Fosavance (Vitamin D3, Alendronate Sodium)

Overdose:

If you take too many tablets, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting. Do not lie down.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose, just take one FOSAVANCE tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

FOSAVANCE may have unintended or undesirable effects.

• digestive problems such as nausea, vomiting, diarrhea or constipation.
• disorders of your esophagus (the tube that connects your mouth with your stomach) including irritation which can cause chest pain, heartburn or difficulty or pain upon swallowing. Esophageal reactions may worsen if patients continue to take FOSAVANCE after developing symptoms suggesting irritation of the esophagus.

If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE immediately and call your doctor.

• bone, muscle and/or joint pain which is rarely severe.
• joint swelling or swelling in their 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 you severely, tell your doctor or your pharmacist.

BEFORE you use FOSAVANCE talk to your doctor or pharmacist if you:

• have cancer, gum disease, poor oral hygiene, or diabetes.
• get chemotherapy, or radiotherapy.
• take corticosteroids, or immunosuppressive drugs.
• take angiogenesis inhibitors; they are drugs that slow down the growth of new blood vessels and are used mostly to treat cancer (e.g. bevacizumab).
• are or have been a smoker.
• are a heavy alcohol user.

If any of the above apply to you, have a dental check-up before starting FOSAVANCE.

• have or have had any medical problems including known kidney disease.
• have or have had any dental problems.
• have any allergies.
• have any swallowing or digestive problems.

Digestive problems:

Some patients may experience digestive problems while taking FOSAVANCE, which may be severe, including irritation or ulceration of the esophagus (the tube that connects your mouth with your stomach), 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 FOSAVANCE and/or if they lie down in less than 30 minutes or before their first food of the day.

Talk to your doctor:

• if you have ear pain and/or discharge from the ear while taking FOSAVANCE as these could be signs of bone damage in the ear.

Use in pregnancy and breast-feeding:

Do not take FOSAVANCE if you are pregnant or breast-feeding.

Use in children:

FOSAVANCE is not indicated for anyone under 18 years of age and should not be given to them.

Use in elderly:

FOSAVANCE works equally well in, and is equally well tolerated by, patients older and younger than 65 years of age.

There have been side effects reported with FOSAVANCE that may affect your ability to drive or operate machinery. Individual responses to FOSAVANCE may vary.

You should always tell your doctor about all drugs you are taking or plan 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. You must wait at least one-half hour after taking FOSAVANCE before taking any other oral medication.

It is likely that certain medicines or food additives may prevent the vitamin D in FOSAVANCE from getting into your 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.