Arthrosilen, gel 5% 50 g

It has anti-inflammatory, analgesic and antipyretic effects. By inhibiting COX-1 and -2 it inhibits the synthesis of PG. It has anti-bradykinin activity, stabilizes lysosomal membranes and inhibits the release of enzymes from them that contribute to tissue destruction during chronic inflammation. It reduces release of cytokines, inhibits activity of neutrophils.

Limits morning stiffness and swelling of the joints and increases range of motion.

Ketoprofen lysine salt, unlike ketoprofen, is a rapidly soluble molecule with a neutral pH and is almost non-irritating to the gastrointestinal tract.

When used topically, it has a local anti-inflammatory, anti-exudative and analgesic effect. In the form of a spray or gel it provides local therapeutic effect on the affected joints, tendons, ligaments, muscles. < br>

In joint syndrome, it relieves joint pain at rest and on movement, reduces morning stiffness and joint swelling. The lysine salt of ketoprofen has no catabolic effect on articular cartilage.

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Indications

Diseases of the musculoskeletal system (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine, rheumatic lesions of soft tissues).
Muscle pain of rheumatic and non-rheumatic origin.
Traumatic injuries of soft tissues.

Pharmacological effect

It has anti-inflammatory, analgesic and antipyretic effects. By inhibiting COX-1 and -2, it inhibits the synthesis of PG. It has anti-bradykinin activity, stabilizes lysosomal membranes and delays the release of enzymes from them that contribute to tissue destruction during chronic inflammation. Reduces the release of cytokines, inhibits the activity of neutrophils.

Reduces morning stiffness and swelling of joints, increases range of motion.

Ketoprofen lysine salt, unlike ketoprofen, is a rapidly soluble molecule with a neutral pH and is almost non-irritating to the gastrointestinal tract.

When applied topically, it has local anti-inflammatory, antiexudative and analgesic effects. In the form of a spray or gel, it provides a local therapeutic effect on affected joints, tendons, ligaments, and muscles.

In case of articular syndrome, it causes a decrease in joint pain at rest and during movement, a decrease in morning stiffness and swelling of the joints. The lysine salt of ketoprofen does not have a catabolic effect on articular cartilage.

Special instructions

The drug should be applied only to intact skin. Avoid contact with eyes and mucous membranes.

To avoid hypersensitivity and photosensitivity, it is recommended to avoid exposure of the skin to sunlight during the course of treatment.

Active ingredient

Ketoprofen

Composition

1 g of gel contains ketoprofen lysine salt 50 mg

Pregnancy

Cannot be used in the third trimester of pregnancy.

There is no experience with the use of Artrosilene during lactation.

Use in the first and second trimesters is possible only after consultation with a doctor.

Contraindicated for children under 6 years of age.

Contraindications

Hypersensitivity, incl. to other NSAIDs.
Aspirin asthma.
Lactation period.
Peptic ulcer of the stomach and duodenum in the acute phase, peptic ulcer.
Ulcerative colitis in the acute phase.
Crohn’s disease.
Diverticulitis.
Hemophilia and other blood clotting disorders.
Chronic renal failure.
Weeping dermatoses.
Eczema.
Violation of the integrity of the skin.

Side Effects

From the gastrointestinal tract: abdominal pain, diarrhea, stomatitis, esophagitis, gastritis, duodenitis, erosive and ulcerative lesions of the gastrointestinal tract, hematomesis, melena.

From the liver: increased bilirubin levels, increased activity of liver enzymes, hepatitis, liver failure, increased liver size.

From the nervous system: dizziness, hyperkinesia, tremor, vertigo, mood swings, anxiety, hallucinations, irritability, general malaise.

From the senses: conjunctivitis, visual impairment.

From the skin: urticaria, angioedema, erythematous exanthema, itching, maculopapular exanthema, increased sweating, exudative erythema multiforme (including Stevens-Johnson syndrome).

From the genitourinary system: painful urination, cystitis, edema, hematuria, menstrual irregularities.

From the hematopoietic organs: leukocytopenia, leukocytosis, lymphangitis, decreased PV, thrombocytopenia, thrombocytopenic purpura, enlarged spleen, vasculitis.

From the respiratory system: bronchospasm, dyspnea, sensation of laryngeal spasm, laryngospasm, laryngeal edema, rhinitis.

From the cardiovascular system: hypertension, hypotension, tachycardia, chest pain, syncope, peripheral edema, pallor.

Allergic reactions: anaphylactoid reactions, swelling of the oral mucosa, pharyngeal edema, periorbital edema.

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants), when used simultaneously with the drug Artrosilene, increase the metabolism of ketoprofen (increase the production of hydroxylated active metabolites).

During simultaneous use with the drug Artrosilene, the effectiveness of uricosuric drugs decreases, the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, and the side effects of mineralocorticoids, glucocorticoids, and estrogens are enhanced; the effectiveness of antihypertensive drugs and diuretics decreases.

The simultaneous use of the drug Artrosilene with other NSAIDs, corticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, increasing the risk of developing renal dysfunction.

The simultaneous administration of Artrosilene with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandole and cefotetan increases the risk of bleeding.

The drug Artrosilene, when used simultaneously, enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

The combined administration of Artrosilene with sodium valproate causes a violation of platelet aggregation.

Ketoprofen, when used simultaneously, increases the plasma concentration of verapamil and nifedipine, lithium, and methotrexate.

Antacids and cholestyramine, when taken orally with Artrosilene, reduce the absorption of ketoprofen.

Overdose

Currently, no cases of overdose with Artrosilene have been reported.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Doppel Pharmaceutici S.R.L., Italy