Flector 180mg 10 medicated plasters

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 states of a rheumatic or traumatic nature of: • Joints; • Muscles; • Tendons; • Ligaments.

CONTRAINDICATIONS

• Hypersensitivity to the active substance or to acetylsalicylic acid or to other analgesics or other non-steroidal anti-inflammatory preparations (NSAIDs) or to any of the excipients listed in paragraph 6.1. • Patients in whom asthma attacks, urticaria or acute rhinitis have occurred after taking 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 : 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. Asthmatic patients with chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to treatment with NSAIDs more often than other patients. 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, the use of FLECTOR, as with any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women intending to become pregnant. The administration of FLECTOR should be suspended in women who have fertility problems or who are undergoing fertility investigations. 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 should be stopped immediately if a skin rash develops after applying the medicated plaster. • Do not simultaneously administer topically or systemically another medicine containing diclofenac or other NSAIDs. • Although systemic effects should be low, 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 sun lamps for approximately one day after removal of the medicated plaster to reduce the risk of photosensitivity. Important information about some excipients. FLECTOR contains: - methyl parahydroxybenzoate, propyl parahydroxybenzoate: may cause allergic reactions (even delayed); - 420 mg of propylene glycol in each patch: may cause skin irritation; - an aroma (perfume) in turn containing amyl cinnamal, 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: 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. Clinical investigations carried out with FLECTOR 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 is not recommended (see section 4.8).

SIDE EFFECTS

Adverse reactions (Table 1) are listed by frequency, 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. Table 1

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

Following applications for long periods of time on large skin surfaces, due to the amount of active ingredient that is absorbed, the appearance of systemic undesirable effects, especially at the gastrointestinal level, cannot be excluded. The use of the product in association with other drugs containing diclofenac can give rise to phenomena of hypersensitivity to light, skin rash with the formation of vesicles, eczema, erythema and, in rare cases, severe skin reactions (severe Stevens-Johnson, Lyell syndrome) (see section 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.