NB-Alendronate-Fc: Uses, Side Effects and Dosage

What is NB-ALENDRONATE-FC used for?

NB-ALENDRONATE-FC is used in adults to treat osteoporosis in men and postmenopausal women. Osteoporosis is a thinning and weakening of the bones.

NB-ALENDRONATE-FC helps to rebuild bone and makes bone less likely to fracture.

NB-ALENDRONATE-FC is not for use in children under 18 years of age.

How does NB-ALENDRONATE-FC work?

NB-ALENDRONATE-FC contains a medicinal ingredient called alendronate sodium. Alendronate sodium belongs to a class of non-hormonal drugs called bisphosphonates. The bisphosphonates are similar to a molecule naturally made in your body that will break down bone tissue.

Alendronate binds to the receptors in your body to prevent the bone from breaking down. This process also helps rebuild bone.

What are the ingredients in NB-ALENDRONATE-FC?

Medicinal ingredient: alendronate sodium.

Non-medicinal ingredients: Hypromellose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Sodium Starch Glycolate, and Starch.

NB-ALENDRONATE-FC comes in the following dosage forms:

NB-ALENDRONATE-FC: film-coated tablet: 70 mg

Do not use NB-ALENDRONATE-FC if you:

• Have certain disorders of the esophagus (the tube that connects your mouth with your stomach).
• Are unable to stand or sit upright for at least 30 minutes.

• Are allergic to alendronate sodium or any other ingredients in NB-ALENDRONATE-FC. If you

  • are not sure about this, talk to your healthcare professional before taking NB-ALENDRONATE-FC.
• Have low blood calcium.
• Have SEVERE kidney disease. If you have any doubts if this applies to you, speak to your healthcare professional.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NB-ALENDRONATE-FC. Talk about any health conditions or problems you may have, including if you:

• have low blood calcium or a condition that affects your ability to absorb minerals (i.e., Vitamin D deficiency). This condition must be treated before you begin treatment with NB-ALENDRONATE-FC. Your healthcare professional will monitor your condition during your treatment. You should consume a sufficient amount of calcium and Vitamin D if you are already receiving glucocorticoids medicines. Speak to your healthcare professional if you experience muscle spasms or nerve problems (i.e. abnormal tingling or prickling sensations).
• have digestive problems. These may include difficulty swallowing, esophagus diseases, ulcers, inflammation of the first part of the small intestines, and inflammation of the lining of the stomach.

• may be at risk of developing osteonecrosis (bone damage in the jaw). Speak to your healthcare professional if you have a planned dental extraction. Your healthcare professional may request a dental check-up before starting NB-ALENDRONATE-FC. You may also be at risk of causing bone damage to your jaw if you:

  • have cancer
  • have or had poor dental health, gum or teeth disease
  • have poor oral hygiene, dentures that do not fit well.
  • have anemia (low red blood cell count)
  • have infection
  • have a blood disorder where your blood cannot form clots in the normal way
  • have diabetes (high blood sugar).
  • 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.

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

Other warnings you should know about:

Gastrointestinal Problems

Taking NB-ALENDRONATE-FC incorrectly may cause you to experience problems with your esophagus. Stop taking NB-ALENDRONATE-FC and speak to your healthcare professional if you experience difficulty or pain upon swallowing, chest/breastbone pain or new or worsening heartburn. To avoid problems with your esophagus and allow the drug to reach the stomach, consider the following instructions:

• swallow each tablet of NB-ALENDRONATE-FC with a full glass of water.
• do NOT cut, chew, crush or suck the tablet.
• do NOT lie down for at least 30 minutes and until your first meal of the day.
• do NOT take NB-ALENDRONATE-FC at bedtime or before starting your day.

Muscle and skeletal problems

Drugs such as NB-ALENDRONATE-FC may cause serious bone, joint or muscle pain. You may experience relief from these symptoms after you end your treatment. Long-term treatment with NB-ALENDRONATE-FC may cause stress fractures (repetitive trauma) or low energy fractures (falls from standing). If you develop new or unusual pain in the hip, thigh or any other bone, contact your healthcare professional. Your healthcare professional will:

• evaluate your condition if they suspect you have developed a fracture.
• examine the cause of the stress fracture and provide appropriate care
• pause your treatment depending on your condition.

Eye problems

Drugs such as NB-ALENDRONATE-FC may cause vision problems. Different parts of your eye may experience inflammation or you may develop an eye infection. Your healthcare professional may end your treatment if they identify symptoms of inflammation.

