Instruction for use: Dolgit

Active substance Ibuprofen

ATX code M02AÀ13 Ibuprofen

Pharmacological group

Non-steroidal anti-inflammatory drug (NSAID) [NSAIDs - Propionic acid derivatives]

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 of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M07.3 Other psoriatic arthropathies (L40.5 +)

Arthritis psoriatic, The generalized form of psoriatic arthritis, Psoriatic arthritis

M10.9 Gout, unspecified

Arthritis Gouty, Acute gouty arthritis, Acute attack of gout, Gouty Arthritis, Articular syndrome with exacerbation of gout, Articular syndrome with gout, Urarturia, Chronic arthritic arthritis, Acute gout, Salt diathesis

M13.9 Arthritis, unspecified

Arthritis,Purulent arthritis (non-infectious), acute Arthritis,Pain in acute inflammatory diseases of the musculoskeletal system,Pain in chronic inflammatory diseases of the musculoskeletal system,The pain in osteoarthritis, Inflammation in osteoarthritis, Inflammatory arthropathy, Inflammatory and degenerative joint diseases, Inflammatory disease of the musculoskeletal system, Inflammatory joint disease, Inflammatory diseases of the musculoskeletal system, destructive arthritis, The disease of the musculoskeletal system, Diseases of the musculoskeletal system, Diseases of the musculoskeletal system and connective tissue, Infections musculoskeletal system, monoartrit, Non-infectious arthritis, rheumatic arthritis, Osteoarthritis, Acute inflammation of the musculoskeletal tissue, Acute inflammatory diseases of the musculoskeletal system, Acute inflammatory condition of the musculoskeletal system, Acute arthritis, Acute osteoarthritis, Post-traumatic osteoarthritis, Reactive arthritis, Chronic inflammatory diseases of the joints, Chronic arthritis, Chronic inflammatory arthritis, Chronic inflammation of the inner layer of the joint capsule, Chronic inflammation of the joint capsule,Chronic inflammatory disease of the joints, Exudative arthritis

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

M25.9 Joint disease, unspecified

Arthropathy, Diseases of the joints, Swelling in the joints, Swelling of the joints, Articular Syndrome, Edema after interventions during sprains

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

M42 Osteochondrosis

Pain in spinal osteochondrosis, Cervical osteochondrosis, Radicular syndrome in osteochondrosis, intervertebral osteochondrosis, osteochondrosis, Osteochondrosis with radicular syndrome, Osteocondritis of the spine

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

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

M71 Other bursopathies

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

M75.0 Adhesive shoulder capsulitis

Acute shoulder-scapular periarthritis, Duplay's disease, Duplay Syndrome, Frozen shoulder, Shoulder-shoulder periarthritis, Periarteritis humeroscapular, Shoulder periarthritis, Pleiraptocular periarthritis, Capsule, Frozen shoulder

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

M95.8 Other specified musculoskeletal deformities

Degenerative and dystrophic disease of the musculoskeletal system ,Degenerative disease of the musculoskeletal system, Obmenno-dystrophic diseases of the musculoskeletal system

R60.0 Localized swelling

Allergic laryngeal edema, Local swelling, local edema, localized swelling, Swelling of the lower extremities, Swelling caused by inflammation of the tendon sheath, The swelling after dental surgery, Swelling of the mucosa of the nasopharynx, Swelling of traumatic origin, Traumatic edema, Swelling with injuries, Post-traumatic swelling, Post-traumatic edema, Post-traumatic soft tissue edema, Traumatic edema, Edema oral

T14.0 Surface injury of unspecified body region

Abrasions, Scratch, Skin Wounds, Wounds of soft tissues, Hematoma, Hematoma of traumatic origin, Hematomas, Hematomas of muscles, Hematomas of soft tissues, Healing of the skin, Bruise, Bruising due to sprains and bruises, Microtrauma, External bruises, Small combing, Superficial hematoma, Superficial damage to the skin and mucous membranes, Subcutaneous hematoma, Post-traumatic hematoma, Post-traumatic disturbance of microcirculation, Skinness of the skin, Traumatic plexus lesions, Injury, Contusion of soft tissues, Joint bruise, Traumatic bruises, Traumatic injury, Primary treatment of surface contaminated wounds, Abrasion, Bruise

T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of the joint of the unspecified area of the body

Painful stretching of muscles, Pain and inflammation in tension, Dislocation of dislocation, Degenerative changes in the ligamentous apparatus, Edema due to sprains and bruises, Edema after interventions for sprains, Damage and rupture of ligaments, The musculoskeletal system is damaged, Damage to ligaments, Damage to the joints, Ligament ruptures, Tendon tendons,Ruptures of the tendons of muscles,Stretching, Crick, Stretching of the muscle, Sprain, Tension of the tendons, Extensions,Stretch muscles, Sprains, Tension of the tendons, Injury of the musculoskeletal system, Injuries to the joints, Injuries of capsule-articular tissues, Injuries of the osteoarticular system, Injuries to ligamentsInjuries to the joints, Joint wounds, Stretching of the ligamentous apparatus, Habitual stretching and tearing

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

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

Composition

Cream for external use 100 g

active substance:

ibuprofen 5 g

auxiliary substances: medium-chain triglycerides; purified water; glyceryl monostearate; propylene glycol; macrogol-100-stearate; macrogol-30-stearate; gum xanthan (Keltrol F); methylparahydroxybenzoate sodium; lavender oil; orange flowers oil (neroli oil)

Gel for external use 100 g

active substance:

ibuprofen 5 g

auxiliary substances: isopropanol; dimethylhydroxymethyldioxolane (Salketal); poloxamer a, b, c = 101, 56, 101 (Poloxamer 407, Pluronic F 127); medium chain triglycerides (Miglyol 812); purified water; lavender oil; orange flowers oil (neroli oil)

Description of dosage form

Cream: smooth, soft, from white to white with a creamy shade of color with a slight specific odor.

