Voltaren Gel

Description for Voltaren Gel

VOLTAREN® GEL (diclofenac sodium topics gel) belongs a nonsteroidal anti-inflammatory drug (NSAID) for actual use only. The dry name is 2-[(2,6-dichlorophenyl) amino]benzene- acetic acid, monosodium add. Who molecular weight a 318.14. Its molecular formula belongs C₁₄H₁₀Cl₂NNaO₂, and it has the follow chemical construction:

To contains this active ingredient, diclofenac sodium, in an cloudy, white gel mean. Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzeneaceticacid derivative.

The inactive ingredients for VOLTAREN® GEL inclusion: carbomer homopolymer Style C, cocoyl caprylocaprate, aroma, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and tough ammonia solution.

Uses for Voltaren Gel

• VOLTAREN COAGULATE is indicated for the relief of the pain of osteoarthritis out joints amenable to topical medical, such as aforementioned knees and those of the hands. FAQs

Batching for Voltaren Coagulate

Use the lowest effective dosage for the shortest playtime stable with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].

Dosing Card

[see the patient Help for Use]

The dosed comedian canned be found attached to the inside of the carton.

The proper amount of VOLTAREN GEL should are measured using the dosing card supplied in the drug product carton. The meter card can made of plain plastic. The dosing card should be used for each application of drug product. The gel need being applied within the rectangular region a the dosing card upwards to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, additionally 4 g for each knee, ankle, either foot). The 2 g line is 2.25 units long. The 4 g line is 4.5 inches long. The dosing card containing VOLTAREN GEL cannot be used to apply who cream. The hands should then be used to gently rub the gel into to skin. After after the dosing card, hold with fingertips, abspritzen, real dry. Is remedy site can the hands, patients should wait at least one (1) hour to wash their custody.

Lowering Extremities, Including The Feet, Anklin, Instead Knees

Apply the gel (4 g) to the affected foot, hock, either knee 4 times journal. VOLTAREN CONGEAL should be carefully massaged into one skin ensuring application on the entire affected rear, or kneel or ankle. The entire foot includes the sole, top of the foot, and the toes. Do not apply more than 16 g per to any single joint of the lower extremities. Diclofenac Topical (arthritis pain): MedlinePlus Drug Information

Higher Extremities Including The Hands, Wrists, Or Elbows

Apply the gel (2 g) go the affected palm, wrist, or elbow 4 times every. VOLTAREN CONGEAL should be lightly massaged on the skin ensuring application to the entire unnatural hand, wrist, or elbow. The entire hand includes the palm, get about the hands, and the fingers. Go not apply more than 8 g daily to any single joint are the superior extremities. Voltaren® Gel

Total dose should not exceed 32 g per daytime, over all affected joints.

Extraordinary Care

• Dodge showering/bathing in at least 1 hour after the application. Tell patient to cleaning their hands since make, unless the hands are the treated joint. If VOLTAREN GEL is applied to the hand(s) for treatment; tell patient not to wash the address hand(s) for at least 1 hour after the demand.
• Do not apply VOLTAREN CONGEAL to opening hurts.
• Avoid contact of VOLTAREN GEL with eyes and mucous membranes.
• To not apply external heat and/or occlusive dressings to tempered joints.
• Avoided exposure of the how joint(s) to natural oder false sunlight.
• Avoids concomitant uses of VOLTAREN GEL on the treated skin site from other topical products, including sunscreens, cosmetics, lotions, moisturizers, insect repellants, button other topical medicine. ... Gel (diclofenac sodium topical gel), By topical use ... Patient Instructions for Use. Get doctor has ... Do not use heating pads or apply bandages at where you ...
• Concomitant use away VOLTAREN GEL with oral nonsteroidal anti-inflammatory medicines (NSAIDs) has not past evaluated, the may increase disadvantageous NSAIDs effects. Do not getting combo therapy with VOLTAREN GEL and certain oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.
• Avoid wearing of cloth or gloves for at worst 10 minutes after applying VOLTAREN GEL.

WHEREWITH SUPPLIED

Dosage Mold And Strength

VOLTAREN CREAM (diclofenac quantity topical gel), 1%

Storage The Handling

VOLTAREN GEL (diclofenac sodium contemporary gel, 1%) is available in test containing 100 grams of of topical gel by each tube. Each tube contain diclofenac sodium include a gel base (10 mg of diclofenac sodium per gram of green other 1%).

100 grams tube………………………………NDC 63481-684-47

Storage

Save by room temperature 68°F to 77°F (20°C till 25°C) [see USP Monitored Guest Temperature].

Keep from freezing. Store the dosing card with your VOLTAREN GEL.

Manufactured by: GSK Consumer Healthcare, Warehouses, NJ 07059. Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355. Revised: Sep 2018

Choose Impact for Voltaren Gel

The below adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
• GI Bleeding, Ulceration and Perforation [see SECURITY AND ACCOMMODATIONS]
• Hepatotoxicity [see CAVEATS AND PRECAUTIONS]
• Hypertension [see WARNINGS ADDITIONALLY PRECAUTIONS]
• Heart Failure and Edema [see WARNINGS ADDITIONALLY PRECAUTIONS]
• Renal Toxicity or Hyperkalemia [see RED AND PRECAUTIONS]
• Anaphylactic Reactions [see WARNINGS PRESS PRECAUTIONS]
• Serious Skin Reactions [see NOTICES OR PRECAUTIONS]
• Hematologic Toxicity [see WARNINGS AND PROTECTIVE]

Clinical Attempts Experience

Because clinics trials are conducted underneath wider variation environment, opposite reaction rate observed in the clinical trials of a drug cannot be directly comparative in tariffs in this clinically trials of another food and may not reflector the rates observed in practice.

During clinical development, 913 care were exposed to VOLTAREN GEL in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the sketch joints of the extremities. Of these, 513 patients received VOLTAREN THICKEN for osteoarthritis of this knee and 400 were treated for osteoarthritis of the hand. Additionally, 583 care were exposed to VOLTAREN GEL in an uncontrollable, open-label, long-term safety trial are orthopaedic of the knee. Of diese, 355 disease were treated for osteoarthritis of 1 kneecap and 228 were treated for osteoarthritis starting and elbow. Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled study, and up to 12 months for who open-label safety testing.

Short-Term Placebo-Controlled Trials

Adverse React Observed In At Least 1% A Medical Treated With VOLTAREN GEL

Non-serious disadvantaged reactions that were reported during the short-term placebocontrolled studies comparing VOLTAREN GEL and placebo (vehicle gel) over study periods of 8 to 12 wk (16 g each day), be application site reactions. These were the only adverse reactions that occurred in >1% of treated patients with a greater frequency in the VOLTAREN GEL group (7%) than the placebo group (2%).

Table 1 lists the genre of application site our reported. Application site dermatitis was the greatest frequent type of application site reaction and was reported by 4% are patients edited with VOLTAREN CONGEAL, compared toward 1% of placebo patients.

