Diclofenac

March 21, 2017

Diclofenac Epolamine Medicated topical patch

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to treat pain from bruises, sprains, or strains.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

asthma
bleeding problems
coronary artery bypass graft (CABG) surgery within the past 2 weeks
drink more than 3 alcohol containing drinks a day
heart disease
high blood pressure
kidney disease
liver disease
open or infected skin
stomach bleeding or ulcers
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, polysorbate 80, gelatin, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Use your medicine at regular intervals. Do not use it more often than directed.

Wash hands before and after use. Apply the patch only to normal, intact skin. Do not apply to damaged skin such as wounds or burns. Tape the edges of the patch to your skin if the patch begins to peel off. Wear only one patch at a time.

Take the patch off before bathing or showering. Bathe or shower immediately before you need to apply a new patch. Do not get the patch wet.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

cidofovir
ketorolac
methotrexate

This medicine may also interact with the following medications:

alcohol
aspirin and aspirin-like medicines
diuretics
lithium
medicines for blood pressure
medicines for osteoporosis
medicines that affect platelets
medicines that treat or prevent blood clots like warfarin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
pemetrexed
steroid medicines like prednisone or cortisone

Do not use any other skin products on the affected area without asking your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Do not take medicines such as ibuprofen and naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine does not prevent heart attack or stroke. In fact, this medicine may increase the chance of a heart attack or stroke. The chance may increase with longer use of this medicine and in people who have heart disease. If you take aspirin to prevent heart attack or stroke, talk with your doctor or health care professional.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Do not smoke cigarettes or drink alcohol. These increase irritation to your stomach and can make it more susceptible to damage from this medicine. Ulcers and bleeding can happen without warning symptoms and can cause death.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
breathing problems
changes in vision
chest pain
nausea or vomiting
redness, blistering, peeling or loosening of the skin, including inside the mouth
slurred speech or weakness on one side of the body
trouble passing urine or change in the amount of urine
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

dizziness
dry skin
headache
heartburn
increased sensitivity to the sun
stomach pain
tingling at the application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) in the resealable envelopes. Seal the envelope after removing a patch for use. Protect from moisture. Throw away any unused medicine after the expiration date.

Diclofenac Potassium Oral capsule, liquid filled

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to reduce swelling and to treat pain. It may be used to treat osteoarthritis, rheumatoid arthritis, mild to moderate pain, and painful monthly periods.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

asthma, especially aspirin sensitive asthma
coronary artery bypass graft (CABG) surgery within the past 2 weeks
drink more than 3 alcohol containing drinks a day
heart disease or circulation problems like heart failure or leg edema (fluid retention)
high blood pressure
kidney disease
liver disease
stomach bleeding or ulcers
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, bovine or cow proteins, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

Take this medicine by mouth with food and a full glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Long-term, continuous use may increase the risk of heart attack or stroke.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Elderly patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

cidofovir
ketorolac
methotrexate

This medicine may also interact with the following medications:

alcohol
aspirin and aspirin-like medicines
cyclosporine
diuretics
lithium
medicines for blood pressure
medicines for osteoporosis
medicines that affect platelets
medicines that treat or prevent blood clots like warfarin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
pemetrexed
steroid medicines like prednisone or cortisone

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
blurred vision
chest pain
difficulty breathing or wheezing
nausea or vomiting
rash or fever
redness, blistering, peeling or loosening of the skin, including inside the mouth
slurred speech or weakness on one side of the body
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

constipation
diarrhea
dizziness
headache
heartburn

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Diclofenac Potassium Oral solution

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to treat migraine pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

asthma, especially aspirin sensitive asthma
coronary artery bypass graft (CABG) surgery within the past 2 weeks
drink more than 3 alcohol-containing drinks a day
heart disease or circulation problems like heart failure or leg edema (fluid retention)
high blood pressure
kidney disease
liver disease
phenylketonuria
stomach problems
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

Mix this medicine with 1 to 2 ounces of water. Drink the medicine and water together. Follow the directions on the prescription label. Do not take your medicine more often than directed. Long-term, continuous use may increase the risk of heart attack or stroke.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Elderly patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

cidofovir
ketorolac
methotrexate

This medicine may also interact with the following medications:

alcohol
aspirin and aspirin-like medicines
cyclosporine
diuretics
lithium
medicines for blood pressure
medicines for osteoporosis
medicines that affect platelets
medicines that treat or prevent blood clots like warfarin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
pemetrexed
steroid medicines like prednisone or cortisone

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

If you take migraine medicines for 10 or more days a month, your migraines may get worse. Keep a diary of headache days and medicine use. Contact your healthcare professional if your migraine attacks occur more frequently.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
blurred vision
chest pain
difficulty breathing or wheezing
nausea or vomiting
fever
redness, blistering, peeling or loosening of the skin, including inside the mouth
slurred speech or weakness on one side of the body
trouble passing urine or change in the amount of urine
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

constipation
diarrhea
dizziness
headache
heartburn

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Diclofenac Potassium Oral tablet

What is this medicine?

