Voltaren Patch for pain in the back, muscles and joints, transdermal patch 15 mg/day No. 2

Voltaren Patch for pain in the back, muscles and joints, transdermal patch 15 mg/day No. 2

A country

Greece, Japan
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Description

Voltaren is the only therapeutic patch.* The components of the patch are continuously delivered to the source of pain, eliminating pain and inflammation.
Used for: - Back pain due to inflammatory and degenerative diseases of the spine - Joint pain - Muscle pain - Inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases. It is enough to apply only 1 patch for 24 hours**. Advantages of the Voltaren patch: • Applied once a day • Invisible under clothing (ultra-thin, flesh-colored) • Does not stain hands and clothes * Among Voltaren products in Russia ** Instructions for medical use, RU No. LP-001089

Compound

Each transdermal patch 15 mg/day (70 cm2) contains: Active ingredient: 15 mg diclofenac sodium (1%). Excipients: levomenthol 22.5 mg, methylpyrrolidone 60.0 mg, propylene glycol esters of fatty acids 30.0 mg, citric acid 6.0 mg, isoprene styrene copolymer 536.1 mg, polyisobutylene 30.0 mg, esterified gum 300.0 mg , mercaptobenzimidazole 3.7 mg, butylated hydroxytoluene 3.7 mg, liquid paraffin up to 1500.00 mg; base made of polyester fibers (50 den) 70 cm2; protective film made of polyester (thickness 75 microns) 70 cm2.

Product description

Rectangular patches with rounded edges, consisting of a beige polyester base with a uniformly applied adhesive layer from colorless to pale yellow with a faint aromatic odor. The adhesive surface is covered with a transparent protective film 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 70 x 100 mm.

pharmachologic effect

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. The Voltaren® patch provides anti-inflammatory and analgesic effects at the site of application, eliminating pain and reducing swelling associated with the inflammatory process. Pharmacokinetics Absorption and distribution in the body: The amount of diclofenac absorbed systemically from the Voltaren® patch over 24 hours is similar to that when using an equivalent amount of Voltaren® Emulgel® (gel for external use 1%). 99.7% of diclofenac is bound to serum proteins, mainly to albumin (99.4%). Elimination: The total systemic clearance of diclofenac from plasma is 263 ± 56 ml/min. The terminal half-life in plasma is 1-2 hours. Four metabolites, including two active ones, also have a short half-life of 1-3 hours. One metabolite, 3`-hydroxy-4`-methoxydiclofenac, has a longer half-life, however, is inactive. Diclofenac and its metabolites are excreted mainly in the urine. In patients with impaired renal function, accumulation of diclofenac and its metabolites does not occur. In patients suffering from chronic hepatitis or undecompensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as in patients without liver disease. Preclinical studies have shown the safety of using the drug.

Indications for use

Back pain due to inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica). Pain in the joints (fingers, knees, etc.) with osteoarthritis. Muscle pain (due to sprains, strains, bruises, injuries). Inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tenosynovitis, bursitis, lesions of periarticular tissues).

Contraindications

Hypersensitivity to diclofenac or other components of the drug; tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs; pregnancy (III trimester); breast-feeding; children's age (up to 15 years); violation of the integrity of the skin at the site where the patch is supposed to be applied. With caution: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe dysfunction of the liver and kidneys, chronic heart failure, bronchial asthma, old age.

Use during pregnancy and lactation

The use of the drug in pregnant women has not been studied, therefore the Voltaren® patch should not be used during pregnancy, especially in the third trimester due to the possibility of decreased uterine tone and/or premature closure of the fetal ductus arteriosus. Animal studies have not revealed any direct or indirect negative effects on pregnancy, childbirth, embryonic or post-embryonic development. There is no data on the penetration of the drug into breast milk, therefore the Voltaren® patch is not recommended for use during breastfeeding.

Directions for use and doses

Externally in the form of applications to the skin. Adults and adolescents over 15 years of age: The Voltaren® patch is applied to the skin over the painful area for 24 hours. Only 1 patch is allowed to be used per day. When treating soft tissue injuries, the Voltaren® patch is used for no more than 14 days, and when treating diseases of muscles and joints - no more than 21 days, unless there are special recommendations from a doctor. If there is no improvement after 7 days and if your health worsens, you should consult a doctor. Children: The use of Voltaren® patch in children under 15 years of age is not recommended. Elderly: Similar to the method of administration and doses for adults

Side effect

Adverse reactions are mainly characterized by moderate and transient skin manifestations at the site of application of the patch. Very rare manifestations (Overdose) The extremely low systemic absorption of the active components and the dosage form of the drug when used externally makes an overdose almost impossible.

