Ratio-Salbutamol (Teva Canada, 1 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your doctor has prescribed a medicine called ratio-SALBUTAMOL Respirator Solution (salbutamol sulphate) to you. It is used to help breathing problems in:

• Asthma
• Other chest illnesses

What it does:

Salbutamol is one of a group of medicines called bronchodilators. Salbutamol relaxes the muscles in the walls of the small air passages in the lungs. This helps to open up the airways and so helps to relieve chest tightness, wheezing and cough so that you can breathe more easily.

When it should not be used:

Do not use ratio-SALBUTAMOL Respirator Solution if:

• your are allergic to it or any of the components of its

  formulation (see What the important nonmedicinal ingredients are).

• your heart beats faster than normal.

What the medicinal ingredient is:

ratio-SALBUTAMOL Respirator Solution contains the active ingredient, salbutamol sulphate.

What the important nonmedicinal ingredients are:

Benzalkonium chloride, dilute sulphuric acid and water.

What dosage forms it comes in:

ratio-SALBUTAMOL Respirator Solution contains 1 mg per mL.

WARNINGS AND PRECAUTIONS

Before you use ratio-SALBUTAMOL Respirator Solution talk to your doctor or pharmacist if:

• You have ever had to stop taking another medicine for

  this illness because you were allergic to it or because it caused problems.

  • You are having treatment for a thyroid condition.
  • You are having treatment for high blood pressure or a heart problem.
  • You have diabetes.
  • You have a past history of seizures.

  • You are pregnant or breastfeeding.

Rare cases of lactic acidosis (too much lactic acid in the blood) have been reported in patients receiving high doses of ratio-SALBUTAMOL Respirator Solution. If you suffer symptoms (see Serious Side Effects Table), contact your doctor immediately.

If the relief of wheezing or chest tightness is not as good as usual, tell your doctor as soon as possible. If you notice a sudden worsening of your shortness of breath and wheeze shortly after taking your medicine, tell your doctor as soon as possible.

It may be that your chest condition is worsening and you may need to add another type of medicine to your treatment.

Your doctor may decide not to prescribe this medicine during the first 3 months of pregnancy, nor if you are breast feeding a baby. However, there may be circumstances when your doctor advises you differently.

Children

ratio-SALBUTAMOL Respirator Solution should be used under the supervision of an adult who understands the proper use of the nebulizer and only as prescribed by the doctor.

INTERACTIONS WITH THIS MEDICATION

Make sure that your doctor knows what other medicines you are taking (such as those for depression, allergies, other airway-opening medications (e.g. other asthma medications), blood pressure and heart medications, and water pills (diuretics), etc.) including those you can buy without a prescription as well as herbal and alternative medicines.

PROPER USE OF THIS MEDICATION

Please follow these instructions carefully. It is important that you use your ratio-SALBUTAMOL Respirator Solution properly to ensure that you receive the maximum benefit from your medicine.

ratio-SALBUTAMOL Respirator Solution contains salbutamol 5 mg per mL. For proper administration, 1 mL of solution is usually diluted with 2 to 5 mL of sterile normal saline.

In the home, ratio-SALBUTAMOL Respirator Solution may be diluted immediately before use. Pre-diluted

solutions of ratio-SALBUTAMOL Respirator Solution should not be stored.

Before starting treatment with this drug, be sure that you are fully familiar with the proper use and care of your nebulizer.

1. 1.

   When preparing the solution for inhalation, use a

   graduated syringe to draw up ratio-SALBUTAMOL Respirator Solution from the bottle at the dose directed by your physician. Note: Close the ratio-SALBUTAMOL bottle as soon as the solution is drawn into the syringe. Keep the bottle closed at all times and do not open it unnecessarily. Discard unused, diluted ratio-SALBUTAMOL Respirator Solution after each use.

2. 2.

   Inject the solution into the nebulizer through the

   appropriate opening.

3. 3.

   Draw into the syringe the amount of diluting fluid

   (sterile normal saline) directed by your physician and add it to the nebulizer.

4. 4.

   Gently shake the nebulizer and connect it with the

   mouthpiece or face mask.

5. 5.

   Connect the apparatus to the air pump or oxygen

   and start the treatment.

6. 6.

   Breathe calmly and evenly as much as possible

   until no more mist is formed in the nebulizer chamber. At this point, treatment is finished.

7. 7.

   Any unused solution in the respirator should be

   discarded.

Care of the ratio-SALBUTAMOL Respirator Solution and Nebulizer

Cleaning: after each use, clean the syringe and nebulizer as instructed in the nebulizer manual or as follows:

To clean the nebulizer:

1. 1. Disassemble the supply tube and the nebulizer.
2. 2.

   Wash in warm detergent solution. Rinse the tube

   with water.

3. 3.

   To wash the suction tubes:

   a. Place 3 mL of detergent solution in the

   vial, assemble the unit and operate for 2 minutes.

   b. Disassemble and rinse the vial with warm

   water, place 3 mL of warm water in the vial, assemble the unit and operate for 2 minutes.

   c. Disassemble and rinse with warm water.

