting, diarrhea or constipation; Disorders of the esophagus including irritation which can cause chest pain, heartburn or difficulty or pain upon swallowing. Esophageal reactions may worsen if patients continue to take APO-ALENDRONATE / VITAMIN D
3 after developing symptoms suggesting irritation of the esophagus. If difficulty or pain upon swallowing, chest pain, or new or worsening heartburn develop, stop taking APO-ALENDRONATE / VITAMIN D
3 immediately and call the doctor.
Bone, muscle and/or joint pain which is rarely severe; Joint swelling or swelling in the hands or legs; Transient flu-like symptoms (rarely with fever); Rash that may be made worse by sunlight, hair loss; Allergic reactions such as hives or, rarely, swelling of the face, lips, tongue and/or throat, which may cause difficulty in breathing or swallowing, may occur; Dizziness, vertigo (spinning sensation) or a changed sense of taste; Symptoms of low blood calcium (for example, numbness or tingling around the mouth or in the hands or feet; muscle spasms in the face, hands, or feet); Mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth.
If any of these affects the patient severely, he/she should tell the doctor or pharmacist. (See table.)
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This is not a complete list of side effects. For any unexpected effects while taking APO-ALENDRONATE / VITAMIN D
3, contact the doctor or pharmacist.
The patient should always tell the doctor about all drugs he/she is taking or plans to take, including those obtained without a prescription, vitamins, and herbal products.
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of alendronate if taken at the same time of the day. The patient must wait at least one-half hour after taking APO-ALENDRONATE / VITAMIN D3 before taking any other oral medication.
It is likely that certain medicines or food additives may prevent the vitamin D in APO-ALENDRONATE / VITAMIN D3 from getting into the body, including artificial fat substitutes, mineral oils, orlistat and the cholesterol-lowering medicines, cholestyramine and colestipol. Medicines for seizures (convulsions), cimetidine and thiazides (diuretic) may decrease the effectiveness of vitamin D.
Store below 25°C.
Protect from moisture and light. Store tablets in the original package until use.
M05BB03 - alendronic acid and colecalciferol ; Belongs to the class bisphosphonates, combinations. Used in the treatment of bone diseases.
Apo-Alendronate/Vitamin D3 70 mg/140 mcg tab
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