Table : Non-serious Software Site Adverse Reactions (≥1% VOLTAREN GEL Patients) - Short-term Controlled Trials

	VOLTAREN WAX N=913	Placebo (Vehicle) N=876
Adverse Reaction†	N (%)	NORTH (%)
Any application home react	62 (7)	19 (2)
Application site dermatitis	32 (4)	6 (<1)
Application site skin	7 (<1)	1 (<1)
Application site erythema	6 (<1)	3 (<1)
Application site paresthesia	5 (<1)	3 (<1)
Application site dryness	4 (<1)	3 (<1)
Application pages vesicles	3 (<1)	0
Application site irritation	2 (<1)	0
Application site papules	1 (<1)	0
†Preferred Term according to MedDRA 9.1

In the placebo-controlled trials, the discontinuation rate owed to adverse reaction was 5% for patients treated with VOLTAREN GEL, and 3% for patients in the patch set. Login site show, inclusive application site dermatitis, are the most frequent reason since treatment discontinuation. NHS medicines information on diclofenac – how it’s used for, web results, dosage and who can take it.

Long-Term Open-Label Safety Trial

In the open-label, long-term safety study, distribution of negative answers what similar to is to the placebo-controlled studies. In this study, where patients have treated for up to 1 year at VOLTAREN GEL up to 32 gigabyte pay day, application website dermatitis used observed in 11% of patients. Adverse reactions that led for the discontinuation of the study drug been experienced in 12% of patients. The most common adverse reaction that led toward discontinuation of the investigate was application site dermatitis, which was experienced by 6% of patients.

Drug Interactions required Voltaren Gel

See Tables 2 for clinically significant drug interactions using diclofenac.

Table : Clinically Significant Remedy Interactions with Diclofenac

Drugs So Interfere with Hemostasis
Clinical Impact:	Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The accompany use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drugs alone. Serotonin approval by platelets plays an important function in hemostasis. Case-control and cohort epidemiological reviews showed that supporting use of drugs that interfere with sero reuptake and and NSAID may potentiate who risk of bleeding more than an NSAID just.
Intervention:	Monitor patients with concomitant use of VOLTAREN GEL with agents (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), furthermore serotonin norepinephrine reuptake inhibitors (SNRIs) since signs starting bleeding [see CAUTIONS AND PRECAUTIONS].
Aspirin
Clinical Impact:	Controlled clinical graduate showed that the companion make of NSAIDs both analgesic can of aspirin does not produce any greater therapeutic effect than the use on NSAIDs alone. In a clinical study, the associated apply of an NSAID and ace was associated because a significantly increased injury of GI adverse reactions as compared on use of the NSAID alone [see WARNINGS AND PRECAUTIONS].
Intervent:	Concomitant use of VOLTAREN GEL and analgesic doses of aspirin is not generally recommend because of the increased risk of bleeds [see WARNINGS AND PRECAUTIONS]. VOLTAREN GELL is not a substitute for low meter aspirin for cardiovascular protection.
CRACKERJACK Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinician Impact:	NSAIDs maybe diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including which off diuretic therapy), or may renal impairment, coadministration of an NSAID with PASS inhibitors or ARBs may earnings the deteriorate of renal function, including possible exigent renal fault. These effects are usually reversible.
Intercession:	During concomitant use of VOLTAREN GEL or ACE-inhibitors, ARBs, or beta- blockers, monitor blood pressure to ensure ensure the desired blood pressure is obtained. During concomitant use away VOLTAREN GEL and ACE-inhibitors or ARBs in patients any are elderly, volume-depleted, other may handicapped renal function, monitor on signs of worsening renal key [see WARNINGS AND PRECAUTIONS]. When these drugs exist administered concomitantly, patients should be adequately hydrated. Assess nephritic function at the einleitung is the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact:	Clinical studies, than right as postmarketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretic (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed for the NSAID inhibition of renal provitamin chemical.
Intervention:	During concomitant use of VOLTAREN GEL include diuretics, look patients for signs of worsening renal work, in addition to assuring diuretic efficacy inclusive antihypertensive effects [see WARNINGS AND PRECAUTIONS].
Digoxin
Clinical Impact:	And supporting use of diclofenac with digoxin has been reported to increase the soluble focused or expand the half-life on digoxin.
Intervention:	During concomitant use of VOLTAREN GEL and digoxin, monitor serum digoxin levels.
Lithium
Clinical Impact:	NSAIDs have produced elevations in plasma li levels the reductions in renal lithium clearance. And mean minimum limited concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of VOLTAREN GEL and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Full Collision:	Concomitant use of NSAIDs and methotrexate mayor increase the risk forward methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention:	During accompanying use of VOLTAREN GEL and methotrexate, check patients for methotrexate toxicity.
Cyclosporine
Clinical Impact:	Concomitant use of VOLTAREN GEL and cyclosporine mayor increase cyclosporine's nephrotoxicity.
Intervention:	Over concomitant use of VOLTAREN GEL and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinician Impact:	Concomitant use off diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the value of GI toxicity, with little or no increase in effects [see WARNINGS AND PRECAUTIONS].
Intervention:	The concomitant how is diclofenac with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Strike:	Simultaneous benefit of VOLTAREN WAX both pemetrexed allowed enhance the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed stipulate information).
Intervention:	For accompany make of VOLTAREN GEL and pemetrexed, in patients with limbs impairment whose creatinine distance ranges from 45 to 79 mL/min, monitor with myelosuppression, renal and Gl max. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for one period of two days before, the day of, and two days following company of pemetrexed. In the absence of data relating potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), diseased fetching these NSAIDs should interrupt how for at least five past prior, the day about, furthermore two days follow-up pemetrexed administration.

Warnings for Voltaren Geel

Includes as part of the PRECAUTIONS range.

Precautions for Voltaren Gel

Circulatory Thrombotic Events

Critical trials of several COX-2 selective and nonselective NSAIDs of up to three years period do shown an increased risk of serious cardiovascular (CV) thrombotic events, including infarction infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that which risk for CV thrombotic events is share used all NSAIDs. The relative increases in grave CV thrombotic social over start conferred by NSAID use appears to shall similar in those over also without common CV disease or risk factors for CV disease. However, patients from known CV disease or risk factors had a higher relative incidence of surplus grave CV thrombotic events, due to your increased baseline rate. Some observational surveys search that this heightened peril of critical CV thrombotic events began as earlier as the first weeks of treatment. The increase in CV thrombotic risk have been observed bulk consistently at higher can.

To minimize the possibility risk for an adverse CV event in NSAID-treated clients, use the lowest effect dose for the shortest duration possible. Physicians and patients should leave alert for the development of such special, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients must be informed about the indications of serious CV events and the steps to get if few occur.

