Instruction for use: Voltaren

Active substance Diclofenac

ATX Code M02AA15 Diclofenac

Pharmacological group

Non-steroidal anti-inflammatory drug (NSAID) [NSAIDs - Acetic acid derivatives and related compounds]

Nosological classification (ICD-10)

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis, Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid periarthritis, Rheumatoid polyarthritis, Acute Rheumatic Arthritis, Acute rheumatism

M17 Gonarthrosis [arthrosis of the knee]

Knee osteoarthritis, Gonarthrosis

M18 Osteoarthritis of the first carpometacarpal joint

Osteoarthritis of small joints of hands

M19.8 Other specified arthrosis

Osteoarthritis of temporomandibular joint, Osteoarthritis of small joints of legs, Osteoarthritis of small joints of hands, Exacerbation of degenerative arthrosis, Primary osteoarthritis with knee and / or hip joint damage, Osteoarthritis of the fingers,Osteoarthrosis of the first metatarsophalangeal joint

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M35.3 Rheumatic polymyalgia

Pseudoarthritis rhizomelic, Rheumatic polymyalgia, Pain syndrome in rheumatic diseases, Muscle pain with rheumatism, Extra-articular rheumatism, Extra-articular rheumatic syndrome, Extra-articular rheumatic diseases, Extra-articular rheumatic soft tissue injury, Extra-articular forms of rheumatism, Rheumatic soft tissue damage, Rheumatism of soft tissues, Rheumatic diseases of soft tissues, Rheumatic diseases of the periarticular soft tissues, Rheumatic affections of soft tissues, Rheumatic collagen diseases

M54.1 Radiculopathy

Acute sciatica, Radiculopathy, Radiculitis, Radiculitis with radicular syndrome, Acute radiculopathy, Pain syndrome with radiculitis, Subacute radiculitis, Radiculitis, Chronic radiculitis, Diseases of the spinal column

M54.3 Sciatica

Ishialgia, Neuralgia of the sciatic nerve, Sciatic neuritis

M54.4 Lumbago with sciatica

Pain in the lumbosacral spine, Lumbago, Sciatica, Lumbar syndrome

M54.9 Dorsalgia, unspecified

Pain syndrome with radiculitis, Pain syndrome in the back,Pain with radiculitis, Degenerative changes in the spine, Degenerative and dystrophic disease of the spine and joints, Degenerative disease of the spine, Osteoarthrosis of the spine, Painful lesions of the spine

M65 Synovitis and tendosynovitis

Acute tenosynovitis, Tendovaginitis (tenovaginitis), Tendosinovit (tenosynovitis), Tendovaginitis, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Nonspecific tenosynovitis, Tendosinovit

M70 Diseases of soft tissues associated with exercise, overload and pressure

M71 Other bursopathies

Bursitis, Bursopathy, Diseases of soft tissues, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Subacute bursitis

M77.9 Other unspecified

Capsule, Periarthritis, Tendonitis, Tendopathy, Periarthropathy

M79.0 Other unspecified rheumatism

Degenerative rheumatic disease, Degenerative and rheumatic diseases of the tendons, Degenerative rheumatic diseases, Localized forms of rheumatism of soft tissues, Rheumatism, Rheumatism with a pronounced allergic component, Rheumatism of the articular and extraarticular, Rheumatic attack, Rheumatic complaints, Rheumatic diseases, Rheumatic disease of the spine, Relapses of rheumatism, Articular and extra-articular rheumatism, Articular and muscular rheumatism, Articular rheumatism, Articular syndrome with rheumatism, Chronic rheumatic pain, Chronic articular rheumatism, Rheumatoid diseases, Rheumatic diseases of the intervertebral disc

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

M79.6 Pain in the limb

Pain in the posterior space, Pain with changes in pseudofalangeal joints, Pain in the upper extremity, Pain in the legs, Pain in the toes, Pain in the feet, Pain of the extremities, Pain in the legs, Pain and a feeling of heaviness in the legs, Pain in the musculoskeletal system, Pain in the heel

