Consumer Information for: JAMP DICLOFENAC

JAMP Diclofenac is used to treat:

• eye inflammation after cataract surgery and

• eye inflammation after a non-penetrating eye injury.

JAMP Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It helps reduce chemicals produced in your eye (prostaglandins) which cause pain and swelling.

Medicinal ingredients: Diclofenac sodium, 0.1% w/v

Non-medicinal ingredients: Boric acid, Edetate Disodium, PEG-35 castor oil, 0.2% of sorbic acid (as preservative), Tromethamine, Water for Injection

JAMP Diclofenac is available in:

Preserved multi-dose bottles of 5 mL with 1 bottle of 5 mL per box.

• you are allergic to diclofenac sodium, any other ingredient in the formulation (see What are the ingredients- nonmedicinal ingredients)

• you have had reactions to other NSAID medications, such as:

  • acetylsalicylic acid

  • diflunisal

  • ibuprofen

  • flurbiprofen

  • ketoprofen

  • indomethacin

  • mefenamic acid

  • piroxicam

  • sulindac

  • tiaprofenic acid.

• Have had complicated eye surgery or multiple eye surgeries

• Have pre-existing corneal problems or problems with your eye surface (such as dry eye)

• Have diabetes

• Have rheumatoid arthritis

• Taking JAMP Diclofenac more than 24 hours before eye surgery or for more than 14 days after surgery may increase your risk for developing serious eye side effects;

• Check with your healthcare professional if you are not getting any relief or if any problems develop, such as an eye infection or bleeding problems;

• Report any reactions to your healthcare professional. This is very important Because it will help in the early detection and prevention of problems;

• If you experience any vision problems, in particular blurring of vision, DO NOT drive or operate any machinery.

• Your regular medical check-ups, including monitoring of eye pressure, are essential.

Pregnancy and breast feeding

You should tell your healthcare professional if you are pregnant or think that you may be pregnant. You should not use JAMP Diclofenac while pregnant unless absolutely necessary. As with other anti-inflammatory medicines, you must not use JAMP Diclofenac during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery.

You should tell your healthcare professional if you are breast-feeding.

You should not breast-feed if you are taking JAMP Diclofenac as it might be harmful for your infant.

Your healthcare professional will discuss with you the potential risk of using JAMP Diclofenac during pregnancy or breast-feeding.

Fertility in Women:

JAMP Diclofenac is not recommended to use in women attempting to conceive as it may impair female fertility.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

• Corticosteroids

• Medications that prolong bleeding time

JAMP Diclofenac is for topical use only.

• Wash your hands and sit or stand comfortably. If you wear contact lenses, remove them before using your eye drops.

• Visually inspect the dropper tip to make sure that it is not chipped or cracked.

• Avoid touching the dropper tip against your eye or anything else to avoid contamination. Eye drops and eye dropper must be kept clean.

• 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.

• Gently press on the base of the bottle to release one drop of JAMP Diclofenac 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).

• Close your eyelid and gently press the inner corner of your eye with your forefinger for 2 minutes (picture 3).

• If you use drops in both eyes, repeat the steps for your other eye.

• Close the bottle cap firmly immediately after use. DO NOT wipe or rinse the dropper tip.

• If a drop misses your eye, try again.

• Wipe any excess liquid from your face with a tissue.

• If you are to use more than one drop in the same eye, wait at least 5 minutes before applying the next drop. Eye ointments should be applied last.

• Wash your hands to remove any medication.

Cataract surgery

Before surgery: Apply 1 drop into the affected eye(s) up to 5 times during the 3 hours before your scheduled surgery.

After surgery: Apply 1 drop into the affected eye(s) 15, 30 and 45 minutes following surgery. Then apply 1 drop 3 to 5 times per day for up to 4 weeks.

Inflammation from non-penetrating wounds

Apply 1 drop into the affected eye(s) 4 to 5 times per day as directed by your healthcare professional.

If JAMP Diclofenac is accidentally ingested, fluids should be taken to dilute the medication.

If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. DO NOT double doses.

These are not all the possible side effects you may have when taking JAMP Diclofenac. If you experience any side effects not listed here, tell your healthcare professional.

Occasionally you may experience a mild to moderate burning sensation when JAMP Diclofenac is instilled in the eye. This symptom usually disappears rapidly, but if it or any other side effects persist, check with your healthcare professional.

Uncommon eye side effects are: itchy eye(s), reddening of eye and blurred vision immediately after instillation of the eye drops, eye pain, eye surface inflammation with surface damage, sensitivity to light, abnormal vision, eye allergy, pink eye, eye swelling, clouding of the eye surface, eyelid swelling, eye irritation, eye discharge, eyelid reddening, swelling or rash, eyelid crusting, eye discomfort, slower healing and a stainable cornea

Uncommon side effects in the rest of the body are: bad taste, feeling of pressure, abdominal pain, feeling weak, chills, dizziness, swelling of the face, fever, headache, problems sleeping, nausea, pain, nose irritation, a viral infection, hives, rash, eczema, skin redness, cough and vomiting.

If you are using JAMP Diclofenac after cataract surgery, you may feel increased eye pressure (intraocular pressure).

If you are using JAMP Diclofenac after refractive surgery, you may notice tearing.

If you use corticosteroids, have infections or have rheumatoid arthritis, you may develop ulcers, thinning or inflammation of your cornea, which may cause loss of vision.

Report any reactions to your healthcare professional. This is very important because it will help in the early detection and prevention of problems.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Store at 15 to 25°C. Protect from light. Discard 28 days after opening.

Keep bottle tightly closed when not in use. Keep this and all medication in a safe place out of reach and sight of children.

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.jamppharma.com), or by calling 1-866-399-9091.

This leaflet was prepared by:

JAMP Pharma Corporation

1310 rue Nobel,

Boucherville, Quebec,

J4B 5H3, Canada

Last Revised: September 25, 2023