FLECTOR- diclofenac epolamine patch
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Patient Information leaflet
(PIL)
19-01-2012
Summary of Product characteristics
(SPC)
19-01-2012
Active ingredient:
Diclofenac Epolamine (UNII: X5F8EKL9ZG) (Diclofenac - UNII:144O8QL0L1)
Available from:
H.J. Harkins Company, Inc.
INN (International Name):
Diclofenac Epolamine
Composition:
Diclofenac Epolamine 180 mg
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
- Flector Patch is contraindicated in patients with a known hypersensitivity to diclofenac. - Flector Patch is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.13)]. - Flector Patch is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)]. - Flector Patch is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds. Teratogenic Effects Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Starting at 30 weeks gestation, avoid use of Flector Patch, and other NSAIDS, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur, Flector Pat
Product summary:
The Flector Patch is supplied in resealable envelopes, each containing 5 patches (10 cm × 14 cm), with 6 envelopes per box (NDC 60793-411-30). Each individual patch is embossed with "FLECTOR PATCH
Authorization status:
New Drug Application
Patient Information leaflet
H.J. Harkins Company, Inc.
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Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft" (CABG).
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as:
•
different types of arthritis
•
menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant, NSAID medicines should not be used
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Summary of Product characteristics
FLECTOR - DICLOFENAC EPOLAMINE PATCH
H.J. HARKINS COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLECTOR® PATCH 1.3% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLECTOR PATCH.
FLECTOR PATCH® (DICLOFENAC EPOLAMINE PATCH) 1.3%
INITIAL U.S. APPROVAL: 1988
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CARDIOVASCULAR RISK
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (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. (5.1)
FLECTOR PATCH IS CONTRAINDICATED IN THE PERI-OPERATIVE SETTING OF
CORONARY ARTERY BYPASS GRAFT (CABG)
SURGERY. (4)
GASTROINTESTINAL RISK
NSAIDS, INCLUDING DICLOFENAC, 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. (5.2)
RECENT MAJOR CHANGES
None
INDICATIONS AND USAGE
Flector Patch contains diclofenac epolamine, a nonsteroidal
anti-inflammatory drug (NSAID) and is indicated for the
topical treatment of acute pain due to minor strains, sprains, and
contusions. (1)
DOSAGE AND ADMINISTRATION
The recommended dose of Flector Patch is one (1) patch to the most
painful area twice a day. (2)
Flector Patch should not be applied to damaged or non-intact skin. (2)
DOSAGE FORMS AND STRENGTHS
Patch: 180 mg of diclofenac epolamine. Each individual patch is
embossed. (3)
CONTRAINDICATIONS
Known hypersensitivity to diclofenac. (4)
History of asthma, urticaria, or allergic-type reactions after taking
aspirin or other NSAIDs. (4)
Use in the peri-operative period of coro
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