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

R68.8.0 * Inflammatory syndrome

Painful syndrome of inflammatory genesis, Pain syndrome with inflammation of non-rheumatic nature, Pain syndrome with inflammatory lesions of the peripheral nervous system, Painful inflammation of the shoulder joint, Painful inflammation after trauma or surgery, Painful inflammation after surgery, Painful hemorrhoids, Inflammation of the tympanic membrane, Inflammation of the larynx, Inflammation of the gums, Inflammation of cellulose, Inflammation of lymph nodes, Tonsillitis, Inflammation of muscles, Inflammation of soft tissues, Inflammation of the mouth, Inflammation after surgery and trauma, Inflammation after orthopedic surgery, Inflammation after trauma, Inflammation in rheumatoid arthritis, Inflammation of the middle ear, Inflammatory gum disease, Inflammatory diseases of the eyelids, Inflammatory eye diseases, Inflammatory swelling of soft tissues, Inflammatory processes, Inflammatory processes after surgical interventions, Inflammatory process, Inflammatory Syndrome, Inflammatory syndrome of non-rheumatic origin, Inflammatory syndrome after surgery, Purulent infections, Infringements of function of a liver of an inflammatory etiology, Acute inflammation of the musculoskeletal tissue, Pre-inflammatory soft tissue inflammation

T13.0 Superficial injury of lower limb, level unspecified

T13.3 Trauma of unspecified nerve of lower limb, level unspecified

T14.6 Injury of muscles and tendons of unspecified body region

Pain syndrome in the pathology of tendons, Pain in tendons, Pre-inflammatory soft tissue inflammation, Muscle rupture, Rupture of muscles without compromising the integrity of the skin, Muscle ruptures, Soft tissue injuries, Injuries of muscle-tendon tissues, Muscle injuries, Soft tissue injuries, Injuries to tendons

Composition

Transdermal patch 15 mg / day (70 cm2) 1 plaster

active substance:

diclofenac sodium (1%) 15 mg

auxiliary substances: 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; Esterized gum - 300 mg; mercaptobenzimidazole - 3.7 mg; butylhydroxytoluene - 3.7 mg; paraffin liquid - up to 1500 mg; base of polyester fibers (50 den) - 70 cm2; protective film of polyester (thickness 75 microns) - 70 cm2

Transdermal patch 30 mg / day (140 cm2) 1 plaster

active substance:

diclofenac sodium (1%) 30 mg

auxiliary substances: levomenthol - 45 mg; methylpyrrolidone 120 mg; propylene glycol esters of fatty acids - 60 mg; citric acid - 12 mg; isoprene-styrene copolymer-1072.2 mg; polyisobutylene - 60 mg; gum etherified - 600 mg; mercaptobenzimidazole 7.4 mg; butylhydroxytoluene 7.4 mg; paraffin liquid - up to 3000 mg; base of polyester fibers (50 den) - 140 cm2; protective film of polyester (thickness 75 microns) - 140 cm2

Description of dosage form

Transdermal patch, 15 mg / day. Rectangular shape with rounded edges, consisting of a polyester beige base with a uniformly applied adhesive layer from colorless to pale yellow with a weak aromatic odor. Adhesive surface is covered with a transparent protective film of PE with two transverse notches, one of which has a wavy line. A transparent film is shown on the transparent protective film showing how to remove the film from the surface of the patch. The dimensions are 70 × 100 mm.

Transdermal patch, 30 mg / day. Rectangular with rounded edges, consisting of a polyester beige base with a uniformly applied adhesive layer from colorless to pale yellow with a weak aromatic odor. Adhesive surface is covered with a transparent protective film of PE with two transverse notches, one of which has a wavy line. A transparent film is shown on the transparent protective film showing how to remove the film from the surface of the patch. The dimensions are 100 × 140 mm.

pharmachologic effect

Pharmacological action - anti-inflammatory local, analgesic local.

Pharmacodynamics

Voltaren® in the form of a transdermal patch is the basis with the applied adhesive layer containing diclofenac, which has pronounced analgesic and anti-inflammatory properties. The mechanisms of diclofenac action are based on the inhibition of PG synthesis. Plaster Voltaren® provides anti-inflammatory and analgesic action at the site of application, eliminating pain syndrome 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 within 24 hours is similar to that when an equivalent amount of Voltaren® Emulgel® is used (1% gel for external use). 99.7% of diclofenac binds to serum proteins, mainly - to albumin (99.4%).

