Voltaren Emulgel 1% Gel 60 g

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 the joints (such as osteoarthritis and arthritis), muscles (such as contractures or injuries), tendons and ligaments (such as tendonitis).

CONTRAINDICATIONS

- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. - Patients in whom asthma, angioedema, urticaria or acute rhinitis have occurred after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). - Third trimester of pregnancy. Children and adolescents: Use in children and adolescents under 14 years of age is contraindicated.

WARNINGS AND PRECAUTIONS FOR USE

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period (see the summary of product characteristics of systemic forms of diclofenac). Topical diclofenac should only be applied to intact, non-diseased skin and not to skin wounds or open lesions. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested. Discontinue treatment if skin rash develops after application of the product. Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass through. Important information about some excipients Voltaren Emulgel 1% gel contains 200 mg of propylene glycol per dose (4 g) equivalent to 50 mg/g and 4 mg of benzyl benzoate per dose (4 g) equivalent to 1 mg/g which may cause skin irritation. Voltaren Emulgel 1% gel contains Cream 45 perfume, an aroma which in turn contains benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farinasol, geraniol, linalool which may cause allergic reactions.

INTERACTIONS

Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely.

SIDE EFFECTS

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

Immune system disorders

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

Infections and infestations

Very rare | Rash with pustules.

Respiratory, thoracic and mediastinal disorders

Very rare | Asthma.

Pathologies of the skin and subcutaneous tissue

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

Rare | Bullous dermatitis.

Very rare | Photosensitivity reaction, allergic reactions.

Not known | Burning sensation at the application site, dry skin.

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.