Baca Respiclick: Uses, Side Effects and Dosage

What is BACA RESPICLICK used for?

BACA RESPICLICK is used in adults and children of 4 years and older to:

• treat and/or prevent bronchospasm in patients who have narrowing of the airways and,
• prevent exercise-induced bronchospasm.

Bronchospasm is a sudden worsening of shortness of breath and wheezing.

The safety and efficacy of BACA RESPICLICK in children under 4 years of age has not been established.

How does BACA RESPICLICK work?

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 relieve chest tightness, wheezing and cough so that you can breathe more easily.

What are the ingredients in BACA RESPICLICK?

Medicinal ingredients: salbutamol (as salbutamol sulphate).

Non-medicinal ingredients: lactose monohydrate (which contains milk proteins).

BACA RESPICLICK comes in the following dosage forms:

• Inhalation powder.
• Each actuation contains 97 mcg salbutamol base (equivalent to 117 mcg of salbutamol sulphate).
• Each inhaler has a red cap, contains a minimum of 200 actuations (inhalations) and has a counter which displays the number of actuations (inhalations) remaining.

Do not use BACA RESPICLICK if:

• You are allergic to salbutamol sulphate, lactose or milk protein, or any component of the container.
• You are having preterm labour or are at risk for a miscarriage. BACA RESPICLICK has the potential to affect the way the uterus contracts.

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

• have ever had to stop taking other medicines for your condition because you were allergic to them or they caused problems.
• have a heart problem, irregular heart beat or high blood pressure (hypertension).
• have convulsions (seizures).
• have been told that you are allergic to lactose or milk protein.
• have thyroid problems.
• have kidney problems.
• have high blood sugar (diabetes).

• have low potassium levels in your blood, especially if you are taking:

  • drugs known as xanthine derivatives (such as theophylline)
  • steroids to treat asthma
  • water pills (diuretics)
• have any other medical conditions.

• are pregnant or plan to become pregnant. Taking BACA RESPICLICK may cause harm to your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

• are breastfeeding or plan to breastfeed. It is not known if BACA RESPICLICK passes into your breast milk and whether it may harm your baby. Talk to your doctor about the best way to feed your baby if you are using BACA RESPICLICK.

Other warnings you should know about:

• You should always carry your inhaler with you. You may need to use it immediately in case you experience a sudden worsening of shortness of breath and wheezing.
• See your doctor as soon as possible if your condition does not improve or if it worsens while you are taking BACA RESPICLICK. Get medical help right away if your shortness of breath gets really bad very quickly.
• Excessive use: Some patients have died when using an excessive amount of their inhalers that are of a specific type like salbutamol. The exact cause of death is unknown. Be sure to only take BACA RESPICLICK as recommended by your doctor. Your doctor will monitor you if you need to take a drug that is similar to BACA RESPICLICK at the same time you are taking BACA RESPICLICK.

• You may also need to take anti-inflammatory medicines while you take BACA

  RESPICLICK to better help control your asthma.

• Severe wheezing (paradoxical bronchospasm): as with other inhaled medicines, you may develop severe wheezing after taking BACA RESPICLICK. This could be life-threatening. If this happens, stop taking BACA RESPICLICK right away and seek medical help. You will need to use a different medication to help relieve your symptoms. Severe wheezing frequently happens with the first use of a new inhaler.
• Elderly patients: if you are elderly, your doctor may adjust your dose and/or monitor your kidneys while you are taking BACA RESPICLICK.

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

Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.

You and your healthcare provider will discuss whether it is appropriate for you to continue to receive your medications, or change your treatment plan.

The following may interact with BACA RESPICLICK:

• other inhaled medicines or asthma medicines
• epinephrine
• beta blocker medicines used to lower blood pressure (propranolol, metoprolol, etc.)
• diuretics (“water pills”)
• digoxin, a heart medication
• anti-depressants

How to USE BACA RESPICLICK:

• BACA RESPICLICK is for oral inhalation only.
• Use BACA RESPICLICK exactly as your doctor tells you to use it.
• Do not use a spacer or volume holding chamber with BACA RESPICLICK.
• BACA RESPICLICK does not need priming.
• If your child needs to use BACA RESPICLICK, watch them closely to make sure they use the inhaler correctly. Your doctor will show you how your child should use BACA RESPICLICK.

• Get medical help right away if:

  • the effects of one dose last less than 3 hours;
  • you notice a sudden worsening of your shortness of breath;
  • your symptoms gets worse;
  • your usual dose does not provide relief of wheezing or chest tightness;
  • you need to use BACA RESPICLICK more often than before; These may be signs that your asthma or chest condition is getting worse. Your doctor may want to reassess your treatment plan.
• Do not increase the dose or the number of times you use your medicine without asking your doctor, as this may make you feel worse.
• Do not use other inhaled rescue and asthma medicines unless your doctor tells you to do so.

Usual dose:

Adults and Children 4 years of age and older

• Each dose is equal to 2 actuations (inhalations).

  • To relieve bronchospasm: 2 actuations (inhalations) as needed. If you have a more severe attack, you can repeat the dose every 4 to 6 hours, and immediately consult your doctor or the nearest hospital.
  • To prevent bronchospasm: 2 actuations (inhalations) repeated every 4 to 6 hours as needed up to a maximum three or four times a day, as prescribed by your doctor.

