Cambia

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild-to-moderate pain, and helps to relieve symptoms of arthritis (eg, osteoarthritis or rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will only help you as long as you continue to take it.

This medicine is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine, and other painful conditions such as menstrual cramps.

Diclofenac is also used to treat acute migraine attacks, with or without aura, in adults. It will not prevent or lessen the number of migraine attacks.

This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:

• Capsule
• Powder for Solution
• Capsule, Liquid Filled
• Tablet
• Tablet, Enteric Coated
• Tablet, Extended Release

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

1. Allergies:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

2. Pediatric Population:
Appropriate studies have not been performed on the relationship of age to the effects of diclofenac in the pediatric population. Safety and efficacy have not been established.

3. Geriatric Population:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac in the elderly. However, elderly patients are more likely to have age-related kidney or stomach problems, which may require caution for patients receiving diclofenac.

4. Pregnancy:
1st and 2nd Trimester: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

3rd Trimester: Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

5. Breastfeeding:
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

6. Drug Interactions:
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab Acenocoumarol Amineptine Amitriptyline Amitriptylinoxide Amoxapine Anagrelide Apixaban Ardeparin Argatroban
• Beta Glucan Bivalirudin
• Ceritinib Certoparin Cilostazol Citalopram Clomipramine Clopidogrel Cyclosporine
• Dabigatran Etexilate Dabrafenib Dalteparin Danaparoid Deferiprone Desipramine Desirudin Desvenlafaxine Dibenzepin Dipyridamole Dothiepin Doxepin Duloxetine
• Edoxaban Enoxaparin Eptifibatide Erlotinib Escitalopram
• Feverfew Fluoxetine Fluvoxamine Fondaparinux
• Ginkgo Gossypol
• Heparin
• Imipramine
• Lepirudin Levomilnacipran Lofepramine
• Meadowsweet Melitracen Methotrexate Milnacipran
• Nadroparin Nefazodone Nortriptyline
• Opipramol
• Parnaparin Paroxetine Pemetrexed Pentosan Polysulfate Sodium Pentoxifylline Phenindione Phenprocoumon Pralatrexate Prasugrel Protein C Protriptyline
• Reboxetine Reviparin Rivaroxaban
• Sertraline Sibutramine
• Tacrolimus Tianeptine Ticlopidine Tinzaparin Tirofiban Trimipramine
• Venlafaxine Vilazodone Vortioxetine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol Alacepril Alprenolol Amiloride Arotinolol Atenolol Azosemide
• Befunolol Bemetizide Benazepril Bendroflumethiazide Benzthiazide Betaxolol Bevantolol Bisoprolol Bopindolol Bucindolol Bumetanide Bupranolol Buthiazide
• Canrenoate Captopril Carteolol Carvedilol Celiprolol Chlorothiazide Chlorthalidone Cholestyramine Cilazapril Ciprofloxacin Clopamide Colestipol Cyclopenthiazide
• Delapril Dilevalol
• Enalapril Enalaprilat Esmolol Ethacrynic Acid
• Fosinopril Furosemide
• Hydrochlorothiazide Hydroflumethiazide
• Imidapril Indapamide
• Labetalol Landiolol Levobunolol Lisinopril Lithium
• Mepindolol Methyclothiazide Metipranolol Metolazone Metoprolol Moexipril
• Nadolol Nebivolol Nipradilol
• Oxprenolol
• Penbutolol Pentopril Perindopril Pindolol Piretanide Polythiazide Propranolol
• Quinapril
• Ramipril
• Sotalol Spirapril Spironolactone
• Talinolol Temocapril Tertatolol Timolol Torsemide Trandolapril Triamterene Trichlormethiazide
• Xipamide
• Zofenopril

7. Other Interactions:
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

8. Other Medical Problems:
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia
• Bleeding problems
• Blood clots
• Congestive heart failure
• Edema (fluid retention)
• Heart attack, history of
• Heart disease
• Hypertension (high blood pressure)
• Kidney disease
• Porphyria (blood disorder)
• Stomach ulcers or bleeding, history of
• Stroke, history of—Use with caution. May make these conditions worse.
• Aspirin-sensitive asthma, history of
• Aspirin (or other NSAIDs) sensitivity, history of
• Kidney disease, severe—Should not be used in patients with these conditions.
• Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
• Phenylketonuria (PKU)—The oral powder for solution contains phenylalanine, which can make this condition worse.

