Diclofenac epolamine topical patch generic

Gastrointestinal disorders were reported for Diclofenac Epolamine Topical Patch, 1. For more information, please see accompanying Full Prescribing Information , including the Boxed Warning. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs.

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All medications may cause side effects, though some people may not encounter side effects or may only encounter mild side effects. Call your doctor or get medical help if any of the following side effects or any other side effects bother you or do not go away:. If you believe you may have overdosed, call your poison control center or seek emergency in-person medical care right away. Be prepared to share what was taken, when, and in what amount.

If your health condition or symptoms fail to improve or worsen, please call your doctor. Keep a list of all your healthcare treatments prescription and OTC medications, vitamins, supplements, alternative therapy regimens and provide this list to your doctor.

Talk with your healthcare provider before starting any new treatment. If you have a medical emergency at any point, please immediately contact or seek emergency in-person medical care.

Limited Time: Day Free Trial. Login Get Started. Diclofenac Epolamine Patch 1. Cautions Tell all of your healthcare providers, including your doctors, nurses, dentists, and pharmacists, that you take this drug. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.

If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur e. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible.

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. If eye contact occurs, immediately wash out the eye with water or saline. Consult a physician if irritation persists for more than an hour. Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding.

If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur e. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.

This response has been attributed to inhibition of renal prostaglandin synthesis. NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate.

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. Long-term studies in animals have not been performed to evaluate the carcinogenic potential of either diclofenac epolamine or Flector Patch. Diclofenac epolamine is not mutagenic in Salmonella Typhimurium strains, nor does it induce an increase in metabolic aberrations in cultured human lymphocytes, or the frequency of micronucleated cells in the bone marrow micronucleus test performed in rats.

There are no adequate and well-controlled studies in pregnant women. Flector Patch should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system closure of ductus arteriosus , use during pregnancy particularly late pregnancy should be avoided.

The number of live born and total born were also reduced as was F1 postnatal survival, but the physical and behavioral development of surviving F1 pups in all groups was the same as the deionized water control, nor was reproductive performance adversely affected despite a slight treatment-related reduction in body weight. In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred.

It is not known whether this drug is excreted in human milk. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Application site reactions leading to dropout included pruritus, dermatitis, and burning. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation. There were no serious adverse events. Should systemic side effects occur due to incorrect use or accidental overdose of this product, the general measures recommended for intoxication with non-steroidal anti-inflammatory drugs should be taken.

Patients and caregivers should wash their hands after applying, handling or removing the patch.