Jamp Diclofenac Topical Solution: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is JAMP Diclofenac Topical Solution used for?

JAMP Diclofenac Topical Solution is used in adults to treat the signs and symptoms of osteoarthritis in the knee(s). It helps relieve pain, swelling and stiffness.

How does JAMP Diclofenac Topical Solution work?

• JAMP Diclofenac Topical Solution belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used topically (on the skin) to reduce the chemicals produced by your body which cause pain and swelling.
• JAMP Diclofenac Topical Solution only treats the symptoms and relieves pain and inflammation as long as you use it. JAMP Diclofenac Topical Solution does not cure your arthritis or stops it from getting worse.

What are the ingredients in JAMP Diclofenac Topical Solution?

Medicinal ingredients: diclofenac sodium

Non-medicinal ingredients: dimethyl sulfoxide, ethanol, glycerine, propylene glycol, purified water.

JAMP Diclofenac Topical Solution comes in the following dosage forms:

Topical solution: 1.5% w/w

Do not use JAMP Diclofenac Topical Solution if you:

• are planning to have or have recently had heart bypass surgery
• have severe, uncontrolled heart failure
• have active stomach or intestinal ulcers
• have inflammatory bowel disease (Crohn’s disease or Ulcerative Colitis)
• are allergic to diclofenac sodium, or to any of the non-medicinal ingredients in JAMP Diclofenac Topical Solution or component of the container (see What are the ingredients in JAMP Diclofenac Topical Solution?)
• have a history of asthma, hives, growths in your nose, sinus swelling or symptoms of an allergic reaction after taking acetylsalicylic acid (ASA) or other NSAIDs
• have liver disease (active or severe)
• have kidney disease (severe or worsening)
• have high levels of potassium in your blood
• are using other NSAIDs
• are under 18 years of age
• have been prescribed JAMP Diclofenac Topical Solution for longer than 3 months, JAMP Diclofenac Topical Solution cannot be used longer than 3 months

• are pregnant or breastfeeding

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAMP Diclofenac Topical Solution. Talk about any health conditions or problems you may have, including if you:

• have or have had a heart attack, chest pain, heart disease, stroke or heart failure
• have asthma
• have a stomach infection
• have a history of ulcer or bleeding from the stomach or gut (small or large intestines)
• have other bleeding or blood problems
• have liver or kidney problems, urine problems or are dehydrated
• have high blood pressure, high cholesterol or diabetes
• have poor blood flow to your extremities (like your hands and feet)
• smoke or used to smoke

• drink a lot of alcohol

• are planning on becoming pregnant. JAMP Diclofenac Topical Solution cannot be used if you are pregnant
• are planning to breastfeed, JAMP Diclofenac Topical Solution cannot be used if you are breastfeeding
• have immune system problems

Other warnings you should know about:

Serious Skin Reactions: In rare cases, serious or life-threatening skin reactions listed below have been reported with some NSAIDs, such as JAMP Diclofenac Topical Solution.

• drug reaction with eosinophilia and systemic symptoms (DRESS),
• Stevens-Johnson syndrome (SJS),
• toxic epidermal necrolysis (TEN),
• exfoliative dermatitis and
• erythema multiforme

You may be at a greater risk of experiencing a serious skin reaction during the first month of treatment.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

JAMP Diclofenac Topical Solution might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rashes, redness, itching and discoloration or vision changes. If you have a reaction from the sun, talk to your healthcare professional.

Check-ups and Testing: You should have regular visits with your healthcare professional while you are using JAMP Diclofenac Topical Solution to monitor your health. They should:

• Check your blood pressure.
• Check your eyes. JAMP Diclofenac Topical Solution can cause blurred or reduced vision.
• Do blood and urine tests to check your liver, kidney and blood health.

Surgery: Tell any doctor, dentist, pharmacist or healthcare professional that you see, that you are using this medicine. This is especially important if you are planning to have heart surgery.

Driving and Using Machines: Be careful about driving or doing activities that require you to be alert, as JAMP Diclofenac Topical Solution may affect your vision or nervous system. If you become drowsy, dizzy or light-headed after using JAMP Diclofenac Topical Solution, do NOT drive or operate machinery.

