Consumer Information for: TEVA-SALBUTAMOL HFA

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

TEVA-SALBUTAMOL HFA is used in Adults and Children 4 years or older to:

  • relieve bronchospasm
  • prevent bronchospasm
  • prevent bronchospasm caused by exercise

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

The safety and effectiveness of TEVA-SALBUTAMOL HFA in children under the age of 4 are not known.

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 TEVA-SALBUTAMOL HFA:

  • if you are allergic to it or any of the components of its formulation (see what the nonmedicinal ingredients are)
  • for the treatment of preterm labour or miscarriage.
What the medicinal ingredient is

salbutamol sulfate.

What the non-medicinal ingredients are

HFA (Hydro Fluoro Alkane) and Ethanol.

TEVA-SALBUTAMOL HFA is suspended in a CFC-free propellant.

Please note that indicates that this inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

What dosage form it comes in

TEVA-SALBUTAMOL HFA is supplied to you in an inhaler containing 100 mcg of salbutamol per puff. The inhaler contains 200 puffs. The inhaler should be thrown out when 200 puffs have been used.

Warnings and precautions

BEFORE you use TEVA-SALBUTAMOL HFA, talk to your doctor or pharmacist if you:

  • have ever had to stop taking other medications for this illness because you were allergic to them or they caused problems.
  • are having treatment for a thyroid condition.
  • are having treatment for high blood pressure or a heart problem.
  • have diabetes.
  • have a past history of seizures.
  • have reduced kidney function
  • have low levels of potassium in your blood (hypokalemia), especially if you are taking:
    • Drugs known as xanthine derivatives (such as theophylline)
    • Steroids to treat asthma
    • Water pills (diuretics)
  • are pregnant or intend to become pregnant. Taking TEVA-SALBUTAMOL HFA during pregnancy may cause harm to your baby. Your doctor will consider the benefit to you and the risk to your baby of taking TEVASALBUTAMOL HFA while you're pregnant.
  • are breastfeeding. It is not known if TEVASALBUTAMOL HFA passes into breast milk.

Effects on Children:

Children may experience:

  • changes in sleep patterns
  • changes in behaviour such as restlessness, excitability (hyperactivity)
  • seeing or hearing things that are not there
Interactions with this medication

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with TEVA-SALBUTAMOL HFA:

  • Anti-depressants
  • Allergy medication
  • Blood pressure-lowering drugs, including propranolol
  • Diuretics (“water pills”)
  • Bronchodilators used to open the airway (such as other asthma medication)
  • Epinephrine
  • Digoxin, a heart medication
  • Disulfiram, a medicine used to treat alcoholism
  • Metronidazole, an antibiotic medication
Proper use of this medication

TEVA-SALBUTAMOL HFA should only be inhaled. Do not swallow.

If you are also using an inhaled corticosteroid:

  • Always use TEVA-SALBUTAMOL HFA first
  • Wait a few minutes
  • Then use your inhaled corticosteroid

The effects of TEVA-SALBUTAMOL HFA should last for 4 to 6 hours.

You should call your doctor immediately 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;
  • you need to use TEVA-SALBUTAMOL HFA 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.

Usual Dose

Adults and Adolescents 12 years or older

  • To relieve and prevent bronchospasm: 1 to 2 puffs every 4 to 6 hours as needed. If you have a more severe attack, you can repeat the dose, and immediately consult your doctor or the nearest hospital.
  • To prevent bronchospasm caused by exercise: 2 puffs 15 minutes before exercise.
    Maximum dose – 8 puffs in a 24 hour period

Children 4-11 years

  • To relieve and prevent bronchospasm: 1 puff every 4 to 6 hours as needed. The dose may be increased to 2 puffs if required. Follow your doctor’s instructions.
  • To prevent bronchospasm caused by exercise: 1 puff 15 minutes before exercise. The dose may be increased to 2 puffs if required. Follow your doctor’s instructions.
    Maximum dose – 4 puffs in a 24 hour period

DO NOT EXCEED RECOMMENDED DOSE.

Do not increase the dose or the number of times you use TEVASALBUTAMOL HFA without asking your doctor, as this may make you feel worse.

If you have to go into hospital for an operation, take your inhaler with you and tell the doctor what medicine(s) you are taking

How to Use TEVA-SALBUTAMOL HFA:
Carefully follow the instructions shown. If you have any problems, tell your doctor or pharmacist.

It is extremely important that you use your TEVASALBUTAMOL HFA properly to ensure that your medicine is delivered correctly so that you receive maximum benefit.

Before using TEVA-SALBUTAMOL HFA for the first time, or if your inhaler has not been used for more than 2 weeks, release four sprays into the air to ensure that it works properly.

