Aertal cream 15 mg/g tube 60 g

Instructions for Aertal cream 15 mg/g tube 60 g

Composition

active ingredient: aceclofenac;

1 g of cream contains 15 mg of aceclofenac;

excipients: emulsified wax, liquid paraffin, methylparaben (E 218), propylparaben (E 216), purified water.

Dosage form

Cream.

Main physicochemical properties: white cream.

Pharmacotherapeutic group

Topical agents for joint and muscle pain. Nonsteroidal anti-inflammatory drugs for topical use.

ATX code M02A A25.

Pharmacological properties

Pharmacodynamics.

Mechanism of action

Aceclofenac is a nonsteroidal anti-inflammatory drug that also has analgesic and antipyretic effects. In experimental models, it inhibits the development of edema and hyperemia regardless of the nature of inflammation. Studies of the mechanisms of action of this drug in both animals and humans have shown that aceclofenac most likely inhibits the secretion of prostaglandins and leukotrienes by reversible inhibition of cyclooxygenase.

Clinical efficacy and safety

In a four-day skin tolerance (irritancy) study of a cream containing aceclofenac, in a comparative analysis with a placebo cream and double distilled water, a less pronounced irritant effect of the cream containing aceclofenac was found compared to the other test substances.

Another study in 12 volunteers assessed the extent of hyperemia under UV light exposure before and after application of a cream containing aceclofenac. It was found that after application of the cream, the area of hyperemia spread after 7 hours was smaller in the areas treated with aceclofenac compared to the areas treated with placebo and the control (untreated) areas.

It has been proven that a cream containing aceclofenac has anti-inflammatory and analgesic effects when applied topically to treat musculoskeletal injuries.

Comparative clinical studies have confirmed that the efficacy of aceclofenac is at least comparable to that of other topical preparations.

Clinical efficacy is combined with satisfactory local and systemic tolerability.

Therefore, Aertal® cream is an effective drug for use in injuries or inflammatory diseases of the musculoskeletal system.

Pharmacokinetics.

The pharmacokinetics of aceclofenac-containing cream when applied topically have been studied in various experimental models in animals and humans.

Absorption.

Airtal® cream is absorbed from the application area, quickly reaching saturation. It accumulates in the absorption area, which contributes to increased anti-inflammatory activity, and gradually enters the systemic bloodstream in small concentrations, which minimizes the risk of adverse reactions, including from the gastrointestinal tract.

Distribution.

Aceclofenac is distributed throughout the body.

Breeding.

Aceclofenac is metabolized in the liver and excreted slowly, partly unchanged, in urine and feces.

Indication

Treatment of all types of local pain and inflammation due to any musculoskeletal injuries, including sports injuries.

Reducing inflammation of tendons, ligaments, muscles and joints in cases of sprain, strain or impact, as well as as part of complex therapy for the treatment of lumbago, torticollis and periarthrosis.

Contraindication

Hypersensitivity to aceclofenac or any of the excipients.

History of hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs). Although possible cross-hypersensitivity with diclofenac has not been confirmed, this drug is not recommended for patients with a history of hypersensitivity to diclofenac.

Aceclofenac, like other nonsteroidal anti-inflammatory drugs, is contraindicated in patients in whom acetylsalicylic acid or nonsteroidal anti-inflammatory drugs cause asthma attacks, urticarial rash, or acute rhinitis.

Third trimester of pregnancy.

Interaction with other medicinal products and other types of interactions

Although no data have been obtained on possible interactions of aceclofenac with other drugs, caution should be exercised when prescribing the drug to a patient taking other medications, especially those containing lithium, digoxin, or in the case of concomitant therapy with anticoagulants, diuretics or analgesics.

Application features

If irritation occurs at the site of application of Aertal® cream, it is necessary to discontinue its use and conduct appropriate treatment.

