Teva-Salbutamol HFA: Uses, Side Effects and Dosage

What TEVA-SALBUTAMOL HFA is used for:

TEVA-SALBUTAMOL HFA is used in adults and children (4 years and older) to:

• relieve and prevent worsening breathing problems (bronchospasm) due to chronic bronchitis (inflammation of the airways of the lungs with mucus production), bronchial asthma (inflammation of the airways of the lungs) and other problems with the airways of the lungs.
• prevent breathing problems caused by exercise.

How TEVA-SALBUTAMOL HFA works:

TEVA-SALBUTAMOL HFA belongs to a group of medicines known as “bronchodilators”. TEVA-SALBUTAMOL HFA relaxes the muscles in the walls of the small air passages in the lungs. This helps to open up the airways of the lungs making it easier to breathe.

The ingredients in TEVA-SALBUTAMOL HFA are:

Medicinal ingredient: Salbutamol sulfate.

Nonmedicinal ingredients: 1,1,1,2-tetrafluoroethane (HFA-134a) and ethanol.

TEVA-SALBUTAMOL HFA comes in the following dosage forms:

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.

Do not use TEVA-SALBUTAMOL HFA if:

• you are allergic to salbutamol sulphate or any of the other ingredients in TEVA-SALBUTAMOL HFA.
• for the treatment of preterm labour or miscarriage.

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

• have ever had to stop taking other medications for this illness because you were allergic to them or they caused problems.
• have thyroid problems.
• have a heart problem.
• have high blood pressure.
• have diabetes.
• have a seizures or a past history of seizures.
• have reduced kidney function

• have low levels of potassium in your blood (hypokalemia), especially if you are taking:

  • medicines known as xanthine derivatives (such as theophylline)
  • steroids to treat asthma
  • diuretics also known as “water pills”, used to lower fluid levels and treat high blood pressure
• have low oxygen levels in your body (hypoxia).

• are pregnant or plan to become pregnant. Taking TEVA-SALBUTAMOL HFA during pregnancy may cause harm to your baby. Your healthcare professional will consider the benefit to you and the risk to your baby of taking TEVA-SALBUTAMOL HFA while you're pregnant.

• are breastfeeding. It is not known if TEVA-SALBUTAMOL HFA passes into breast milk.

Other warnings you should know about:

You should always carry your TEVA-SALBUTAMOL HFA with you to use immediately in case you experience an asthma attack.

Monitoring: Your healthcare professional might monitor your health throughout your treatment with TEVA-SALBUTAMOL HFA. This can include monitoring your lungs, the level of potassium in your blood and how you respond to TEVA-SALBUTAMOL HFA.

Overuse: If you are using TEVA-SALBUTAMOL HFA more than twice a week to treat your asthma symptoms (not including before or after exercise or other triggers) talk to your healthcare professional. This may be a sign that your asthma is not well controlled and may increase the risk of severe asthma attacks. Your healthcare professional may need to reassess your treatment.

Paradoxical bronchospasm: If you feel tightness of the chest, coughing, wheezing or breathlessness right after using TEVA-SALBUTAMOL HFA, you may have a serious condition called “paradoxical bronchospasm” (an unexpected closing of your airways). Stop using TEVA-SALBUTAMOL HFA and seek medical help right away.

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 TEVA-SALBUTAMOL HFA:

• anti-depressants, medicines used to treat depression (such as monoamine oxidase inhibitors, and tricyclic antidepressants).
• medicines used to treat allergies.
• beta-blockers, medicines used to lower blood pressure (such as propranolol).
• diuretics also known as “water pills”, medicines used to lower fluid levels and treat high blood pressure.
• other bronchodilators, medicines used to open the airway (such as asthma medicines such as ipratropium bromide).
• epinephrine, a medicine that can be used to treat allergic reactions or sudden asthma attacks.
• digoxin, a medicine used to treat certain heart problems.