4. 4.

   To dry the external passage:

   a. Connect the nebulizer tube to the pump

   with the supply tube.

   b. Turn the pump and blow air through for 1

   minute.

5. 5.

   If there is evidence of clogging, clean the openings

   and tube connectors with the detergent, then rinse with water.

6. 6.

   Reassemble.

   To clean the syringe:

   1. 1. Clean the syringe and needle several times in detergent solution by alternatively drawing up and expelling the detergent solution.
   2. 2. Repeat using a rinse of warm water.
   3. 3. Dry the needle by drawing air into the syringe several times, by moving the plunger back and forth in the barrel of the syringe. Remove the needle.
   4. 4. Remove the plunger from the syringe, allow to air dry.
   5. 5. Keep unassembled needle, plunger and barrel of syringe wrapped in clean tissue, stored in a refrigerator along with the ratio-SALBUTAMOL bottle.

Discard any solution left in the nebulizer after you finish treatment, clean and dry the nebulizer as instructed by the nebulizer manual.

Follow all the instructions of the nebulizer and air pump manufacturers for the proper care and maintenance of the apparatus.

Do not swallow or inject ratio-SALBUTAMOL Respirator Solution. The solution is inhaled into your lungs using a nebulizer.

Usual dose:

Use your ratio-SALBUTAMOL Respirator Solution only as directed by your doctor. He will tell you how often, and how much to take for a treatment. If you are not sure how much or when to take your medicine, ask your doctor or pharmacist.

The action of ratio-SALBUTAMOL Respirator Solution may last for up to 6 hours and should last at least 4 hours. Call your doctor immediately if the effect of your usual dose lasts for less than t 3 hours or if you suddenly get worse shortness of breath and you wheeze after using your ratio-SALBUTAMOL

Respirator Solution. Do not increase the dose or how often you take your medicine without informing your doctor. If symptoms get worse, tell your doctor as soon as possible.

When using ratio-SALBUTAMOL Respirator Solution, other medicines (including asthma medicines) should only be used when prescribed by your doctor.

If you regularly use ratio-SALBUTAMOL Respirator Solution two or more times a day, and take no other asthma medication, you should talk to your doctor who may want to reassess your treatment plan.

Adults: ratio-SALBUTAMOL Respirator Solution 0.5 to 1.0 mL (2.5 to 5.0 mg of salbutamol) should be diluted in 2 to 5 mL or more of sterile normal saline. Treatment may be repeated four times a day if necessary.

Children: (5 - 12 years): The average dose for a single treatment is 0.25 to 0.5 mL of ratio-SALBUTAMOL Respirator Solution (1.25 to 2.5 mg of salbutamol) diluted in 2 to 5 mL or more of sterile normal saline. For more refractory cases, the single dose of ratio-SALBUTAMOL Respirator Solution may be increased to 1 mL (5 mg salbutamol). Treatment may be repeated four times a day if necessary.

Overdose:

If you accidentally take a larger dose than prescribed, you are more likely to get side effects like a faster heart beat, headaches and feeling shaky or restless. These effects usually wear off within a few hours, but you should tell your doctor as soon as possible.

In the event of an excessive overdosage, tell your doctor without delay or contact your nearest hospital emergency department or poison control centre. Take this leaflet or your medication with you so that the hospital or poison control centre will know what you have taken.

Missed dose:

If you forget to inhale a dose do not worry, inhale the next dose at the time you would normally take it or inhale a dose sooner than when it is due if you become wheezy.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Very occasionally some people feel a little shaky or have a headache or notice that their heart is beating a little faster and/or more forcefully than usual after using ratio-SALBUTAMOL Respirator Solution. Muscle cramps can occur although these are quite rare. These effects usually wear off with continued treatment. Tell your doctor but do not stop using the medicine unless told to do so. If your heart beat feels irregular, tell your doctor as soon as possible.

This is not a complete list of side effects. If you have any unexpected effects after receiving ratio-SALBUTAMOL Respirator Solution, contact your doctor or pharmacist.

* If you think you have these side effects, it is important that you seek medical advice from your doctor immediately.

HOW TO STORE IT

Keep your ratio-SALBUTAMOL Respirator Solution in a safe place where children cannot reach them. Your medicines may harm children.

Keep the ratio-SALBUTAMOL Respirator Solution in a dry place and store them between 15^oC to 25^oC. Protect from light. One month after opening the bottle, throw away any solution which is left over.

MORE INFORMATION

You may need to read this leaflet again. PLEASE DO NOT THROW IT AWAY until you have finished your medicine.

REPORTING SUSPECTED SIDE EFFECTS

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

-------------------------------------------------------------------

$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ 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, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

This document plus the full product monograph, prepared for health professionals or by contacting the sponsor, Teva Canada Limited, at:

1-800-268-4127 ext. 1255005 (English)

1-877-777-9117 (French)

or druginfo@tevacanada.com

Last revised: July 24, 2013