Adults (65 years or older): Side effects like gastrointestinal problems may happen more often. Your healthcare professional might have you start with a lower dose of JAMP Diclofenac Topical Solution. They will monitor your health during and after treatment.

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

The following may interact with JAMP Diclofenac Topical Solution:

• acetylsalicylic acid (ASA) or other NSAIDs, used to treat pain, fever and inflammation, such as celecoxib, diclofenac, ibuprofen, naproxen
• digoxin, used for heart problems
• medicines used as blood thinners or to prevent blood clots, such as heparin, warfarin, ASA, clopidogrel
• oral medicines used to treat diabetes
• medicines used to lower extra fluid levels (diuretics), such as furosemide, hydrochlorothiazide
• medicines used to lower blood pressure
• corticosteroids used as an anti-inflammatory, such as glucocorticoids, like prednisone
• methotrexate, used to treat some cancers or arthritis
• acetaminophen, used to treat pain and fevers
• cyclosporine, used to lower the risk of organ rejection
• lithium, used to treat bipolar disorder
• medicines used to treat gout, such as probenecid and sulfinpyrazone
• antibiotics used to treat bacterial infections, such as quinolone
• phenytoin, used to treat seizures
• voriconazole, used to treat infections
• alcohol

How to take JAMP Diclofenac Topical Solution:

• Use JAMP Diclofenac Topical Solution exactly how your healthcare professional has told you to. Talk to your healthcare professional if you are unsure.
• Do not stop using JAMP Diclofenac Topical Solution or change your dose without talking to your healthcare professional.
• JAMP Diclofenac Topical Solution is for external use only. Avoid contact with your eyes and mucous membranes.
• Apply JAMP Diclofenac Topical Solution to clean, dry skin.
• Do not use JAMP Diclofenac Topical Solution under bandages or dressings.
• Do not apply JAMP Diclofenac Topical Solution to open, broken or infected skin.
• Do not apply any other medication to the treated area
• Do not use JAMP Diclofenac Topical Solution for longer than 3 months.

Usual Dose:

Adults 18 years and older: Apply 40 drops to affected knee only, 4 times a day, or 50 drops, 3 times a day.

How to Apply JAMP Diclofenac Topical Solution:

• Use the plastic dropper to dispense 10 drops of JAMP Diclofenac Topical Solution into your hand, or directly onto your affected knee.
• Spread JAMP Diclofenac Topical Solution evenly around the front, back and sides of your knee.
• Repeat these steps until you have applied the prescribed amount of JAMP Diclofenac Topical Solution (either 40 or 50 drops) and your knee is completely covered.
• If you are using JAMP Diclofenac Topical Solution on both your knees, repeat the above steps to treat your other knee.
• Wash your hands when you are finished using JAMP Diclofenac Topical Solution.
• Allow several minutes for JAMP Diclofenac Topical Solution to dry.

Overdose:

Missed Dose:

If you miss applying a dose of JAMP Diclofenac Topical Solution, skip the missed dose. Then continue with your next dose at the usual time. Do not double the next dose to make up for a missed dose.

What are possible side effects from using JAMP Diclofenac Topical Solution?

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

Side effects may include:

• confusion, dizziness, light-headedness, spinning
• diarrhea, constipation
• feeling gassy
• feeling of burning/prickliness/numbing
• hair loss
• hard to concentrate or think
• nervousness
• skin rash

• sore throat

  • headache
  • heartburn, indigestion
  • irritation on the skin where you apply JAMP Diclofenac Topical Solution including rash, itchiness, dryness, tingling
  • mouth sores
  • muscle pain
  • stomach upset/abdominal pain
  • taste disorder, thirst, dry mouth
  • vomiting, nausea

Serious side effects and what to do about them

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.

Reporting Side Effects

Storage:

• Store upright at room temperature 15 – 30°C.
• Do not keep outdated medicine or medicine no longer needed.
• Keep out of reach and sight of children.

If you want more information about JAMP Diclofenac Topical Solution:

• 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.

JAMP Pharma Corporation

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last Revised: MAY 25, 2023