Flector Patch (diclofenac epolamine)

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• Flector Patch is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

• NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Flector Patch may cause serious side effects including:

• runny or stuffy nose,
• hives,
• wheezing,
• difficult breathing,
• swelling in your face or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• chest pain spreading to your jaw or shoulder,
• sudden numbness or weakness on one side of the body,
• slurred speech,
• leg swelling,
• shortness of breath,
• skin rash,
• swelling,
• rapid weight gain,
• bloody or tarry stools,
• coughing up blood,
• vomit that looks like coffee grounds,
• nausea,
• upper stomach pain,
• itching,
• tired feeling,
• flu-like symptoms,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• little or no urination,
• swelling in your feet or ankles,
• tiredness,
• pale skin,
• unusual tiredness, and
• cold hands and feet

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Flector Patch include:

• heartburn,
• gas,
• stomach pain,
• nausea,
• vomiting,
• diarrhea,
• constipation, and
• mild itching, burning, redness, or other skin irritation where the patch was worn

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Flector Patch. For more information, ask your doctor or pharmacist.

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

General Dosing Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

The recommended dose of Flector is one (1) topical system to the most painful area twice a day both in adults and pediatric patients 6 years of age and older.

Special Precautions

• Inform patients that if Flector begins to peel-off, the edges of the topical system may be taped down. If problems with adhesion persist, patients may overlay the topical system with a mesh netting sleeve, where appropriate (e.g. to secure topical systems applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad Hold Tite, Surgilast Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable).
• Do not apply Flector to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds.
• Do not wear a Flector when bathing or showering.
• Wash your hands after applying, handling or removing the topical system.
• Avoid eye contact.
• Do not use combination therapy with Flector and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

See Table 2 for clinically significant drug interactions with diclofenac.

Table 2: Clinically Significant Drug Interactions with Diclofenac

• Published literature reports that use of NSAIDs, including Flector Patch, after 30 weeks' gestation increases the risk of premature closure of the fetal ductus arteriosus.
• Data from observational studies regarding potential embryofetal risks of NSAID use, including diclofenac, in women in the first or second trimester of pregnancy are inconclusive.
• Avoid use of NSAIDs, including Flector Patch, in pregnant women starting at 30 weeks of gestation (third trimester).
• Data from published literature reports with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk.
• There are no data on the effects on the breastfed infant, or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Flector Patch and any potential adverse effects on the breastfed infant from the Flector Patch or from the underlying maternal condition.