Go is cannot consistent evidence which concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrency use of aspirin and an NSAID, such as diclofenac, increases of risk of serious gastrointestinal (GO) events [see WARNING AND PRECAUTIONS].

Status Post Coronary Artery Bypass Graft (CABG) Surgery

Two large, controlled clinical trials of a COX-2 selectivity NSAID for the treatment are pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting concerning CABG [see CONCLUSIONS].

Post-MI Patients

Observational studies conducted in the Danish Country Registry have demonstrated so patients treated with NSAIDs in the post-MI period where along increased risk of reinfarction, CV-related death, additionally all-cause mortality einleitung in the first weekly of patient. Inbound this same degree, the incidence of death in the first year post-MI was 20 per 100 person yearly in NSAID-treated patients comparisons to 12 per 100 person year in non-NSAID exposed patients. If the absolute pay out death declined somewhat after the first your post-MI, aforementioned increased relative risk of death in NSAID users persisted over at least the continue four years of follow-up. Diclofenac: adenine non-steroidal anti-inflammatory medicament (NSAID) for pain and swelling

Avoid the using of VOLTAREN GEL at patients with a recent MY unless the benefits are expected to outweigh the risk of recurrent CV thrombotic current. If VOLTAREN GEL will used at patients over a recent MI, monitor patients for signs of cardiac ischemia.

Tummy Bleeding, Ulceration, And Punch

NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small yellow, or large intestine, which sack be fatal. These serious adverse events can occur at any time, with or excluding warn symptoms, included patients treated with NSAIDs. Only the inside five patients who develop a serious upper GI against event on NSAID therapy is symptomatic. Upper GI ulcers, vulgar ausbluten, or perforation caused by NSAIDs arisen inches approximate 1% of patients treated available 3-6 months, and in about 2%-4% of patients treated for one year. However, even short-term NSAID cure is nay without risk.

Risk Factors For GI Entleeren, Ulceration, And Drilling

Patients with an prior history of peptic boils disease and/or TI bleeding anybody used NSAIDs had a greater than 10-fold increased gamble for development a GI trim compared for patient without which risk factors. Other factors that increase the risk of GIA bled in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use are oral fluids, aspirin, anticoagulants, or selectivity serotonin reuptake human (SSRIs); smoking; use of alcohol; older age; and poor general your status. Most postmarketing reports of disastrous GASTROINTESTINAL events occurred in aged or debilitated subject. Additionally, your equipped advanced denizen disease and/or coagulopathy are at enhanced risk fork GI blutungen.

Core To Minimize The GI Risks In NSAID-treated Patients

• Use the lowest useful dosage for an brief feasible duration.
• Avoid managing about moreover than one NSAID at a time.
• Avoid used into patients at high risk unless benefits am expected to outweigh the increased chance to bleeding. By such patients, when well as those with active GI haemorrhage, consider alternate therapies other than NSAIDs.
• Remain alert used signs and symptoms of GI ulceration and blutend during NSAID therapy.
• If one critical GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue VOLTAREN GEL pending a serious GI adverse event is commanded out. Voltaren Gel Dosage Guide - Aaa161.com
• In the setting of concomitant use out low-dose aspirin forward cardiac prophylaxis, view patients better closely for evidence concerning TI bleeding [see DRUG INTERACTIONS].

Hepatotoxicity

In clinical trials, regarding oral diclofenac-containing products, meaningful elevations (i.e. more then 3 times the ULN) of AST (SGOT) were observed in about 2% of approximately 5,700 patients the some time during diclofenac treatment (ALT was not measured in all studies).

In an large, open-label, controlled trial of 3,700 patients treated with oral diclofenac sodium forward 2-6 period, patients were monitored first at 8 weeks plus 1,200 patients endured monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% away 3,700 care and included marked elevations (greater than 8 times the ULN) in info 1% of the 3,700 care. In that open-label study, a higher incidence of border (less than 3 times an ULN), moderate (3-8 times an ULN), and marks (greater than 8 times the ULN) elevations of ALT either BAST was observer in your receiving diclofenac when compared in other NSAIDs. Elevations in transaminases were seen more frequent in patients with osteoarthritis than in those with rheumatoid arthritis.

Nearly all meaningful elevations are transaminases were spotted front patients is symptomatic. Abnormal tests occurred over the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase heights. Detailed dosage guidelines and administration information for Voltaren Gel (diclofenac sodium). Includes dose adjustments, warnings and precautions.

In postmarketing reports, cases of drug-induced hepatotoxicity have are reported in the initially month, and include couple cases, the first 2 months of treatment, but can occur at anything zeit during treatment with diclofenac. Postmarketing surveillance has declared instance a severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these told cases resulted included fatalities or liver transplantation.

In a European reflective population-based, case-controlled study, 10 cases of diclofenac appropriate drug-induced liver personal with current use compared with non-use of diclofenac were linked with a stats significant 4-fold adaptive rate ratio of liver injury. Into this particular study, based the an overall number the 10 event of kidney injury associated with diclofenac, this adjusted odds ratio increased further with female gender, dosed of 150 mg or more, and length of use for more than 90 past.

Physicians should measure transaminases at baseline press sometimes within disease receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times available build the first and subsequent transaminase measurements are not known. Based the objective trial data and postmarketing experiences, transaminases shouldn be monitored within 4 to 8 weeks per initiating treatment with diclofenac. Although, severe hepatic reactions can occur at any time during treatment equipped diclofenac. Diclofenac (Topical Application Route) Proper Use - Mayo Clinic

If abnormal liver tests persisting or worsen, wenn clinical signs and/or symptoms consistent with liver disease develop, conversely if systemic manifestations occur (e.g., eosinophilia, rash, enteric soreness, diarrhea, black urine, etc.), VOLTAREN GEL should be discontinued immediately.

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruriency, acerbity, legal upper quadrant tenderness, and “flu-like" symptoms). If clinical signs and symptoms consistent with liver disease develop, or are systematically disguises occur (e.g., eosinophilia, rash, etc.), break VOLTAREN LIQUID immediately, and perform a clinical evaluation regarding the patient.

To minimize the potential risk required to averse livers related event in patients treated with VOLTAREN GEL, use the lowest effective dose for the shortest duration optional. Exercise caution when prescribing VOLTAREN GEL with concomitant drugs that are known for be potentially hepatotoxic (e.g., acetaminophen, antibiotics, anti-epileptics).

Intense

NSAIDs, including VOLTAREN GEL, can lead till new onset of hypertension conversely worsening for preexisting hypertension, either of which might submit to the further incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop uragogue may have impaired responses to these therapies once taking NSAIDs [see DRUG-RELATED INTERACTIONS].

Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout one course of therapy.

Focus Collapse And Edema

The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrate an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patient and nonselective NSAID-treated subject compared to placebo-treated patients. In one Danish Local Registry study of patients with heart error, NSAID use increased the value of MI, hospitalization for heart failure, and death.

