Active ingredients 100 g of Voltaren Emulgel 1% gel contain 1.16 g of diclofenac diethylammonium, equivalent to 1 g of diclofenac sodium. Excipients with known effect: propylene glycol (50 mg/g of gel), benzyl benzoate (1 mg/g of gel), perfume, Cream 45. For a full list of excipients, see section 6.1. Excipients Diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, Cream 45 perfume (contains benzyl benzoate), propylene glycol, purified water. Therapeutic indications Local treatment of painful and inflammatory conditions 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 tendinitis). Contraindications/Side effects -Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. -Patients who have experienced asthma, angioedema, urticaria, or acute rhinitis after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). -Third trimester of pregnancy. Children and adolescents: Use in children and adolescents under 14 years of age is contraindicated. Dosage For cutaneous use. Adults over 18 years: Apply Voltaren Emulgel 1% gel 3 or 4 times daily to the affected area, rubbing in gently. The amount applied depends on the size of the affected area. For example, 2-4 g of Voltaren Emulgel 1% gel (an amount between the size of a cherry and a walnut) is sufficient to treat an area of ​​400-800 cm². After application, clean hands with absorbent paper and then wash them, unless they are the site to be treated. Absorbent paper should be disposed of in household waste after use. Patients should wait for Voltaren Emulgel 1% to dry before showering or bathing. Caution: Use only for short-term treatment. Adolescents 14 to 18 years: Apply Voltaren Emulgel 1% gel 3 or 4 times daily to the affected area, rubbing in gently. The amount applied depends on the size of the affected area. For example, 2-4 g of Voltaren Emulgel 1% gel (an amount between the size of a cherry and a walnut) is sufficient to treat an area of ​​400-800 cm². After application, clean hands with absorbent paper and then wash them, unless they are the site to be treated. Absorbent paper should be disposed of in household waste after use. Patients should wait for Voltaren Emulgel 1% to dry before showering or bathing. If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years: Insufficient data on efficacy and safety are available in children and adolescents under 14 years of age (see also section 4.3 Contraindications). Therefore, the use of Voltaren Emulgel 1% gel is contraindicated in children under 14 years of age. Elderly (over 65 years): The usual adult dosage may be used. Conservation Tubes of 60 g, 100 g, 120 g, and 150 g gel, and 120 g 1% gel with applicator cap: Store below 30°C. 50 g pressurized container: Store below 30°C. Caution: The container is pressurized. Store away from direct sunlight. Do not pierce or burn the container, even after use. Warnings The possibility of systemic adverse events with topical diclofenac cannot be ruled out if the preparation is used on large areas of skin and for a prolonged period (see the summary of product characteristics for systemic forms of diclofenac). Topical diclofenac should be applied only to intact, non-diseased skin, and not to skin wounds or open lesions. It should not be allowed to come into contact with eyes or mucous membranes and should not be ingested. Discontinue treatment if a 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 of the excipients Voltaren Emulgel 1% gel contains 200 mg propylene glycol per dose (4 g) equivalent to 50 mg/g and 4 mg benzyl benzoate per dose (4 g) equivalent to 1 mg/g which may cause skin irritation. Voltaren Emulgel 1% gel contains Cream 45 perfume, a flavouring containing benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool which may cause allergic reactions. Interactions Since 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, 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 (cannot be estimated from the available data). Table 1 Immune system disorders Very rare Hypersensitivity (including urticaria), angioneurotic oedema. Infections and infestations Very rare Rash with pustules. Respiratory, thoracic and mediastinal disorders Very rare Asthma. Skin and subcutaneous tissue disorders Common 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 medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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. Overdose The low systemic absorption of topical diclofenac makes overdose very unlikely. However, adverse effects similar to those observed after an overdose of diclofenac tablets can be expected if topical diclofenac is ingested (one 60 g tube contains the equivalent of 600 mg of diclofenac sodium). If ingestion results in significant systemic adverse effects, general therapeutic measures normally used to treat poisoning with nonsteroidal anti-inflammatory drugs should be initiated. Further treatment options, initiated shortly after ingestion, should take into account clinical indications or the recommendations of the poison control center, where available. Pregnancy and breastfeeding Pregnancy: Compared to oral formulations, the systemic concentration of diclofenac is lower after topical administration. Based on experience with systemic NSAID treatment, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, diclofenac should not be administered unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligohydramnios; - the mother and newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and an antiplatelet effect that may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Breastfeeding: Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Voltaren Emulgel 1% gel, no effects on the infant are anticipated. Due to the lack of controlled studies in breastfeeding women, the product should be used during breastfeeding only under the advice of a healthcare professional. In this circumstance, Voltaren Emulgel 1% gel should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).