Aertal® (Airtal®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAceclofenacAceclofenac
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  • Aertal®
    powder inwards 
    Almiral S.A.     Spain
  • Aertal®
    cream externally 
    Almiral S.A.     Spain
  • Aertal®
    pills inwards 
    Almiral S.A.     Spain
    • Dosage form: & nbspcream for external use
    Composition:

    Composition per 1 g of cream:

    Active substance: aceclofenac 100% micronized 0.015 g.

    Excipients: wax emulsion 0.1 g, paraffin liquid 0.04 g, methyl parahydroxybenzoate 0.002 g, propyl parahydroxybenzoate 0.0005 g, water 0.8425 g.

    Description:

    White homogeneous cream.

    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)
    ATX: & nbsp

    M.01.A.B   Derivatives of acetic acid

    M.01.A.B.16   Aceclofenac

    Pharmacodynamics:

    Aceclofenac is a non-steroidal anti-inflammatory drug that has an anti-inflammatory and analgesic effect. The drug inhibits the development of edema and erythema, regardless of the etiology of inflammation. Aceclofenac Suppresses the formation of prostaglandins and leukotrienes due to reversible suppression of cyclooxygenase types 1 and 2.

    The established clinical efficacy of the drug is supplemented by good tolerability.

    The use of Aertal® cream is useful in patients with traumatic injuries or inflammatory diseases of the musculoskeletal system.

    Pharmacokinetics:

    Suction

    After application aceclofenac absorbed from the application area, quickly reaching saturation. It accumulates in the suction zone, which contributes to an increase in anti-inflammatory activity, and gradually enters the systemic bloodstream in small amounts, and therefore the risk of side effects, including the gastrointestinal tract, is minimized.

    Distribution

    Aceclofenac is distributed throughout the body.

    Excretion

    Aceclofenac is metabolized in the liver and is excreted slowly by the kidneys and through the intestine, partly unchanged.

    Indications:

    Treatment of local pain due to traumatic injuries and inflammatory diseases of the musculoskeletal system, including sports injuries.

    The drug can be used to reduce inflammation of tendons, ligaments, muscles and joints in cases of stretching, overstrain or bruises, as well as for the treatment of lumbago, torticollis and periarthritis.

    Contraindications:

    - Hypersensitivity to the drug components (aceclofenac) or any of the excipients.

    - The presence in the past of intolerance to NSAIDs, including diclofenac.

    - The presence in the past of attacks of bronchial asthma, urticaria rash or acute rhinitis on the background of taking acetylsalicylic acid (ASA) or other NSAIDs.

    - The presence of infection caused by the varicella-zoster virus.

    - Pregnancy.

    - Children under 18 years.

    - Violation of the integrity of the skin in the intended site of application.

    Carefully:

    Hepatic porphyria (exacerbation), erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation), severe violations of the liver and kidney function, CHF; bronchial asthma, hives, or acute rhinitis, triggered by the use of ASA or other NSAIDs; disorders of blood clotting (including hemophilia, lengthening bleeding time, a tendency to bleeding), advanced age, lactation.

    Pregnancy and lactation:

    Pregnancy

    Cream Avertal is contraindicated in pregnancy. Information on the use of Aertal® cream during pregnancy is absent.

    Breastfeeding period

    It is not known whether the aceclofenac in breast milk.Avital® cream should not be used during breastfeeding.

    Dosing and Administration:

    The Avital® cream is intended for external use only and should not be applied under occlusive dressings. Aertal® should be applied lightly massaging to the affected area three times a day. The dose applied depends on the size of the affected area: 1.5-2 g of Aertal® cream (approximately corresponds to a strip of cream 5-7 cm long).

    Use in children

    Experience with the use of the cream of Aertal® in children is absent, therefore the cream of Aertal® is contraindicated in children.

    Elderly patients

    Correction of the dosing regimen in the elderly is not required.

    Side effects:

    The following are undesirable phenomena, information about which was obtained in clinical studies and during post-marketing surveillance; Undesirable phenomena are grouped according to the classes of systems of organs according to the Medical dictionary for regulatory activities (MedDRA) and frequency of occurrence. Often (≥1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 to <1/100), rarely (from≥ 1/10000 to <1/1000), very rarely (<1/10000).

    General disorders and disorders at the site of administration

    Infrequent: photosensitivity reaction, erythema, itchy skin.

    Rarely: skin irritation.

    Very rarely: bullous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

    There are very few reports of severe skin reactions, sometimes leading to death, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of NSAIDs.

    Overdose:

    Symptoms

    Cases of an overdose of aceclofenac are unknown. The exact symptoms of an overdose of aceclofenac are unknown. In case of misuse or accidental ingestion, arterial hypotension, renal failure, convulsions, irritation of the gastrointestinal mucosa, and respiratory depression may develop.

    Treatment

    Symptomatic and supportive therapy is performed. It is necessary to prevent absorption of the drug as soon as possible by washing the stomach and administering activated charcoal.

    Forced diuresis or hemoperfusion is ineffective due to the high degree of binding of aceclofenac to plasma proteins and its intensive metabolism.

    Interaction:

    Despite the lack of data on possible interactions of aceclofenac with other drugs,caution should be exercised in prescribing it to patients taking other medications, especially those containing lithium, digoxin. Also, be careful with concomitant therapy with anticoagulants, diuretics or pain medications.

    Special instructions:

    - If the irritation develops at the site of the application of Aertal® cream, it is necessary to discontinue its use and conduct appropriate treatment. After applying Aeralt® cream, you should wash your hands, except when the hands are the place of application of the cream.

    - Avital® cream should not be applied to the eyes and mouth.

    - Aertal® Cream can not be used to treat open wounds, mucous membranes, or irritation (eczematous) skin, or in cases where there is some other pathological process on the skin at the site of the cream application. The cream should be applied only to intact skin.

    - Data on the use of Aertal® cream in children are absent.

    - To prevent photosensitivity reactions, protect the area on which the cream is applied from exposure to sunlight.

    - Hypersensitivity and skin reactions.Just like other NSAIDs, the Airtal® cream at the beginning of the application can cause allergic reactions, including anaphylactic / anaphylactoid reactions. There are reports of the occurrence in rare cases of serious skin reactions, including fatalities, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of NSAIDs. Patients are at the highest risk of similar reactions at the beginning of the course of treatment, skin reactions in most cases occur during the first month of treatment. If skin rashes, mucous membranes or other manifestations of hypersensitivity occur, treatment with Aeralt® cream should be discontinued.

    - In rare cases, the varicella-zoster virus can cause serious complications in the form of infection of the skin and soft tissues. At present, the negative impact of NSAIDs on the course of these infections can not be completely excluded. In this regard, it is not recommended to apply aceclofenac with infection caused by the varicella-zoster virus.

    - 1 g of Aertal® cream contains 0.002 g of methyl parahydroxybenzoate and 0.0005 g of propyl parahydroxybenzoate, which can cause allergic reactions (including delayed ones). The Aertal® cream also contains cetyl stearyl alcohol.It can cause local skin reactions (eg, contact dermatitis).

    Effect on the ability to drive transp. cf. and fur:

    The Aeralt® cream does not affect the ability to drive means and work with mechanisms.

    Form release / dosage:

    Cream for external use, 1.5%.

    Packaging:

    60 grams of cream is placed in an aluminum tube. One tube is placed in a cardboard box together with instructions for use.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001289
    Date of registration:28.11.2011 / 29.11.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Almiral S.A.Almiral S.A. Spain
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp24.09.2017
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