DiclArtis^® (Transdermal patch) Instructions for Use

Marketing Authorization Holder

Pharmartis International, LLC (Russia)

Manufactured By

Dae Hwa Pharm, Co. Ltd. (Republic of Korea)

Packaging and Quality Control Release

DAE HWA PHARM, Co. Ltd. (Republic of Korea)

Or

PHARMSTANDARD-LEKSREDSTVA, JSC (Russia)

ATC Code

M02AA15 (Diclofenac)

Active Substance

Diclofenac (Rec.INN registered by WHO)

Dosage Form

DiclArtis®

Transdermal patch 15 mg/day: pkg. 2, 5, 7 or 10 pcs.

Dosage Form, Packaging, and Composition

Transdermal patch of rectangular shape with rounded edges, consisting of a non-woven base (polyester) of orange-brown color with a uniformly applied adhesive layer of transparent color, with a faint smell of menthol; the adhesive surface is covered with a protective film made of polyethylene terephthalate; patch dimensions 70×100 mm (70 cm²).

Excipients: acrylate-vinyl acetate copolymer – 339.5 mg, sorbitan sesquioleate – 10 mg, polyoxyethylene (2) lauryl ether (BL2) – 40 mg, aluminum acetoacetate solution – 30 mg, L-menthol – 40 mg, ethyl acetate – 60 mg, non-woven base – 70 cm², polyethylene terephthalate protective film – 70 cm².

2 pcs. – heat-sealed bags (1) – cardboard packs.
5 pcs. – heat-sealed bags (1) – cardboard packs.
7 pcs. – heat-sealed bags (1) – cardboard packs.
10 pcs. – heat-sealed bags (1) – cardboard packs.

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

Nonsteroidal anti-inflammatory drug

Pharmacological Action

NSAID, a derivative of phenylacetic acid. It has anti-inflammatory and analgesic effects. The mechanism of action is due to the inhibition of COX-1 and COX-2 activity, which leads to a disruption in the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

It leads to the disappearance or reduction of pain at the application site, reduces joint pain at rest and during movement, as well as morning stiffness and joint swelling. Promotes an increase in the range of motion in the affected joints.

Pharmacokinetics

The amount of diclofenac absorbed through the skin is proportional to the size of the area to which the drug is applied and depends on the total dose applied and the degree of skin hydration.

The amount of diclofenac absorbed systemically after transdermal application is similar to that after topical application of an equivalent amount of the drug.

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

The metabolism of diclofenac involves stages of single and multiple hydroxylation followed by glucuronidation and glucuronidation of the whole molecule.

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

The terminal T_1/2 is 1-2 h. The T_1/2 of metabolites, including two pharmacologically active ones, is also short and is 1-3 h. One of the metabolites (3'-hydroxy-4'-methoxydiclofenac) has a longer T_1/2, but this metabolite is completely inactive. Most of the diclofenac and its metabolites are excreted in the urine.

Indications

Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica); joint pain (including finger joints, knees) 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 (tenosynovitis, bursitis, lesions of periarticular tissues).

ICD codes

Dosage Regimen

Apply to the skin in the form of applications.

For adults, elderly patients, and adolescents over 15 years old, the patch is applied to the skin over the painful area for 24 hours. Only 1 patch may be used within 24 hours.

When treating soft tissue injuries, the patch should be used for no more than 14 days, and when treating muscle and joint diseases – for no more than 21 days, unless otherwise recommended by a doctor.

If there is no improvement in the condition after 7 days and if you feel worse, you should consult a doctor.

Adverse Reactions

Definition of the frequency of adverse reactions: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10 000, <1/1000) and very rare (<10 000), frequency unknown (frequency of occurrence cannot be determined from the available data).

Infections and infestations: very rare – pustular rash.

Immune system disorders: very rare – generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioedema).

Respiratory, thoracic and mediastinal disorders: very rare – asthma attacks, bronchospastic reactions.

Skin and subcutaneous tissue disorders: common – erythema, dermatitis, including contact dermatitis (symptoms: eczema, itching, swelling of the treated skin area, rash, papules, vesicles, peeling); rare – bullous dermatitis; very rare – photosensitivity reactions.

Contraindications

“Aspirin triad” (attacks of bronchial asthma, urticaria and acute rhinitis when taking acetylsalicylic acid or other NSAIDs); impaired skin integrity at the site of application of the drug; third trimester of pregnancy; lactation period (breastfeeding); children under 15 years of age; hypersensitivity to diclofenac, other NSAIDs or to any of the excipients of the drug used.

With caution: hepatic porphyria (in the acute phase); erosive and ulcerative lesions of the gastrointestinal tract; severe impairment of liver and kidney function; chronic heart failure; bronchial asthma; first and second trimesters of pregnancy; elderly patients.

Use in Pregnancy and Lactation

Contraindicated in the third trimester of pregnancy due to the possibility of reducing uterine tone and/or premature closure of the fetal arterial duct.

Use in the first and second trimesters of pregnancy is possible in cases where the potential benefit to the mother outweighs the potential risk to the fetus or infant.

Use during lactation (breastfeeding) is contraindicated.

Use in Hepatic Impairment

Use with particular caution in patients with a history of liver disease.

Use in Renal Impairment

Use with particular caution in patients with a history of kidney disease.

Pediatric Use

Not recommended for use in children under 6 years of age.

Geriatric Use

Use with particular caution in elderly patients.

Special Precautions

Apply only to intact skin areas.

Avoid contact of the drug with eyes, mucous membranes, or open wounds.

Should not be used under airtight (occlusive) dressings.

Caution is required when applying large amounts of the drug to large areas of sensitive skin for a prolonged period. When used with other dosage forms of diclofenac, the total maximum daily dose should be taken into account.

Avoid prolonged exposure to sunlight during use.

Drug Interactions

Drugs that cause photosensitization – enhancement of the effect of drugs that can cause photosensitization.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.