Gladio*crema 50g 1,5g/100g

NAME
GLADIO 1,5 G / 100 G CREAM

PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatories for topical use.

ACTIVE PRINCIPLES
100 g of cream contain: aceclofenac 1,5 g.

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

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, lumbago, stiff neck, bursitis, strains and after-effects of trauma.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance (aceclofenac) or to non-steroidal anti-inflammatory drugs, including acetylsalicylic acid, or to any of the listed excipients. 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 with hypersensitivity to diclofenac. The product is also contraindicated in pediatric age, in pregnancy and during lactation.

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

STORAGE
Store at a temperature not exceeding 30 degrees C.

WARNINGS
For external use only. The medicine 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. Allergic reactions, including anaphylactic / anaphylactoid reactions, may occur even in the absence of previous drug exposure. Serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johns syndrome, and toxic epidermal necrolysis, have been reported very rarely with concomitant use of NSAIDs. 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 sign of hypersensitivity occur. The safety and efficacy of aceclofenac in children up to 14 years of age have not yet been established. No relevant data are available. Exceptionally, chickenpox can cause severe infectious skin and soft tissue complications. 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.

INTERACTIONS
Although information on diaceclofenac cream interactions is not yet available, caution is recommended when used with lithium, digoxin, oral anticoagulant agents, diuretics and pain relievers.

SIDE EFFECTS
The most commonly reported adverse reactions are mild or moderate irritation accompanied by redness and mild itching which disappears upon discontinuation of treatment. Exceptionally, severe skin and soft tissue 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, adverse reactions reported during clinical studies and post-registration experience with aceclofenac are presented and grouped by systemic and organ class (SOC) and by frequency. Skin and subcutaneous tissue disorders. Uncommon (> = 1/1000, <1/100): photosensitivity, erythema, pruritus; very rare (<1 / 10,000): 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. At the moment it is not known whether the drug is excreted in breast milk, therefore it is not recommended to use the product during the lactation period. Its use is not recommended for women intending to become pregnant. The administration of the drug should be suspended in women who have fertility problems 'or who are undergoing investigation of fertility'.