ARACLOF (DICLOFENAC) INDICATIONS
Araclof is used primarily for the treatment of inflammation and pain caused by conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is also effective in treating soft tissue inflammations due to tendinitis and bursitis, and treating dysmenorrhea (menstrual cramps). Araclof is an NSAID. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.
ARACLOF (DICLOFENAC) INSTRUCTIONS
Use Araclof as directed by your doctor!
- Take Araclof by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
- Take Araclof with a full glass of water (8 oz/240 mL) as directed by your doctor.
- If you miss a dose of Araclof, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Araclof.
ARACLOF (DICLOFENAC) STORAGE
Store Araclof at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Araclof out of the reach of children and away from pets.
Do NOT use Araclof if:
- you are allergic to any ingredient in Araclof or to bovine (cow) protein
- you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)
- you have recently had or will be having bypass heart surgery
- you have severe kidney problems
- you are in the last 3 months of pregnancy.
Contact your doctor or health care provider right away if this applies to you.
Some medical conditions may interact with Araclof. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
- if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
- if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases
- if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you smoke, drink alcohol, or have a history of alcohol abuse
- if you are taking an antibiotic or an anti-seizure medicine. The risk of liver problems may be increased with some of these medicines.
Some medicines may interact with Araclof. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), heparin and other blood thinners (eg, dalteparin), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased
- Acetaminophen because the risk of liver problems may be increased
- Probenecid because it may increase the risk of Araclof's side effects
- Cyclosporine, lithium, metformin, methotrexate, oral NSAIDs (eg, ibuprofen), or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Araclof
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Araclof.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Araclof may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Important safety information:
- Araclof may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Araclof with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
- Serious stomach ulcers or bleeding can occur with the use of Araclof. Taking it in high doses, for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Araclof with food will NOT reduce the risk of these effects. If you have severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling, contact your doctor or emergency room right away.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Araclof is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using Araclof unless your doctor tells you to.
- Check with your doctor or pharmacist before you take acetaminophen while you are taking Araclof. The risk of liver problems may be increased.
- Do not switch between different forms of Araclof (eg, enteric-coated tablets, immediate-release tablets, capsules) unless your doctor tells you to. They may not provide the same amount of medicine to your body.
- Lab tests, including kidney function, liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use Araclof. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Araclof with caution in the elderly; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
- Araclof should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
- Pregnancy and breast-feeding: Araclof may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Araclof while you are pregnant. It is not known if Araclof is found in breast milk. Do not breastfeed while taking Araclof.
All medicines may cause side effects, but many people have no, or minor, side effects.
Check with your doctor if any of these most common side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; headache; mild stomach pain or heartburn; nausea; vomiting.
Seek medical attention right away if any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; persistent flu-like symptoms; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes); unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.