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Diclofenac 30g of 5% gel for topical application


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The instruction for medical use of DICLOFENAC medicine the Trade name DICLOFENAC the International unlicensed name Diclofenac Dosage Form Gel for external use, 5% Structure of 100 g of gel contains active agent – diclofenac of sodium of 5.0 g, excipients: ethanol, propylene glycol, karbopol, methylparahydroxybenzoate, trolamin, lavenders oil, water the Pharmacotherapeutic group cleaned the Description gel, Uniform, white or white with a yellowish or creamy shade, with a specific smell Non-steroidal anti-inflammatory drugs (NPVP) for topical administration. Diclofenac the ATX M02AA15 Code the Pharmacological Pharmacokinetics Drug properties is used for elimination of a pain syndrome and reduction of puffiness connected with inflammatory process. At topical administration causes easing or disappearance of joint pains at rest and at the movement. Reduces morning constraint and a swelling of joints, promotes increase in volume of movements. At the recommended way of putting drug no more than 6% of diclofenac are absorbed. A pharmacodynamics Active component of drug diclofenac – the non-steroidal anti-inflammatory drug (NPVP) possessing expressed analgeziruyushchy (anesthetics) and anti-inflammatory properties. Not selectively oppressing type cyclooxygenase 1 and 2, breaks metabolism of arachidonic acid and synthesis of prostaglandins which are the main link in inflammation development. Indications – posttraumatic inflammation of soft tissues, for example owing to stretchings, retension and bruises – rheumatic diseases of soft tissues (tendovaginitis, a bursitis, defeat of periartikulyarny fabrics) – the pain syndrome and puffiness connected with diseases of muscles and joints (pseudorheumatism, an osteoarthrosis, sciaticas, a lumbago, a sciatica, muscular pains of rheumatic and not rheumatic origin) the Route of administration and doses Outwardly. To adults and children 12 years drug are more senior apply to skin 2-3 times a day and slightly rub. The necessary amount of drug depends on the size of a painful zone. A single dose of drug – up to 2 g (about 4 cm at completely open mouth of a tuba). After putting drug of a hand it is necessary to wash up. Duration of treatment depends on indications and noted effect. After 2 weeks of use of drug it is necessary to consult with the doctor. Side effects Often – generalized skin rash Seldom – eczema, a photosensitization, contact dermatitis (itching, reddening, puffiness of the processed site of skin, a papule, a vesicle, peeling) It is very rare – allergic reactions (urticaria, a Quincke’s disease, bronkhospastichesky reactions) of the Contraindication – hypersensitivity to diclofenac or other components of drug, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs – tendency to emergence of attacks of bronchial asthma, urticaria or acute rhinitises at use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (aspirinovy asthma) – disturbance of integrity of integuments – pregnancy (III trimester) and the lactation period – the children’s age of 12 years Medicinal interactions Drug can strengthen effect of the drugs causing a photosensitization. Clinically significant interaction with other medicines is not described. Special instructions With care: hepatic porphyria (aggravation), digestive tract erosive cankers, heavy abnormal liver functions and kidneys, chronic heart failure, bronchial asthma, disturbances of blood clotting (including hemophilia, lengthening of a bleeding time, tendency to bleedings), advanced age, pregnancy I and II trimester. Gel should be applied only to the uninjured skin, avoiding hit on open wounds. After drawing it is not necessary to apply an occlusive bandage. It is not necessary to allow hits of drug on eyes and mucous membranes. At long use of large amounts of drug it is impossible to exclude emergence of the side effects characteristic of NPVP. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms are not revealed Overdose Symptoms: extremely low system absorption of active components of drug at external use makes overdose almost impossible. At accidental ingestion of large amounts of ointment (more than 20 g) the emergence of the system undesirable reactions characteristic of NPVP is possible. Treatment: gastric lavage, intake of activated carbon is necessary. A form of release and packing On 30 g, 50 g in tubas aluminum with the screwed polymeric bushona or in tubas laminatny with the screwed polymeric bushona. On 100 g in tubas aluminum with the screwed polymeric bushona or in tubas laminatny with the screwed polymeric bushona. Each tuba with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard. To Store storage conditions at a temperature from 15 C up to 25 C. Not to freeze to Store out of children’s reach! 3 years not to use a period of storage after an expiration date. Prescription status Without prescription JSC Sintez Producer. Russian Federation, 640008, Kurgan, Konstitutsii Avenue, 7 the Owner of the registration certificate of JSC Sintez, the Russian Federation the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products of STOFARM LLP, 000100, Republic of Kazakhstan, Kostanay region, Kostanay, Uralskaya St., 14

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