Voltaren Patch for back, muscle and joint pain, 15mg/day, 2pcs

Composition

1 patch:

diclofenac sodium (1%)

Auxiliary substances:

levomenthol – 22.5 mg,

methylpyrrolidone – 60 mg,

sea buckthorn propylene glycol esters of fatty acids 30 mg,

citric acid 6 mg,

isopentanol copolymer – 536.1 mg,

polyisobutylene 30 mg

gum affilirovannaja 300 mg,

mercaptobenzimidazole – 3.7 mg

butylhydroxytoluene a – 3.7 mg

liquid paraffin – up to 1500 mg, the

core of polyester fibers (50 den) 70 cm 2;

a protective film made of polyester (thickness 75 µm) 70 cm 2.

Pharmacological action

NSAIDs for outdoor use. Voltaren® in the form of a transdermal patch is a base with an applied adhesive layer containing diclofenac, which has pronounced analgesic and anti-inflammatory properties. The mechanisms of action of diclofenac are based on inhibition of prostaglandin synthesis. Voltaren ® patch provides anti-inflammatory and analgesic action at the application site, eliminating pain and reducing swelling associated with the inflammatory process.

Clinical pharmacology

Absorption and DISTRIBUTIONTHE amount of diclofenac that is absorbed systemically from the Voltaren ® patch for 24 hours is similar to that of an equivalent amount of Voltaren® Emulsifier® (gel for external use 1%). The binding of diclofenac to plasma proteins is 99.7%, mainly to albumin (99.4%). Metabolism and elimination The total systemic clearance of diclofenac from plasma is 263 ± 56 ml/min. The final T1 / 2 in blood plasma is 1-2 h. 4 metabolites, including 2 active ones, also have a short T1/2 – 1-3 h. One metabolite,3 ‘- hydroxy-4 ‘ – methoxydiclofenac, has a longer T1 / 2, but is inactive. Diclofenac and its metabolites are mainly excreted in the urine. Pharmacokinetics There is no accumulation of diclofenac and its metabolites in special clinical cases in patients with impaired renal function. In patients with chronic hepatitis or non-compensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as in patients without liver disease.

Indications

Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica); joint pain (including finger joints, knee joints) in rheumatoid arthritis, osteoarthritis; muscle pain (due to sprains, overexertion, bruises, injuries); inflammation and swelling of soft tissues and joints due to injuries and in rheumatic diseases (tendovaginitis, bursitis, lesions periarticular tissues).

Use during pregnancy and lactation

The use of the drug in pregnant women has not been studied, so the Voltaren ® patch should not be prescribed during pregnancy, especially in the third trimester, because of the possibility of a decrease in uterine tone and/or premature closure of the fetal ductus arteriosus. Experimental animal studies have not revealed any direct or indirect negative effects on pregnancy, childbirth, embryonic and postembryonic development. There are no data on the ability of the drug to penetrate into breast milk, so the Voltaren ® patch is not recommended for use during breastfeeding.

Contraindications

A tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs; III trimester of pregnancy; breastfeeding; children under 15 years of age; violation of the integrity of the skin at the site of the intended sticking of the patch; hypersensitivity to the components of the drug. With caution: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney function disorders, chronic heart failure, bronchial asthma, the elderly.

Side effects

Adverse reactions are mainly characterized by moderate and passing skin manifestations at the site of application of the patch. Local reactions: often (≥1/100, <1/10) – erythema, dermatitis, including contact dermatitis (symptoms: erythema, pruritus, swelling of the treated skin area, rash, papules, vesicles, peeling), eczema; rarely (≥1/10 000,1/1000) – bullous dermatitis; very rarely (Systemic reactions: very rare (

Interaction

Voltaren ® patch may enhance the effect of drugs that cause photosensitization. No clinically significant interactions with other drugs have been described.

How to take, course of use and dosage

Apply externally in the form of applications on the skin. For adults and adolescents over 15 years of age, the Voltaren ® patch is applied to the skin over the painful area for 24 hours. During the day, only 1 patch is allowed. In the treatment of soft tissue injuries, the Voltaren ® patch is used for no more than 14 days, and in the treatment of muscle and joint diseases-no more than 21 days, unless there are special recommendations from the doctor. If there is no improvement in the condition after 7 days and if you feel worse, you should consult a doctor. In elderly patients, it is used similarly to the method of use and doses for adults.

Overdose

Extremely low systemic absorption of active ingredients and the dosage form of the drug when used externally makes overdose almost impossible.

Description

Transdermal patch 15 mg/day (70 cm 2), rectangular shape with rounded edges, consisting of a beige polyester base with a uniformly applied adhesive layer from colorless to pale yellow with a faint aromatic smell;the adhesive surface is covered with a transparent protective film made of polyethylene with two transverse incisions, one of which has a wavy line; the transparent protective film has a drawing showing how to remove the film from the surface of the patch; the size of the patch 70×100 mm.

Special instructions

Voltaren ® patch should only be applied to undamaged skin, avoiding contact with open wounds. Do not allow the drug to get on the eyes and mucous membranes. When using the Voltaren® patch for too long, the possibility of developing systemic adverse reactions cannot be excluded. With the additional use of other dosage forms of diclofenac, its quantitative content in the patch should be taken into account so as not to exceed the maximum daily dose of diclofenac (150 mg/day). Preclinical studies have shown the safety of the drug. Influence on the ability to drive vehicles and mechanisms The drug does not affect the speed of psychomotor reactions when driving and working with mechanisms.

Form of production

2 patches each in an aluminum foil bag. Text is applied directly to the package or a label is pasted. The package together with the instructions for use is placed in a cardboard pack.

Storage conditions

The drug should be stored out of the reach of children, in its original packaging, at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Diclofenac

Dosage form

transdermal system

Description

Children over 15 years of age, For adults, Pregnant women in the first and second trimester as prescribed by a doctor

Indications

Osteoarthritis and Arthritis, Tendon Inflammation, Periarthritis, Rheumatoid Arthritis, Sciatica, Lumbago, Osteoarthritis, Bursitis, Adnexitis