The instruction for medical use
of Aertal® medicine
the Trade name
the International unlicensed
name Atseklofenak Lekarstvennaya a form
of 1 g of cream contains
active agent: atseklofenak 15.0 mg,
excipients: propilparagidroksibenzoat, metilpara-hydroxybenzoate, liquid paraffin, wax emulsion (EWA), water cleaned
Cream of white color.
Non-steroidal anti-inflammatory drugs for topical treatment. Atseklofenak.
The ATX M02AA25 code
Atseklofenak Pharmacokinetics Absorption properties is soaked up from a drawing zone, quickly reaching a condition of saturation. Drug is late in the field of absorption that increases
its anti-inflammatory efficiency, and constantly comes to a system blood stream, but in such small concentration that secondary effects, especially from digestive tract, no.
Atseklofenak is distributed on all organism.
Metabolism of an atseklofenak is carried out in a liver, drug is removed slowly by kidneys and through intestines, partially in not changed look.
Atseklofenak represents the non-steroidal anti-inflammatory drug possessing also anesthetizing and febrifugal action. Drug suppresses development of hypostasis and an erythema irrespective of an inflammation etiology. Atseklofenak suppresses formation of prostaglandins and leukotrienes due to reversible suppression cyclooxygenases 1 and 2 of types.
The established clinical performance of drug is complemented with good tolerance.
Use of Aertal® cream is reasonable at patients with traumatic damages or inflammatory diseases of the musculoskeletal system.
– treatment of all types of local pain and inflammation owing to any damages of the musculoskeletal system, including sports injuries
– for reduction of inflammation of sinews, ligaments, muscles and joints in cases of stretching, an overstrain or bruises and also for treatment of a lumbago, a wryneck and a periarthritis
the Route of administration and doses
Aertal® Cream is intended only for external use. It should not be applied when imposing compressing bandages.
Aertal® cream should be applied three times a day with the easy massing movements on an affected area. The applied dose depends on the size of an affected area: 1.5-2 g of Aertal® cream (the size approximately about a pea, there correspond about 5-7 cm2 of a surface of skin).
Without the recommendation of the doctor of Aertal® cream should not be applied within more than 2 weeks to treatment of an injury of joints and muscles (stretching, an overstrain, a bruise) and also inflammation of a sinew. At inflammation of a joint it is longer not necessary to use drug than 3 weeks without consultation with the doctor.
When strengthening pain and signs of inflammation or lack of improvement after 7 days of treatment it is necessary to see a doctor.
Experience of use of Aertal®u cream of children is absent therefore Aertal® cream, it is not recommended to apply at children.
Need for dose adjustment of drug at elderly patients is absent.
Infrequently (from ≥ 1/1,000 to & lt, 1/100)
– reactions of photosensitivity, hyperaemia, a skin itching
Seldom (from ≥ 1/10,000 to & lt, 1/1,000)
– the irritation of skin
is Very rare (& lt, 1/10,000)
– violent reactions (including, exfoliative dermatitis, Stephens-Johnson’s syndrome, a toxic epidermal necrolysis)
– hypersensitivity to drug components (atseklofenak) or any of excipients
– patients with existence in the anamnesis of hypersensitivity to other non-steroidal anti-inflammatory drugs (NPVP). In spite of the fact that the possible cross hypersensitivity with diclofenac was not confirmed, this drug is not recommended to patients with hypersensitivity for diclofenac in the anamnesis
– patients in whom acetylsalicylic acid or non-steroidal anti-inflammatory drugs cause asthmatic attacks, urtikarny rash or acute rhinitis
– pregnancy and the period of a lactation
– children’s and teenage age up to 18 years
In spite of the fact that now data on possible interaction of drug with other means are not obtained, it is necessary to observe precautionary measures in case of simultaneous use by the patient of any other drugs which are especially containing lithium, digoxin at reception of oral contraceptives, diuretics, anticoagulants or other non-steroidal anti-inflammatory drugs.
If at intake of Aertal® cream are noted symptoms of local irritation, then use of drug it is necessary to stop and begin the corresponding treatment.
After putting cream it is necessary to wash up carefully hands unless hands are a zone of putting cream. Not to apply cream in eyes and a mouth.
Not to apply Aertal® cream for treatment of open wounds, mucous membranes and also the angry skin (eczema). Cream should be applied only to the uninjured skin.
Aertal® cream contains cetostearyl alcohol, methylparahydroxybenzoate and propilparagidroksibenzoat which can cause local skin reactions (for example, contact dermatitis, which development, can be delayed in time).
For prevention of reactions of photosensitivity it is necessary to avoid impact of sunlight on the site on which cream, without use of special protective equipment is applied.
As well as other NPVS, this medicine can cause allergic reactions at the beginning of use, including, anaphylactic/anaphylactoid reactions. There are rare messages about emergence of serious skin reactions, including with a lethal outcome, among them, exfoliative dermatitis, Stephens-Johnson’s syndrome and a toxic epidermal necrolysis connected with use of NPVP. Patients are subject to the highest risk of similar reactions at the beginning of a course of treatment, skin reactions in most cases arise within the first month of treatment. When developing skin rash, defeats of mucous or other manifestations of hypersensitivity treatment atseklofenaky needs to be stopped.
In rare instances a virus the varitsella-zoster can cause serious complications in the form of an infection of skin and soft tissues. Now it is impossible to exclude completely negative influence of NPVP on a course of these infections. In this regard, it is not recommended to apply atseklofenak in the infection caused by a virus a varitsella-zoster.
Pregnancy and the period of a lactation
of Data on safety of use of drug during pregnancy are not enough now therefore Aertal® cream, it is not necessary to apply during pregnancy.
Now there are no data on whether gets atseklofenak into breast milk therefore it is not recommended to take the drug in the period of a lactation.
Features of influence on ability to run the vehicle and potentially dangerous mechanisms
Aertal® Cream does not affect ability to run vehicles and work with mechanisms.
Symptoms: the typical picture of overdose atseklofenaky is unknown.
Treatment: symptomatic, in case of overdose or unpremeditated ingestion of drug.
The form of release and packing
On 60 g of drug place in aluminum tubas with the screwing-up polyethylene (PE) cap of white color.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions at a temperature not over 25 of 0C.
To store out of children’s reach!
not to use a period of storage after expiry date!
the Name and the country
of the JSC Gideon Richter manufacturing organization,
1103 Budapest, Dyomryoi St., 19-21, Hungary
the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, Hungary
the Name and the country of the holder of the license
of Almiral AG, Switzerland
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of JSC Gideon Richter in RK
Phone number: 8-(727) 258-26-22, 8-(727) 258-26-23