VOLTAREN EMULGEL 1% GEL 100 G TUBE

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) For the 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 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

-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 a day to the area to be treated, rubbing in lightly. The amount to be applied depends on the size of the affected area. For example, 2-4 g of Voltaren Emulgel 1% gel (an amount varying in size from a cherry to a walnut) are sufficient to treat an area of ​​400-800 cm². Wash your hands after application, otherwise they will also be treated with the gel. Caution: use only for short periods of treatment. Adolescents aged 14 to 18 years : Apply Voltaren Emulgel 1% gel 3 or 4 times a day to the area to be treated, rubbing in lightly. The amount to be 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. Wash your hands after application, otherwise they will also be treated with the gel. If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years: There are insufficient data on efficacy and safety in children and adolescents under 14 years (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.

Warnings and precautions

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and for a prolonged period (see the summary of product characteristics of the 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 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.

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 edema.
Infections and infestations
Very rare	Rash with pustules.
Respiratory, thoracic and mediastinal pathologies
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.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation 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: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .

Pregnancy and breastfeeding

Pregnancy The systemic concentration of diclofenac compared to oral formulations is lower after topical administration. Based on experience with treatment with systemic NSAIDs, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of 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%, up to approximately 1.5%. The risk was 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 given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and 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 oligo-hydroamniosis; the mother and neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which 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).