Diclofenac Topical Gel (DICLOFENAC 1% - TOPICAL)

Instructions

DO NOT take this medicine by mouth.

Apply the medicine to the affected area.

Use dosing card to measure each dose of medicine. Use 2 grams for hands, wrists or elbows. Use 4 grams for feet, ankles or knees.

Massage the medicine gently into skin to cover the entire joint area.

If you are using this on the hands, massage into the fingers and the top and palm of the hand. If you are using this on the feet, massage into the toes, and the top and bottom of the feet.

Use medicine only on clean, intact, dry skin. Rub medication thoroughly into skin. Allow medicine to dry before it touches your clothing.

Do not apply heat to the areas where this medicine is used.

Do not cover the area after applying the medicine.

Keep the medicine at room temperature. Avoid heat and direct light.

Do not apply other lotions, creams or gels to the same place you apply this medicine.

Avoid prolonged or excessive sunlight exposure. Use sunscreen lotion with SPF 15 or higher.

Let the medicine dry completely before allowing anyone else to touch the area.

Do not touch your eyes, nose or mouth after handling the medicine.

Do not shower, bathe, or swim for at least 1 hour before or after applying the medicine.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

You may stop using this medicine if you no longer have symptoms.

Keep all appointments for medical exams and tests while on this medicine.

Do not freeze the medicine.

Do not use more than 32 grams total in 24 hours. Do not use more than 8 grams in 24 hours on any single hand, wrist, or elbow. Do not use more than 16 grams in 24 hours on any single foot, ankle, or knee.

Cautions

Do NOT take aspirin or other NSAID medicines while using this medicine. Please speak with your doctor or pharmacist to review your medications if you need help.

This medicine may cause bleeding from the stomach or bowels. Stop this medicine and call your doctor right away if you have pain in the stomach, red or dark tarry stools, or vomit that looks like coffee grounds.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Please check with your doctor before drinking alcohol while on this medicine.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

If you are using this medicine regularly, it is important to take each dose of medicine on time. Keep taking the medicine even if you feel well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Do not share this medicine with anyone who has not been prescribed this medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• high blood pressure
• skin irritation where medicine is applied
• vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding or bruising
• chest or jaw pain
• coughing up blood or vomit that looks like coffee grounds
• swelling of the legs, feet, and hands
• fever
• fast or irregular heart beats
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• shortness of breath
• bloody or dark, tarry stools
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• excessive or unusual sweating
• swelling in the neck or throat
• blurring or changes of vision
• severe or persistent vomiting
• sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.