Patient Medication Information: uses, side effects, how to take - Ilevro
ABOUT THIS MEDICATION
What the medication is used for:
ILEVRO (nepafenac) ophthalmic suspension, 0.3% is used to manage eye pain and inflammation following cataract surgery.
What it does:
ILEVRO is a nonsteroidal anti-inflammatory drug (NSAID) and can reduce formation of prostaglandins by your body, which cause pain and swelling in your eye.
When it should not be used:
Do not use ILEVRO if you:
- are allergic (hypersensitive) to nepafenac or any of the other ingredients of this medicine (see What the important nonmedicinal ingredients are).
- are allergic to other NSAIDs.
- have had reactions, such as asthma, itchy or runny nose, after taking acetylsalicylic acid or other NSAIDs.
What the medicinal ingredient is:
Nepafenac, 0.3% w/v
What the important nonmedicinal ingredients are:
Preservative: benzalkonium chloride.
Inactive ingredients: boric acid, propylene glycol, carbomer 974P, sodium chloride, guar, carmellose sodium, disodium edetate. Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added during the manufacture of the product to adjust to the proper pH.
What dosage forms it comes in:
ILEVRO contains tiny yellow particles suspended in a clear liquid. It is supplied as 3 mL of suspension in a 4 mL plastic DROP-TAINER bottle with a screw cap.
WARNINGS AND PRECAUTIONS
BEFORE you use ILEVRO ophthalmic suspension, talk to your doctor or pharmacist if you:
- have any allergies to ILEVRO or any of its ingredients (see What the important nonmedicinal ingredients are)
- bruise easily or have or have had bleeding problems
have had any other eye disorder (e.g. an eye infection), or recent eye surgery
- are using other medications in the eye (especially topical steroids)
- have ever had an allergic reaction to NSAIDs, including acetylsalicylic acid, as you may be allergic to ILEVRO
Pregnancy or breast-feeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, talk to your doctor before you use ILEVRO. The use of ILEVRO is not recommended during pregnancy. If you are breast-feeding, ILEVRO may get into your milk. Talk to your doctor about breastfeeding.
Other Medications
Please tell your doctor or pharmacist if you are taking (or recently took) any other medicines. Remember to mention also medicines that you bought without prescription, over the counter.
While taking ILEVRO
Tell your doctor if you are not getting any relief or if problems develop.
If you wear contact lenses
There is a preservative in ILEVRO (benzalkonium chloride) that can discolour soft lenses and may cause eye irritation. Additionally, wearing contact lenses is not recommended after cataract surgery. Do not wear contact lenses while using ILEVRO.
Driving and using machines
You may find that your vision is blurred or you may have other vision changes just after you use ILEVRO. Do not drive or use machines until your vision is clear.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor about all drugs that you are using or planning to use, including those without a prescription.
Do not use acetylsalicylic acid, phenylacetic acid or other nonsteroidal anti-inflammatories with ILEVRO if you have previously developed reactions to the use of these products (See When it should not be used).
PROPER USE OF THIS MEDICATION
Always use ILEVRO exactly as your doctor has told you.
Usual adult dose:
One drop of ILEVRO should be applied to the affected eye(s) once daily. Begin 1 day before cataract surgery. Continue on the day of surgery. Then use it for as long as your doctor told you to. This may be up to 2 weeks after your operation.
How to Use:
1 2 3
- Get the ILEVRO suspension bottle and a mirror.
- Wash your hands.
- Shake well before use.
- Turn the closed bottle upside down and shake down once before each use
- Twist off the bottle cap.
- After cap is removed: if tamper evident 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. It could infect the drops.
- Gently squeeze the sides of the bottle until one drop is released into your eye (picture 2).
- •
- After using ILEVRO suspension, press a finger into the corner of your eye, by the nose (picture 3). This helps to stop ILEVRO suspension getting into the rest of the body.
- If you use drops in both eyes, repeat the steps for your other eye.
- Close the bottle cap firmly immediately after use.
- Use up one bottle before opening the next bottle.
- If a drop misses your eye, try again.
If you are using other eye drops wait at least 5 minutes between putting in ILEVRO and the other drops.
Overdose:
If you use more ILEVRO than you should, rinse it all out with warm water. Don’t put in any more drops until it’s time for your next regular dose. If accidentally ingested, contact your local poison control centre or doctor.
Missed Dose:
If you forget to use ILEVRO, 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. Do not use more than one drop in the affected eye(s) once daily.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
A small number of people who use ILEVRO may get side effects. They can be unpleasant, but most of them disappear rapidly.
Do not stop taking ILEVRO without speaking to your doctor. You can usually continue using ILEVRO, unless the effects are serious. If you're worried, talk to a doctor or pharmacist.
The most common side effects include eye pain, abnormal sensation in the eye, crusty eyelids, and eye surface inflammation.
Less common side effects include eye surface damage with loss of cells, blurred vision, eye itching, dry eye, eye discharge, increased tear production, eyelid inflammation, sensitivity to light, eye allergy, increased allergic symptoms, nausea, skin allergy, and headache.
Additional side effects may also affect people using ILEVRO including reduced vision, eye swelling, eye irritation, eye redness, dizziness, vomiting and increased blood pressure.
| 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 | ||
| Eyes get redder, eyes become more painful | ✓ | ||
| Cornea (protective outer layer of the eye) side effects, including corneal disorder, eye surface damage with loss of cells, impaired healing of the eye surface, thinning of the surface of the eye, clouding, eye surface scar | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking ILEVRO, contact your doctor or pharmacist.
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.
HOW TO STORE IT
Store at 2oC - 25°C. Protect from light. Discard 28 days after opening. Keep out of the reach and sight of children.
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 the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
www.novartis.ca or by contacting the sponsor, Novartis Pharmaceuticals Canada Inc., at: 1-800-363-8883.