AIRTAL * CR 50G 1,5G / 100G

AIRTAL * CR 50G 1,5G / 100G

Therapeutic indications

Local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments such as tendinitis, tenosynovitis, sprains, bruises, periarthritis, dislocations, low back pain, 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 section 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 has not been demonstrated with diclofenac, it is not recommended in patients hypersensitive to diclofenac. The product is also contraindicated in pediatric age, in pregnancy and during lactation (see "Fertility, pregnancy and lactation").

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, severe skin and soft tissue infectious complications have been reported to occur in conjunction with NSAID treatment during chickenpox. Occasionally (≥1 / 1,000 a

MedDRa SOC	Common (≥1 / 100,	Uncommon (≥ 1 / 1,000,	Rare (≥ / 10,000,	Very rare (
Skin and subcutaneous tissue disorders		Photosensitivity, erythema, itching.		Bullous rash (including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis)

Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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 open sores or wounds. Avoid contact with eyes or mucous membranes or any other application site with ongoing skin lesions. If the use of aceclofenac cream causes symptoms of local irritation, administration must be discontinued and appropriate therapeutic treatment 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 drug exposure. Very rarely, severe 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). Patients appear to be 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 should be discontinued as soon as skin rash, mucosal lesions or any other signs of hypersensitivity occur. The safety and efficacy of aceclofenac in children up to 14 years have not yet been established. No data are available in this regard. Exceptionally, chickenpox can cause severe skin and soft tissue infectious complications. To date, the role of NSAIDs in the aggravation of these infections cannot be excluded. It is therefore advisable to avoid the use of aceclofenac in case of chickenpox. Warnings about 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 unknown whether Airtal is excreted in breast milk, therefore it is not recommended to use the product during the breastfeeding period. The use of Airtal, like any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women intending to become pregnant. Administration of Airtal should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Expiration and retention

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 pain relievers.

Overdose

There are no known cases of overdose. In the event of misuse or accidental ingestion, general therapeutic measures of the type normally adopted in case of poisoning with non-steroidal anti-inflammatory drugs should be used.

Active principles

100 g of cream contain: Active ingredient Aceclofenac 1,5 g Excipients with known effects propyl parahydroxybenzoate, methyl parahydroxybenzoate For the full list of excipients, see section 6.1.

Excipients

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