Bone damage in ear

Treatment with NB-ALENDRONATE-FC may cause bone damage in your ear. Talk to your healthcare professional if you have ear pain and/or discharge from the ear while taking NB-ALENDRONATE-FC.

Use in pregnancy and breast-feeding

Do not take NB-ALENDRONATE-FC if you are pregnant or breast-feeding.

Lifestyle changes

Consult with your healthcare professional about lifestyle changes when taking NB-ALENDRONATE-FC. These may include changes to your diet, use of dietary supplements, exercising and stop smoking.

Driving and using machines:

Before you do tasks that may require special attention, wait until you know how you respond to NB-ALENDRONATE-FC. There have been side effects reported with NB-ALENDRONATE-FC that may affect your ability to drive or operate machinery.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NB-ALENDRONATE-FC:

• Calcium supplements, antacids, and other oral medications will interfere with the absorption of NB-ALENDRONATE-FC if they are taken at the same time. You must wait at least half an hour after taking NB-ALENDRONATE-FC before taking any other oral medication.
• Intravenous ranitidine
• herbal products, food and beverages other than plain water may impact your ability to absorb NB-ALENDRONATE-FC. Wait at least half an hour after taking NB-ALENDRONATE-FC before you take any herbal products, food or beverages.

How to take NB-ALENDRONATE-FC:

• Always take NB-ALENDRONATE-FC exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• It is important that you continue taking NB-ALENDRONATE-FC for as long as your healthcare professional prescribes it.
• Your healthcare professional may ask you to take calcium and vitamin D while you are on NB-ALENDRONATE-FC therapy.

Usual dose:

Take one NB-ALENDRONATE-FC tablet once a week.

Follow these instructions carefully:

1. 1. Choose the day of the week that best fits your schedule. Every week, take one tablet of NB-ALENDRONATE-FC on your chosen day.
2. 2.

   After getting up for the day and before taking your first food, beverage, or other medication, swallow your NB-ALENDRONATE-FC tablet only with plain water (200 to 250 mL). Do NOT cut, chew, crush or suck on the tablet. To make sure NB-ALENDRONATE-FC is absorbed by your body, do NOT take NB-ALENDRONATE-FC with:

   • mineral water
   • coffee or tea
   • juice

If your normal drinking water is classified as “hard water”, you should consider taking this medication with distilled water (i.e., not mineral water).

1. 3. After taking your NB-ALENDRONATE-FC, do not lie down - stay fully upright (sitting, standing or walking) for at least 30 minutes and do not lie down until after your first food of the day.
2. 4.

   Do NOT take NB-ALENDRONATE-FC at bedtime or before getting up for the day. This will help NB-ALENDRONATE-FC:

   • reach your stomach quickly and;
   • reduce the potential for irritation of your esophagus (the tube that connects your mouth with your stomach).
3. 5. After taking your NB-ALENDRONATE-FC, wait at least 30 minutes before taking your first food, beverage, or other medication of the day. This includes antacids, calcium supplements and vitamins. NB-ALENDRONATE-FC is effective only if taken when your stomach is empty.
4. 6. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking NB-ALENDRONATE-FC immediately and call your healthcare professional.

Overdose:

If you take too much NB-ALENDRONATE-FC, drink a full glass of milk and contact your healthcare professional immediately. Do not make yourself vomit. Do not lie down.

If you think you, or a person you are caring for, have taken too much NB-ALENDRONATE-FC, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, just take one dose of NB-ALENDRONATE-FC on the morning after you remember. Do NOT take two doses on the same day. Return to taking one dose once a week, as originally scheduled on your chosen day.

What are possible side effects from using NB-ALENDRONATE-FC?

These are not all the possible side effects you may have when taking NB-ALENDRONATE-FC. If you experience any side effects not listed here, tell your healthcare professional.

• digestive problems

  • Acid reflux
  • Bloated feeling in stomach
  • Constipation
  • Diarrhea
  • Excessive gas
  • Nausea
  • Stomach pain
  • Vomiting
• dizziness, spinning sensation or a changed sense of taste.
• flu-like symptoms (rarely with fever) and/or generally feeling unwell.
• joint swelling or swelling in your hands or legs.
• lack or loss of strength
• mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth.
• muscle cramps and/or aches

• skin problems

  • Rash that may be made worse by sunlight
  • Hair loss
  • Itchy skin

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store between 15°C and 30°C.

Do not use this medicine after the month and year written after EXP (expiry date) on the container.

Keep out of reach and sight of children.

If you want more information about NB-ALENDRONATE-FC:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html); the manufacturer’s website