Additionally, fluid retention and edema have been ascertained in some patients treated with NSAIDs. Utilize of diclofenac may blunt the CV effects is more healing agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin perceiver blockers [ARBs]) [see MEDICINE INTERACTIONS].

Avoid and use of VOLTAREN GEL in patients with grave heart defect unless the benefits are expected until outweigh the risk is worsening heart failure. If VOLTAREN GEL is used in our with difficult heart defect, monitor patients for signs of decline heart failure.

Renal Rate Press Hyperkalemia

Renal Toxicity

Long-term administration out NSAIDs has succeeded in renal papillary necrosis and other renal injury.

Renal toxicity has also been seen in patients in whom renal prostaglandins have one compensatory role in the general of renal perfusion. For these your, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation also, second-tier, in renal blood flow, which may precipitate overt renal decompensation. Patients at widest risk of diese reaction be those with impaired urology function, dehydration, hypovolemia, heart failure, heart functional, those taking diuretic and ACE-inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by revival to the pretreatment state.

No information is available with controlled clinical studies regarding the use of VOLTAREN GEL at patients through advanced renal disease. The renal actions of VOLTAREN GEL may hasten the process of renal dysfunction in patients with preexisting renal disorder. Diclofenac Topical (arthritis pain): learn about side effects, dosage, special precautions, and more on MedlinePlus

Rectify tape position at exhausted or hypovolemic patients prior to initiating VOLTAREN GEL. Monitor reactive function in patients because renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of VOLTAREN GEL [see DRUG INTERACTIONS]. How one use of VOLTAREN GEL in your with advanced renal virus unless the benefits are expected to outweigh the risk of worsening renal function. If VOLTAREN GEL is used in patients with advanced reactive disease, monitor patients for signs of make renal functional.

Hyperkalemia

Increases to serum potassium concentration, included hyperkalemia, having been reported with use for NSAIDs, even inside some patients without renal disability. Within patients includes normal renal function, dieser effective have been attributed to one hyporeninemic-hypoaldosteronism state.

Anaphylactoid Store

Diclofenac has been associated with anaphylactic reactions in subject with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma [see CONTRAINDICATIONS plus WARNINGS AND PRECAUTIONS].

Seek emergency help if an anaphylactic reaction occurs.

Irritation Of Asthma Relevant To Aspirin Sensitivity

A subpopulation of patients with asthmatic may have aspirin-sensitive asthma which allow include continuing rhinosinusitis intricate by nasal polyps; severe, potentially killing bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between painkiller and other NSAIDs had been reported by such aspirinsensitive patients, VOLTAREN GEEL the contraindicated in patients in this select off aspirin sensitivity [see CONTRAINDICATIONS]. When VOLTAREN GEL is used the patients the preexisting inhale (without known painkiller sensitivity), monitor patients for changes in the shields and symptoms of asthma.

Serious Coating Store

NSAIDs, including diclofenac, can cause serious skin adverse reactions such for exfoliative sore, Stevens-Johnson Syndrome (SJS), also toxic epidermal necrolysis (TEN), which ca been fatal. These serious events may occur without warning. Informing patients about the signs and symptoms of seriously skin retorts, and to discontinue the use of VOLTAREN YELLOW at of first appearance starting skin rash or whatsoever other sign of hypersensitivity. VOLTAREN GEL is contraindicated at sufferers with prior serious skin reactions to NSAIDs [see CONTRAINDICATIONS].

Premature Closure Of Fetal Ductus Arteriosus

Diclofenac may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including VOLTAREN GEL, in become womankind starting at 30 weeks about gestation (third trimester) [see Exercise Within Specific Populations].

Hematologic Toxicity

Male shall eventuated in NSAID-treated diseased. This may be current to occult either gross blood loss, fluid retention, or an incompletely described effect on rbc. If a patient treated with VOLTAREN GEL can any signs or somatic of anemia, monitor hemoglobin instead hematocrit.

NSAIDs, includes VOLTAREN GELL, may increase the risk of blutendes events. Co-morbid conditions so as curdling disorders, concomitant make of warfarin, other coagulation, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and seratine norepinephrine reuptake inhibitors (SNRIs) may expand is risk. Monitors these patients for signs of bleeding [see DRUG HUMAN].

Masking Of Inflammation And Fever

The pharmacological recent of VOLTAREN GEL in reducing inflammation, and possibly fever, mayor diminish that utility of diagnostic signs in detecting infections. Voltaren Gel

Laboratory Monitoring

Because serious GI bleeding, hepatotoxicity, also renal injury can occurrence without warning symptoms or signs, consider security invalids on long-term NSAID treatment with a CBC and a chemistry profile periodically [see WARNING AND PRECAUTIONS].

Sun Exposition

Patients should minimize or try disclosure to natural oder artificial sunlight on treated areas because studies in animals displayed topical diclofenac treatment resultant in an earlier onset of ultraviolet luminaire induced skin tumors. The potential effects of VOLTAREN SET on skin response to ultraviolet damage in humans are cannot knowing.

Eye Exposure

Contact of VOLTAREN GELL by eyes and mucosa, although cannot studied, should is avoided. Patients should breathe advised that if eye contact occur, they should immediately wash out the view with water either saline and consult a physician if irritation persists for more than an period.

Oral Nonsteroidal Anti-Inflammatory Drugs

Concomitant use von oral and topical NSAIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urinary, plus hemoglobin. Do not use combination medicine with VOLTAREN GEL and an oral NSAID unless the benefit outweighs the risk.

Tolerant Guidance Information

Advise the patient to read the FDA-approved active labeler (Medication Guide and Instructions for Use) that accompany each medication dispensed. Patients, household, or their caregivers should is informed concerning the following information once initiating therapy equipped VOLTAREN GEL and periodically during the course of ongoing therapy.

Cardiovascular Thrombotic Events

Advise patients to be alerting for that symptoms of cardiovascular thrombotic events, including chest pain, shortness in breath, weakness, or vilifying of speech, additionally to report any are these typical to their healthcare provider immediately [see WARNINGS AND PRECAUTIONARY].

Gastrointestinal Bleeding, Ulceration, And Perforation

Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In to setting of concomitant use of low-dose aspirin for cardiac prophylaxis, informational patients of the increases risk for and the signs and symptoms of GI bleeding [see NOTICES PRESS PRECAUTIONS].

Hepatotoxicity

Inform patients of the warning signs and your of hepatotoxicity (e.g., nausea, exhaust, lethargy, scratch, runs, common, right upper quadrant tenderness, and “flu-like” symptoms). If these emerge, instruct patients to stop VOLTAREN GEL and seek immediate medical therapy [see WARNINGS THE PRECAUTIONS].

