Consumer Information for: PMS-IPRATROPIUM
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
pms-IPRATROPIUM is used to treat the wheezing or shortness of breath caused by COPD (chronic obstructive pulmonary disease which includes chronic bronchitis and emphysema). For the treatment of asthma, pms-IPRATROPIUM must be used in conjunction with some other bronchodilating medication. pms-IPRATROPIUM contains 250 mcg/mL (0.025%) ipratropium bromide and the preservatives Benzalkonium Chloride and disodium ethylene diamine tetraacetic acid (EDTA-disodium).
What it does
pms-IPRATROPIUM belongs to a group of medicines known as “bronchodilators” which make breathing easier by opening your narrowed airways.
When it should not be used
pms-IPRATROPIUM should not be used by patients with allergic reactions to ipratropium bromide, atropinics or any component of the drug.
If you do not get the expected relief from your treatment, you should contact your doctor.
What the medicinal ingredient is
Ipratropium bromide
What the non-medicinal ingredients are
Benzalkonium chloride solution (50% w/v), Edetate Disodium Dihydrate, Hydrochloric Acid, Purified Water and Sodium Chloride
What dosage form it comes in
Nebulizer Solution; 20 mL Bottle
Warnings and precautions
The solution is intended for inhalation only. Do not inject or drink.
Do not let the nebulized mist get into your eyes as this may cause blindness known as acute angle glaucoma. This may present as eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes. If any combination of these symptoms occurs, seek immediate medical attention. Patients with glaucoma should use swimming goggles or a nebulizer with a mouthpiece to prevent nebulized solution getting into the eyes.
BEFORE you use pms-IPRATROPIUM talk to your doctor or pharmacist if you:
- are pregnant or intend to become pregnant;
- are breast feeding;
- are having treatment for a thyroid or adrenal gland condition;
- are having treatment for high blood pressure, angina or a heart problem;
- have diabetes;
- 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)
- have eye problems, such as glaucoma or eye pain;
- are taking any other medications, including eye drops or any medications you can buy without a prescription;
- have difficulty in urination;
- have enlarged prostate;
- have any allergies or reactions to foods or drugs;
- have a history of convulsions (uncontrolled shaking or seizures);
- have liver or kidney disease.
Contact your doctor immediately if:
- you require more than one dose to relieve your breathing problems;
- your shortness of breath becomes worse;
- you don’t get the same benefit from your medicine as you did before;
- you have breathing difficulties and chest pain;
- you experience difficulty with urination.
pms-IPRATROPIUM may cause dizziness, difficulty in focusing the eyes, dilated pupils, and blurred vision. You should not drive or operate machinery if this occurs.
Interactions with this medication
Do not mix pms-IPRATROPIUM with other drugs in the same nebulizer.
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-IPRATROPIUM:
- digitalis;
- other anticholinergic drugs, such as ipratropium bromide and other beta2- adrenergic agents such as salbutamol;
- beta blockers, such as propranolol;
- xanthine derivatives such as theophylline;
- monoamine oxidase inhibitors such as isocarboxazid;
- tricyclic antidepressants such as amitriptyline;
- epinephrine;
- certain diuretics or “water pills” such as furosemide, hydrochlorothiazide.
Proper use of this medication
pms-IPRATROPIUM should only be inhaled from a nebulizer.
It must not be injected or swallowed.
Do not let the pms-IPRATROPIUM 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 pms-IPRATROPIUM only as directed by your doctor.
During administration your doctor may want to monitor your
blood.
pms-IPRATROPIUM has been prescribed to treat your current
condition. DO NOT give it to other people. Always use pms-
IPRATROPIUM exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
pms-IPRATROPIUM should be used only in a properly
functioning and regularly maintained nebulizer or an intermittent
positive pressure ventilator. Before starting treatment, be certain
that you are completely familiar with the use and proper care of
your nebulizer. The content of the bottle does not need to be
diluted for nebulization.
Usage Instructions:
Your doctor or pharmacist will tell you how to prepare your
pms-IPRATROPIUM nebulizer solution. Your doctor or
pharmacist might instruct you to use sterile sodium chloride
solution (0.9%) to dilute the pms-IPRATROPIUM solution. If
you are told to dilute pms-IPRATROPIUM solution, you must
do so immediately before you plan to use the solution. If
necessary, doses may be diluted to a total nebulization volume of
3-5 mL with preservative free 0.9% sterile sodium chloride
solution and used immediately. Discard any unused solution.
