Sandoz-Calcitonin Ns: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Calcitonin NS is used in the treatment of postmenopausal osteoporosis in women, in addition to exercises and adequate calcium and vitamin D intake.

What it does:

Sandoz Calcitonin NS reduces the removal of calcium from bone in conditions with an increased rate of bone resorption such as osteoporosis.

What is Osteoporosis?

Osteoporosis is a thinning and weakening of the bones that is common in postmenopausal women. The menopause occurs when the ovaries stop producing the female hormone, estrogen, or are removed (which may occur, for example, at the time of a hysterectomy). After the menopause, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. The earlier a woman reached the menopause, the greater the risk of osteoporosis. Maintaining bone mass and preventing further bone loss are important to keep your skeleton healthy.

Early on, osteoporosis usually has no symptoms, if left untreated, however, it can result in fractures (broken bones). Although fractures usually cause pain, fractures of the bones of the spine may go unnoticed until they cause height loss. Fractures may occur during normal, everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone. Fractures usually occur at the hip, spine, or wrist and can lead not only to pain, but also to considerable deformity and disability (such as stooped posture from curvature of the spine, and loss of mobility).

When it should not be used:

You should not take Sandoz Calcitonin NS if you are allergic to salmon calcitonin or to any nonmedicinal ingredients of Sandoz Calcitonin NS.

If you think you may be allergic to Sandoz Calcitonin NS solution, ask your doctor for advice. You may need to undergo a skin test before you start your treatment.

What the medicinal ingredient is:

Synthetic calcitonin (salmon)

What the important nonmedicinal ingredients are: Benzalkonium chloride (as a preservative), hydrochloric acid (for pH adjustment), sodium chloride and purified water.

What dosage forms it comes in:

Sandoz Calcitonin NS is available in spray bottles delivering at least 14 metered doses. Each metered dose delivers 200 IU synthetic calcitonin (salmon)

WARNINGS AND PRECAUTIONS

BEFORE you use Sandoz Calcitonin NS talk to your doctor or pharmacist if:

• You have chronic rhinitis
• You are pregnant or planning to get pregnant
• You are breast feeding

Sandoz Calcitonin NS can cause serious allergic reactions. Sandoz Calcitonin NS should not be used in children under 18 years of age.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine including those not prescribed by a doctor.

It is particularly important that you tell your doctor if you are taking a medicine containing lithium.

PROPER USE OF THIS MEDICATION

Usual dose: one spray (200 IU) once a day administered intranasally, alternating nostrils daily into one nostril only. You should switch between each nostril every time you use Sandoz Calcitonin NS. Your physician may prescribe calcium and vitamin D together with Sandoz Calcitonin NS to help retard the progressive loss of bone mass. Please see the instructions below on how to prepare the spray bottle.

Use in pregnancy and breast feeding.

Do not take Sandoz Calcitonin NS if you are pregnant or breast feeding.

Use in children

Sandoz Calcitonin NS is not indicated for children under 18 years of age and should not be given to them.

Use in elderly

Sandoz Calcitonin NS works equally well in and is equally well tolerated by patients older and younger than 65 years of age.

Instructions for use/handling of Sandoz Calcitonin NS Nasal Spray

Please read the instructions carefully so that you know how to use your nasal spray.

• If the spray mechanism should become blocked, this may be resolved by pressing down firmly on the pump; do not attempt to unblock it by using a sharp pointed object as this may cause damage. If you think your nasal spray is not working properly, take it back to your pharmacist. Never try to fix the nasal spray yourself or take it apart, as this may affect your dose.

• Always follow your doctor’s instructions regarding dosage carefully.
• Keep this leaflet in a safe place so that you can read it again.

The different parts of your nasal spray

1. 1. Protective cap: Keeps the nozzle clean and protects the jet. Always replace the protective cap after you have used the nasal spray.
2. 2. Jet: The tiny hole from which the solution sprays out.
3. 3. Nozzle: The part you insert into your nostril.
4. 4. Pump: The part you press down to operate the spray.
5. 5.

   Counter: The dose counter window on a new nasal spray shows

   , as shown in this picture. The display will change as you use the pump (see below).

6. 6. Dip tube: The tube inside the spray bottle that draws up the

solution when you press the pump.

1. 7.

   Bottle: Contains

   enough solution for at least 14 doses.

