GLADIO*CREAM 50G 1.5G/100G

GLADIO 1.5 g/100 g cream
Aceclofenac

What it is and what it is used for
GLADIO contains the active ingredient aceclofenac, which belongs to the category of non-steroidal anti-inflammatory drugs (NSAIDs) and anti-rheumatic drugs (drugs used for conditions affecting bones, cartilage, and muscles).

This medicine is indicated for the local treatment of painful and phlogistic (inflammatory) conditions of a rheumatic or traumatic nature affecting joints, muscles, tendons, and ligaments, such as tendinitis (inflammation of the tendons), tenosynovitis (inflammation of the membrane covering the tendon), sprains, contusions, periarthritis (inflammatory diseases involving the fibrous tissues surrounding a joint), dislocations (displacement of articular surfaces relative to each other), low back pain, stiff neck, bursitis (inflammation of the fluid-filled sacs that cushion between bones and tendons and/or muscles surrounding a joint), strains, and post-traumatic conditions.

Consult your doctor if you do not feel better or if you feel worse.

What you need to know before taking the medicine
Do not use GLADIO
- if you are allergic to aceclofenac, other NSAIDs (including acetylsalicylic acid) or any of the other ingredients of this medicine (listed in paragraph 6);
- if you have previously experienced, after taking acetylsalicylic acid, diclofenac, or other NSAIDs, an aggravation of asthmatic attacks, acute rhinitis (inflammation of the nasal mucosa), or urticaria (skin redness with intense itching);
- if you have or have previously experienced hypersensitivity reactions (allergy) to diclofenac, even if cross-allergenicity with this medicine has not been demonstrated;
- if you are in the last 3 months of pregnancy or during breastfeeding (see Pregnancy, breastfeeding, and fertility).

GLADIO is contraindicated in pediatric age (see Children and adolescents).

Warnings and precautions
Consult your doctor or pharmacist before using GLADIO.

Use GLADIO cream only for external use.
During treatment with GLADIO, you should avoid:
- Inappropriate exposure of the treated area to sunlight without adequate protection to prevent photosensitivity reactions (immune system reaction to sunlight).
- Application of the cream to open sores or wounds.
- Contact with the eyes, mucous membranes, or any other application site with ongoing skin lesions.

Discontinue treatment with GLADIO and consult your doctor for appropriate therapeutic treatment if you experience symptoms of local irritation.

Prolonged use of dermatological products can lead to sensitization (allergy).

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions (rapid onset allergic reactions), may also occur, even without prior exposure to aceclofenac (see paragraph 4 Possible side effects).

Severe skin reactions, some of which fatal, including exfoliative dermatitis (skin irritation with scaling), Stevens-Johnson syndrome (severe disease with skin and mucous membrane lesions), and toxic epidermal necrolysis (severe skin disease where the epidermis detaches in sheets), have been reported very rarely in association with the use of NSAIDs (see paragraph 4 Possible side effects). The risk appears to be higher in the early stages of therapy, as the onset of the reaction occurs in most cases within the first month of treatment.

Stop taking GLADIO at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity (allergy).

Avoid using GLADIO in case of chickenpox; in some cases, chickenpox can cause serious infectious complications of the skin and soft tissues, and the role of NSAIDs in the aggravation of these infections cannot be excluded (see paragraph 4 Possible side effects).

Children and adolescents
There is currently no data available regarding the safety and efficacy of aceclofenac in children up to 14 years of age, therefore its administration is not recommended (see Do not use GLADIO).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects that may occur after taking GLADIO are:

Common side effects (may affect up to 1 in 10 patients)
Mild or moderate skin irritation accompanied by redness and mild itching that disappear with the discontinuation of treatment.

Uncommon side effects (may affect up to 1 in 100 patients)
- Photosensitivity (increased sensitivity to light) if treated skin areas have been exposed to strong sunlight without adequate protection (see Warnings and precautions).
- Erythema (skin irritation).
- Itching.

Very rare side effects (may affect up to 1 in 10,000 patients)
Bullous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

Exceptionally, severe infectious skin and soft tissue complications have been reported during chickenpox in conjunction with NSAID treatment (see Warnings and precautions).

Adherence to the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.