Diclovit, gel for external use 1% 20g

Composition

The Active ingredient is diclofenac sodium 10 mg;excipients — lactic acid — 0,44 mg (in terms of 100% substance), isopropanol — 150 mg, ethanol is 150 mg, sodium disulfite — 0.5 mg, karbomer — to 15 mg, trolamine to 30 mg (to obtain a gel with a pH of 7.0 to 8.5), water — up to 1 g.

Pharmacological action

The active component of diclofenac is a nonsteroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase types 1 and 2, it disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation. Diclovit® is used to eliminate pain and reduce swelling associated with the inflammatory process. When applied externally, it reduces or disappears joint pain at rest and when moving. Reduces morning stiffness and swelling of the joints, helps to increase the volume of movement in the affected joints. The water-alcohol base of the gel additionally has a local anesthetic effect.

Indications

Inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis, rheumatic soft tissue lesions, gouty arthritis). Pain and inflammation of tendons, ligaments, muscles and joints as a result of sprains, stress and bruises. Pain and swelling associated with diseases of the muscles and joints (lumbago, sciatica, neuralgia, myalgia, tendovaginitis, bursitis; degenerative diseases of the musculoskeletal system: deforming osteoarthritis, osteochondrosis).

Contraindications

Hypersensitivity, including to aspirin or other NSAIDs; peptic ulcer of the stomach or duodenum in the acute phase;hematopoiesis disorders of unclear etiology;erosive and ulcerative lesions of the gastrointestinal tract (in the acute stage);”aspirin” asthma, “aspirin” triad; pregnancy; children under 6 years of age.

With caution: induced acute hepatic porphyria; impaired renal and hepatic function.

Side effects

The resulting side effects depend on individual sensitivity, the amount of dose used, and the duration of treatment.

In applying the drug may local irritating effect on the mucous membrane of the colon, mucous discharge mixed with blood, pain when urinating; gastrointestinal disorders: nausea, vomiting,

anorexia, flatulence, constipation, diarrhea, interstitial nephritis (rare – nephrotic syndrome, papillary necrosis, acute renal failure); headache, dizziness, agitation, insomnia,

irritability, fatigue, skin allergic reactions: rash, erythema, eczema, erythema multiforme syndrome, Stevens-Johnson syndrome, Lyell, erythroderma, angioedema, bronchospasm;

photosensitivity, purpura; violations of the hematopoietic: anemia – hemolytic and aplastic, leukopenia, agranulocytosis, thrombocytopenia; increased blood pressure; numbness and vision; convulsions.

Interaction

With the simultaneous use of the drug “Diklovit” and digoxin, phenytoin or drugs lithium may increase the level of concentration in the plasma of these drugs – diuretics and antihypertensives –

reduces the action of these agents – potassium-sparing diuretics – may be observed hyperkalemia – other NSAIDs or corticosteroids increases the risk of side effects from the gastrointestinal tract

of acetylsalicylic acid – decreased concentration of diclofenac in serum cyclosporine – increased the toxic effects of the latter on the kidneys – antidiabetic funds – may be Hypo or hyperglycemia.

With this combination of drugs, blood sugar control is necessary – methotrexate within 24 hours before or after taking it – may lead to an increase in the concentration of methotrexate and to an increase in its toxic effect – anticoagulants-regular blood clotting monitoring is necessary.

How to take, course of use and dosage

Externally. For adults and children over 12 years of age, the drug is applied in a thin layer over the focus of inflammation 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 gel is 2-4 g (which is comparable in volume to the size of a large cherry or walnut). Children from 6 to 12 years of age should be used no more than 2 times a day, a single dose of the drug is up to 2 g. After applying the gel, wash your hands. The duration of treatment depends on the indications and the observed effect. After 2 weeks of using the drug, you should consult your doctor. To enhance the effect, on the recommendation of a doctor, Diclovit ® gel can be used together with systemic nonsteroidal anti-inflammatory drugs (for example, with other medicinal forms of Diclovit®).

Special instructions

The gel is applied only to undamaged areas of the skin. After application, do not apply an occlusive dressing. Avoid contact with eyes, mucous membranes, or open wounds. When using the drug together with other dosage forms of diclofenac, the maximum daily dose should be taken into account. When applied to large areas of the skin and/or for a long time, the risk of developing systemic side effects characteristic of nonsteroidal anti-inflammatory drugs increases.

Form of production

Gel for external use 1%.20,30,40 and 50 g each in aluminum or polyethylene laminate tubes. 1 tube is placed in a cardboard pack with instructions for medical use of the drug.

Storage conditions

At a temperature not exceeding 25°C. Keep out of reach of children.

Shelf life

2 years

Active ingredient

Diclofenac

Dosage form

gel for external use

Description

Children over 12 years of age, Pregnant women in the first and second trimester as prescribed by a doctor, For adults

Indications

Arthritis, Osteoarthritis, Periarthritis, Bursitis, Tendon Inflammation, Lumbago, Osteoarthritis, Rheumatoid Arthritis, Gout, Sciatica, Adnexitis, Swelling after injuries and operations