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 nasal spray 0.03% is used to treat the runny nose associated with perennial allergic or nonallergic rhinitis

pms-IPRATROPIUM nasal spray is intended to relieve your rhinorrhea (runny nose) with regular use. It is therefore important that you use pms-IPRATROPIUM nasal spray as prescribed by your physician. Some improvement in rhinorrhea is usually apparent during the first full day of treatment with pms-IPRATROPIUM nasal spray. However, maximum benefit may not occur for up to several weeks after treatment has started.

What it does

pms-IPRATROPIUM nasal spray works to stop the glands in your nose from producing excessive nasal secretions. pms-IPRATROPIUM nasal spray must be prescribed by a doctor

When it should not be used

Nasal spray should not be used by patients with a history of allergy to ipratropium bromide, or to any component of this formulation.

pms-IPRATROPIUM nasal spray should not be used by patients with allergic reaction to ipratropium bromide, atropinics (atropine or atropine-like drugs) or to any component of the drug (See What the nonmedicinal ingredients are)

What the medicinal ingredient is

Ipratropium bromide

What the non-medicinal ingredients are

Benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, sodium hydroxide and purified water.

What dosage form it comes in

Nasal Spray: 0.03% w/v

Warnings and precautions

BEFORE you use pms-IPRATROPIUM talk to your doctor or pharmacist if:

  • you are pregnant or intend to become pregnant;
  • you are breast feeding;
  • you have any other health problems, now or in the past;
  • you have eye problems, such as predisposition to glaucoma;
  • you have difficulty/trouble urinating or problems with your prostate;
  • you are taking any other medications including eye drops or any medications you can buy without prescription;
  • you have any allergies or reactions to foods or drugs.

pms-IPRATROPIUM Nasal Spray 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

Drugs that may interact with pms-IPRATROPIUM nasal spray include: Other anticholinergic drugs.

Proper use of this medication

    Usual dose

  1. Remove the clear plastic dust cap and the safety clip from the nasal spray pump. The safety clip prevents the accidental discharge of the spray in your pocket or purse.
    		2.
  2. The nasal spray pump must be primed before pms- IPRATROPIUM nasal spray is used for the first time. To prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. Make sure the bottle points upright and away from your eyes. Press your thumb firmly and quickly against the bottle seven times. The pump is now primed and can be used. Your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require one or two sprays.
    		3.
  3. Before using pms-IPRATROPIUM nasal spray, blow your nose gently to clear your nostrils if necessary.
    		4.
  4. Close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril. Point the tip toward the back and outer side of the nose.
    		5.
  5. Press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. Following each spray, sniff deeply and breathe out through your mouth.
    		6.
  6. After spraying the nostril and removing the unit, tilt your head backwards for a few seconds to let the spray spread over the back of the nose.
    		7.
  7. Repeat steps 4 through 6 in the other nostril.
    		8.
  8. Replace the clear plastic dust cap and safety clip.
    		9.
  9. When the amount of pms-IPRATROPIUM nasal spray begins to run low, the amount of medication in each spray cannot be assured. Therefore, at some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. You should not take extra doses of pms-IPRATROPIUM nasal spray without consulting your physician.
    		10.

To Clean:

If the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. Hold the nasal tip under running warm tap water for about a minute. Dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip.

Avoid spraying pms-IPRATROPIUM nasal spray in or around your eyes. Should this occur, immediately flush your eyes with cool tap water for several minutes. If you accidentally spray pms-IPRATROPIUM nasal spray in your eyes, you may experience a temporary blurring of vision and increased sensitivity to light, which may last a few hours.

Do not exceed the number of sprays, or the length of use, prescribed by your doctor.

pms-IPRATROPIUM nasal spray has been prescribed to treat your current condition. Do not give it to other people.

Do not take other medication without your doctor’s advice.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms. Always take the labeled medicine container with you.

Missed Dose

If you forget to take your dose, don’t worry. Take your next dose as usual. Do not double your dose.

Side effects and what to do about them

Like any other drug product, pms-IPRATROPIUM nasal spray may cause unwanted effects along with its good effects. If you do experience any of the unwanted effects listed below, you should contact your doctor. He/she may recommend that you lower your dose of pms-IPRATROPIUM nasal spray.

The most frequent side effects are headache, throat irritation, nasal discomfort, nasal dryness and nosebleeds.

Other side effects include: increased heart rate and a feeling that your heart is beating fast, heart problems such as fast or irregular heart beat ; eye disorders such as difficulty in focusing the eyes, seeing halos, swelling of the cornea, build up or increased pressure in the eye, dilated pupils, swelling of the blood vessels in the conjunctiva (outermost layer of the eye and inner surface of the eyelids), blurred vision, eye pain; difficulty in passing urine; swelling of the muscles around the voice box; dry throat, dry mouth, swelling of the mouth and throat, increased wheezing or tightness in the chest or difficulty in breathing (bronchospasm) ; digestive problems like constipation, diarrhoea and vomiting; dizziness.

Some people can be allergic to medicines. If you have any of the following symptoms soon after taking pms-IPRATROPIUM nasal spray, stop taking this medicine and tell your doctor immediately or go the nearest hospital:

  • Sudden wheeziness and chest pain or tightness
  • Sudden difficulty in breathing and reduction in your blood pressure
  • Swelling of eyelids, face, tongue or throat
  • Lumpy skin rash, or “hives” anywhere on the body.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
Uncommon
Blurred vision or pain in he eyes     ✔
Fast or irregular heart beat     ✔
Difficult or painful urination     ✔
Rash     ✔
Increased wheezing or tightness in the chest or difficulty in breathing (bronchospasm     ✔
Swelling of the tongue or lips     ✔
Difficulty in swallowing     ✔

This is not a complete list of side effects. For any unexpected effects while taking pms-IPRATROPIUM nasal spray, contact your doctor or pharmacist.
How to store

Store tightly closed between 15°C and 30°C. Avoid excessive heat or freezing. Keep out of reach of children.

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 0701E
                     Ottawa, Ontario
                     K1A 0K9

    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.

This leaflet was prepared by
        Pharmascience Inc.
        Montreal Quebec
        H4P 2T4

Last revised: October 26, 2012

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