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

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

In patients with impaired renal function, no cumulation of diclofenac and its metabolites occurs. In patients with chronic hepatitis or undi-compensated cirrhosis, the kinetics and metabolism of diclofenac follow the same pattern as in patients who do not have liver disease. Preclinical studies have shown the safety of the drug.

Indications

pain in the back with inflammatory and degenerative diseases of the spine (radiculitis, osteoarthrosis, lumbago, sciatica);

pain in the joints (joints of the fingers, knees, etc.) with rheumatoid arthritis, osteoarthritis;

pain in muscles (due to stretching, overstrain, bruises, injuries);

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

Contraindications

hypersensitivity to diclofenac or other components of the drug;

propensity to occurrence of attacks of a bronchial asthma, skin rashes or sharp rhinitis at application of acetylsalicylic acid or other NSAIDs;

pregnancy (III trimester);

violation of the integrity of the skin in the place of the alleged gluing of the patch;

breast-feeding;

children's age (up to 15 years).

With caution: hepatic porphyria (exacerbation); erosive and ulcerative lesions of the gastrointestinal tract; severe violations of the liver and kidneys; chronic heart failure; bronchial asthma; elderly age.

pregnancy and lactation

The use of the drug in pregnant women has not been studied, so the transdermal patch Voltaren® should not be used during pregnancy, especially in the third trimester because of the possibility of lowering the tone of the uterus and / or premature closure of the arterial duct of the fetus.

Studies in animals have not revealed any direct or indirect adverse effects on pregnancy, childbirth, embryonic and postembryonic development.

There is no data on the penetration of the drug into breast milk, so the transdermal patch Voltaren® is not recommended for breastfeeding.

Side effects

Undesirable reactions are mainly characterized by moderately expressed and passing skin manifestations at the place of patch application.

Very rare manifestations (<1/10000)

Local reactions: pustular eruptions.

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

Rare (≥1 / 10000, <1/1000)

Local reactions: bullous dermatitis.

Frequent occurrences (≥1 / 100, <1/10)

Local reactions: erythema, dermatitis, incl. contact dermatitis (symptoms - erythema, pruritus, swelling of the treated area of the skin, rash, papules, vesicles, peeling), eczema.

Interaction

The patch of Voltaren® can enhance the effect of drugs that cause photosensitivity.

Clinically significant interaction with other drugs is not described.

Dosing and Administration

External, in the form of applications on the skin.

Adults and adolescents older than 15 years: the transdermal patch Voltaren® is glued on the skin over the painful area for 24 hours. Only 1 patch is allowed within 24 hours.

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

In the treatment of soft tissue injuries, the transdermal Voltaren® patch is used no more than 14 days, and in the treatment of muscle and joint diseases - no more than 21 days, unless there are special recommendations of the doctor.

If there is no improvement in the condition after 7 days and with a deterioration of well-being, it is necessary to consult a doctor.

Children. It is not recommended to use the Voltaren® patch in children under the age of 15 years.

The elderly. Similar to the method of administration and doses for adults.

Overdose

Extremely low systemic absorption of active ingredients and dosage form of the drug with external application makes an overdose almost impossible.

special instructions

Transdermal patch Voltaren ® should be glued only to intact skin, avoiding contact with open wounds. Do not allow the drug to enter the eyes and mucous membranes.

When using transdermal Voltaren® patch for too long, the possibility of developing systemic adverse reactions can not be ruled out. With the additional use of other dosage forms of diclofenac, its quantitative content in the plaster should be taken into account so as not to exceed the maximum daily dose of diclofenac (150 mg / day).

Influence on ability of driving of motor transport and management of mechanisms. Does not affect.

Form of issue

Transdermal patch, 15 mg / day (area 70 cm2). By 2, 5, 7 or 10 patches in a package of aluminum foil. On a package put the information from section Markings or paste a label on which the information from this section is put. The package is placed in a cardboard box.

Transdermal patch, 30 mg / day (area 140 cm2). For 2, 5, 7 or 10 patches in an aluminum foil bag with Zip-Lock buckle for repeated opening. On a package put the information from section Markings or paste a label on which the information from this section is put. The package is placed in a cardboard box.

Conditions of leave from pharmacies

Without recipe.

Storage conditions

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf Life

2 years.

Do not use after the expiry date printed on the package.