CREMA 50G 1.5G/100G

GLADIO 1.5 G/100 G CREMA

active ingredients

100 g cream contain: Active ingredient aceclofenac 1.5 g. Excipients with known effects propylparahydroxybenzoate, methylparahydroxybenzoate For the full list of excipients, see paragraph 6.1.

Excellent

Emulsifier wax, liquid paraffin, propylparahydroxybenzoate, methylparahydroxybenzoate, purified water.

Therapeutic indications

Local treatment of the painful and phlogistic states of rheumatic or traumatic nature of joints, muscles, tendons and ligaments such as: tendonitis, tenosinovitis, distortions, contusions, periartriti, dislocations, lombaggine, torcicollo, borsiti, ironing and trauma postures.

Contraindications

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

Population

Apply from 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 different prescription.

Conservation

Store at temperature not exceeding 30°C.

Warnings

Only for external use. GLADIO 1.5 g/100 g cream should not be applied on open wounds or wounds. Avoid contact with eyes or mucous membranes or any other application site with ongoing skin injury. If the use of aceclofenac cream causes symptoms of local irritation, the administration must be suspended and proper therapeutic treatment must be initiated. Avoid inappropriate exposure of the area treated with sunlight without adequate protection to prevent photosensitivity reactions. Hypersensitivity and skin reactions: prolonged use of dermatological products can lead to awareness-raising. As with other NSAIDs, allergic reactions can be manifested, including anaphylactic/anaphylactic reactions even in the absence of a previous exposure to the drug. Very rarely, with the concomitant use of NSAIDs, serious skin reactions were reported, some fatal, including exfoliatory dermatitis, Stevens–Johnson syndrome and toxic epidermal necrolysis (see paragraph 4.8). It seems that patients take a higher risk for these reactions at the beginning of therapy as, in most cases, the reaction occurs in the first month of treatment. Aceclofenac must be suspended as soon as skin rash occurs, mucosa lesions or any other sign of hypersensitivity. The safety and effectiveness of aceclofenac in children up to 14 years have not yet been established. Data is not available. Exceptionally, chickenpox can cause severe infectious skin complications 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.

Interactions

Although there is still no information on the interactions of aceclofenac cream, it is recommended caution when used with lithium, digoxin, oral anticoagulant agents, diuretics and painkillers.

Effects

The most commonly reported adverse reactions are mild or moderate irritation accompanied by redness and mild itching that disappears with the interruption of treatment. Exceptionally, during the chickenpox the occurrence of severe infectious skin complications and soft tissues in conjunction with the treatment with NSAIDs was reported. Occasionally from (≥1/1000 to 1/100) photosensitivity reactions were reported when treated skin areas were exposed to strong sunlight without adequate protection. In the following table, adverse reactions reported during clinical studies and post-recording experience with aceclofenac are reported and grouped according to systemic and organ classification (SOC) and by frequency. Very common (≥ 1/10); common (≥1/100, MedDRa SOC Municipalities (≥1/100, Not common (≥ 1/1000, Rare (≥1/10.000, Very rare ( Pathologies of skin and subcutaneous tissue   Photosensitivity, erythema, itching.   Bollose reactions (including Stevens–Johnson Syndrome and Epidermal Toxic Necrolysis)

Overdosing

No known overdose cases. In case of improper use or accidental ingestion, intervene with general therapeutic measures of the type normally adopted in case of poisoning with non-steroidal anti-inflammatory drugs.

Although no teratogenic effects have been observed in experimental studies, the safety of aceclofenac has not been established in pregnant women and during breastfeeding, so administration is not recommended under these circumstances. At the moment it is not known whether GLADIO is excreted in breast milk, therefore it is not recommended to use the product during the breastfeeding period. The use of GLADIO, as of any drug inhibitor of the synthesis of prostaglandins and cycloxygenase is not recommended in women who intend to start a pregnancy. The administration of GLADIO should be suspended in women who have fertility problems or who are subject to fertility surveys.

Source: Farmadati