WHAT IS Cataflam xr/Diclofenac TABLETS?

DICLOFENAC/Cataflam xr is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms. 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.

Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin) pills are tablets or capsules formulated to dissolve slowly and release a drug over time. The advantages of sustained-release tablets or capsules are that they can often be taken less frequently than instant-release formulations of the same drug, and that they keep steadier levels of the drug in the bloodstream.

WHERE SHOULD I KEEP Cataflam xr/Diclofenac?

Store at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep out of the reach of children and away from pets.

HOW SHOULD I USE Cataflam xr/Diclofenac?

Take Cataflam/Cataflam xr 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 the medicinewith a full glass of water (8 oz/240 mL) as directed by your doctor.

WHAT IF I MISS A DOSE?

If you miss a dose and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

WHAT SHOULD I WATCH FOR WHILE USING Cataflam xr/Diclofenac?

Cataflam/Cataflam xr may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Cataflam/Cataflam xr with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Serious stomach ulcers or bleeding can occur with the use of Cataflam/Cataflam xr . Taking it in high doses, for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Cataflam/Cataflam xr 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. Do not switch between different forms of Cataflam/Cataflam xr (eg, enteric-coated tablets, immediate-release tablets) unless your doctor tells you to. They may not provide the same amount of medicine to your body.

Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Cataflam/Cataflam xr . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Cataflam/Cataflam xr with caution in the elderly and children; they may be more sensitive to its effects, especially stomach bleeding and kidney problems. Cataflam/Cataflam xr 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 Cataflam/Cataflam xr Immediate-Release Tablets while you are pregnant. It is not known if Cataflam/Cataflam xr Immediate-Release Tablets is found in breast milk. Do not breast-feed while taking it.

WHAT MAY INTERACT WITH Cataflam xr/Diclofenac?

Do not take this medicine with any of the following:

• Probenecid/Probalan
• NSAIDs, medicines for pain and inflammation, like ibuprofen/Motrin or naproxen/Anaprox
• Angiotensin-converting enzyme (ACE) inhibitors or diuretics alcohol
• Anticoagulants, aspirin, corticosteroids, heparin, selective serotonin reuptake inhibitors (SSRIs)
• Cyclosporine/Neoral, lithium/Lithobid, methotrexate/Rheumatrex, quinolones
• medicines for high blood pressure

This list may not describe all possible interactions. Give your health care providers 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 SIDE EFFECTS MAY I NOTICE FROM Cataflam xr/Diclofenac?

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

• severe or persistent stomach pain or nausea
• confusion, depression
• bloody or black, tarry stools
• yellowing of the skin or eyes
• severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
• shortness of breath
• ringing in the ears
• change in the amount of urine produced, dark urine
• red, swollen, blistered, or peeling skin
• unusual tiredness or weakness
• swelling of hands, legs, or feet

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

• dizziness
• diarrhea
• headache
• gas
• drowsiness
• heartburn
• constipation
• stomach upset
• nausea

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.

WHAT SHOULD I TELL MY HEALTH CARE PROVIDERS BEFORE I TAKE Cataflam xr/Diclofenac?

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

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

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.