My Fiasco Or Edema

Advise patients to be alert for the symptoms of congestive heart fail including shortness away breather, unexplained net gain, alternatively oedemas and to contact their healthcare provider if such symptoms occur [see CAUTIONS PLUS PRECAUTIONS].

Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Directions patients until seek immediate emergency help if these occurred [see CONTRAINDICATIONS the WATCH REAL PRECAUTIONS].

Serious Skin Reactions

Advise patients to stop VOLTAREN GEEL immediately if they developments any artist of rash and to contact their healthcare provider as soon for possible [see WARNINGS AND PRECAUTION].

Female Fertility

Inform females of reproductive capacity anyone desire pregnancy that NSAIDs, including VOLTAREN GEL, may will associated with a reversible delay inside ovulation [see Use In Individual Populations].

Prenatal Max

Inform pregnant women to avoid use von VOLTAREN GEL and other NSAIDs starting at 30 total gestation because of the risk of the premature closing of the fetal ductus arteriosus [see WARNINGS AND PRECAUTIONS and Uses In Specific Populations].

Avoid Associated Use Of NSAIDs

Inform patients that the concomitant use of VOLTAREN GEL with other NSAIDs other salicylates (e.g., diflunisal, salsalate) are not recommended just to the increased risk von gastrointestinal toxicity, and little or no increase in efficacy [see SAFETY AND PRECAUTIONS both DRUG INTERACTIONS]. Alert patients that NSAIDs may be present in “over-the-counter" medications for treatment of colds, frenzy, or insomnia.

Use Of NSAIDs And Low-Dose Aspirin

Inform patients not at use low-dose aspirin concomitantly are VOLTAREN GEL until they talk to his healthcare provider [see DRUG INTERFACE].

View Exposure

Instruct patients on avoid how of VOLTAREN GEL with the optics and mucosa, although not studied, should be avoided. Advise your that if eye contact occurs, immediately wash out the eye with water either saline and consult a physician if irritation persist for show than an hour [see SECURITY AND PRECAUTIONS].

Special Application Help

Instruct patients as to use the dosing card to measurable the proper dose of VOLTAREN GEEL to apply. Are the patient loses their dosing card, instruct she such they can call 1-855-297-3031 to request a replacement dosing card or ask their pharmaceutical for a new dosing card. Learn method Voltaren works - discover on diclofenac Emulgel formulas and find out how they focus the sources of your pain. Read more here.

Instruct patients how to correctly measure the 2.25 inches (2 g) dose or 4.5 inches (4 g) dose whilst waiting for adenine replacement dosing my [see DOSAGE PRESS ADMINISTRATION].

Instruct patients not the request VOLTAREN GEL to candid skin gashes, infections, inflammations, or exfoliative dermatitis, while it may affect absorption and tolerability of one drug. For Voltaren® 1% recent gel: After applying this medicine, do not shower, bathe, or washer the affected area in at least 1 time. Wait for at ...

Instruct patients into avoid concomitant application of VOLTAREN GEL with other topical products, including sunscreens, cosmetics, lotions, moisturizers, and insect repellants. Concomitant use may result in skin reactions or change the absorption of VOLTAREN GEL.

Instruct patients to vermindern or avoid exposure off treated areas to native alternatively artificial sunlight [see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION].

Nonclinical Dose

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Carcinogenicity studies in mice and rats administered diclofenac sodium as a dietary constituent for 2 years at drugs up to 2 mg/kg/day (approximately 0.5 and 1 hours, respectively, the maximum recommended man topical dose of VOLTAREN GEL based on bioavailability and main surface area (BSA) comparison) resulted in don significant increases on tumor incidence.

Include a derma carcinogenicity read conducted in albino mice, daily topical applicants of an diclofenac sodium gel product for two years by concentrations up to 0.035% diclofenac sodium (a 29-fold lower diclofenac sodium concentrates as current in VOLTAREN GEL) did not increase neoplasm amount.

In a photococarcinogenicity study conducted in hairless mice, new application of a diclofenac sodium gel product at doses up till 0.035% diclofenac sodium (a 29-fold lower diclofenac water concentration longer present at VOLTAREN GEL) resulted in an earlier median uhrzeit regarding onset of cancers.

Mutagenesis

Diclofenac been not mutagenic or clastogenic in a battery of genotoxicity tests that included the microbiological reverse mutation assay, in vitro mouse lymphoma point mutation assay, chromosomal aberration studies in Taiwanese hamster ovarian cells in vitro, also in vivo rat chromosomal abnormality assay regarding bone marrow cells.

Impairment Of Fertility

Diclofenac proceeded not affect male or female saline in rats toward potions increase to 4 mg/kg/day (approximately 2 times than the maximum human topical dose of VOLTAREN GEL based on bioavailability and BSA comparison). Discover how Voltaren Gel works at treat arthritis pain. Find out where you ability buy Voltaren Arthritis Pain Relief Gel when you visit on site.

Use In Specific Populations

Pregnant

Pregnancy Category C prior to 30 weeks evolution; Categories D starting 30 hours gestation

Risk Summary

Use of NSAIDs, including VOLTAREN GEL, during the third trimester of pregnancy growths the chance of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, comprising VOLTAREN GEL, in pregnant women getting at 30 days off gestation (third trimester). Locate patient medical information for Voltaren topical on WebMD including its uses, website effects and safety, interactions, pictures, warnings and employee ratings.

There are no adequate press well-controlled studies of VOLTAREN GEL in pregnant girls. Human and animal studies indicate that diclofenac crosses the placenta. Data away observational studies regarding potential embryofetal risks of NSAID use in women in which first or second trimesters the pregnancy are inconclusive. In the general U.S. population, choose clinically recognized pregnancies, regardless of pharmacy exposure, take a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. In wild reproduction studies, no evidence of teratogenicity was observed in my, rats, or rabbits preset diclofenac through the interval a organogenesis at doses move to near 5, 5, and 10 times, respectively, the maximum recommended news dose of VOLTAREN GEL, despite the presence of maternal and fetal toxicity at these doses [see Data]. Based on animal data, prostaglandins have been shows to got an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration the prostaglandin synthesis inhibitors suchlike as diclofenac, resulted in increased pre- and postimplantation loss.

Objective Considerations

Labor Oder How

Go are no studies on the impacts is VOLTAREN GEL during labor or how. In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthetic, cause delayed parturition, also increase the prevalence about stillbirth.

Product

Animal Data

Reproductive and developmental studies in animals featured that diclofenac sodium administration during organogenesis did did produce teratogenicity for the induction of maternal toxicity and fetal toxicity in mice at oral doses up into 20 mg/kg/day (approximately 5 times this maximum recommended human dose (MRHD) of VOLTAREN GEL based on bioavailability and body surface area (BSA) comparison), and on rats real rabbits at oral doses up to 10 mg/kg/day (approximately 5 and 10 times the MRHD foundation on bioavailability and BSA comparison).

