Details for: VENTOLIN DISKUS
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02243115 | VENTOLIN DISKUS | SALBUTAMOL (SALBUTAMOL SULFATE) | 200 MCG / ACT | POWDER | INHALATION |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VENTOLIN DISKUS 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 VENTOLIN DISKUS 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 VENTOLIN DISKUS if you are allergic to it or any of the components of its formulation including lactose (milk sugar) or milk protein or for the treatment of preterm labour or miscarriage.
What the medicinal ingredient is
Salbutamol sulphate.
What the non-medicinal ingredients are
Lactose (milk sugar which includes milk protein).
What dosage form it comes in
VENTOLIN DISKUS inhalation powder is a disposable blue-coloured plastic inhaler device containing a foil strip with 60 blisters. Each blister contains 200 mcg of the active ingredient salbutamol (as the sulphate salt). The blisters protect the powder for inhalation from effects of the atmosphere. It cannot be refilled.
Warnings and precautions
Before you use VENTOLIN DISKUS talk to your doctor or pharmacist if:
- You have ever had to stop taking other medicines for this illness because you were allergic to them or they caused problems.
- You are having treatment for a thyroid condition.
- You are having treatment for high blood pressure or a heart problem.
- You have been told that you are allergic to lactose (milk sugar) or milk protein.
- 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 VENTOLIN DISKUS during pregnancy may cause harm to your baby. Your doctor will consider the benefit to you and the risk to your baby of taking VENTOLIN DISKUS while you're pregnant
- You are breastfeeding. It is not known if VENTOLIN DISKUS passes into breast milk
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 your VENTOLIN DISKUS 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 VENTOLIN DISKUS:
- 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
Proper use of this medication
VENTOLIN DISKUS should only be inhaled. Do not swallow.
If You Are Also Using an Inhaled Corticosteroid:
- Always use VENTOLIN DISKUS first
- Wait a few minutes
- Then use your inhaled corticosteroid.
Your doctor may prescribe VENTOLIN DISKUS regularly every day, or only for when you are wheezy or short of breath. Use VENTOLIN DISKUS only as directed by your doctor.
The action of VENTOLIN DISKUS may last up to 6 hours and should last at least 4 hours.
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 VENTOLIN DISKUS 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.
If you have to go to hospital for an operation, take VENTOLIN DISKUS with you and tell the doctor what medicine(s) you are taking.
Usual Dose
Adults and Children 4 years or older
- To relieve bronchospasm: 1 inhalation 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: 1 inhalation repeated every 4 to 6 hours up to a maximum three or four times a day as prescribed by your doctor
- To prevent bronchospasm caused by exercise: 1 inhalation 15 minutes before exercise
Maximum dose - 4 inhalations in a 24 hour period
How to Use VENTOLIN DISKUS:
VENTOLIN DISKUS is closed when you first take it out of the box. It counts down from 60 to 1. To show when the last five doses have been reached the numbers appear in red.
Before you use VENTOLIN DISKUS read through this entire section carefully.
| 1. Open
To open your DISKUS inhalation device hold the outer case in one hand and put the thumb of your other hand on the thumb grip. Push your thumb away from you as far as it will go. |
 |
| 2. Slide
Hold your DISKUS inhalation device with the mouthpiece towards you. Slide the lever away from you as far as it will go – until it clicks. Your DISKUS inhalation device is now ready to use. Every time the lever is pushed back a dose is made available for inhaling. This is shown by the dose counter. Do not play with the lever as this releases dose which will be wasted. |
 |
3. Inhale
|
 |
| 4. Close
To close your DISKUS inhalation device, put your thumb in the thumb grip, and slide the thumb grip back towards you, as far as it will go. When you close the DISKUS inhalation device, it clicks shut. The lever automatically returns to its original position and is reset. Your DISKUS inhalation device is now ready for you to use again. |
|
When you close the DISKUS inhalation device, it clicks shut. The lever automatically returns to its original position and is reset. Your DISKUS inhalation device is now ready for you to use again.
Remember:
Keep your DISKUS inhalation device dry.
Keep it closed when not in use.
Only slide the lever when you are ready to take a dose.
Children - During inhalation, children should be assisted or supervised by an adult who knows the proper use of the inhaler.
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.
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. Your doctor may have told you to use your DISKUS inhalation device regularly every day, or only when you are wheezy or short of breath.
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
- Fever
- Respiratory infections and/or inflammation
- Nausea and vomiting
- Chest pain or discomfort
- Flushing
- Difficulty urinating
- Unusual taste in your mouth
- Dry or irritated throat
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Faster heart beat than usual | ✔ | ||
| Uncommon | |||
| Irregular heart beat (palpitations) | ✔ | ||
| Rare | |||
| Low Blood Potassium (hypokalemia): muscle weakness and muscle spasms | ✔ | ||
| Hallucinations in Children: see or hear things that are not there | ✔ | ||
| Very Rare | |||
| Bronchospasm: Sudden worsening of shortness of breath and wheezing shortly after using VENTOLIN HFA | ✔ | ||
| Allergic Reactions: sudden wheeziness and chest pain or tightness; or swelling of eyelids, face, lips, tongue or throat. | ✔ | ||
| Irregular Heart Beat (atrial fibrillation, supraventricular tachycardia, extrasystoles) | ✔ | ||
This is not a complete list of side effects. If you have any unexpected effects after receiving VENTOLIN DISKUS, contact your doctor or pharmacist.
How to store
Keep out of sight and reach of children.
Do not store VENTOLIN DISKUS inhalation powder above 30°C. Keep in a dry place.
Protect from frost and light.
Reporting 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 three 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 1908C
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. 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 at:
http://www.gsk.ca
or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga (Ontario)
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Last revised: November 17, 2017
© 2017 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.