Consumer Information for: NEVANAC

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

NEVANAC* is used to manage eye pain and inflammation following cataract surgery on the eye.

What it does

NEVANAC*, as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the substances produced by your body, such as prostaglandins, which cause pain and swelling in your eye.

When it should not be used

NEVANAC* should not be used if you are:

  • allergic (hypersensitive) to nepafenac or any of the other ingredients in NEVANAC* (see What the important nonmedicinal ingredients are).
  • Allergic to other NSAIDs

Tell your doctor if you have allergies.

What the medicinal ingredient is

Nepafenac

What the non-medicinal ingredients are

Preservative: benzalkonium chloride.
Inactive ingredients: carbomer 974P, edetate disodium, mannitol, purified water, sodium chloride and tyloxapol. 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 form it comes in

NEVANAC* contains tiny yellow particles suspended in a clear liquid. It is supplied as 5 mL of suspension in an 8 mL plastic DROP-TAINER* bottle with a screw cap.

Warnings and precautions

BEFORE you use NEVANAC*, talk to your doctor or pharmacist if you:

  • have any allergies to NEVANAC* or any of its ingredients (see What the important nonmedicinal ingredients are).
  • bruise easily or have bleeding problems or have had them in the past.
  • have had any other eye disorder (e.g. an eye infection), or recent eye surgery.
  • are using other medications in the eye.
  • have ever had an allergic reaction to nonsteroidal anti-inflammatory drugs including acetylsalicylic acid, as you may be allergic to NEVANAC*.

Pregnancy or breast-feeding
If you are pregnant, or might get pregnant, talk to your doctor before you use NEVANAC*. If you are breast-feeding, do not use NEVANAC*; it may get into your milk.

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 NEVANAC*
Tell your doctor if you are not getting any relief or if problems develop.

If you wear contact lenses
There is a preservative in NEVANAC* (benzalkonium chloride) that can discolour soft lenses and may cause eye irritation. Wearing contact lenses is not recommended after cataract surgery. Do not wear contact lenses while NEVANAC*.

Driving and using machines
You may find that your vision is blurred for a time just after you use NEVANAC*. Do not drive or use machines until your vision is clear.

Interactions with this medication

Tell your doctor or pharmactist about all the medications you are taking, recently took or planning to use, including those without a prescription.

Do not use acetylsalicylic acid, phenylacetic acid or other nonsteroidal anti-inflammatories with NEVANAC* if you have previously developed reactions to the use of these products (see When it should not be used).

Taking a topical NSAID, like NEVANAC*, at the same time with a topical steroid may delay healing. Taking NEVANAC* at the same time as other drugs that prolong bleeding time may also increase the risk of bleeding problems.

Proper use of this medication

Always use NEVANAC* exactly as your doctor has told you.

Usual adult dose

One drop of NEVANAC* should be applied to the affected eye(s) three times a day – morning, mid-afternoon, and prior to bed. Use at the same time each day. 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

  • Get the NEVANAC* bottle and a mirror.
  • Wash your hands.
  • Shake well before use.
  • 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. It could infect the drops.
  • Gently press on the base of the bottle to release one drop of NEVANAC* 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).
  • After using NEVANAC*, press a finger into the corner of your eye, by the nose (picture 3). This helps to stop NEVANAC* 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 use drops in both eyes, repeat the steps for your other eye. Close the bottle cap firmly immediately after use.

If you are using other eye drops wait at least 5 minutes between putting in NEVANAC* and the other drops.

Overdose

If you use more NEVANAC* 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.

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.

Missed Dose

If you forget to use NEVANAC*, 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) 3 times daily.

Side effects and what to do about them

A small number of people who use NEVANAC* may get side effects. They can be unpleasant, but most of them disappear rapidly.

Do not stop taking NEVANAC* without speaking to your doctor. You can usually continue using the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist.

The most common side effects include eye pain, blurred vision, eye itching, dry eye, increased tear production, abnormal sensation in the eye, crusty eyelids, inflammation inside the eye, and headache.

Less common side effects include deposits on the eye surface, fluid in the back of the eye, eye discharge, sensitivity to light, eye irritation, eye allergy, eyelid swelling or drooping, eye redness, increased allergic symptoms, nausea, and dry mouth.

Additional side effects may also affect people using NEVANAC* including reduced vision, eye swelling, eyelid inflammation, eye redness, dizziness, skin inflammation, redness and itching, 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 Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and talk with your doctor or pharmacist
Eyes get redder or more painful    
Cornea (protective outer layer of the eye) side effects, including ulcers, problems with the surface, injury, impaired healing, scar, clouding and thinning of the surface of the eye    

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

How to store

Store at 2°C - 30°C. Keep out of reach and sight of children. Discard 28 days after opening.

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;
  • 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 0701E
                    Ottawa, ON
                    K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

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 found at:
www.novartis.ca or by contacting the sponsor, Novartis Pharmaceuticals Canada Inc., at: 1-800-363-8883.

This leaflet was prepared by Novartis Pharmaceuticals Canada Inc.

Last revised: February 28, 2017

© 2015 Novartis
*a trademark of Novartis