Patient Medication Information: uses, side effects, how to take - Alcon Atropine

ABOUT THIS MEDICATION

What the medication is used for:

ALCON ATROPINE is used to:

Treat inflammation of the uvea (uveitis), a structure of the eye.
Temporarily freeze the muscles of the eye for a test known as cycloplegic refraction.

What it does:

ALCON ATROPINE contains atropine sulfate, which works on two types of muscles in the eye (sphincter and accommodative). The result is:

Increasing the pupil size, which may help prevent scar tissue from forming between the lens and the iris, in patients with uveitis.
Temporary paralysis of some muscles in the eye and increasing the pupil size for cycloplegic refraction.

When it should not be used:

Do NOT use ALCON ATROPINE if you or your child:

Are allergic to atropine sulfate or any other of the ingredients in ALCON ATROPINE (see What the important nonmedicinal ingredients are).
Have or think you may have angle-closure glaucoma.
Are under the age of 12 years.
Has Down’s syndrome, spastic paralysis or brain damage.

What the medicinal ingredient is:

Atropine sulfate, 1 % w/v

What the important nonmedicinal ingredients are:

Preservative: benzalkonium chloride

Others: boric acid, hydroxypropyl methylcellulose, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.

What dosage forms it comes in:

Sterile eye drop in 5 mL DROP-TAINER^TMbottle.

WARNINGS AND PRECAUTIONS

BEFORE you use ALCON ATROPINE, talk to your doctor or pharmacist if you or your child:

Have a fever or are exposed to hot temperatures. ALCON ATROPINE may cause your body temperature to rise.
Have Down syndrome, spastic paralysis, brain damage or fair skin and blue eyes. Your child may be a higher risk of
- developing serious side effects.
- Are taking any other medicines.
- Are pregnant, may be pregnant, or are planning to become pregnant. Your doctor will only prescribe ALCON ATROPINE if the benefit to you is greater than the possible risk to your fetus.
- Are breastfeeding or planning to breast-feed.

STOP using ALCON ATROPINE and talk to your doctor if you or your child:

Develop any signs of toxicity, such as flushing, dryness of the skin, a rash in children, blurred vision, rapid and irregular heartbeat, fever, fits (convulsions), hallucinations or loss of coordination.

While using ALCON ATROPINE

ALCON ATROPINE may increase the pressure in your eyes (intraocular pressure). Your doctor should check the pressure in your eyes regularly, especially if you are elderly.

ALCON ATROPINE may cause your eyes to become more sensitive to light. Protect your eyes in bright light.

ALCON ATROPINE may cause changes in behaviour, such as restlessness, hyperactivity, troubled speech, confusion and hallucinations. This can happen at any age, but is more likely to happen in children and the elderly. Talk to your doctor or pharmacist if this happens.

Contact lens wearers

ALCON ATROPINE contains the preservative benzalkonium chloride, which is known to affect soft contact lenses. Remove your contact lenses before using ALCON ATROPINE and wait at least 15 minutes before putting your contact lenses back in.

Driving and Using Machines

ALCON ATROPINE may cause drowsiness, blurry vision or sensitivity to light. If any of these effects happen to you, wait until they clear before driving or using machines.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about all the medicines you take, recently took or are planning to take, including those without a prescription.

Drug interaction studies have not been done for ALCON ATROPINE.

Drugs that may interact with ALCON ATROPINE include:

Amantadine (a medicine used to treat Parkinson’s disease and influenza A infections).
Antihistamines.
Antipsychotics.
Antidepressants.

PROPER USE OF THIS MEDICATION

Always use ALCON ATROPINE exactly as your doctor has told you.

Usual dose – adults and children over 12 years of age:

Uveitis: apply 1 drop in the affected eye(s) 3 times a day.

Cycloplegic refraction: apply 1 drop in the affected eye(s) 3 times a day for 3 days. Apply 1 drop in the affected eye(s) 1 hour before your scheduled eye examination.

How to use:

1 2 3

Get the ALCON ATROPINE bottle and a mirror.
Wash your hands.
Twist off the bottle cap.
After cap is removed: if security snap collar is loose, remove before using product.
Hold the bottle, pointing down, between your thumb and fingers.
Tilt your head back.
Pull down your lower eyelid with a clean finger until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1).
Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Gently press on the base of the bottle to release one drop of ALCON ATROPINE at a time. Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2).
If you miss a drop, try again. If you accidentally get a drop on your skin, wipe it off.
After using ALCON ATROPINE, press a finger into the corner of your eye by the nose (picture 3). This helps to stop ALCON ATROPINE getting into the rest of the body and may lower the chances of getting side effects in the body.
If you use drops in both eyes, repeat the steps for your other eye.
Close the bottle cap firmly immediately after use.
Wash your hands after use.

If you are using other eye drops, wait at least 5 to 10 minutes before between applying ALCON ATROPINE and the other drops. Eye ointments should be added last.

Instructions for parents:

Do NOT get ALCON ATROPINE in your child’s mouth or cheeks. Wash your hands and your child’s mouth and cheeks after using ALCON ATROPINE.

Overdose:

If you use more ALCON ATROPINE than you should, rinse it out with warm water. Do not apply any more drops until it is time for your next regular dose.

Signs of an overdose may include: flushing and dryness of the skin, rash in children, blurred vision, rapid and irregular heart rate, fever, convulsions, hallucinations or loss of coordination.

If you think you, or a person you are caring for, have taken too much ALCON ATROPINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to use ALCON ATROPINE, use a single dose as soon as you remember. If it is almost time for the next dose, leave out the missed dose and continue with the next dose of your regular routine. Do not use a double dose to make up for a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, ALCON ATROPINE can cause side effects, although not everybody gets them.

Side effects observed with ALCON ATROPINE include eyelid swelling, sensitivity to light, increase in pupil size, dizziness, headache, allergy, intestinal blockage, abdominal swelling, vomiting, skin inflammation or redness and rash.

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 call your doctor or pharmacist
Only if severe	In all cases
Unknown
Toxic effects (may include) flushing and dryness of the skin, a rash in children, blurred vision, rapid and irregular heartbeat, fever, fits, hallucination, loss of coordination, state of confusion or disorientation
✓

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 call your doctor or pharmacist
Unknown	Allergic reaction (symptoms include swelling of mouth or tongue, shortness or breath, hives, severe itching or rash)			✓

This is not a complete list of side effects. For any unexpected effects while taking ALCON ATROPINE, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature. Avoid excessive heat. Keep tightly closed. Keep out of the reach and sight of children.

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.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

This document plus the full prescribing information, prepared for health professionals can be found at:

www.alcon.ca

or by contacting the sponsor,

Alcon Canada Inc., at:

1-800-613-2245.

Rx or OTC	Prescription (Rx)?
DIN	00035017
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Atropine sulfate 1 %
Dosage form(s)	Solution
Route(s) of administration	Ophthalmic
Drug class (WHO ATC)	S Sensory organ drugs S01 Ophthalmologicals S01F Mydriatics and cycloplegics S01FA Anticholinergic mydriatics and cycloplegics S01FA01 Atropine
Company	ALCON CANADA INC
Current status	Marketed
Current status date	September 11, 2023

Alcon Atropine: Uses, Side Effects and Dosage