Nebulize over 10-15 minutes at gas flow of 6-10L/min. Repeat
every 4-6 hours as necessary.
- Immediately before you plan to use the nebulizer, using a
syringe, withdraw the prescribed dose, usually ½ to 2 mL
(cc), of pms-IPRATROPIUM from the bottle and add to the
nebulizer chamber. Do not store the prescribed dose in the
syringe for later use.
- If your doctor has instructed you to use another inhalation solution in combination with pms-IPRATROPIUM, you should add the appropriate amount of that solution to the nebulizer chamber as well.
- Add sodium chloride solution to the chamber, if you have
been directed to do so by your physician or pharmacist.
- Gently shake the nebulizer chamber and connect it to the
mouthpiece or face mask. Then connect the nebulizer tube to
the air or oxygen pump and begin therapy.
- Breathe calmly and deeply through the mask or mouthpiece
until no more mist is formed in the nebulizer chamber. This
usually takes 10 - 15 minutes. It is very important to adjust
the face mask, if required, to prevent the mist from getting in
your eyes.
- Store your re-capped bottle of pms-IPRATROPIUM and sodium chloride solution in the refrigerator until the next treatment.
- Follow the instructions provided by the nebulizer and air pump manufacturers for the proper care and maintenance of the equipment. Keep the nebulizer, nebulizer tube and face mask clean to minimize microbial contamination.
Do not mix pms-IPRATROPIUM with other drugs in the same
nebulizer.
Keep out of the reach of children.
Overdose
Missed Dose
If a dose is missed and no symptoms occur, the regular next dose according to the dosing schedule should be taken. If a dose is missed and respiratory symptoms are experienced, the missing dose should be taken and the dosing schedule according to the recommended dosage should be resumed.
Side effects and what to do about them
Side effects may include:
- wheezing after inhalation;
- headache, dizziness
- nausea (feeling sick), digestive problems like constipation, diarrhoea and vomiting;
- muscle problems such as cramps, weakness, pain, feeling weak, tremor (shaking);
- feeling nervous;
- mental disorder;
- impaired voice sounds;
- increased sweating;
- bronchitis and upper respiratory tract infection (a cold)
- throat irritation, cough, dry mouth or throat, bad taste-sucking on a sour candy or rinsing your mouth may help.
Check with your doctor if the dry mouth or bad taste persist or if you experience constipation for a prolonged period of time.
Stop taking the medication and tell your doctor immediately if you notice any of the following:
- you are wheezy or have any other difficulties in breathing;
- you are having an allergic reaction – the signs may include skin rash, itching and nettle rash. In severe cases the signs include swelling of your tongue, lips and face, sudden difficulties in breathing and reduction of your blood pressure.
If you have any questions about pms-IPRATROPIUM or your nebulizer, contact your doctor or pharmacist.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get imme-diate medi-cal help |
|---|---|---|---|
| Uncommon | |||
| Bronchospasm: Increased wheezing or tightness in the chest, difficulty in breathing, coughing bouts | ✔ | ||
| Shortness of breath | ✔ | ||
| Hypotension or Hypertension, Changes in blood pressure: dizziness, fainting, light-headedness | ✔ | ||
| Skin rash | ✔ | ||
| Rare | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, choking due to swelling of the muscles around the voice box | ✔ | ||
| Fast or irregular heart beat / chest pain | ✔ | ||
| Eye Disorders: new or worsened pressure in your eyes, eye pain, blurred vision, seeing halos or rainbows around items or red eyes | ✔ | ||
| Urinary Retention: difficulty and pain when passing urine, urinating frequently, urination in a weak stream or drips | ✔ | ||
| Muscle pain, weakness or spasms; paralysis | ✔ | ||
| Myocardial Ischaemia: decreased blood flow to the heart leading to angina (chest pain), shortness of breath, or a heart attack | ✔ | ||
| Angina: Chest pain | ✔ | ||
| Decreased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking pms-IPRATROPIUM contact your doctor or pharmacist.
How to store
Keep this medication out of the reach of children.
Unopened bottles of pms-IPRATROPIUM should be stored at controlled room temperature (between 15°C and 30°C).
Solutions diluted with preservative free sterile Sodium Chloride Inhalation Solution, USP 0.9% should be used within 24 hours from time of dilution when stored at room temperature and within 48 hours when stored in the refrigerator.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada,
Postal Locator 1908C
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php).
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
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Pharmascience Inc. at, 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal Canada
H4P 2T4
www.pharmascience.com
Last revised: May 11, 2017
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