Gel: clear, colorless, with a characteristic odor.

pharmachologic effect

Pharmacological action - anti-inflammatory, decongestant, local anesthetic.

Pharmacodynamics

The cream has a local anesthetic, anti-inflammatory and anti-edematic effect.

The gel has a local anesthetic and anti-inflammatory effect.

Common for cream and gel

Suppresses the production of inflammatory mediators. Non-selectively blocks COX-1 and COX-2 and has an inhibitory effect on the synthesis of PGE2, prostacyclin (PGI2) and thromboxane (TB2). Analgesic effect is most pronounced for inflammatory pains. It causes a decrease or disappearance of the pain syndrome, incl. pain in rest and movement; reduces the morning stiffness and swelling of the joints. Promotes an increase in the volume of movements. In addition to the anti-inflammatory effect, ibuprofen reduces platelet aggregation at the site of inflammation, as well as migration of leukocytes and the release of lysosomal enzymes in the inflammation zone.

Pharmacokinetics

When the cream / gel is applied to the skin, ibuprofen penetrates into deeper tissues (subcutaneous tissue, muscles, joints, synovial fluid) and reaches therapeutic concentrations in them. The therapeutic effect in the area of application is achieved by direct distribution through the skin in the target tissue. In an insignificant amount is determined in blood plasma. With the recommended method of application, the concentration in the synovial fluid is about 2 μg / ml.

Indications

inflammatory and degenerative diseases of the musculoskeletal system: articular syndrome with exacerbation of gout, arthritis (rheumatoid, psoriatic, gouty), humerous periarthritis, ankylosing spondylitis (Bechterew's disease), deforming osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, tendonitis, tendovaginitis, bursitis, lumbago, sciatica;

muscular pain (myalgia) of rheumatic and non-rheumatic origin;

injuries (sports, industrial, household) without disrupting the integrity of the skin (dislocations, sprains or ruptures of muscles and ligaments, bruises, posttraumatic swelling of soft tissues).

Contraindications

Common for cream and gel

hypersensitivity to ibuprofen, other components of the drug and other NSAIDs;

wetting dermatoses, eczema;

violation of the integrity of the skin (including infected abrasions and wounds) at the site of application of the cream / gel.

Optional for cream

pregnancy, lactation;

children's age till 14 years.

Optional for gel

A bronchial asthma, a urticaria, a rhinitis caused by reception of an acetylsalicylic acid;

pregnancy (III trimester);

children under 12 years.

With caution: pregnancy (I-II trimester), lactation.

Side effects

Usually the drug is well tolerated. In rare cases, temporary signs of local irritation of the skin in the form of redness, swelling, rashes, itching of the skin, a burning sensation and tingling may occur. In the case of hypersensitivity to NSAIDs, the phenomena of bronchospasm are possible. With prolonged use of the drug in particularly sensitive patients, it is possible to develop systemic side effects, upon appearance of which it is necessary to stop using the drug and consult a doctor.

Interaction

Cream. You should consult your doctor before using the drug if any other medicines are used.

Gel. Drug interaction with other drugs is not described. However, it should be borne in mind that even with topical application ibuprofen has a systemic effect and, theoretically, with simultaneous use with other NSAIDs, side effects can be exacerbated.

Dosing and Administration

Outwardly.

Cream. Apply on the skin in the area of the painful area 3-4 times a day and rub with light movements until the drug is completely absorbed. A strip of cream 4-10 cm long is used, depending on the area of the affected surface.

The duration of treatment depends on the severity of the disease and the nature of the damage and is on average 2-3 weeks.

Gel. A strip of gel 5-10 cm long is applied to the area of injury and carefully rubbed with light movements until completely absorbed 3-4 times a day.

The duration of treatment depends on the severity of the disease and the nature of the damage and is on average 2-3 weeks.

Gel. A strip of gel 5-10 cm long is applied to the area of injury and carefully rubbed with light movements until completely absorbed 3-4 times a day.

The duration of treatment depends on the severity of the disease and the nature of the damage and is on average 2-3 weeks.

Overdose

Cases of an overdose of cream or gel are not described.

Treatment: In case of accidental ingestion, it is necessary to clean the stomach (induce vomiting, prescribe activated charcoal) and consult a doctor. Further treatment, if necessary, symptomatic.

special instructions

In severe cases, combined use of the cream or gel is recommended externally with the administration of other medicinal forms of NSAIDs (parenterally, orally, rectally).

Avoid contact with the cream or gel in the eyes and other mucous membranes.

Influence on the ability to drive vehicles or perform work that requires an increased speed of physical and mental reactions. The use of the drug does not affect the ability to engage in activities requiring increased attention, coordination of movements, high speed of mental and physical reactions (for example, vehicle management, work with complex mechanisms, etc.).

Form of issue

Cream for external use, 5%. In aluminum tubes of 20 g, 50 g and 100 g, sealed with a membrane and screwed on a plastic cap. One tube in a cardboard box.

Gel for external use, 5%. In aluminum tubes with an internal protective lacquer coating of 20, 50 or 100 g, sealed with a membrane and screwed on a plastic cap. One tube in a cardboard box.

Conditions of leave from pharmacies

Without recipe.

storage Conditions

In a dry place, at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life

cream for external use 5% - 3 years.

gel for external use 5% - 2.5 years.

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