  • To prevent bronchospasm caused by exercise: 2 actuations (inhalations) 15 to

    30 minutes before exercise.

  • Maximum daily dose: 8 actuations (inhalations) per day.

Instructions for Use:

About the inhaler:

When you are ready to use BACA RESPICLICK for the first time, remove the inhaler from the foil pouch.

There are 2 main parts of the inhaler including (see Figure A):

• the white inhaler with the mouthpiece.
• the red dust cap that covers the mouthpiece of the inhaler.

There is a counter in the back of the inhaler with a viewing window that shows you how many actuations of medicine you have left.

Figure A

About the counter:

• The inhaler contains ‘200’ actuations (inhalations) (see Figure B).
• The counter on the back of your inhaler shows how many actuations (inhalations) you have remaining.
• When there are 20 actuations (inhalations) left, the counter will change to red and you should refill your prescription or ask your doctor for another prescription.

• Bring your inhaler to your pharmacy for safe disposal:

  • 13 months after removing it from the foil pouch for the first time OR
  • when the dose counter displays ‘0’ OR
  • after the expiration date on the package, whichever comes first.

Figure B

IMPORTANT POINTS TO REMEMBER ABOUT USING YOUR INHALER:

• Always close the cap after each actuation (inhalation) so your inhaler will be ready for you to take your next dose.
• Do not open the cap unless you are ready for your next dose. Opening and closing the cap a lot without inhaling will waste the medicine and may damage your inhaler.
• BACA RESPICLICK does not have an activation button or medicine canister. When you open the cap, the inhaler will be ready to deliver the medicine.

• You will hear a “click” sound when the cap is opened fully. If you do not hear the “click”

  sound the inhaler may not deliver the medicine.

• In general, children will take BACA RESPICLICK in a similar way as for adults.

  Supervise your child when they use BACA RESPICLICK.

• Your BACA RESPICLICK inhaler contains dry powder so it is important that you do not blow or breathe into it.

Step-by-step instructions

Important: Make sure the cap is closed before you start.

Step 1: Open

Figure C

Figure D

Hold the inhaler upright as you open the red cap.

• Open the red cap all the way back until you feel and hear a “click”.
• Every time the red cap is opened and it clicks, one actuation is ready.
• Do not open the red cap unless you are ready to use the inhaler.

Step 2: Inhale

Figure E

Figure F

Step 3: Close

Figure G

• Breathe out fully away from the inhaler before inhaling. Never breathe out into the inhaler mouthpiece.

  • Close the red cap after inhaling to reload your next actuation.
  • If you need another actuation, repeat steps 1-3.

  • If you do not need another actuation, keep the cap closed until it is time to take your next dose.

    • Place the mouthpiece in your mouth and close your lips around it so you form a good seal.
    • Do not block the vent above the mouthpiece with your lips or fingers.
    • Breathe in quickly and deeply through your mouth, until your lungs feel completely full of air.
    • Remove the inhaler from your mouth.
    • Hold your breath for about 10 seconds or for as long as you comfortably can.
    • Your BACA RESPICLICK inhaler delivers your medicine as a very fine powder that you may or may not taste or feel. Do not take an extra actuation from the inhaler even if you do not taste or feel the medicine.

Cleaning your BACA RESPICLICK Inhaler

• Do not wash or put any part of your BACA RESPICLICK inhaler in water.
• BACA RESPICLICK contains a powder and must be kept clean and dry at all times.
• Once a week, gently wipe with a dry cloth or tissue.

Overdose:

If you think you have taken too much BACA RESPICLICK contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, take the next dose when it is due or if you become wheezy.

What are possible side effects from using BACA RESPICLICK?

These are not all the possible side effects you may feel when taking BACA RESPICLICK.

The most common side effects of BACA RESPICLICK include:

Effects on heart

• High blood pressure

Effects on nervous system

• Sinus headache
• Feeling restless
• Feeling irritable
• Feeling tired or weak
• Trouble sleeping (insomnia)
• Shakiness
• Nervousness
• Hyperactivity in children
• Dizziness
• Drowsiness

Effects on muscles and joints

• Back pain, body aches and pain

Other Effects

• Chest pain
• Runny nose
• Unusual taste in the mouth
• Dry or irritated throat
• Difficulty urinating
• Upset stomach, including feeling nauseous and vomiting
• Urinary tract infection

Rarely, children treated with salbutamol were hyperactive, and they sometimes had trouble sleeping, or had hallucinations.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of BACA RESPICLICK. For more information, ask your doctor or pharmacist.

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, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Store BACA RESPICLICK at room temperature between 15ºC and 30ºC.
• Avoid exposure to extreme heat, cold, or humidity.
• Keep the red cap on the inhaler closed during storage.
• Keep your BACA RESPICLICK inhaler dry and clean at all times.
• Keep out of reach and sight of children.

If you want more information about BACA RESPICLICK:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); Teva Canada Innovation site at http://www.tevacanadainnovation.ca
• or by contacting the sponsor, Teva Canada Innovation at: 1-855-514-8382.

BACA RESPICLICK^TM is a trademark of Ivax International B.V., a member of the Teva Group; used under license.

Last Revised: November 1, 2017