Voltaren Emulgel Gel 2% 100 Gr

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).

ACTIVE INGREDIENTS

100 g of Voltaren Emulgel contain 2.32 g of diclofenac diethylammonium, equivalent to 2 g of diclofenac sodium. Excipients with known effects: propylene glycol (50 mg/g gel); butylated hydroxytoluene (0.2 mg/g of gel); pungent eucalyptus perfume For the complete list of excipients, see section 6.1.

EXCIPIENTS

Butylated hydroxytoluene, carbomers, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleic alcohol, propylene glycol, pungent eucalyptus scent, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

• 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.

DOSAGE

For cutaneous use.

Adults over 18 years: Voltaren Emulgel 2% gel provides pain relief for up to 12 hours: Apply Voltaren Emulgel 2% gel 2 times a day on the area to be treated (preferably in the morning and evening), rubbing lightly. The quantity to be applied depends on the size of the affected part. For example, 2-4 g of Voltaren Emulgel 2% gel (a quantity varying in size between a cherry and a walnut) are sufficient to treat an area of ​​400-800 cm². After application, clean your hands with absorbent paper and then wash them, unless they are the site to be treated. Paper towels should be disposed of in household waste after use. Patients should wait for Voltaren Emulgel 2% to dry before showering or bathing. Caution: Use only for short treatment periods. The duration of treatment depends on the indication for use and the clinical response. The gel should not be used for more than 14 days without medical advice. Consult your doctor if symptoms persist or worsen after 7 days of treatment. Adolescents aged 14 to 18: Apply Voltaren Emulgel 2% gel 2 times a day on the area to be treated (preferably in the morning and evening), rubbing lightly. The quantity to be applied depends on the size of the affected part. For example, 2-4 g of Voltaren Emulgel 2% gel (a quantity varying in size between a cherry and a walnut) are sufficient to treat an area of ​​400-800 cm². After application, clean your hands with absorbent paper and then wash them, unless they are the site to be treated. Paper towels should be disposed of in household waste after use. Patients should wait for Voltaren Emulgel 2% 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 are available on efficacy and safety in children and adolescents under 14 years of age (see section 4.3 Contraindications). Therefore, the use of Voltaren Emulgel 2% gel is contraindicated in children under 14 years of age. Elderly (over 65 years old) The usual dosage for adults can be used.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

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.

Common: 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.

OVERDOSE

The low systemic absorption of topical diclofenac makes overdose very unlikely; however side effects similar to those observed after an overdose of diclofenac tablets, can be expected just in case Voltaren Emulgel 2% is ingested (1 60 g tube contains the equivalent of 1.2 g of diclofenac sodium). In case of ingestion, which gives rise to significant systemic side effects, the general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Further treatment modalities, within the short term of ingestion, should take into account clinical indications or the recommendation of the poison control center, where available.

PREGNANCY AND BREASTFEEDING

Pregnancy The systemic concentration of diclofenac compared to oral formulations is lower after topical administration. Referring to experience with treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increases from less than 1% to approximately 1.5%. The risk is believed to increase with the dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality; furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors had been administered during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered unless strictly 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 as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Diclofenac is contraindicated during the third trimester of pregnancy. Breastfeeding Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of Voltaren Emulgel 2% no effects on the infant are expected. 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 2% it must not be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4 Special warnings and precautions for use).

EFFECTS ON DRIVING ABILITY

Voltaren Emulgel 2% does not alter the ability to drive or use machinery.