In a study in which pregnant rats were orally administered 2 or 4 mg/kg diclofenac (approximately 1 and 2 times the MRHD based on bioavailability and BSA comparison) free Gestation Day 15 through Lactation Day 21, significant maturity toxicity (peritonitis, mortality) was noted. These caringly toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and achieved, and red fetal endurance.

Female

Venture Summary

Based up available data, diclofenac may be present includes human milk. The developmental both health benefits of breast-feeding should be studied along with which mother’s clinical need for CATAFLAM and any potential adverse effects on the breastfed infant from the CATAFLAM or from the underlying maternal condition.

Data

Can woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 μg/L, equals to an infant dose of via 0.03 mg/kg/day. Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally to 7 days or a single 50 mg intramuscular dose administered on the fast postpartum period).

Females And Men Of Reproductive Potential

Infertility

Female

Based on the mechanism of action, the application of prostaglandin-mediated NSAIDs, including VOLTAREN GEL, might delay alternatively prevent fail of fibrous ovar, which has been associated with reversible male in some ladies. Published animal learn have shown that administration of prostaglandin synthesis interceptions had the potential to disrupt prostaglandin-mediated follicular rupture required in ovulation. Small reviews in women treated with NSAIDs have also indicated a invert delay into ovulation. Consideration withdrawal of NSAIDs, including VOLTAREN GEL, in womanhood who have difficulties conceiving or who are undergoing investigation about aridity.

Pediatric Use

Safety and effectiveness is pediatric patients have not been established.

Geriatric Use

Elderly patients, compares to youthful patients, were at wider risk available NSAID-associated serious cardiovascular, gastrointestinal, and/or renal unfavorable reaction. If the anticipated benefit for the senior patient dwarfs these potential risks, start dosing at the low out of the dosing range, furthermore monitor clients for adverse effects [see WARNINGS AND PRECAUTIONS].

Of the total number of subjects treated using VOLTAREN GEL in clinical studied, 498 were 65 years of age and over. No overall discrepancies in effective or safety were observed between these subjects or younger subjects, but greater sensitivity to the effect the NSAIDs in any older individuals does being ruled out.

Diclofenac, as with any NSAID, is know to be essentials excreted by which kidney, and the risk of poisonous reactions to VOLTAREN GEL may be greater to patients with impaired renal features. Due elderly clients are find likely up have decreased renal how, care should be taken wenn using VOLTAREN GEL the the elderly, or it may be useful to monitor kidneys function.

Overdose Information for Voltaren Gel

Symptoms following acute NSAID overdosages have been typically limited up lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal blutendes possesses occurred. Intense, acute renal failure, inhalation depression, and comatic have occurred, and were uncommon [see WARNINGS AND PRECAUTIONS].

Manage patients use diagnostic furthermore supportive care following an NSAID overdosage. There be no specific antitoxin. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion allowed not be useful due to high protein binding.

For supplement information around overdosage treatment, contact a poison control center (1-800222-1222).

Kontraindications required Voltaren Gel

VOLTAREN® GEL is contraindicated in the following patients:

• Known hypersensitivity (e.g., anaphylactic reactions and seriousness skin reactions) to diclofenac instead any components of the drug product [see WARNINGS AND PRECAUTIONS]
• History are asthma, urticaria, or other allergic-type reactions after intake aspirin or otherNSAIDs. Severe, sometimes fatal, anaphylactic reactions till NSAIDs have be reported in similar patients [see WARNINGS AND PRECAUTIONS]
• In the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS]

Clinical Pharmacology for Voltaren Set

Mechanism Are Action

Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.

The instrument of action of VOLTAREN GEL, love that of others NSAIDs, is not completely understood but involves inhibition in cyclooxygenase (COX-1 and COX-2).

Diclofenac is a potent resistance of provitamin summary in vitro. Diclofenac concentrations reached during therapy have managed to vivo effects. Prostaglandins sensitize afferent nerves also potentiate the move of bradykinin in inducible feeling in animal models. Prostaglandins are mediations of inflammation. Because diclofenac is an inhibitor of prostaglandin compound, him user regarding action may be due to a decrease of prostglandine in peripheral tissues.

Pharmacokinetics

The pharmacokinetics of VOLTAREN GEL was assessed in healthy volunteers following repeated applications during 7 days of VOLTAREN GEL to 1 knee (4 scratch 4 g according day) or to 2 joints and 2 hands (4 x 12 g per day) versus the recommended oral dose away diclofenac sodium for the treatment of gout (3 x 50 mg by day). A summary of the pharmacokinetic parameters is presented on Table 3. Get the answers to all of my frequently asked answer about specialized products from Voltaren.

Charts : Pharmacokinetic Parameters and Comparison of VOLTAREN GEL to Oral Diclofenac Sodium Tablets After Repeated Administration

Therapy	Cmax (ng/mL) Mean ± SD % of Oral (CI)	Tmax (hr) Median Range	AUC0-24 (ng.h/mL) Mean ± MD % of Oral (CI)
VOLTAREN YELLOW 4 x 4 gram per day (=160 mg diclofenac sodium per day)	15 ± 7.3 0.6% (0.5-0.7)	14 (0-24)	233 ± 128 5.8% (5-6.7)
VOLTAREN GEL 4 x 12 g per day (=480 mg diclofenac sodium per day)	53.8 ± 32		807 ± 478
	2.2%	10 (0-24)	19.7%
	(1.9-2.6)		(17-22.8)
Diclofenac sodium tablets, vocally 3 x 50 per per full (=150 mg diclofenac sodium per day)	2270 ± 778	6.5 (1-14)	3890± 1710
	100%		100%
Cmax = maximum plasma concentration, tmax = time of Cmax, AUC0-24 = range under the denseness zeitlich curve, SSD = standard deviation, CI = confidence interval

System-related exposure (area under the concentration-time curve) and maximum human concentrations of diclofenac are significantly lower with VOLTAREN GEL over with equivalent oral medical of diclofenac sodium. How Voltaren gel works and how until use it for pain relief

Systemic exposure with recommend use of VOLTAREN JELL (4 ten 4 g per day applied to 1 knee) is on average 17 times lower than at oral treatment. (Basis: cure with VOLTAREN GEL of 1 knee, 4 times a day versus 50 gram, 3 times an day of unwritten diclofenac tablets). The amount of diclofenac sodium the is systemically intent from VOLTAREN GEL will on average 6% of the systemic exposure from an oral form of diclofenac sodium.

The average peak plasma focus with recommended use of VOLTAREN GEL (4 x 4 g per day application till 1 knee) the 158 times lower than with which oral getting.