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

asthma, especially aspirin sensitive asthma
coronary artery bypass graft (CABG) surgery within the past 2 weeks
drink more than 3 alcohol containing drinks a day
heart disease or circulation problems like heart failure or leg edema (fluid retention)
high blood pressure
kidney disease
liver disease
stomach bleeding or ulcers
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

Take this medicine by mouth with food and with a full glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Long-term, continuous use may increase the risk of heart attack or stroke.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Elderly patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

cidofovir
ketorolac
methotrexate

This medicine may also interact with the following medications:

alcohol
aspirin and aspirin-like medicines
cyclosporine
diuretics
lithium
medicines for blood pressure
medicines for osteoporosis
medicines that affect platelets
medicines that treat or prevent blood clots like warfarin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
pemetrexed
steroid medicines like prednisone or cortisone

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
blurred vision
chest pain
difficulty breathing or wheezing
nausea or vomiting
rash or fever
redness, blistering, peeling or loosening of the skin, including inside the mouth
slurred speech or weakness on one side of the body
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

constipation
diarrhea
dizziness
headache
heartburn

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

Diclofenac Sodium Gastro-resistant tablet

What is this medicine?

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

asthma, especially aspirin sensitive asthma
coronary artery bypass graft (CABG) surgery within the past 2 weeks
drink more than 3 alcohol containing drinks a day
heart disease or circulation problems like heart failure or leg edema (fluid retention)
high blood pressure
kidney disease
liver disease
stomach bleeding or ulcers
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

Take this medicine by mouth with food and with a full glass of water. Do not crush or chew the medicine. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Long-term, continuous use may increase the risk of heart attack or stroke.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Elderly patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

cidofovir
ketorolac
methotrexate

This medicine may also interact with the following medications:

alcohol
aspirin and aspirin like medicines
cyclosporine
diuretics
lithium
medicines for blood pressure
medicines for osteoporosis
medicines that affect platelets
medicines that treat or prevent blood clots like warfarin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
pemetrexed
steroid medicines like prednisone or cortisone

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
blurred vision
chest pain
difficulty breathing or wheezing
nausea or vomiting
slurred speech or weakness on one side of the body
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

constipation
diarrhea
dizziness
headache
heartburn

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

Diclofenac Sodium Ophthalmic drops, solution

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). The eye drops are used in the eye to treat swelling after eye surgery. They also help treat pain and sensitivity to light after the surgery.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

bleeding problems
diabetes
dry eye syndrome, other eye problems, or recent eye surgery
rheumatoid arthritis
wear soft contact lenses
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye gently to spread the drops. Your vision may blur for a few minutes. Use your doses at regular intervals. Do not use your medicine more often than directed.

If you have soft contact lenses, you should not wear them while you are using this medicine.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

agents that may increase bleeding time such as warfarin or other blood thinners
corticosteroid eye drops or ointments such as dexamethasone

Do not use any other eye products without asking your doctor or health care professional.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your eye symptoms do not get better within 2 to 3 days. Do not use for longer than directed by your doctor or health care professional.

You may have to wear a special bandage for up to 3 days after your surgery.

Wear sunglasses if your eyes are more sensitive to light.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
bleeding in the white part of your eye
flu like symptoms or eye infection
sores in the eye or eye irritation that gets worse

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

blurred vision
burning or stinging after instilling the drops
tearing

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from light. Throw away any unused eye solution after one month.

Diclofenac Sodium Oral tablet, extended-release

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to reduce swelling and to treat pain. It is used for osteoarthritis and rheumatoid arthritis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

asthma, especially aspirin sensitive asthma
coronary artery bypass graft (CABG) surgery within the past 2 weeks
drink more than 3 alcohol containing drinks a day
heart disease or circulation problems like heart failure or leg edema (fluid retention)
high blood pressure
kidney disease
liver disease
stomach bleeding or ulcers
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Elderly patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

cidofovir
ketorolac
methotrexate

This medicine may also interact with the following medications:

alcohol
aspirin and aspirin-like medicines
cyclosporine
diuretics
lithium
medicines for blood pressure
medicines for osteoporosis
medicines that affect platelets
medicines that treat or prevent blood clots like warfarin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
pemetrexed
steroid medicines like prednisone or cortisone