Interaction with other drugs

Voltaren® patch may enhance the effect of drugs that cause photosensitivity. Clinically significant interactions with other drugs have not been described.

special instructions

The Voltaren® patch should only be applied to intact skin, avoiding contact with open wounds. The drug should not come into contact with the eyes and mucous membranes. When using the Voltaren® patch for too long a time, the possibility of developing systemic adverse reactions cannot be excluded. When additionally using 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).

Release form

Transdermal patch 15 mg/day (area 70 cm2). 2 patches in an aluminum foil bag. Text or label is applied directly to the package. The package along with instructions for use is placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 C in the original packaging. Keep out of the reach of children.

Best before date

2 years. Do not use after expiration date.

Voltaren®

Manufacturer: NOVARTIS CONSUMER HEALTH SA (Switzerland)

◊ transdermal patch 15 mg/day: 2, 5, 7 or 10 pcs. Reg. No.: LP-001089

Clinical and pharmacological group:

NSAIDs

Release form, composition and packaging

Transdermal patch

15 mg/day (70 cm2), rectangular in 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 odor; the adhesive surface is covered with a transparent protective film 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; patch size 70×100 mm.

Excipients:

levomenthol - 22.5 mg, methylpyrrolidone - 60 mg, propylene glycol esters of fatty acids - 30 mg, citric acid - 6 mg, isoprene styrene copolymer - 536.1 mg, polyisobutylene - 30 mg, esterified gum - 300 mg, mercaptobenzimidazole - 3.7 mg, butylated hydroxytoluene - 3.7 mg , liquid paraffin - up to 1500 mg, polyester fiber base (50 den) 70 cm2; protective film made of polyester (thickness 75 microns) 70 cm2.

2 pcs. - aluminum foil bags (1) - cardboard packs. 5 pieces. - aluminum foil bags (1) - cardboard packs. 7 pcs. - aluminum foil bags (1) - cardboard packs. 10 pieces. - aluminum foil bags (1) - cardboard packs.

Description of the active components of the drug "Voltaren®"

pharmachologic effect

NSAIDs for external 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.

The Voltaren® patch provides anti-inflammatory and analgesic effects at the site of application, eliminating pain and reducing swelling associated with the inflammatory process.

Indications

— back pain due to inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);

— joint pain (including finger joints, knee joints) with rheumatoid arthritis, osteoarthritis;

— muscle pain (due to sprains, strains, bruises, injuries);

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

Dosage regimen

Apply externally in the form of applications to the skin.

Adults and teenagers over 15 years old

Voltaren® patch 15 mg/day (70 cm2) or 30 mg/day (140 cm2) is applied to the skin over the painful area for 24 hours. Only 1 patch is allowed to be used per day.

Voltaren® patch 30 mg/day (140 cm2) is intended for gluing to large painful areas.

When treating soft tissue injuries, the Voltaren® patch is used for no more than 14 days, and when treating diseases of muscles and joints - no more than 21 days, unless there are special recommendations from a doctor.

If there is no improvement after 7 days and if your health worsens, you should consult a doctor.

In elderly patients

used similarly to the method of administration and doses for adults.

Side effect

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

Local reactions:

often (≥1/100, <1/10) - erythema, dermatitis, incl. contact dermatitis (symptoms: erythema, itching, swelling of the treated skin area, rash, papules, vesicles, peeling), eczema; rarely (≥1/10,000, 1/1000) - bullous dermatitis; very rarely (<1/10,000) - pustular rashes.

Systemic reactions:

very rarely (<1/10,000) - generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioedema, asthma attacks, bronchospastic reactions), photosensitivity reactions.

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;

- breast-feeding;

- children under 15 years of age;

— violation of the integrity of the skin at the site where the patch is supposed to be applied;

- hypersensitivity to the components of the drug.

Carefully :

hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe dysfunction of the liver and kidneys, chronic heart failure, bronchial asthma, old age.

Pregnancy and lactation

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

In experimental studies

in animals, no direct or indirect negative effects on pregnancy, childbirth, embryonic and post-embryonic development were detected.

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

special instructions

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

The drug should not come into contact with the eyes and mucous membranes.

When using the Voltaren® patch for too long a time, the possibility of developing systemic adverse reactions cannot be excluded.

When additionally using 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.

Impact on the ability to drive vehicles and operate machinery

The drug does not affect the speed of psychomotor reactions when driving and working with machinery.

Overdose

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

Drug interactions

Voltaren® patch may enhance the effect of drugs that cause photosensitivity. Clinically significant interactions with other drugs have not been described.

Conditions for dispensing from pharmacies

The drug is approved for use as a means of OTC.

Storage conditions and periods

The drug should be stored out of the reach of children, in its original packaging, at a temperature not exceeding 25°C. Shelf life: 2 years.

Drug interactions

Voltaren® patch may enhance the effect of drugs that cause photosensitivity. Clinically significant interactions with other drugs have not been described.