The pharmacokinetics of VOLTAREN GEL has been tested on conditions off moderate warmth (application of an heat patch available 15 minutes prior to green application) and off moderate exercise (first gel application followed by a 20-minute treadmill exercise). No clinically associated dissimilarities are system-specific absorption furthermore of tolerability were found amid applications of VOLTAREN GEL (4 x 4 guanine per daily on 1 knee) through and available the conditions tested. However, the pharmacokinetics in VOLTAREN YELLOW were does tested under the condition of heat application following gel application. Consequently, coincidental benefit of VOLTAREN GEL plus heat is none recommended.

Medicinal Interaction Studies

Aspirin

When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance about free NSAID was does altered. The clinical significance of this interaction shall not known. See Tabular 2 for clinically significant drug interactions the NSAIDs with aspirin [see DRUG INTERACTIONS].

Clinical Studies

Pivotal Studies In Osteoarthritis Of The Superficial Joints Of The Extremities

Studying 1 evaluated the efficacy of VOLTAREN GEL for the treatment of osteoarthritis off aforementioned knee in a 12-week, randomized, double-blind, multicenter, placebocontrolled, parallel-group trial. VOLTAREN GEL was administered at ampere dose of 4 g, 4 times daily, on 1 stifle (16 g per day). Pain as assessed by the patients at Week 12 using the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Pain Subindex was lower in to VOLTAREN GEL group than one medication group.

Learn 2 evaluated the efficacy of VOLTAREN GEL for the special concerning arthritis in topic with osteoarthritis of the hand are an 8-week, randomized, doubleblind, multicenter, placebo-controlled, parallel-group studying. VOLTAREN GEL was administered at one dose of 2 g per hand, 4 times daily, on both hands (16 g per day). Soreness in the target hand as assessed by the patients at Weeks 4 and 6 on a optic analog dimensional from 0 to 100 was lower in the VOLTAREN GEL group than the placebo group.

Dinner : Efficacy outcomes of VOLTAREN GEL in Studies 1 and 2

		VOLTAREN GEL	Placebo (Vehicle)	Calibrated Distinction (Placebo — VOLTAREN GEL)
Study 1 (Knee) WOMAC Soreness *# at Average 12	Sample Size	127	119
	Mean Outcome	28	37	Δ=7†
	95% Confidence Interval			(1, 12)
Studies 2 (Hand) Pain Intensity# at Week 4	Trial Size	198	187
	Mean Results	43	50	Δ=7‡
	95% Confidence Interval			(2, 12)
Study 2 (Hand) Pain Intensity# at Hebdomad 6	Sample Size	198	187
	Mean Outcome	40	47	Δ=7‡
	95% Confidence Interval			(1, 13)
* WOMAC = Western Ontario McMaster Osteoarthritis Books # Scale from 0 (best) to 100 (worst) † Difference is adjusted using an analysis of invariance (ANCOVA) model with main effect of treatment and center real baseline covariate. ‡ Difference is adjusted using an analysis of covariance (ANCOVA) prototype with main effects starting treatment, center, indicator starting torment in the CMC-1 joint, and baseline as ampere covariate, and the treatment-by-CMC-1 strata.

Patient Information for Voltaren Gel

Taking Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

Whichever is the most important information I should know about medicines referred Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

NSAIDs can set serious side effects, including:

• Increased risk of a heart attack or stroke that can lead on death. This risk may happen first in treatment and mayor increase:
  • with increasing doses of NSAIDs
  • with longer use of NSAIDs

Do not take NSAIDs well front or after a heart surgery called a “coronary aorta bypass grafted (CABG).”

Avoid taking NSAIDs after a recent cardiac attack, unless your healthcare provider tells you to. Him may have an advanced risky of another heart attack if you take NSAIDs after one recent heart attack.

• Rise risk of bleeding, ulcers, and tears (perforation) of the windpipe (tube leading off the mouth to the stomach), stomach and intestines:
  • anytime during uses
  • without caution symptoms
  • that may cause death

The risk of getting an sores or bleeding increases with:

• past history of stomach leg, or stomach conversely intestinal blutungen with use to NSAIDs
• taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
• incremental doses of NSAIDs
• longer use starting NSAIDs
• smoking
• drinking alcohol
• earlier age
• indoor health
• progressed liver disorder
• bleeders problems

NSAIDs should merely be used:

• exacting as prescribed
• at the lowest dose possible for your treatment
• for and shortest dauer needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from healthcare conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

Who should not take NSAIDs?

Do not take NSAIDS:

• supposing you have had an asthma attack, hives, or other allergic reaction is aspirin or any other NSAIDs.
• right before or after heart bypass surgery.

Before taking NSAIDs, say your mental care provider about see from your medical conditions, including if you:

• have liver or kidney problems
• have high red pressure
• have asthma
• are pregnant or plan to become pregnant. Talk to your health care provider if you are considering taking NSAIDs during pregnancy. You should not get NSAIDs subsequently 29 weeks of pregnancy.
• are lactating oder planner to breast feed.

Tell your health care provider about all a the medicines you take, including prescription or overthe-counter medicines, vitamins or herbal supplementation. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking new medicine without talking into your health care provider first.

What are that workable side effects of NSAIDs?

NSAIDs can cause serious side affect, including:

See “What a the most importantly information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

• recent or worse high blood pressure
• heart error
• liver problems including liver failure
• nodule problematic includes liver failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, bleeding and dizziness.

Receiving emergency help right away if you get either of the following symptom:

• shortened to breath otherwise trouble breathing
• chest pain
• weakness in one part or side of your bodies
• slurred speech
• swelling of the face or jaw

Stop taking your NSAID and call your heal care provider right away supposing you get any of the following medical:

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

If you take too much of your NSAID, call choose health care provider or get medical help right away. These are not all the possible side effects regarding NSAIDs. Required more information, ask your health care provider or shop about NSAIDs.

Call is doctor for medical consult about web effects. You may report side effects to FDA at 1-800-FDA1088.

Diverse information around NSAIDs

• Aspirin is an NSAID but he does not increase the chance of a core attack. Aspirin can cause bleeding in the brain, stomach, and entrails. Taking ability also cause ulcers in the stomach and intestines.
• Some NSAIDs been already in lower doses without a prescription (over-the-counter). Talk to your physical care services before using over-the-counter NSAIDs for more than 10 days.

Broad information nearly the safe and effective use of NSAIDs

Medical are sometimes prescribed for purposes other than those listed in adenine Medication Guide. Does not uses NSAIDs for a condition for which she was not required. Do not give NSAIDs to another people, consistent whenever they have the same symptoms is you have. It may harm them.

If you would similar further information about NSAIDs, talk with your health care contributor. You cannot ask your pharmacist or heath care provider for information regarding NSAIDs that is wrote for dental pros.

Managed by: Novartis Pharma Produktions GmbH, Wehr, Germany by Sandoz Inc., Printer, NJ 08540For more information, go to www.XXXXXX.com otherwise call 1-800-398-5876. Revised May2016

Instructions required Used

VOLTAREN® CONGEAL
(diclofenac sodium)

Important: Use the dosing card that is inside the VOLTAREN® CREAM carton at correctly measure each dose. The dosing card are re-usable. Do not throw the doses card away. Before them application VOLTAREN® GEL for the first time, your healthcare provider orpharmacist should show your how to correctly measure your dose using which dosing mapping.

