Voltaren Emulgel Gel 2% 100 Gr

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. • History of asthma, angioedema, urticaria or acute rhinitis following the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). • During the third trimester of pregnancy. • 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 Voltaren Emulgel 2% cannot be excluded if the preparation is used on large skin areas and for a prolonged period. Voltaren Emulgel 2% it must 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. Voltaren Emulgel 2% it can be used with non-occlusive dressings, but must not be used with an occlusive dressing that does not allow air to pass through. Important information about some excipients Voltaren Emulgel 2% gel contains 200 mg of propylene glycol per dose (4 g) equivalent to 50 mg/g which may cause skin irritation. Voltaren Emulgel 2% gel contains butylated hydroxytoluene which may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. Voltaren Emulgel 2% gel contains pungent eucalyptus scent, an aroma which in turn contains benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool which may cause allergic reactions.

INTERACTIONS

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

SIDE EFFECTS

Side effects include mild, transient skin reactions at the application site. In very rare cases, allergic reactions may occur. Undesirable effects (Table 1) are listed below by organ, system/system and MedDRA frequency. Frequencies are defined as: very common (≥ 1/10) common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) not known (frequency cannot be estimated from the available data). Table 1

Infections and infestations

Very rare | Rash with pustules.

Immune system disorders

Very rare | Hypersensitivity (including urticaria), angioedema.

Respiratory, thoracic and mediastinal disorders

Very rare | Asthma.

Pathologies of the skin and subcutaneous tissue

Municipality | Dermatitis (including contact dermatitis), rash, erythema, eczema, 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.