Edifenac tablets

Edifenac

  • Active Ingredient: Diclofenac
  • 100 mg
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What is Edifenac?

The active ingredient of Edifenac brand is diclofenac. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation. The inactive ingredients in Diclofenac sodium delayed-release tablets include: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

Used for

Edifenac is used to treat diseases such as: Ankylosing Spondylitis, Aseptic Necrosis, Back Pain, Frozen Shoulder, Migraine, Muscle Pain, Osteoarthritis, Pain, Period Pain, Rheumatoid Arthritis, Sciatica, Spondyloarthritis.

Side Effect

Possible side effects of Edifenac include: loss of consciousness; blurred vision; unusual tiredness or weakness; troubled breathing with exertion; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; diarrhea; swelling of the face, ankles, or hands; hostility.

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5. Taking Edifenac with other painkillers

It's safe to take Edifenac with paracetamol or codeine.

Do not take Edifenac with similar painkillers - like aspirin, ibuprofen or naproxen - without talking to a doctor.

Edifenac, aspirin, ibuprofen and naproxen all belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Taking Edifenac together with other NSAIDs may increase your chances of getting side effects like a stomach ache.

NSAIDs are also used in medicines you can buy from pharmacies - for example, cough and cold remedies. Before taking any other medicines, check the label to see if they contain aspirin, ibuprofen or other NSAIDs.

Like all medicines, Edifenac can cause side effects, although not everyone gets them.

Serious Skin Reactions

NSAIDs, including Edifenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions and to discontinue the use of VOLTAREN at the first appearance of skin rash or any other sign of hypersensitivity. VOLTAREN is contraindicated in patients with previous serious skin reactions to NSAIDs (see CONTRAINDICATIONS).

What to do about:

  • headaches - make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend an alternative painkiller. Headaches should usually go away after the first week of taking Edifenac. Talk to your doctor if they last longer than a week or are severe.
  • feeling dizzy or vertigo - if you feel dizzy or unsteady, stop what you're doing and sit or lie down until you feel better. Do not drive or use tools or machinery if you're feeling dizzy or lightheaded. As your body gets used to Edifenac, these side effects should wear off.
  • stomach ache, wind or loss of appetite - try not to eat foods that cause wind (like peas, lentils, beans and onions). Eat smaller meals, eat and drink slowly, and exercise regularly.
  • feeling sick (nausea) - take Edifenac with or after a meal or snack. It may also help if you avoid rich or spicy food.
  • being sick (vomiting) or diarrhoea - drink plenty of water or other fluids. If you're being sick, try small frequent sips of water. Speak to a pharmacist if you have signs of dehydration, such as peeing less than usual or having dark, strong-smelling pee. Do not take any other medicines without speaking to a pharmacist or doctor.
  • a mild rash and dry or irritated, itchy or inflamed skin - an emollient cream or ointment can be used to moisturise, soothe and hydrate the affected area. If it does not get better within a week or you're worried, speak to a pharmacist or doctor.
  • skin being more sensitive to sunlight - stay out of bright sun and use a high factor sun cream (SPF 15 or above), even on cloudy days. Do not use a sunlamp or sunbeds.

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as Edifenac, increases the risk of serious gastrointestinal (GI) events (see WARNINGS; Gastrointestinal Bleeding, Ulceration, And Perforation).

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In patients taking VOLTAREN ® (Edifenac sodium enteric-coated tablets), or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.

Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.

Additional adverse experiences reported occasionally include:

Body as a Whole: fever, infection, sepsis

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo

Special Senses: blurred vision

Other adverse reactions, which occur rarely are:

Body as a Whole: anaphylactic reactions, appetite changes, death

Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis

Nervous System: convulsions, coma, hallucinations, meningitis

Respiratory System: respiratory depression, pneumonia

Special Senses: conjunctivitis, hearing impairment

Mechanism Of Action

Edifenac has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of VOLTAREN, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Edifenac is a potent inhibitor of prostaglandin synthesis in vitro. Edifenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because Edifenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Q: I take Edifenac 50 mg, 1 daily, for arthritis pain and it eliminates the pain but causes severe constipation. I have tried Celebrex and Aleve, but they do not relieve the pain. Do you have any suggestions?

A: Your question regards problems with constipation while using Edifenac (Cataflam). //www.everydayhealth.com/drugs/Edifenac. constipation is one of the listed possible side effects for Edifenac. Edifenac is an NSAID (nonsteroidal anti-inflammatory drug, and there are many medications available in this class of medications. Sometimes one medication will work better than a different medication or have fewer side effects. Please talk to your health care provider regarding trying a different medication to treat your arthritis pain. You can also find helpful information on arthritis at //www.everydayhealth.com/arthritis/arthritis-treatment-know-your-options.aspx As always, talk to your health care provider regarding your concerns with your medications. Jen Marsico, RPh

Serious Side Effects

Stop taking Edifenac and get immediate medical attention if you experience any of the following:

  • Nosebleeds
  • Liver damage or inflammation of the liver (watch for yellowing or graying of the skin or eyes, swelling of the abdomen or lower extremities)
  • Low blood pressure (one sign of low blood pressure is dizziness when getting up to stand)
  • Blood disorders, such as low platelet count, decreased hemoglobin, and decreased bone marrow activity
  • Congestive heart failure (watch for swelling in your lower limbs, shortness of breath, trouble walking normal distances’, extra tiredness)
  • Bruising
  • Severe and potentially life-threatening skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (tell your doctor about any skin abnormalities; get emergency medical help right away if you have any dramatic or severe skin reactions)

Edifenac Interactions

Edifenac interacts with many different drugs. It’s always important to tell your doctor and pharmacist about all of the treatments you are taking.

This includes not only all of your prescription and over-the-counter medicines, but also products that may not seem like medication, such as: vitamins and other dietary supplements (nutritional shakes, protein powders, etc.), and herbals along with any legal or illegal recreational drugs.

You should not take Edifenac if you are taking the following drugs:

  • Apixaban (Eliquis)
  • Elvitegravir/cobicistat/emtricitabine/tenofovir (Stirbild)
  • Ketorolac
  • Ketorolac nasal spray (Sprix)
  • Methotrexate (Trexall)
  • Premetrexed (Alimta)
  • Pirfinidone (Esbriet)

If you are taking any of the following, talk to your doctor about drug options other than Edifenac:

  • Blood thinners, such as fondaparinux (Arixtra), dabigatran (Pradaxa) warfarin (Jantoven, Coumadin) or heparin
  • Antidepressants, such as citalopram (Celexa), paroxetine (Paxil), or escitalopram (Lexapro)
  • Water pills, such as hydrochlorothiazide (Esidrix, Microzide), chorthalidone (Thalitone), or chlorothiazide (Diuril)
  • Beta blockers, such as acebutolol (Sectral), bisoprolol ( Zebeta), atenolol (Tenormin), esmolol (Brevibloc), or carvedilol (Coreg)
  • Other NSAIDS, including: celecoxib (Celebrex), naproxen (Aleve, Naprosyn), meloxicam (Mobic), nabumetone (Relafen), or etodolac (Lodine)
  • Diabetes medications called sulfonylureas, such as glimepiride (Amaryl), glyburide (DiaBeta, Micronase, Glynase), and glipizide (Glucotrol)


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