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not get better. Talk to your doctor before taking another medicine for pain. Do not treat yourself.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
blurred vision
chest pain
difficulty breathing or wheezing
nausea or vomiting
rash or fever
redness, blistering, peeling or loosening of the skin, including inside the mouth
slurred speech or weakness on one side of the body
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

constipation
diarrhea
dizziness
headache
heartburn

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

Diclofenac Sodium Solution for injection

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to reduce swelling and to treat pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

coronary artery bypass graft (CABG) surgery within the past 2 weeks
dehydration
drink more than 3 alcohol containing drinks a day
heart disease
high blood pressure
history of stomach bleeding
kidney disease
liver disease
lung or breathing disease, like asthma
stomach or intestine problems
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often that directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment. If you give yourself the medicine and you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

cidofovir
ketorolac

This medicine may also interact with the following medications:

aspirin and aspirin-like medicines
certain medicines for blood pressure like benazepril, enalapril, lisinopril
certain medicines for fungal infection like fluconazole, voriconazole
certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, rivaroxaban
cyclosporine
diuretics
lithium
methotrexate
rifampin

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Your condition will be monitored carefully while you are receiving this medicine.

Do not take other medicines that contain aspirin, ibuprofen, or naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. This can happen with no warning and may cause death. There is increased risk with taking this medicine for a long time. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your doctor right away if you have stomach pain or blood in your vomit or stool.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm, or leg
signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose
signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

constipation
diarrhea
dizziness
headache
injection site pain
nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Diclofenac Sodium Topical gel

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). The 1% skin gel is used to treat osteoarthritis of the hands or knees. The 3% skin gel is used to treat actinic keratosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

asthma
bleeding problems
coronary artery bypass graft (CABG) surgery within the past 2 weeks
heart disease
high blood pressure
if you frequently drink alcohol containing drinks
kidney disease
liver disease
open or infected skin
stomach problems
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, benzyl alcohol (3% gel only), foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Wash hands before and after use. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Use your doses at regular intervals. Do not use your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill of the 1% gel. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. The 3% gel is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

aspirin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

Do not use any other skin products without telling your doctor or health care professional.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You will need to follow up with your health care provider to monitor your progress. You may need to be treated for up to 3 months if you are using the 3% gel, but the full effect may not occur until 1 month after stopping treatment. If you develop a severe skin reaction, contact your doctor or health care professional immediately.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
blurred vision
chest pain
difficulty breathing or wheezing
nausea or vomiting
redness, blistering, peeling or loosening of the skin, including inside the mouth
slurred speech or weakness on one side of the body
trouble passing urine or change in the amount of urine
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

dizziness
dry skin
headache
heartburn
increased sensitivity to the sun
stomach pain
tingling at the application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store the 1% gel at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Store the 3% gel at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

Diclofenac Sodium Topical solution

What is this medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). It is used to treat osteoarthritis of the knees.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

asthma
bleeding problems
coronary artery bypass graft (CABG) surgery within the past 2 weeks
heart disease
high blood pressure
if you frequently drink alcohol containing drinks
kidney disease
liver disease
open or infected skin
stomach problems
an unusual or allergic reaction to diclofenac, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Wash hands before and after use. Apply to the clean, dry skin of the knee. Rub around front, back, and sides of the knee. Do not apply to open wounds, infections, swelling, or areas of exfoliative dermatitis. Allow medicine to dry before using any other lotion or medicine on the same place. Do not get this medicine in your mouth or eyes. If this medicine gets in your eye, rinse out with plenty of cool tap water. Protect treatment area from sunlight and sun lamps. Use your doses at regular intervals. Do not use it more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

cidofovir
ketorolac
methotrexate

This medicine may also interact with the following medications:

aspirin
cyclosporine
lithium
medicines for blood pressure
medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
other products used on the skin
steroid medicines like prednisone or cortisone

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

This medicine can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding can happen without warning symptoms and can cause death. To reduce your risk, do not smoke cigarettes or drink alcohol while you are taking this medicine.

This medicine can cause you to bleed more easily. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
black or bloody stools, blood in the urine or vomit
blurred vision
chest pain
difficulty breathing or wheezing
nausea or vomiting
redness, blistering, peeling or loosening of the skin, including inside the mouth
slurred speech or weakness on one side of the body
trouble passing urine or change in the amount of urine
unexplained weight gain or swelling
unusually weak or tired
yellowing of eyes or skin

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

dizziness
dry skin
headache
increased sensitivity to the sun
stomach upset
tingling at the application

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Updated:

March 21, 2017

Sources:

U.S. FDA-approved Package Insert