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. This medicine is not for long-term use.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken every day as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or longer may pass before you begin to feel better. Several weeks may pass before you feel the full effects of this medicine.

You may take this medicine with or without food. However, diclofenac capsules should be taken on an empty stomach.

To use the oral solution:

• Open the packet of medicine right before you use it.
• Empty the contents of the packet into a cup with 1 to 2 ounces (30 to 60 milliliters [mL]) of water. Do not use any liquid other than water for mixing the medicine.
• Mix well and drink it immediately on an empty stomach.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For acute pain:
    • Adults—18 or 35 milligrams (mg) three times a day.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis:
    • Adults—35 milligrams (mg) three times a day.
    • Children—Use and dose must be determined by your doctor.

• For oral dosage forms (delayed-release tablets, enteric-coated tablets):
  • For ankylosing spondylitis:
    • Adults—25 milligrams (mg) four times a day, with an extra 25 mg dose at bedtime if necessary.
    • Children—Use and dose must be determined by your doctor.
  • For osteoarthritis:
    • Adults—50 milligrams (mg) two or three times a day, or 75 mg two times a day.
    • Children—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis:
    • Adults—50 milligrams (mg) three or four times a day, or 75 mg two times a day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (immediate-release tablets):
  • For osteoarthritis:
    • Adults—50 milligrams (mg) two or three times a day.
    • Children—Use and dose must be determined by your doctor.
  • For pain or menstrual cramps:
    • Adults—50 milligrams (mg) three times a day. Your doctor may direct you to take 100 mg for the first dose only.
    • Children—Use and dose must be determined by your doctor.
  • For rheumatoid arthritis:
    • Adults—50 milligrams (mg) three or four times a day.
    • Children—Use and dose must be determined by your doctor.

• For oral dosage form (solution):
  • For migraine headaches:
    • Adults—One packet (50 milligrams) as a single, one tiChildren—Use and dose must be determined by your doctor.

Missed Dose:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage:
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Heart Disease:
This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

Bleeding:
This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain medicines (such as a steroid medicine or a blood thinner).

Skin Reactions:
Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin, red skin lesions, sores or ulcers on the skin, or fever or chills.

Serious side effects:
Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur, such as chest pain, fast or irregular heartbeat, tightness in the chest, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor right away if you notice any of these warning signs.

Allergic Reactions:
This medicine may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or nonsteroidal antiinflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Pregnancy:
It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. Do not use this medicine during the latter part of a pregnancy unless your doctor tells you to.

Meningitis:
Call your doctor right away if you have confusion, drowsiness, fever, general feeling of illness, headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of meningitis.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Surgery, Medical tests:
Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or Stomach bloating, burning, cramping, or pain
• Belching
• Bloody or Black, tarry stools
• Cloudy urine
• Constipation
• Decrease in urine output or decrease in urine-concentrating ability
• Diarrhea
• Dizziness
• Feeling of indigestion
• Headache
• Increased bleeding time
• Itching skin or rash
• Loss of appetite
• Nausea and Vomiting
• Pain in the chest below the breastbone
• Pale skin
• Severe stomach pain
• Swelling
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting of blood or material that looks like coffee grounds
• Weight loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation
• Blurred vision
• Change in consciousness
• Change in the ability to see colors, especially blue or yellow
• Confusion
• Depression
• Difficult or Troubled breathing
• Hives
• Hostility
• Irregular, Fast or Slow, or shallow breathing
• Irritability
• Loss of consciousness
• Muscle twitching
• Nervousness
• Pain or Discomfort in the chest, upper stomach, or throat
• Pale or Blue lips, fingernails, or skin
• Puffiness or Swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Seizures
• Sleepiness
• Slow or Fast heartbeat
• Stupor
• Swelling of the face, ankles, or hands
• Tightness in the chest
• Trouble sleeping
• Unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Continuing ringing or buzzing or other unexplained noise in the ears
• Excess air or gas in the stomach or intestines
• Hearing loss
• Lack or Loss of strength
• Passing gas

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.