Aertal cream 1.5%, 60 g

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

• to reduce inflammation of tendons, ligaments, muscles and joints in cases of sprains, overexertion and bruises;

• lumbago;

• torticollis;

• periarthritis.

AertalЃ cream is intended for external use only. Do not apply the cream under occlusive dressings.

After applying the cream, you should wash your hands, unless your hands are the area for applying the cream. The drug should not come into contact with the eyes or mouth.

AertalЃ can only be applied to intact skin.

AertalЃ should be applied with light massaging movements to the affected area 3 times / day. The applied dose depends on the size of the affected area: 1.5-2 g of AirtalЃ cream (approximately corresponds to a 5-7 cm long strip of cream).

It is necessary to draw the patient's attention to the fact that when using the drug without prescribing by the attending physician for the treatment of muscle and joint damage (sprains, overexertion, bruises) or tendinitis, the duration of use should not exceed 2 weeks.

The duration of the use of the drug without prescription by the attending physician for the treatment of arthritis should not exceed 3 weeks.

If symptoms worsen or do not improve after 7 days of use, the patient should consult a doctor for further examination.

There is no experience with the use of AertalЃ cream in children, therefore, AirtalЃ cream is contraindicated for use in children.

Correction of the dosage regimen in elderly patients is not required.

White cream for external use.

1 g

aceclofenac (100% micronized) 15 mg

Excipients: emulsion wax, liquid paraffin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water.

• Hypersensitivity to the components of the drug: aceclofenac or any of the excipients;

• an indication in the history of hypersensitivity to other NSAIDs (despite the fact that possible cross-hypersensitivity with diclofenac has not been confirmed, the drug is not recommended for patients with a history of hypersensitivity to diclofenac);

• aceclofenac, by analogy with other NSAIDs, is contraindicated in patients in whom acetylsalicylic acid or other NSAIDs cause asthmatic attacks, urticaria or acute rhinitis;

• the presence of an infection caused by the Varicella zoster virus;

• pregnancy;

• children under 18 years of age;

• violation of the integrity of the skin at the site of the intended application.

  Carefully

• Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the exacerbation phase), severe liver and kidney dysfunction, chronic heart failure; bronchial asthma, urticaria or acute rhinitis, triggered by the intake of acetylsalicylic acid (ASA) or other NSAIDs; bleeding disorders (including hemophilia, lengthening of bleeding time, tendency to bleeding), advanced age, lactation period.

pharmachologic effect

Aceclofenac is an NSAID that also has antipyretic and analgesic effects. The drug suppresses the development of edema and erythema, regardless of the etiology of inflammation. Aceclofenac inhibits the formation of prostaglandins and leukotrienes by reversibly inhibiting COX.

Clinical efficacy and safety

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

The use of AertalЃ cream is advisable in patients with traumatic injuries or inflammatory diseases of the musculoskeletal system.

It has been proven that AertalЃ cream has anti-inflammatory and analgesic effects when applied topically in the treatment of injuries of the musculoskeletal system.

Pharmacokinetics

Suction

After application, aceclofenac is absorbed from the appropriate zone, rapidly reaching saturation. It accumulates in the absorption zone, which contributes to an increase in anti-inflammatory activity, and gradually enters the systemic circulation in small concentrations, and therefore the risk of side effects, incl. on the digestive tract, is minimized.

Distribution

Aceclofenac is distributed throughout the body.

Metabolism and excretion

Aceclofenac is metabolized in the liver and excreted slowly by the kidneys and through the intestines, partially unchanged.

Side effect

General disorders and disorders at the injection site: infrequently - photosensitivity reactions, erythema, pruritus; rarely - skin irritation; very rarely - bullous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

There are very rare 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.

Application during pregnancy and lactation

Pregnancy

AertalЃ cream is contraindicated for use during pregnancy. There is no information on the use of AertalЃ cream during pregnancy.

Breastfeeding period

It is not known whether aceclofenac passes into breast milk. AertalЃ cream should not be used during breastfeeding.

Application for violations of liver function

With caution, the drug should be prescribed for hepatic porphyria (exacerbation), severe liver dysfunction.

Application for impaired renal function

The drug should be prescribed with caution in severe renal impairment.

Application in children

There is no experience with the use of AertalЃ cream in children, therefore, it is not recommended to use AirtalЃ cream in children.

Use in elderly patients

The drug should be prescribed with caution to elderly patients.

special instructions

If irritation develops at the site of application of AirtalЃ cream, it is necessary to stop using it and carry out appropriate treatment.

AertalЃ cream cannot be used to treat open wounds, mucous membranes, as well as irritation (eczematous) of the skin or in cases where there is any other pathological process on the skin at the site of application of the cream. The cream should only be applied to intact skin.

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

Hypersensitivity and skin reactions: just like other NSAIDs, AertalЃ cream at the beginning of use can cause allergic reactions, incl. anaphylactic / anaphylactoid reactions. In rare cases, there have been reports of serious skin reactions, incl. fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of NSAIDs. Patients are at the highest risk of such reactions at the beginning of the course of treatment, skin reactions in most cases occur within the first month of treatment. If a skin rash, lesions of the mucous membranes or other manifestations of hypersensitivity occur, treatment with AertalЃ cream should be discontinued.

In rare cases, the Varicella zoster virus can cause serious complications in the form of skin and soft tissue infections. At present, the negative effect of NSAIDs on the course of these infections cannot be completely ruled out. In this regard, it is not recommended to use aceclofenac for infections caused by the Varicella zoster virus.

AertalЃ, a cream for external use, contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions (including delayed ones). AertalЃ cream also contains cetylstearyl alcohol (an ingredient in emulsion wax), which can cause local skin reactions (eg contact dermatitis).

Use in pediatrics

There are no data on the safety and efficacy of aceclofenac in children and adolescents under the age of 18, so the drug is contraindicated for use in this category of patients.

Influence on the ability to drive vehicles and mechanisms

AertalЃ cream does not affect the ability to drive vehicles and work with mechanisms.

Overdose

Overdose cases of aceclofenac are unknown.

Symptoms: The exact symptoms of an aceclofenac overdose are unknown. In case of improper use or accidental ingestion of the drug, arterial hypotension, renal failure, convulsions, irritation of the gastrointestinal mucosa, as well as respiratory depression may develop.

Treatment: symptomatic and supportive therapy. Absorption of the drug should be prevented as soon as possible by gastric lavage and the appointment of activated charcoal. Forced diuresis, hemodialysis or hemoperfusion are ineffective due to the high degree of binding of aceclofenac to blood plasma proteins and its intensive metabolism.

Drug interactions

Despite the lack of data on the possible interaction of aceclofenac with other drugs, care must be taken when prescribing it to patients taking other drugs, especially those containing lithium, digoxin, or in the case of concomitant therapy with oral anticoagulants, diuretics or pain relievers ...