Dicloreum Local Anti-inflammatory 10 Medicated Patches 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 treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

CONTRAINDICATIONS

• Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory preparations (NSAIDs) or to any of the excipients of the finished product, as well as to isopropanol. • Patients in whom asthma attacks, urticaria or acute rhinitis have occurred after taking acetylsalicylic acid or other non-steroidal inflammatory drugs (NSAIDs). • Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds. • Third trimester of pregnancy and breastfeeding (see section 4.6). • Patients with active peptic ulcer. Children and adolescents: Use in children and adolescents under 16 years of age is contraindicated.

WARNINGS AND PRECAUTIONS FOR USE

If diclofenac medicated plasters are used on large skin surfaces and for a prolonged period of time, the possibility of systemic adverse events cannot be excluded (see the Summary of Product Characteristics of the systemic formulations of diclofenac). The medicated plaster must be applied only to intact and healthy skin and must not be applied to damaged skin or open wounds. The patches should not come into contact with the eyes or mucous membranes. Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. - Do not use with an occlusive dressing that does not allow air to pass through. - Treatment must be stopped immediately if a skin rash develops after application of the medicated plaster. - Do not simultaneously administer topically or systemically another medicinal product based on diclofenac or other NSAIDs. - Although systemic effects should be limited, the medicated plaster should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulcer or inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients who are more predisposed to side effects. - Patients should be advised not to expose themselves to direct sunlight or light from sunlamps for approximately one day after removal of the medicated plaster in order to reduce the risk of photosensitivity. Local anti-inflammatory Dicloreum contains: - methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (even delayed). - 420 mg of propylene glycol per patch which may cause skin irritation. - a perfume containing allergens (amyl cinnamale, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnammal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farinasol, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptin carbonate) which may cause reactions allergic.

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.

SIDE EFFECTS

Adverse reactions (Table 1) are listed by frequency, the most frequent first, using the following convention: 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: cannot be estimated from available data.

Infections and infestations

Very rare | Rash with pustules

Immune system disorders

Very rare | Hypersensitivity (including urticaria), angioneurotic edema, anaphylactoid 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

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

Very rare | Photosensitivity reactions

Systemic pathologies and conditions relating to the administration site

Municipality | Reactions at the administration site

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 risk/benefit ratio 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.