  1. Remove the cap from the mouthpiece; the strap on the cap will stay attached to the actuator, Check the mouthpiece inside and outside to ensure that it is clean.
  2. Shake the inhaler vigorously.
  3. Hold the inhaler upright between fingers and thumb with your thumb on the base, below the mouthpiece. Breathe out as far as is comfortable
  4. Place the mouthpiece in your mouth between your teeth and close your lips around it, but do not bite it. Just after starting to breathe in through your mouth, press down on the top of the inhaler to release the drug while still breathing in steadily and deeply.
  5. While holding your breath, take the inhaler from your mouth and take your finger from the top of the inhaler. Continue holding your breath for as long as is comfortable.
  6. If you are to take further puffs, keep the inhaler upright and wait about half a minute before repeating steps 2 through 5.
  7. After use, always snap the mouthpiece cover back into position to keep out dust and lint.

Important: Do not rush steps 3 and 4. It is important that you start to breathe in as slowly as possible just before operating your inhaler, Practice in front of a mirror for the first few times. If you see “mist” coming from the top of your inhaler or the sides of your mouth, you should start again from step 1.

If your doctor has given you different instructions for using your inhaler, please follow them carefully. Tell your doctor if you have any difficulties.

Children – TEVA-SALBUTAMOL HFA should be used under the supervision of an adult who understands the proper use of the inhaler, and only as prescribed by the doctor. The adult must encourage the child (as described above) to exhale, and then trigger the spray immediately as inhalation begins. Use of a spacer with the inhaler is recommended for children under 5 years of age. Talk to your doctor if your child has difficulties using the inhaler.
Cleaning:
It is very important to keep the plastic actuator clean so the medicine will not build-up and block the spray. Do not try to clean the metal canister or let it get wet. The inhaler may stop spraying if it is not cleaned correctly.

Wash the actuator at least once a week.

Cleaning instructions:

  • Take the canister out of the actuator, and take the cap off the mouthpiece.
  • Wash the actuator through the top with warm running water for 30 seconds (see Fig. 1). Then wash the actuator again through the mouthpiece (see Fig. 2).
  • Shake off as much water from the actuator as you can. Look into the mouthpiece to make sure any medicine build-up has been completely washed away. If
    • there is any build-up, repeat steps in Figures 1 and 2.
  • Let the actuator air-dry completely, such as overnight (see Figure 3
  • When the actuator is dry, put the canister in the actuator and make sure it fits firmly. Shake the inhaler well and spray it twice into the air away from your face. Put the cap back on the mouthpiece.

If your actuator becomes blocked:

Blockage from medicine build-up is more likely to happen if you do not let the actuator air-dry completely. If the actuator gets blocked so that little or no medicine comes out of the mouthpiece (see Figures 4 and 5), wash the actuator as described in the “Cleaning Instructions” section above.

If you need to use your inhaler before the actuator is completely dry, shake as much water off the actuator as you can. Put the canister in the actuator and make sure it fits firmly. Shake the inhaler well and spray it twice into the air away from your face. Then take your dose as prescribed. Then clean and airdry it completely.

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. Take this leaflet or your medication with you so that the hospital or poison control centre will know what you have taken.

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.

Missed Dose

If you forget to inhale a dose, do not worry; just inhale the next dose when it is due or if you become wheezy.

Side effects and what to do about them

Side effects may include:

Effects on heart

  • Hypertension

Effects on nervous system

  • Headache
  • Feeling a little shaky
  • Feeling anxious or irritable
  • Feeling tired or weak
  • Trouble sleeping (insomnia)
  • Hyperactivity in children
  • Dizziness, vertigo
  • Drowsiness

Effects on muscles and joints

  • Muscle cramps
  • Muscle pain

Other Effects

  • Cough
  • Respiratory infections and/or inflammation
  • Diarrhea
  • Nausea and vomiting
  • Chest pain or discomfort
  • Flushing
  • Difficulty urinating
  • Unusual taste in your mouth
  • Dry or irritated throat
    • SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
    Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
    Very Rare
    Bronchospasm:
    Sudden worsening of shortness of breath and wheezing shortly after using TEVASALBUTAMOLHFA    		     ✔
    Allergic Reactions:
    sudden wheeziness and chest pain or tightness; or swelling of eyelids, face, lips, tongue or throat    		     ✔
    Rare
    Low Blood Potassium (hypokalemia): muscle weakness and muscle spasms   ✔  
    Hallucinations in Children: see or hear things that are not there   ✔  
    Unknown
    Heart palpitations, faster than normal heartbeat, irregular heartbeat   ✔  

    This is not a complete list of side effects. If you have any unexpected effects while receiving TEVA-SALBUTAMOL HFA, contact your doctor or pharmacist.

    How to store

    Keep out of sight and reach of children.
    Store at a temperature between 15°C and 25°C. Do not keep any left over medicine unless your doctor tells you to.

    Warning: The canister contents are under pressure. The container may explode if heated. Do not place in hot water or near radiators, stoves or other sources of heat. Even when empty, do not puncture or incinerate container.

    Reporting side effects

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

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

    More information

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

    This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited by:
    Phone: 1-800-268-4127 ext. 3;
    Email: druginfo@tevacanada.com; or
    Fax: 1-416-335-4472

    This leaflet was prepared by:
    Teva Canada Limited
    30 Novopharm Court
    Toronto, Ontario
    Canada, M1B 2K9

    www.tevacanada.com

    Last revised: March 20, 2018

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