AIRTAL 1.5 G/100 G CREAM

AIRTAL 1.5 G/100 G CREAM

Therapeutic indications

Local treatment of painful and inflammatory states of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments such as tendinitis, tenosynovitis, sprains, contusions, periarthritis, dislocations, lumbago, stiff neck, bursitis, strains and after-effects of trauma.

Dosage and method of use

Apply 1.5 g – 2 g of AIRTAL 1.5 g/100 g cream equal to 4–5 cm three times a day on the affected part or according to medical prescription.

Contraindications

Hypersensitivity to the active substance (aceclofenac) or to non-steroidal anti-inflammatory drugs, including acetylsalicylic acid, or to any of the excipients listed in paragraph 6.1. Patients in whom acetylsalicylic acid or NSAIDs aggravate asthma attacks, acute rhinitis or urticaria or who are hypersensitive to these drugs. Patients with a history of hypersensitivity. Although cross-hypersensitivity with diclofenac has not been demonstrated, it is not recommended in patients hypersensitive to diclofenac. The product is also contraindicated in pediatric age, pregnancy and breastfeeding (see "Fertility, pregnancy and breastfeeding").

Side effects

The most commonly reported adverse reactions are mild or moderate irritation accompanied by redness and mild itching which disappear upon discontinuation of treatment. Exceptionally, the occurrence of serious cutaneous and soft tissue infectious complications in association with NSAID treatment has been reported during chickenpox. Occasionally (≥1/1,000 y

Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

For external use only. AIRTAL 1.5 g/100 g cream should not be applied to sores or open wounds. Avoid contact with eyes or mucous membranes or any other application site with active skin lesions. If the use of aceclofenac cream causes symptoms of local irritation, administration must be suspended and appropriate therapeutic treatment must be initiated. Avoid inappropriate exposure of the treated area to sunlight without adequate protection to prevent photosensitivity reactions.Hypersensitivity and skin reactions: prolonged use of products for dermatological use can give rise to sensitization phenomena. As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur even in the absence of previous exposure to the drug. Very rarely, serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with concomitant use of NSAIDs (see section 4.8). It appears that patients are at a higher risk for these reactions at the start of therapy as, in most cases, the reaction occurs in the first month of treatment. Aceclofenac must be discontinued as soon as skin rash, mucosal lesions or any other sign of hypersensitivity occurs. The safety and effectiveness of aceclofenac in children up to 14 years have not yet been established. No data is available in this regard. Exceptionally, chickenpox can cause serious infectious complications of the skin and soft tissues. To date, it is not possible to exclude the role of NSAIDs in the aggravation of these infections. It is therefore advisable to avoid the use of aceclofenac in case of chickenpox.Warnings on some excipients propyl parahydroxybenzoate, methyl parahydroxybenzoate:can cause allergic reactions (even delayed)

Pregnancy and breastfeeding

Although no teratogenic effects were observed in experimental studies, the safety of aceclofenac in pregnancy has not been established and therefore administration is not recommended in this circumstance. It is currently not known whether Airtal is excreted in breast milk, therefore the use of the product during breastfeeding is not recommended. The use of Airtal, like any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women intending to become pregnant. The administration of Airtal should be suspended in women who have fertility problems or who are undergoing fertility investigations.

Expiration and conservation

Store at a temperature not exceeding 30°C.

Interactions with other drugs

Although no information is available on the interactions of aceclofenac cream, caution is recommended when used with lithium, digoxin, oral anticoagulants, diuretics and painkillers.

Overdose

There are no known cases of overdose. In case of improper use or accidental ingestion, it is advisable to resort to general therapeutic measures of the type normally adopted in case of poisoning with non-steroidal anti-inflammatory drugs.

Active principles

100 g of cream contain: Active ingredient Aceclofenac 1.5 g Excipients with known effectspropyl parahydroxybenzoate, methyl parahydroxybenzoateFor the full list of excipients, see section 6.1.

Excipients

Emulsifying wax, liquid paraffin,propyl parahydroxybenzoate, methyl parahydroxybenzoate, purified water.