Instruction for use: Dicloran plus

ATX Code M02AA15 Diclofenac

Pharmacological group

Non-steroidal anti-inflammatory drug [NSAIDs - Acetic acid derivatives and related compounds in combinations]

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

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

M42.9 Osteochondrosis of spine, unspecified

Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Diseases of the spinal column, Osteochondrosis of the spine with radicular syndrome

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

M54.9 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

M65.9 Synovitis and tendosynovitis, unspecified

Synovitis, Inflammation of the tendon sheath, Acute nonspecific tenosynovitis, Reactive synovitis

M71.9 Bursopathy, unspecified

Bursites, Alberta disease, Acute bursitis

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

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 and form of release

Gel for external use 1 g

active substances:

diclofenac diethylamine 11.61 mg

which is equivalent to diclofenac sodium 10 mg

flax seed oil 30 mg

levomenthol 50 mg

methyl salicylate 100 mg

auxiliary substances: butylhydroxyanisole 0.2 mg; butylhydroxytoluene - 2 mg; benzyl alcohol - 10 μl; disodium edetate - 1 mg; diethylamine - 7.1 μl; carbomer 980 - 10.8 mg; citric acid monohydrate - 1 mg; macrogol glyceryl hydroxy stearate (Cremophor RH-40) 35 mg; propylene glycol 100 mg; water - c. demand. up to 1 g

in plastic tubes of 10, 30 or 50 g; in a pack of cardboard 1 tuba.

pharmachologic effect

Pharmacological action - analgesic, anti-inflammatory local.

Pharmacodynamics

NSAIDs for external use. Has a local analgesic, anti-inflammatory and anti-exsudative action. Diclofenac sodium and methyl salicylate are NSAIDs, the mechanism of action of which is due to suppression of GH synthesis. With topical application reduce pain and inflammation in the joints, morning stiffness and swelling of the joints, contribute to an increase in the volume of movements.

The main component of linseed oil is α-linolenic acid, which also has an anti-inflammatory effect.

Levomenthol causes irritation of nerve endings, has a local distracting and easy analgesic effect, causes a feeling of coolness in the place of application of the drug.

Pharmacokinetics

When topical application of diclofenac sodium, methyl salicylate and linseed oil are absorbed and penetrate into the subcutaneous tissue, muscle tissue and the joint capsule.

Indications

diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine, osteochondrosis with radicular syndrome, sciatica);

rheumatic affections of soft tissues (tendovaginitis, bursitis);

muscular pains of rheumatic and non-rheumatic origin (including those caused by excessive physical exertion);

posttraumatic inflammation of soft tissues and joints (due to stretching, overstrain and bruises).

Contraindications

Hypersensitivity to diclofenac, methyl salicylate or other components included in the preparation; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including in the anamnesis); pregnancy (III trimester); lactation period (breastfeeding); children's age (up to 6 years); violation of the integrity of the skin.

With caution: should appoint the drug for severe violations of liver and kidney function, bronchial asthma, in the I and II trimesters of pregnancy, elderly patients.

pregnancy and lactation

The drug is contraindicated in the III trimester of pregnancy. The question of the use of the drug in the first and second trimesters of pregnancy is decided individually.

Due to the lack of experience in the use of Dicloran® Plus in the lactation period, the use of the drug in this period is contraindicated.

Side effects

Local reactions: eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated area of the skin, papules, vesicles, peeling).

Systemic reactions: generalized skin rash, allergic reactions (hives, angioedema, bronchospastic reactions).

Interaction

Diclofenac can enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.

Dosing and Administration

Outwardly. Adults and children over 12 years of age, the drug is applied to the skin 3-4 times a day and lightly rubbed. The required amount of the drug depends on the size of the painful area. A single dose of the drug - 2-4 g (4-8 cm with a fully open neck of the tube). Children from 6 to 12 years of age should not be used more than 2 times a day, a single dose of the drug - up to 2 g.

The duration of treatment without consulting a doctor should not exceed 10 days.

The doctor decides whether to prolong the use of the drug individually.

Overdose

Symptoms: when applied externally at recommended doses, extremely low systemic absorption of the active components of the drug makes an overdose almost impossible. With accidental ingestion, it is possible to develop systemic side effects.

Treatment for ingestion: gastric lavage, induction of vomiting, the appointment of activated charcoal, forced diuresis, symptomatic therapy. Dialysis is ineffective due to the high degree of binding of diclofenac to plasma proteins (about 99%).

Precautionary measures

For external use only. Dicloran® Plus should only be applied to intact skin, avoiding exposure to open wounds. After applying the gel, do not apply an occlusive bandage. With prolonged application to open surfaces, it is possible to develop systemic side effects due to resorptive action. Do not allow the drug to enter the eyes and mucous membranes.

special instructions

If the medicine has become unusable or the expiration date has expired, do not throw it into sewage or into the street. It is necessary to put the medicine in a bag and put it in a garbage container. These measures will help protect the environment.

Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. The drug does not affect the ability to drive and maintain moving mechanical equipment.

Conditions of leave from pharmacies

Without recipe.

storage conditions

At temperatures not higher than 30 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of Dicloran® Plus

3 years.

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