   How to Prepare Sandoz Calcitonin NS Nasal Spray

   Upon starting each new bottle of Sandoz Calcitonin NS, you must prime the pump (step 2). You should allow the bottle to reach room temperature before priming the pump. Once the bottle has been opened and primed, you do not need to repeat step 2 for the remainder of the time you use the bottle

   (approximately 14 sprays).

   NEVER shake the nasal spray bottle as this could cause air bubbles, which may affect your dose. The dose counter window of a new nasal spray bottle is in the position marked as shown in the picture

   1Remove the protective cap.

2 First time of use only:

Hold the nasal spray upright in one or two hands and press down firmly on the pump 3 times. This primes the new spray by clearing air out of the dip tube. You will only need to do this once when you start a new spray.

Do not worry if a little solution sprays out; this is normal.

As you press the pump, watch the changes in the dose counter window.

When green is showing in the dose counter window, your new nasal spray is ready to use. Follow the instructions for ‘Using your nasal spray.

Using the nasal spray

1. 1.

   With the protective cap removed, bend your head slightly forward and insert the applicator nozzle into one of your nostrils. Make sure it is in a straight line with the nasal passage to allow the spray mist to spread more evenly. Depress the plunger once and release (see drawing). In the counter window you will now see the number 1.

   2 . After taking a dose, sniff vigorously several times to prevent the solution from running out of your nose. Do not blow your nose immediately after taking a dose.

   1. 3. After use, clean the nozzle with a dry tissue and always replace the protective cap to prevent the jet from becoming blocked.
   2. 4.

      Checking the counter: Every time you use the nasal spray the number in the dose counter window will change. The number displayed tells you how many puffs you have already taken. The Nasal Spray is guaranteed to deliver 14 metered doses. You may be able to obtain 2 extra doses.

      When the dose counter window shows a red as shown in this picture, 16 puffs have been used and the nasal spray is finished. You may notice that a little liquid is left in the nasal spray bottle, but this is normal.

   3. 5. Under no circumstances attempt to enlarge the jet with a needle or sharp object. This will destroy the function completely. Do not dismantle the pump. To ensure even dosage, store or carry the bottle in an upright position. Avoid shaking and extremes of temperature.
   4. 6. Once opened, the nasal spray bottle must be kept at room temperature and used for a maximum of 4 weeks

Overdose:

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 forget your dose of Sandoz Calcitonin NS, do not double your dose at the next use

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Sandoz Calcitonin NS, as with any medicine, may have side effects.

The most commonly reported adverse events with Sandoz Calcitonin NS Nasal Spray are local effects such as sore nose, runny and stuffy nose (rhinitis), nasal dryness with crusting, non-severe epistaxis,

inflammation of the sinuses (feeling of pressure or pain in nose, cheeks and behind eyes), sneezing, nasal allergy, irritated nose, nasal odour, swelling, redness and damage of the mucus lining of the nose.

Rarely, patients may experience nausea, vomiting or dizziness. These effects usually disappear on their own.

Sandoz Calcitonin NS may cause fatigue, dizziness and disturbed vision, which may impair your reactions. If this happens, you should not drive or use machines.

Tell your doctor or pharmacist if you have any side effect not mentioned in this leaflet, or if any of the side effect mentioned above persists or becomes bothersome.

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Calcitonin NS, contact your doctor or pharmacist.

HOW TO STORE IT

Unopened Sandoz Calcitonin NS Nasal Spray should be stored in the refrigerator between 2 and 8°C and protected from freezing.

• After priming, Sandoz Calcitonin NS Nasal Spray should be stored at room temperature (between 15-30°C ) and used within 4 weeks.
• To ensure correct delivery, the bottle should be kept in an upright position at all time to reduce the risk of air bubbles getting into the dip tube.

Store in the original package.

• Do not use this medicine after the expiry date printed on the label.
• Remember to keep Sandoz Calcitonin NS and all medications out of the reach and sight of children.

MORE INFORMATION

This document, plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Sandoz Canada Inc., at: 1-800-361-3062

or

by written request at:

145, Jules-Léger

Boucherville, (QC), Canada

J4B 7K8

or by e-mail at :

medinfo@sandoz.com

Last revised: October 12, 2010

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associat with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

y Report online at www.healthcanada.gc.ca/medeffect y Call toll-free at 1-866-234-2345 y Complete a Canada Vigilance Reporting Form and :

• Fax toll-free to 1-866-678-6789, or

• Mail to:

  Canada Vigilance Program Health Canada

  Postal Locator 0701D

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect ^TM Canada site at www.healthcanada.gc.ca/medeffect.

Note: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.