Flector (Page 5 of 5)

17.3 Gastrointestinal Effects

Flector Patch, like other NSAIDs, may cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, inform patients to be alert for the signs and symptoms of ulceration and bleeding, and to ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Instruct patients of the importance of this follow-up [see Warnings and Precautions (5.2)].

17.4 Adverse Skin Reactions

Flector Patch, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious systemic skin reactions may occur without warning, instruct patients to be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and to ask for medical advice when observing any indicative signs or symptoms [see Warnings and Precautions (5.8)]. Advise patients to stop Flector Patch immediately if they develop any type of generalized rash and contact their physicians as soon as possible.

Flector Patch can cause a localized skin reaction at the application site. Advise patients to contact their physicians as soon as possible if they develop any type of localized application site rash.

Instruct patients not to apply Flector Patch to open skin wounds or infections.

17.5 Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop therapy with Flector Patch and seek immediate medical therapy [see Warnings and Precautions (5.3)].

17.6 Weight gain and edema

Patients should promptly report to their physician signs or symptoms of unexplained weight gain or edema following treatment with Flector Patch [see Warnings and Precautions (5.5)].

17.7 Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, instruct patients to seek immediate emergency help. Anaphylaxis type reactions have been reported with diclofenac products, including Flector Patch [see Warnings and Precautions (5.7)].

17.8 Preexisting Asthma

Inform patients not to use Flector Patch if they have an aspirin-sensitive asthma. Flector Patch, like other NSAIDs, could cause severe and even fatal bronchospasm in these patients [see Warnings and Precautions (5.13)]. Instruct patients to discontinue use of Flector Patch and to immediately seek emergency help if they experience wheezing or shortness of breath.

17.9 Eye Exposure

Instruct patients to avoid contact of Flector Patch with the eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour [see Warnings and Precautions (5.15)].

17.10 Effects during pregnancy

Starting at 30 weeks gestation, instruct patients to avoid the use of Flector Patch and other NSAIDS, as premature closure of the ductus arteriosus in the fetus may occur [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)].

17.11 General Information on Use

  • Instruct patients and caregivers to wash their hands after applying, handling or removing the patch.
  • Inform patients that, if Flector Patch begins to peel off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches 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).
  • Instruct patients not to wear Flector Patch during bathing or showering. Bathing should take place in between scheduled patch removal and application [see Dosage and Administration (2)].
  • Instruct patients to store Flector Patch and to discard used patches out of the reach of children and pets. If a child or pet accidentally ingests Flector Patch, instruct patients to seek medical help immediately [see Warnings and Precautions (5.14)].
  • Inform patients that Flector Patch should be used only on intact skin.
Distributed by: King Pharmaceuticals Inc501 Fifth StreetBristol, TN 37620 USATelephone: 1-888-840-8884 www.FlectorPatch.com

Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland
Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan
FI/165 1086
Ed. VII/08.11Version August, 2011

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 deathThe 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 past 30 weeks of pregnancy..
  • if you are breastfeeding, talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

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

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over–the–counter). Talk to your healthcare provider before using over–the–counter NSAIDs for more than 10 days.
NSAID medicines that need a prescription
Generic Name Tradename
Celecoxib Celebrex
Diclofenac Flector, Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbirofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by: King Pharmaceuticals Inc.501 Fifth StreetBristol, TN 37620 USATelephone: 1-888-840-8884 www.FlectorPatch.com

Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland
Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan
FI/165 1086
Ed. VII/08.11
Version August, 2011

PRINCIPAL DISPLAY PANEL — 30 Patch Carton

NDC 60793-411-30

FLECTOR® PATCH
(diclofenac epolamine topical patch)
1.3%

Rx Only

30 PATCHES (10 CM X 14 CM EACH)

Dispense with enclosed Medication Guide

Change patch once every 12 hours.

Fold used patches so that the adhesive side sticks to itself and safely discard used patches where children and pets cannot get to them.

IBSA

King Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 30 Patch Carton
(click image for full-size original)
FLECTOR diclofenac epolamine patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-411
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diclofenac Epolamine (Diclofenac) Diclofenac Epolamine 180 mg
Inactive Ingredients
Ingredient Name Strength
Sorbitol
Butylene Glycol
Dihydroxyaluminum Aminoacetate
Edetate Disodium
Tartaric Acid
Titanium Dioxide
Gelatin
Kaolin
Methylparaben
Polysorbate 80
Povidones
Water
Propylene Glycol
Propylparaben
Carboxymethylcellulose Sodium
Product Characteristics
Color WHITE Score
Shape RECTANGLE Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60793-411-02 2 PATCH in 1 POUCH None
2 NDC:60793-411-05 5 PATCH in 1 POUCH None
3 NDC:60793-411-30 6 POUCH in 1 CARTON contains a POUCH (60793-411-05)
3 NDC:60793-411-05 5 PATCH in 1 POUCH This package is contained within the CARTON (60793-411-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021234 01/14/2008
Labeler — King Pharmaceuticals, Inc. (809587413)
Registrant — IBSA Institut Biochimique SA (480278696)

Revised: 12/2012 King Pharmaceuticals, Inc.

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