Teva-Salbutamol Sterinebs P.F.: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-SALBUTAMOL STERINEBS^TM P.F. is used in Adults and Children 5 years or older. It treats severe, worsening breathing problems (bronchospasm) associated with:

• Chronic bronchitis
• Bronchial Asthma

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

The safety and effectiveness of TEVA-SALBUTAMOL STERINEBS^TM P.F. in children below the age of 5 years are not known.

What it does:

It can relieve chest tightness and wheezing if you have asthma or another chest illness.

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 STERINEBS^TM P.F. if:

• you 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.
• for the treatment of preterm labour or miscarriage.

What the medicinal ingredient is:

TEVA-SALBUTAMOL STERINEBS^TM P.F. contains the active ingredient, salbutamol sulphate.

What the important nonmedicinal ingredients are: Sodium chloride, dilute sulphuric acid and water.

What dosage forms it comes in:

TEVA-SALBUTAMOL STERINEBS^TM P.F. is a solution for inhalation that contains salbutamol sulphate equivalent to 1 mg / mL, or 2.0 mg / mL salbutamol base.

TEVA-SALBUTAMOL STERINEBS^TM P.F. are:

• pre-diluted
• preservative free
• unit doses (each ampoule contains 1 dose (2.5 mg or 5 mg) that is ready for use)

WARNINGS AND PRECAUTIONS

BEFORE you use TEVA-SALBUTAMOL STERINEBS^TM P.F. 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 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)

• You are pregnant or intend to become pregnant. Taking TEVA-SALBUTAMOL STERINEBS^TM P.F. during pregnancy may cause harm to your baby. Your doctor will consider the benefit to you and the risk to your baby of taking TEVA-SALBUTAMOL STERINEBS^TM P.F. while you're pregnant.

• You are breastfeeding. It is not known if TEVA-SALBUTAMOL STERINEBS^TM P.F. passes into breast milk.

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

IMPORTANT: PLEASE READ

If the relief of wheezing or chest tightness is not as good as usual, or the effect lasts for less than three hours, 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.

You should always carry other asthma medication with you to use immediately in case you experience an asthma attack.

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 STERINEBS^TM P.F.:

• Anti-depressants
• Allergy medication
• Blood pressure-lowering drugs, including propanolol
• Diuretics (“water pills”)
• Bronchodilators used to open the airway (such as other asthma medication)
• Epinephrine
• Digoxin, a heart medication

PROPER USE OF THIS MEDICATION

TEVA-SALBUTAMOL STERINEBS^TM P.F. should only be inhaled from a nebulizer. It must not be injected or swallowed.

Do not let the TEVA-SALBUTAMOL STERINEBS^TM P.F. or the mist produced by the nebulizer, get in your eyes.

Use your nebulizer in a well ventilated room. Some of the mist will be released into the air and may be breathed in by others.

Use TEVA-SALBUTAMOL STERINEBS^TM P.F. only as directed by your doctor. During administration your doctor may want to monitor your blood.

The action of TEVA-SALBUTAMOL STERINEBS^TM P.F. may last for up to 6 hours and should last at least 4 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 of wheezing or chest tightness;
• you need to use TEVA-SALBUTAMOL STERINEBSTM P.F 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.

When using TEVA-SALBUTAMOL STERINEBS^TM P.F., other medicines (including asthma medicines) should only be used when prescribed by your doctor.

Usual dose:

Adults and Adolescents 13 years and older: 1 ampoule (either 2.5 mg or 5 mg), repeated every 4 to 6 hours to a maximum 4 times a day if necessary.

Children (5-12 years): 1 ampoule (2.5 mg), repeated every 4 to 6 hours to a maximum 4 times a day if necessary.

Patients who have not improved on this dose, may need 1 ampoule (5mg), repeated every 4 to 6 hours to a maximum 4 times a day if necessary.

How to Use TEVA-SALBUTAMOL

STERINEBS^TM P.F.

1. 1. The contents of TEVA-SALBUTAMOL

STERINEBS^TM P.F. are to be inhaled from a nebulizer. Do not open the foil pack until the

TEVA-SALBUTAMOL STERINEBS^TM P.F. are required.

1. 2. Prepare the nebulizer for filling according to the manufacturer’s instructions.

IMPORTANT: PLEASE READ

1. 3. Open the foil pouch and remove the ampoules.

Diagram 1

1. 4. To detach a TEVASALBUTAMOL STERINEBS^TM P.F. push one ampoule

downwards and away while holding

the remaining ampoules securely (diagram 2). Return the remaining ampoules to the foil pouch and place the foil pouch back into the carton.

Diagram 2

1. 5. Holding the top of the ampoule securely, twist the body to open (diagram 3).

Diagram 3

1. 6. Place the open end of the ampoule well into the

nebulizer cup and squeeze slowly (diagram 4).

Ensure the contents are emptied into the nebulizer cup.

Diagram 4

1. 7. Gently shake the nebulizer and connect it with the mouthpiece or face mask. Connect the apparatus to the air pump or oxygen and start the treatment.
2. 8. Breathe calmly and evenly as much as possible until no more mist is formed in the nebulizer

chamber. At this point, treatment is finished.

1. 9. After use discard any solution remaining in the nebulizer cup.

Children – TEVA-SALBUTAMOL STERINEBS^TM P.F should be used under the supervision of an adult who understands the proper use of the nebulizer and only as prescribed by the doctor.

Care of the TEVA-SALBUTAMOL STERINEBS^TM P.F. and Nebulizer

Open only one foil pack at a time and use all 5 ampoules before opening the next foil pack. Always place foil tray (covered with lid) back in the carton after use.

To clean the Nebulizer:

Cleaning: After each use, clean the nebulizer as follows:

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:

   1. a)

      Place 3 mL of detergent solution in the vial,

      assemble the unit and operate for 2 minutes.

   2. 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.

   3. c) Disassemble and rinse with warm water.
4. 4.

   To dry the external passage:

   1. a)

      Connect the nebulizer tube to the pump with

      the supply tube.

   2. b)

      Turn on the pump and blow air through for 1

      minute. If there is evidence of clogging, clean the openings and tube connectors with the detergent, then rinse with water.

   3. c) Reassemble.

Do not swallow or inject TEVA-SALBUTAMOL STERINEBS^TM P.F.

TEVA-SALBUTAMOL STERINEBS^TM P.F. is inhaled into your lungs using a nebulizer.

Overdose:

If you think you, or a person you are caring for, have taken too much TEVA-SALBUTAMOL STERINEBS^TM P.F. , contact a healthcare

IMPORTANT: PLEASE READ professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

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: 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

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

Other Effects

• Nausea and vomiting
• Chest pain or discomfort
• Flushing
• Difficulty urinating
• Unusual taste in your mouth
• Dry or irritated throat

IMPORTANT: PLEASE READ

This is not a complete list of side effects. If you have any unexpected effects after receiving TEVA-SALBUTAMOL STERINEBS^TM P.F. contact your doctor or pharmacist.

HOW TO STORE IT

Keep your TEVA-SALBUTAMOL STERINEBS^TM P.F. in a safe place, out of sight and reach of children.

Store TEVA-SALBUTAMOL STERINEBS^TM P.F. between 2-25°C. Leave product in the carton and pouch when not used to protect from light.

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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 visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) and by contacting Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada

M1B 2K9

www.tevacanada.com

Last revised: October 28, 2022