for medical use
of DIKLOFENAK-AKOS medicine
the Trade name
the International unlicensed
name Diclofenac Dosage Form 1% Ointment Structure of 100 G of Ointment contains
active agent – diclofenac of sodium of 1.0 g,
excipients: a dimethyl sulfoxide, a macrogoal 400, a macrogoal 4000, propylene glycol, methylparahydroxybenzoate, propilparagidroksibenzoat
Ointment of white or almost white color with a slight specific smell
Non-steroidal anti-inflammatory drugs (NPVP) for topical administration. Diclofenac
the ATX M02AA15 Code
Pharmacokinetics At properties the recommended way of putting drug is absorbed no more than 6% of diclofenac. Communication with proteins – 99.7%. It is removed by kidneys. When drawing on area of the affected joint the concentration in synovial fluid is higher, than in plasma.
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.
– 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), muscular pains of rheumatic and not rheumatic origin
– inflammatory diseases of the musculoskeletal system (a pseudorheumatism, the psoriasis, juvenile chronic arthritis ankylosing a spondylarthritis, gouty arthritis as a part of complex therapy
– degenerative diseases of the musculoskeletal system (the deforming osteoarthrosis, osteochondrosis)
– a pain syndrome (sciatica, a lumbago, a sciatica, neuralgia, myalgia, a tendovaginitis, a bursitis)
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 – 2-4 g (about 10 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.
– contact dermatitis (rash, an erythema, eczema, an itching)
it is rare
– bullous dermatitis
– pustulous rashes
– reactions of hypersensitivity (urticaria, a Quincke’s edema)
– bronkhospastichesky reactions, asthma
– reactions of a photosensitization
of the Contraindication
– hypersensitivity to diclofenac or other components of drug
– tendency to emergence of attacks of bronchial asthma, urticaria or acute rhinitises at use acetilsalicylic
– acid or other non-steroidal anti-inflammatory drugs (aspirinovy asthma)
– disturbance of integrity of integuments
– pregnancy and the period of a lactation
– children’s age (up to 12 years)
Drug can strengthen effect of the drugs causing a photosensitization. Clinically significant interaction with other medicines is not described.
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.
Ointment 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.
When sharing with other dosage forms of diclofenac it is necessary to consider the maximum daily dose of this medicine.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
are not revealed.
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 in tubas aluminum.
Each tuba together with the instruction for medical use in
the state and Russian languages is placed in a pack from cardboard.
To Store storage conditions in the dry place at a temperature from 8 °C to 15 °C. Not to freeze
to Store out of children’s reach!
not to use a period of storage after an expiration date.
JSC Sintez Producer.
Russia, 640008, Kurgan, Konstitutsii Avenue, 7
Ph./fax (3522) 48-16-89
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
ph. 714 228 01 79