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

Hypersensitivity and skin reactions: As with other NSAIDs, aceclofenac may cause allergic reactions, including anaphylactic/anaphylactoid reactions, at the beginning of treatment. Rare cases of serious skin reactions, including fatal ones, have been reported, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.8). The risk of such reactions is highest at the beginning of treatment, mainly during the first month of treatment. If skin rash, mucosal lesions or other signs of hypersensitivity occur, aceclofenac should be discontinued.

In rare cases, the Varicella virus can cause serious complications in the form of skin and soft tissue infections. At this time, it is not possible to completely exclude the negative effect of NSAIDs on the course of these infections. In this regard, the use of aceclofenac in infections caused by the Varicella virus is not recommended.

Airtal® cream contains 0.2 g of methylparaben (E 218) and 0.05 g of propylparaben (E 216), which may cause allergic reactions (including delayed ones). Airtal® cream also contains cetylstearyl alcohol (as part of the emulsified wax), which may cause local skin reactions (e.g. contact dermatitis).

Use during pregnancy or breastfeeding

Pregnancy.

There are no clinical data on the use of Aertal® cream during pregnancy.

Even though systemic exposure is lower compared to oral administration, it is not known whether systemic exposure to Aertal® cream achieved after topical application could be harmful to the embryo/fetus. During the first and second trimester of pregnancy, Aertal® cream should not be used unless clearly necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, including Aertal®, cream, may cause cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding may occur in both the mother and the child, and labor may be prolonged. Therefore, Aertal®, cream is contraindicated during the last trimester of pregnancy (see section "Contraindications").

Breastfeeding period.

There is no data on whether aceclofenac is excreted in breast milk. Animal studies have not shown any adverse effects on pregnancy, embryonal/fetal development, parturition or postnatal development.

Ability to influence reaction speed when driving vehicles or other mechanisms

Airtal® cream does not affect the ability to drive a vehicle or operate other mechanisms.

Method of administration and doses

Method of application.

This medicine is for external use only and should not be applied under tight bandages. Wash hands after applying the cream, unless the hands are the site of application. Do not get the cream in your eyes or mouth. Apply the cream only to intact skin.

Dosage

Aertal® should be applied three times a day with light massage movements to the affected area. The dose used 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).

When using the drug without a doctor's prescription for the treatment of muscle or joint injuries (sprains, sprains, bruises) or inflammation of the ligaments, the duration of use should not exceed 2 weeks. The duration of use of the drug without a doctor's prescription for the treatment of arthritis should not exceed 3 weeks. If symptoms worsen or do not improve after 7 days of use, you should consult a doctor for further examination.

Elderly patients

The usual adult dose can be used to treat elderly patients.

Children: The safety and efficacy of aceclofenac in children (under 18 years of age) have not been established. Data are not available.

Airtal® cream is not recommended for use in children.

Overdose

The typical symptoms of an aceclofenac overdose are unknown.

In case of overdose or accidental ingestion of the drug, appropriate treatment should be provided.

Side effects

Airtal® cream demonstrated satisfactory local tolerability.

In some cases, mild or moderate local irritation has been described, accompanied by skin hyperemia and itching, which disappear after discontinuation of treatment.

In rare cases, the Varicella virus in combination with NSAID treatment can cause serious complications in the form of skin and soft tissue infections.

In addition, there have been isolated reports of photosensitivity reactions (≥ 1/1,000 to < 1/100) in areas of skin to which the cream has been applied, when exposed to intense sunlight without adequate UV protection.

Based on clinical studies and post-marketing experience with aceclofenac, the following table lists adverse reactions by system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); rare (< 1/10,000).

Photosensitivity reaction

Hyperemia

Skin itching

There have been rare reports of serious skin reactions, including fatal ones, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, in association with the use of NSAIDs.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions during the post-marketing surveillance period. This allows monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report suspected adverse reactions.

Expiration date

2 years.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of reach of children!

Packaging

60 grams of cream in a sealed aluminum tube with a white polyethylene screw cap and a perforating tip. One tube in a cardboard box.

Vacation category

Without a prescription.

Producer

Gedeon Richter OJSC, Hungary.

Address

H-1103, Budapest, Demrei Street 19-21, Hungary.