Flamidez gel

General characteristics. Structure:

Active ingredients: 11,6 mg of diclofenac of diethyl amine that corresponds to 10 mg of diclofenac of sodium; 100 mg of methyl salicylate; 50 mg of menthol.

Excipients: benzyl alcohol; карбопол 934; propylene glycol; citric acid, monohydrate; isopropyl alcohol; dinatrium эдетат; the oil ricinic polyethoxylated, hydrogenated; diethyl amine; the water purified.

The means applied locally at muscular and joint pains with anesthetic, antiinflammatory and antiedematous action.

Pharmacological properties:

Pharmacodynamics. Pharmacological effect of drug is caused by components which are its part. Diclofenac and methyl salicylate – non-steroidal anti-inflammatory drugs (NPVS) of which antiinflammatory effect ability to suppress synthesis of prostaglandins is the cornerstone and, thus, to reduce manifestations of symptoms of an inflammation.

Menthol at local use has the vasodilating and moderately anesthetizing effect, giving feelings of a cool. Promotes the best penetration of active ingredients through skin. Use of drug at the inflammations caused by injuries or rheumatic diseases leads to reduction of hypostasis of fabrics, pain, and to reduction of the period of recovery of functions of the injured joints, ligaments, sinews, muscles.

Pharmacokinetics. Diclofenac was found in a blood plasma at local use on a shin of 2 g of drug three times a day within 6 days. Average pharmacokinetic values made: AUC0-t – 9 ¡ú*þ/ml, Cmax – 4 ng/ml and Tmax – 4,5 h. Whereas at oral administration of 75 mg of diclofenac the area under pharmacokinetic curve AUC makes 1600 ¡ú*þ/ml. That is system bioavailability of diclofenac at topical administration is much lower, than at peroral that reduces risk of development of side effects.

About 99% of diclofenac contact proteins of a blood plasma. Methyl salicylate is quickly absorbed through skin, removed preferential with urine. Menthol is removed with urine and bile in the form of a glucuronide.

Indications to use:

Topical treatment of a miositis, fibrositis, ischialgia, muscle strain and sinews, traumatic damages of a musculoskeletal system, muscle and joints pain at big exercise stresses, inflammatory and degenerative diseases of joints, rheumatic defeats of a musculoskeletal system: bursitis, arthritis, tendosinovita, tendinitis.

Route of administration and doses:

Only for external use.

A small amount of gel to 2-4 g is applied to adults and children on an affected area of skin aged from 12 years that by the size corresponds to the size of cherry or voloshsky nut, 3-4 times a day, easily rubbing before full absorption.

It is desirable to avoid prolonged use of gel on big sites of skin and in high doses. Gel can be applied along with oral administration of tablets of diclofenac of sodium on condition of preliminary consultation of the doctor. 

After application of drug of a hand it is necessary to wash up if only this site did not respond to treatment. 

Duration of treatment depends on indications and efficiency of treatment and is defined by the doctor. It is not necessary to apply gel more than 14 days at damage and rheumatism of soft tissues or more than 21 day in case of pain at arthritis if another is not recommended the doctor. Patients of advanced age can apply usual doses.

Features of use:

As influence of oppression of synthesis of prostaglandins on the pregnancy course at topical administration of diclofenac is not studied, it is possible to use drug within the first 6 months of pregnancy only if, according to the doctor, the expected advantage for mother exceeds risk for a fruit. In the third trimester of pregnancy of use of drug contraindicated.

During feeding it is impossible to apply with a breast drug on mammary glands or on the big surface of skin, and also to apply for a long time (over 1 week).

Flamidez gel at external use does not influence ability to direct vehicles and difficult mechanisms.

Do not apply to children up to 12 years.

It is necessary to avoid hit of drug on the damaged sites of skin, open wounds, eyes and other mucous membranes. After putting gel it is necessary to wash up hands, in order to avoid contact of drug with eyes and mucous membranes. Flamidez gel contains propylene glycol which can entail weak local irritation of skin at some patients.

Side effects:

Flamidez gel is well had. In isolated cases in a site of application of gel erubescence, an itch, burning or an enanthesis was noted. These phenomena seldom resulted in need of the termination of treatment.

Seldom or never there are allergic reactions.

Sometimes there is contact dermatitis (for example the localized rash on skin, feeling of an itch, reddening, hypostases or papules).

Violent dermatitis is seldom observed.

In single cases generalized skin reactions, urticaria, angionevrichesky hypostasis, a photosensitization, a bronchospasm are observed.

The probability of emergence of system side reactions after topical administration of diclofenac small in comparison with the frequency of side reactions during peroral treatment by diclofenac, however if gel is caused on big sites of skin for a long time, it is impossible to exclude possibility of system side reactions. In that case it is necessary to be guided by information stated in the instruction for a medical use for other forms of production of diclofenac.

In case of any by-effects or other unusual reactions it is necessary to see a doctor.

Interaction with other medicines:

As a result of insignificant system adsorption of drug at external use interaction with other medicines is improbable.

Contraindications:

Individual hypersensitivity to diclofenac or to any of drug components. Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Existence in the anamnesis of the attacks of bronchial asthma, small tortoiseshell or acute rhinitis predetermined by reception of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

Overdose:

The overdose is improbable as system absorption of diclofenac at topical administration very small. At accidental reception internally treatments same, as well as at poisoning with non-steroidal anti-inflammatory drugs. The patient should see a doctor. The symptomatic treatment is carried out with the advent of signs of development of complications, such as the arterial pressure, a renal failure, spasms is increased, respiratory depression, complications from a digestive tract.

Storage conditions:

To store in original packaging in the place, unavailable to children, at a temperature not above 30 °C. Not to freeze.

Issue conditions:

Without recipe

Packaging:

The laminated tuba on 20, 30 or 40 grams of gel. On an otdny tuba in cardboard packaging.