Gladium 1,5 g / 100 g

Dermatological cream

Composition:

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

Excipients

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

Therapeutic indications

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

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").

Dosage

Apply 1.5 to 2 grams of GLADIO 1.5 g / 100 g cream, equal to 4-5 cm, 3 times a day on the affected part or according to a different medical prescription.

Warnings and Precautions

For external use only. GLADIO 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 should 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: the 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 of age have not yet been established. No data are available in this regard. Exceptionally, chickenpox can cause severe infectious skin and soft tissue complications. To date, the role of NSAIDs in the aggravation of these infections cannot be ruled out. It is therefore advisable to avoid the use of aceclofenac in case of chickenpox.

Interactions

Although information on the interactions of aceclofenac cream is not yet available, caution is recommended when used with lithium, digoxin, oral anticoagulants, diuretics and pain relievers.

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 / 1000 to 1/100) photosensitivity reactions have been reported when treated skin areas have been exposed to strong sunlight without adequate protection. In the following table, the adverse reactions reported during clinical studies and in post-registration experience with aceclofenac are presented and grouped by systemic and organ class (SOC) and by frequency. Very common (≥ 1/10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1000 to <1/100); rare (≥1 / 10,000, <1/1000); very rare (<1 / 10,000)

MedDRa SOC Common (≥1 / 100 to <1/10) Uncommon (≥ 1/1000 to <1/100) Rare (≥1 / 10,000 to <1/1000) Very rare (<1 / 10,000)
Skin and subcutaneous tissue disorders Photosensitivity, erythema, pruritus. Bullous reactions (including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis)

Pregnancy and breastfeeding

Although no teratogenic effects were observed in experimental studies, the safety of aceclofenac in pregnant and lactating women has not been established, therefore administration is not recommended in these circumstances. It is not currently known whether GLADIO is excreted in breast milk, therefore it is not recommended to use the product during the lactation period. The use of GLADIO, as with any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women intending to become pregnant. Administration of GLADIO should be discontinued in women who have fertility problems or who are undergoing fertility investigations.