Voltaren transdermal patch 30mg, No. 2

• Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);

• joint pain (finger joints, knee joints, etc.) with rheumatoid arthritis, osteoarthritis;

• muscle pain (due to sprains, overexertion, bruises, injuries);

• inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues).

Outwardly, in the form of applications on the skin.

Adults and adolescents over 15 years of age: the transdermal VoltarenЃ patch is glued to the skin over the painful area for 24 hours. Only 1 patch is allowed per day.

Transdermal patch VoltarenЃ 30 mg / day (140 cm2) is intended for gluing on large painful areas.

In the treatment of soft tissue injuries, the transdermal VoltarenЃ patch is used for no more than 14 days, and in the treatment of diseases of muscles and joints - no more than 21 days, unless there are special doctor's recommendations.

If there is no improvement in the condition after 7 days and if the state of health worsens, it is necessary to consult a doctor.

Children. The use of the VoltarenЃ patch in children under the age of 15 is not recommended.

Elderly. Similar to the route of administration and doses for adults.

Transdermal patch 30 mg / day (140 cm2), rectangular with rounded edges, consisting of a beige polyester base with a uniformly applied adhesive layer from colorless to pale yellow with a weak aromatic odor; the adhesive surface is covered with a transparent protective film made of polyethylene with two transverse cuts, one of which has a wavy line; a drawing is applied to the transparent protective film showing how to remove the film from the surface of the patch; the size of the patch is 100 ? 140 mm.

1 plaster

diclofenac sodium (1%) 30 mg

Excipients: levomenthol - 45 mg, methylpyrrolidone - 120 mg, propylene glycol esters of fatty acids - 60 mg, citric acid - 12 mg, isoprenestyrene copolymer - 1072.2 mg, polyisobutylene - 60 mg, etherized gum - 600 mg, mercaptobenzimidazol butyl urolitolite - 7.4 mg - 7.4 mg, liquid paraffin - up to 3000 mg, polyester fiber base (50 den) - 140 cm2; protective film made of polyester (thickness 75 microns) - 140 cm2.

• Hypersensitivity to diclofenac or other components of the drug;

• a tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs;

• pregnancy (III trimester);

• violation of the integrity of the skin at the site of the alleged sticking of the patch;

• breast-feeding;

• children's age (up to 15 years).

With care: hepatic porphyria (exacerbation); erosive and ulcerative lesions of the gastrointestinal tract; severe impairment of liver and kidney function; chronic heart failure; bronchial asthma; elderly age.

pharmachologic effect

NSAIDs for external use. VoltarenЃ 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.

The VoltarenЃ patch provides an anti-inflammatory and analgesic effect at the site of application, eliminating pain and reducing swelling associated with the inflammatory process.

Pharmacokinetics

Absorption and distribution

The amount of diclofenac absorbed systemically from the VoltarenЃ patch within 24 hours is similar to that when using an equivalent amount of VoltarenЃ EmulgelЃ (gel for external use 1%).

The binding of diclofenac to plasma proteins is 99.7%, mainly to albumin (99.4%).

Metabolism and excretion

The total systemic clearance of diclofenac from plasma is 263 ± 56 ml / min.

The final T1 / 2 in blood plasma is 1-2 hours. 4 metabolites, including 2 active ones, also have a short T1 / 2 - 1-3 hours. One metabolite, 3'-hydroxy-4'-methoxydiclofenac, has a longer T1 / 2, however, is inactive. Diclofenac and its metabolites are excreted mainly in the urine.

Pharmacokinetics in special clinical situations

In patients with impaired renal function, accumulation of diclofenac and its metabolites does not occur.

In patients with chronic hepatitis or undecompensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as in patients without liver disease.

Side effect

Adverse reactions are mainly characterized by moderate and transient skin manifestations at the site of application of the patch.

Local reactions: often - erythema, dermatitis, incl. contact dermatitis (symptoms: erythema, itching, swelling of the treated skin area, rash, papules, vesicles, peeling), eczema; rarely, bullous dermatitis; very rarely - pustular eruptions.

Systemic reactions: very rarely - generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioedema, asthma attacks, bronchospastic reactions), photosensitivity reactions.

Application during pregnancy and lactation

The use of the drug in pregnant women has not been studied, therefore, the VoltarenЃ patch should not be prescribed during pregnancy, especially in the third trimester, due to the possibility of a decrease in the tone of the uterus and / or premature closure of the fetal ductus arteriosus.

Experimental studies on animals have not revealed any direct or indirect negative effects on pregnancy, childbirth, embryonic and postembryonic development.

There is no data on the ability of the drug to penetrate into breast milk, therefore, the VoltarenЃ patch is not recommended for use during breastfeeding.

Application for violations of liver function

Precautions: severe liver dysfunction.

Application for impaired renal function

Precautions: severe renal impairment.

Application in children

Contraindicated in children and adolescents under 15 years of age.

Use in elderly patients

With care: old age.

special instructions

The VoltarenЃ patch should only be applied to intact skin, avoiding contact with open wounds.

Do not allow the drug to come into contact with the eyes and mucous membranes.

When using the VoltarenЃ patch for too long, the possibility of developing systemic adverse reactions cannot be ruled out.

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.

Overdose

The extremely low systemic absorption of active components and the dosage form of the drug when applied externally makes an overdose almost impossible.

Drug interactions

The VoltarenЃ patch can enhance the effect of drugs that cause photosensitization. No clinically significant interactions with other drugs have been described.