• Disulfiram, a medicine used to treat alcoholism

• Metronidazole, an antibiotic medication

How to take TEVA-SALBUTAMOL HFA:

• Take TEVA-SALBUTAMOL HFA exactly as directed by your healthcare professional.
• It is important that you use your TEVA-SALBUTAMOL HFA properly. This will ensure that you receive the prescribed dose of your medicine. Make sure you know how, when, and how much you should use. Follow your healthcare professional’s instructions carefully. If you are not sure, ask your healthcare professional.
• TEVA-SALBUTAMOL HFA should only be inhaled. Do not swallow.
• If you are using an asthma anti-inflammatory medicine daily (such as an inhaled corticosteroid) continue using it regularly, even if you feel better.

• If you are using an inhaled corticosteroid:

  • Always use TEVA-SALBUTAMOL HFA first.
  • Wait a few minutes and then use your inhaled corticosteroid.
• If you have to go into hospital for an operation, take your inhaler with you and tell the healthcare professional what medicine(s) you are taking.
• If your healthcare professional decides to stop your treatment, do not keep any leftover medicine unless your healthcare professional tells you to.

Salbutamol has a duration of action of 4 to 6 hours in most patients.

You should call your healthcare professional immediately if:

• the effects of one dose last less than 3 hours;
• you notice a sudden worsening of your shortness of breath;
• your symptoms get worse (for example you have frequent symptoms or flare ups such as breathlessness, cough, wheezing, tight chest, night-time awakening or limited physical ability);
• your usual dose does not provide relief of wheezing or chest tightness;
• 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 healthcare professional may want to reassess your treatment plan.

Do not increase the dose or the number of times you use your medicine without asking your healthcare professional, as this may make you feel worse.

How to Use TEVA-SALBUTAMOL HFA:

Carefully follow the instructions shown. If you have any problems, tell your healthcare professional.

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

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.

1. 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.

1. 2. Shake the inhaler vigorously.
2. 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.

1. 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.

1. 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.
2. 6. If you are to take further puffs, keep the inhaler upright and wait about 30 seconds before repeating steps 2 through 5.
3. 7. After use, always snap the mouthpiece cover back into position to keep out dust and lint.

If your healthcare professional has given you different instructions for using your inhaler, please follow them carefully. Tell your healthcare professional 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 healthcare professional. 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 healthcare professional if your child has difficulties using the inhaler.

How to clean TEVA-SALBUTAMOL HFA:

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.

To clean your inhaler:

• 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).

  Figure 1 Figure 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).

  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.

Figure 4 Figure 5

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 air-dry it completely.

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 healthcare professional or the nearest hospital.
• To prevent bronchospasm caused by exercise: 2 puffs 15 minutes before exercise.

The maximum dose in adults and adolescents is 8 puffs in a 24 hour period.

Children (4-11 years of age):

• 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 healthcare professional’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 healthcare professional’s instructions.

The maximum dose in children is 4 puffs in a 24 hour period.

DO NOT EXCEED RECOMMENDED DOSE.

Do not increase the dose or the number of times you use TEVA-SALBUTAMOL HFA without asking your healthcare professional, 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 healthcare professional what medicine(s) you are taking.

Overdose:

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

If you think you, or a person you are caring for, have taken too much TEVA-SALBUTAMOL HFA, contact a healthcare professional, hospital emergency department, 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 signs or symptoms.

Possible side effects from using TEVA-SALBUTAMOL HFA:

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

Side effects may include:

• Headache
• Feeling a little shaky
• Feeling anxious or irritable
• Feeling tired or weak
• Trouble sleeping (insomnia)
• Hyperactivity in children
• Dizziness, vertigo
• Drowsiness
• Muscle cramps
• Muscle pain
• Cough
• Respiratory infections and/or inflammation
• Diarrhea
• Nausea and vomiting
• Chest pain or discomfort
• Flushing
• Difficulty urinating

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

• Keep out of sight and reach of children.
• Store at a temperature between 15°C and 25°C.
• Do not keep any leftover medicine unless your healthcare professional 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.

If you want more information about TEVA-SALBUTAMOL HFA:

• 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); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Last revised: APR 30, 2026