GLADIO "1.5% CREAM"50 G TUBE"

Name
GLADIO 1.5 g/100 g cream
Aceclofenac


What is it and what is it for?
GLADIO contains the active ingredient aceclofenac which belongs to the category of nonsteroidal anti-inflammatory drugs (NSAIDs) and antirheumatic drugs (drugs used for diseases affecting the bones, cartilage and muscles).

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

Talk to 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, to other NSAIDs (including acetylsalicylic acid) or to any of the other ingredients of this medicine (listed in section 6);
- if you have experienced in the past, after taking acetylsalicylic acid, diclofenac or other NSAIDs, a worsening of asthma attacks, acute rhinitis (inflammation of the nasal mucosa) or urticaria (redness of the skin with intense itching);
- if you have or have had in the past hypersensitivity (allergy) reactions to diclofenac, even if cross-allergenicity with this medicine has not been demonstrated;
- if you are in the last 3 months of pregnancy and are breastfeeding (see "Pregnancy, breastfeeding and fertility").

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


Warnings and precautions
Talk to your doctor or pharmacist before using GLADIO.

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

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

Prolonged use of dermatological products can give rise to sensitization (allergy) phenomena.

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

Serious skin reactions, some of them fatal, including exfoliative dermatitis (skin irritation with peeling), Stevens-Johnson syndrome (a serious illness involving lesions of the skin and mucous membranes), and toxic epidermal necrolysis (a serious skin disease in which the skin peels off in sheets), have been reported very rarely in association with the use of NSAIDs (see section 4 "Possible side effects"). The risk appears to be highest in the early stages of therapy, with the onset of the reaction occurring in the majority of 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 if you have chickenpox; in some cases, chickenpox can cause serious infectious complications of the skin and soft tissues and the role of NSAIDs in the worsening of these infections cannot be excluded (see section 4 "Possible side effects").

Children and adolescents
There are 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 following the intake of GLADIO are:

Common side effects (may affect up to 1 in 10 patients)
Mild or moderate skin irritation accompanied by redness and mild itching which disappear when treatment is stopped.

Uncommon side effects (may affect up to 1 in 100 people)
- Photosensitivity (increased sensitivity to light) if treated areas of skin 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 people)
Bullous reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).

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

Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you experience 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.