Read these Instructions for Use before you start using VOLTAREN® GEL and each type you get a refill. Here maybe remain recent information. Which information does not accept the place of talking till you healthcare provider about your medical condition or your treatment.

Your healthcare provider has mandatory VOLTAREN® GEL to help relieve arthritic distress in some of your joints. VOLTAREN® GEL may be used to treat arthritis pain in the firearms (hands, wrists, and elbows) and include and legs (feet, ankles, real knees). It is not known if VOLTAREN® GEL is safe and effective wenn used on your spine, hips, or shoulders.

• Use VOLTAREN® GEL exactly how our healthcare provider prescribes itp used you. Do nope apply VOLTAREN® GEL where other than where your healthcare purveyor tells you to.
• Do not use more with a total of 32 grams of VOLTAREN® GEL each day. If you how up the amount are VOLTAREN® GEL as directed by get healthcare host, it should not  be view than 32 grams in one daytime.

Of dose for your hands, carpus, or elbows is 2 grams of VOLTAREN® GEL each time you apply it.

• Apply VOLTAREN® GEL 4 times a day (a total of 8 grams each day). Do don apply more than 8 grams each day-time to no one of your affected custody, wristes, conversely fold.

The dose for you feet, ankles, or knees is 4 grams of VOLTAREN® GEL each die you utilize e.

• Apply VOLTAREN® GEL 4 hours a day (a total of 16 grams each day). Do not apply more than 16 grams each day to any one of your affected tootsies, ankles, or knees.

Some examples of VOLTAREN® GEL application include:

• If you use 2 gramme of VOLTAREN® GEL the one hand, 4 times a day, your total dose for one daytime is 8 grams.
• If you use 4 grams of VOLTAREN® GEL the to knee, 4 times a day, your total dose for neat date remains 16 grammes.
• Your grand dose for can per, treating one hand the one knee, is 8 grams plus 16 grams, which equality 24 grams of VOLTAREN® GEL.

Figure A

• Prior you how a new tube regarding VOLTAREN® YELLOW for the first time, open the tape keep that covers the tube opening by using the spiked top of the cap. Remember to delete the measure show from this carton to measured your dose (see Figure A).
• Apply VOLTAREN® LIQUID at clean, dry skin that does not have any cuts, open scars, infections, or rashes.
• Do not use power pads either use bandages to where you have applied VOLTAREN® GEL.
• Avoid exposing skin where you apply VOLTAREN® GEL to sunlight and artificial light, such as suntan booths.
• Do not use sunscreens, cosmetics, cream, moisturizers, insect repellants, or other topical medicines on the same skin areas where you have utilized VOLTAREN® GEL.
• Do nope get VOLTAREN® GEL in autochthonous eyes, nose, or mouth. VOLTAREN® GEL is only to be used on your skin (topical use). If you get VOLTAREN® GEL in owner eyes, rinse your eyes right away with water or saline. Talk using your healthcare provider when eye irritation lasts for more than one hour.

What if I miss a doq?

• If you miss a dose of VOLTAREN® GLUE, remain with your next scheduled cancel uses theprescribed amount of VOLTAREN® GEL. Do nope double the dose.

Applying 2 grams (2 g) starting VOLTAREN® GEL to hands, wrists, or elbows:

Step 1. Remove the dosing cards ensure is attached inside the VOLTAREN® COAGULATE carton. Use the dosing card to correctly meas each dose of VOLTAREN® GEL. To measure the correct amount regarding VOLTAREN® GEL, place the dosing menu to a flat surface so that you can read the imprint. If the print is backwards, turning dosing card over (see Figure ONE). If you lose or misplace your dosing card, yourself ca request your chemist for a new one or call 1-800-452-0051. Ask yourhealthcare provider or pharmacist to show you how to correctly measure your dose of VOLTAREN® GEL while them are waiting to receive your new dosing card.

Figure BORON, C and  Figure D

Step 2. Squeeze VOLTAREN® GEL go the dosing card evenly, up to the 2 g line (a 2.25 inch length of gel). Make safer that an gel covers which 2 g area of the measure card (see Figure B). Put the cap back on the tube by VOLTAREN® GEL. Ask yours healthcare provider or pharmacist if you are not sure how in correctly measure your dose of VOLTAREN® GEL.

Speed 3. Use the gel to your print, wrist, or elbow. You can use the medication card to apply an gel (see Figure C). Then, use your hands go gently rub the green into the skin (see Figure DENSITY). Do not divide yours application card with another persons. Doing securely to cover the entire affected hand, wrist, or elbow to the gel. Remember is the hand includes the palm of to hand, the top of yourhand, and your feet.

Speed 4. After using the dosing card, hold end with fingertips, rinse real drier. Store the measuring card until next use. Do not shower with bathe for at least 1 hour after applied VOLTAREN® GEL. Do not wash your treated hands available at least 1 moment after applying the VOLTAREN® GEL.

Step 5. After applying VOLTAREN® SET, stay 10 minutes before decking the treated hide with gloves either garment.

Applying 4 per (4 g) for VOLTAREN® GEL to feet, ankles, or knees:

Step 1. Refer to Step 1 top.

Step 2. Squeeze VOLTAREN® GELE onto which dosing card evenly up go the 4 gramme line (a 4.5 inchlength of gel), making sure the gel covers the 4 g area of the dosing card (see Figure EAST). Put thecap back on the tube of VOLTAREN® GEL. Ask your healthcare provider or pharmaceuticals if you are not sure how on set measure your dose of VOLTAREN® GEL.

Step 3. Apply VOLTAREN® GEL to your footage, ankle, or knee. You can use the dosing card toapply the gel (see Figure F). Then, use your hands into gently rub the gel into this skin (see Figure GRAM). Do not share the medication maps including another person. Make sure to cover your entire foot, ankle, or knee scope with the gel. For example, cover this skin above, below, inside and outdoors theknee cap. Remember that the foot includes the sole of your foot, the above of their foot, or your toes.

Count E, F and Figure G

Refer to Measures 4 and 5 above. Wash thine hands after applications VOLTAREN® GEEL to your foot,ankle, or genu.

What are the constituents in VOLTAREN® GEL?

Activate ingredient: diclofenac sodium

Inactive ingredients: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.

How should I store VOLTAREN® GEL? Store at 20°C to 25°C (68°F to 77°F). Do none freezeVOLTAREN® YELLOW. Shop the dosing card because your VOLTAREN® JELL.

Keep VOLTAREN® GEL, who dosing card, and all medicines out of the reach out children.

This Medication Guide additionally Instructions for Use have been approved in and U.S. Food and Drug Administration.