Muscoridol 10 Medicated Patches for Muscle Pain 180 mg

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Local symptomatic treatment of rheumatic or traumatic pain and inflammation of joints, muscles, tendons and ligaments.

CONTRAINDICATIONS

This medicinal product is contraindicated in the following cases: - Hypersensitivity to diclofenac, acetylsalicylic acid, other analgesics or other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1. - Patients who have had asthma attacks, urticaria or acute rhinitis triggered by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). - Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds. - Third trimester of pregnancy (see section 4.6). - Patients with active peptic ulcer. - Children and adolescents under the age of 16.

WARNINGS AND PRECAUTIONS FOR USE

- The medicated plaster must only be applied to intact and healthy skin and must not be applied to damaged skin or open wounds and must not be applied when bathing or showering. - The medicated plaster must not come into contact with or be applied to the mucous membranes or eyes. - Do not use with an occlusive dressing that does not let air pass. - Treatment must be stopped immediately if a rash develops after applying the medicated plaster. - Do not administer simultaneously, topically or systemically, another medicinal product based on diclofenac or other NSAIDs. - The possibility of systemic adverse events produced by the application of topical diclofenac cannot be excluded if the preparation is used on a large skin surface and for a prolonged period (see product information relating to other systemic forms of diclofenac). Although systemic effects may be minimal, the patch should be used with caution in patients with impaired renal, cardiac or hepatic function, a history of peptic ulcer, intestinal inflammation or haemorrhagic diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients, as they are more susceptible to the onset of side effects. - Patients should be advised not to expose themselves to direct sunlight or sun lamps for approximately one day after removing the medicated plaster in order to reduce the risk of photosensitivity. - The medicated plaster should be used with caution in patients with asthma, chronic bronchial obstructive disease, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) who may react with asthma attacks, local inflammation of the skin or mucous membranes (Quincke's edema), urticaria or acute rhinitis after treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory agents more often than other patients (see section 4.3). - In order to minimize the occurrence of side effects, it is recommended to use the lowest effective dose for the shortest duration necessary to control symptoms, without exceeding the approved maximum of 14 days (see sections 4.2 and 4.8). - The use, especially if prolonged, of this as well as other products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt treatment and institute appropriate therapy. - Although systemic absorption is minimal, however the use of the medicated plaster, as of any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women intending to become pregnant (see section 4.6). - The administration of the diclofenac-based medicated plaster must be suspended in women who have fertility problems or who are undergoing fertility investigations (see section 4.6). This medicine contains methyl parahydroxybenzoate e propyl parahydroxybenzoate. They can cause allergic reactions (even delayed); This medicine contains 420 mg of propylene glycol per patch.

INTERACTIONS

Since the systemic absorption of diclofenac following the use of medicated plasters is very low, the risk of developing clinically significant interactions with other medicinal products is negligible. Clinical investigations carried out with the diclofenac-based medicated plaster, used in conjunction with other steroidal and non-steroidal anti-inflammatory drugs (salazopyrin, hydroxyquinoline, etc.), have not highlighted any interaction phenomena. However, the possibility of competition between the absorbed diclofenac and other drugs with high binding to plasma proteins cannot be excluded. Concomitant topical or systemic use of other drugs containing diclofenac or other NSAIDs (see section 4.8) is not recommended.

SIDE EFFECTS

Adverse reactions are listed by frequency, the most frequent first, using the following convention: very common (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known: frequency cannot be estimated from the available data.

Infections and infestations

Very rare | Pustular rash

Immune system disorders

Very rare | Hypersensitivity (including urticaria), angioedema, anaphylactic reaction

Respiratory, thoracic and mediastinal disorders

Very rare | Asthma

Pathologies of the skin and subcutaneous tissue

Municipality | Rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), pruritus

Uncommon | Petechiae

Rare | Bullous dermatitis (e.g. bullous erythema), dry skin

Very rare | Photosensitivity reaction

Not known | Burning sensation at the application site

Systemic pathologies and conditions relating to the administration site

Municipality | Reactions at the site of administration

Uncommon | Feeling hot

The systemic absorption of diclofenac is very low compared to the plasma levels measured after oral intake of diclofenac and the probability of systemic side effects (such as gastric, hepatic and renal disorders) is very low compared to the frequency of side effects associated with oral use of diclofenac. However, if Zaranny is used on large skin surfaces and for long periods of time, the appearance of systemic side effects is possible, especially at the gastrointestinal level due to the amount of active ingredient that is absorbed. The use of the product in combination with other drugs containing diclofenac must be avoided as it can give rise to phenomena of hypersensitivity to light, skin rash with vesicle formation, eczema, erythema and, in rare cases, severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome) (see paragraphs 4.4 and 4.5). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.