Patient Medication Information: uses, side effects, how to take - PMS-Salbutamol Oral Liquid
ABOUT THIS MEDICATION
What the medication is used for:
- pms-SALBUTAMOL ORAL LIQUID is used for prevention or relief of bronchospasm in patients who have breathing problems with asthma and similar conditions.
- Bronchospasm is a sudden worsening of shortness of breath and wheezing.
- The oral solution is used when children 2 years or older and adults cannot use an inhaler device.
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:
pms-SALBUTAMOL ORAL LIQUID is not recommended for:
- Patients who are hypersensitive to salbutamol sulphate or any of the ingredients of pms-SALBUTAMOL ORAL LIQUID.
- Patients with a fast heart rate (tachyarrhythmias).
Children 2 years of age and younger.
- For the treatment of preterm labour or miscarriage
What the medicinal ingredient is:
Salbutamol sulphate.
What the nonmedicinal ingredients are:
Citric acid monohydrate, ethyl alcohol, hydroxypropyl methylcellulose, orange flavour, purified water, sodium benzoate, sodium citrate dihydrate and sodium cyclamate.
What dosage forms it comes in:
Solution: 0.4 mg salbutamol per mL.
WARNINGS AND PRECAUTIONS
BEFORE you use pms-SALBUTAMOL ORAL LIQUID 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 pms-SALBUTAMOL ORAL LIQUID during pregnancy may cause harm to your baby. Your doctor will consider the benefit to you and the risk to your baby of taking pms-SALBUTAMOL ORAL LIQUID while you're pregnant.
- You are breastfeeding. It is not known if salbutamol sulphate solution 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 salbutamol sulphate solution. If you suffer symptoms (see Serious Side Effects Table), contact your doctor immediately.
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.
pms-SALBUTAMOL ORAL LIQUID is not intended for patients experiencing an acute episode of bronchospasm. Patients should always carry their salbutamol aerosol or dry powder inhaler to use immediately if an episode of asthma is experienced.
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 pms-SALBUTAMOL ORAL LIQUID:
- 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
The action of pms-SALBUTAMOL ORAL LIQUID may last for 6 to 8 hours and should last at least 4 hours.
Call your doctor immediately if the effect lasts for less than 3 hours or if you suddenly get worse shortness of breath and you wheeze after using your pms-SALBUTAMOL ORAL LIQUID since this is usually a sign of worsening asthma. Do not increase the dose or how often you take your medicine without informing your doctor, as this may make you feel worse. If symptoms get worse, tell your doctor as soon as possible.
When using pms-SALBUTAMOL ORAL LIQUID, other medicines (including asthma medicines) should only be used when prescribed by your doctor.
Usual dose:
Elderly patients or those known to be unusually sensitive to beta-adrenergic stimulant drugs (e.g. Salbutamol start treatment with 5 mL (2 mg) 3 or 4 times per day.
Adults and children over 12 years of age: 5 mL to 10 mL (2 mg to 4 mg) 3 to 4 times daily.
Children (6 and 12 years of age): 5 mL (2 mg) 3 to 4 times daily.
Children (2 to 6 years of age): 0.25 mL (0.1 mg) per kg body weight 3 to 4 times daily.
Treatment not recommended with pms-SALBUTAMOL ORAL LIQUID in children under 2 years of age, or for chronic therapy in children 2 - 6 years of age.
.
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 doctor as soon as possible.
| 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. |
Missed Dose:
If you miss a dose, take the missed dose as soon as possible, unless it is almost time for your next dose. Skip the missed dose if it is almost time for your next regular dose. Do not take two doses at the same time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- Headache, feeling a little shaky
- Muscle cramps
- Palpitations, faster heartbeat than usual
- Hypertension, chest pain or discomfort
- Feeling anxious or irritable
- Feeling tired or weak, dizziness, vertigo, drowsiness
- Trouble sleeping (insomnia), hyperactivity in children
- Nausea and vomiting
- 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 with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical help | ||
| Only if severe | In all cases | |||
| Ver y Rare | Allergic reactions (symptoms include itching, rash, rapid swelling of the skin, mucosa and submucosal tissues, sudden constriction of the breath way, low blood pressure, and collapse) | ✓ | ||
| Low blood pressure (hypokalemia) : muscle weakness and muscle spasms | ✓ | |||
This is not a complete list of side effects. For any unexpected effects while taking pms-SALBUTAMOL ORAL LIQUID, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of sight and reach of children.
Keep pms-SALBUTAMOL ORAL LIQUID between 15°C and 25°C. Protect from light.
REPORTING SUSPECTED 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 3 ways:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.
Pharmascience Inc.
Montréal, Canada
H4P 2T4
www.pharmascience.com