Flector (Diclofenac Epolamine Topical) - Indications and Dosage

INDICATIONS AND USAGE

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Flector® Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch.  Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

The recommended dose of Flector® Patch is one (1) patch to the most painful area twice a day.

Flector® patch should not be applied to damaged or non-intact skin.

Flector® patch should not be worn when bathing or showering.

HANDLING AND DISPOSAL

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

HOW SUPPLIED

The Flector® Patch is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (NDC 63857-111-33).  Each individual patch is embossed with “Diclofenac Epolamine Patch 1.3%”.

• Each patch contains 180 mg of diclofenac epolamine in an aqueous base (13 mg of active per gram of adhesive or 1.3%).

• The product is intended for topical use only

• Keep out of reach of children and pets.

• The ENVELOPES SHOULD BE SEALED AT ALL TIMES WHEN NOT IN USE.

• Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF).  [See USP Controlled Room Temperature].

Manufacturer:  Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695, Japan
Distributor: Alpharma Pharmaceuticals LLC, One New England Avenue, Piscataway, NJ 08854 (Telephone: 1-877-452-3426)

Version June 2008
8283
Ed II/06.08

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication 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