Relafen

Relafen is a prescription medication used to relieve the pain and swelling of osteoarthritis and rheumatoid arthritis. Relafen belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs), which work by stopping substances in your body that cause inflammation and pain.

This medication comes in tablet form and is taken once or twice daily, with or without food.

Common side effects include diarrhea, stomach pain, and constipation.

Relafen can cause dizziness. Do not drive or operate heavy machinery until you know how Relafen will affect you.

Relafen is a prescription medication used for relief of:

• the signs and symptoms of rheumatoid arthritis
• the signs and symptoms of osteoarthritis

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Glaxo SmithKline Pharmaceuticals

Serious side effects have been reported with Relafen. See “Drug Precautions” section.

Common side effects of Relafen include:

• diarrhea
• constipation
• gas or bloating
• dizziness
• headache
• dry mouth
• sores in the mouth
• nervousness
• difficulty falling asleep or staying asleep
• increased sweating
• ringing in the ears

This is not a complete list of Relafen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ACE inhibitors such as lisinopril (Prinivil), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec) and others
• aspirin (Ecotrin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• diuretics, or water pills, such as thiazides (hydrochlorothiazide) and furosemide (Lasix)
• lithium (Eskalith, Lithobid, others)
• methotrexate (Rheumatrex, Trexall)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• warfarin (Coumadin)
• cholestyramine (Questran)
• cimetidine (Tagamet)
• digoxin (Digitek, Lanoxin)

This is not a complete list of Relafen drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Relafen including:

• Cardiovascular thrombotic events. Relafen can increase your risk of cardiovascular and heart diseases such as strokes and myocardial infarctions, which can lead to death. Tell your doctor if you have a history of heart disease.
• Gastrointestinal effects. Relafen can cause digestive tract problems such as ulcers, bleeding, inflammation, and perforations (small holes). Tell your doctor if you have a history of digestive problems, or if you smoke or frequently drink alcohol. Alert your doctor if you take anticoagulants (blood-thinners) or corticosteroids such as prednisone.
• Hepatic events. Relafen c­­an cause damage to the liver and increase liver tests. Tell your doctor if you have a history of liver disease.
• Hypertension. Relafen may raise your blood pressure. Tell your doctor if you have a history of high blood pressure or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Congestive heart failure and edema. Relafen can increase the chance of congestive heart failure, fluid retention, and weight gain.
• Renal effects. Kidney damage can result from the use of Relafen. Tell your doctor if you have a history of kidney disease or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Hypersensitivity reaction. An allergic reaction to Relafen can occur. Symptoms of a hypersensitivity reaction include:
  • hives
  • rash
  • difficulty breathing or swallowing
  • itching
  • swelling
• Adverse skin reactions. Relafen can lead to dangerous skin reactions. Symptoms of a skin reaction include:
  • rash
  • red, itchy, or scaly skin
  • blisters
  • fever
• Pregnancy. Relafen should not be taken past the 30th week of pregnancy.

Relafen can cause dizziness. Do not drive or operate heavy machinery until you know how Relafen affects you.

Do not take Relafen if you:

• are allergic to Relafen 
• will have or have recently had coronary (heart) surgery

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Relafen, there are no specific foods that you must exclude from your diet when receiving Relafen.

Before taking Relafen tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of heart, liver, or kidney disease
• have a history of gastrointestinal (digestive) problems
• have hypertension, or high blood pressure
• have a history of asthma
• take ACE inhibitors such as lisinopril (Prinivil) and enalapril (Vasotec)
• take aspirin (Ecotrin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• take diuretics, or water pills, such as thiazides (hydrochlorothiazide) and furosemide (Lasix)
• are allergic to Relafen 
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Relafen falls into category C before the 30th week of pregnancy, and category D after the 30th week.

For Pregnancy Category C before the 30th week of pregnancy: Studies in animals have shown a harmful and undesired effect on the unborn baby, yet there are no adequate and well-controlled studies in pregnant women. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

For Pregnancy Category D after the thirtieth week of pregnancy: Relafen should be avoided during the third trimester of pregnancy. There is evidence of risk to the unborn baby based on studies in humans or adverse reaction data. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Relafen is excreted in human breast milk or if it will harm your nursing baby.

• Take Relafen exactly as prescribed.
• This medication comes in tablet form and is taken once or twice daily, with or without food.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Relafen at the same time.

Take Relafen exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended starting dose is 1000 mg taken as a single dose with or without food. Some patients may require 1500 mg to 2000 mg per day. Relafen tablets can be given in either a single or twice-daily dose. Dosages greater than 2000 mg per day have not been studied. 

If you take too much Relafen, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Relafen at room temperature.
• Keep this medication in a dry place.
• Keep this and all medicines out of the reach of children.

Cardiovascular Risk:

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Relafen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk:

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.