Voltaren Emulgel 1% 120 g gel

Voltaren Emulgel 1% 120 g gel is a topical pain reliever based on diclofenac diethylammonium , belonging to the class of nonsteroidal anti-inflammatory drugs (NSAIDs) . This gel is specifically formulated for the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature affecting joints, muscles, tendons and ligaments . Thanks to its targeted action, Voltaren Emulgel 1% is particularly indicated for the relief of muscle pain , joint pain , muscle strains , sprains , contractures , tendonitis and sports injuries .

The gel formulation, contained in a practical 120 g tube with applicator cap , allows for easy application and rapid absorption through the skin, offering effective pain relief and reducing inflammation directly in the affected area. The active ingredient, diclofenac diethylammonium, acts deeply to counteract inflammatory processes and promote the recovery of musculoskeletal function.

Voltaren Emulgel 1% is ideal for those seeking a local and non-invasive treatment of rheumatic and traumatic pain, without having to resort to systemic drugs. The presence of propylene glycol and benzyl benzoate among the excipients helps improve the penetration of the active ingredient and ensures a sensation of freshness on the skin. The Cream 45 perfume makes the application even more pleasant.

Thanks to its effectiveness and practicality, Voltaren Emulgel 1% 120 g gel represents a reference solution for the treatment of muscle and joint pain and inflammation , both in sports and in everyday life. It is a product for local use, also suitable for the treatment of rheumatism and painful conditions associated with injuries , offering rapid relief and promoting the return to normal activities.

ACTIVE INGREDIENTS

Active ingredients contained in Voltaren Emulgel 1% 120 g gel - What is the active ingredient in Voltaren Emulgel 1% 120 g gel?

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); Cream 45 perfume. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Voltaren Emulgel 1% 120 g gel - What does Voltaren Emulgel 1% 120 g gel contain?

Diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, Cream 45 perfume (contains benzyl benzoate ), propylene glycol , purified water .

DIRECTIONS

Therapeutic indications Voltaren Emulgel 1% 120 g gel - Why is Voltaren Emulgel 1% 120 g gel used? What is it for?

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 AND SIDE EFFECTS

Contraindications Voltaren Emulgel 1 % 120 g gel - When should Voltaren Emulgel 1 % 120 g gel not be used?

- 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

Quantity and how to take Voltaren Emulgel 1% 120 g gel - How is Voltaren Emulgel 1% 120 g gel taken?

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 gently. 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. After application, clean your 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 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 gently. The amount to be applied depends on the size of the affected area. For example, 2-4 g of Voltaren Emulgel 1% gel (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, a doctor should be consulted. 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.

CONSERVATION

Storage Voltaren Emulgel 1% 120 g gel - How is Voltaren Emulgel 1% 120 g gel stored?

Tube of 60 g, 100 g, 120 g, 150 g gel and 120 g 1% gel with applicator cap : Store below 30°C. Pressurized container of 50 g : Store below 30°C. Caution: the container is under pressure: store away from direct sunlight, do not pierce or burn the container even after use.

WARNINGS

Warnings Voltaren Emulgel 1% 120 g gel - On Voltaren Emulgel 1% 120 g gel it is important to know that:

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. Voltaren Emulgel 1% gel contains the perfume Cream 45, a flavouring which in turn contains benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, linalool which may cause allergic reactions.

INTERACTIONS

Interactions Voltaren Emulgel 1 % 120 g gel - Which medicines or foods can modify the effect of Voltaren Emulgel 1 % 120 g gel?

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

SIDE EFFECTS

Like all medicines, Voltaren Emulgel 1 % 120 g gel can cause side effects - What are the side effects of Voltaren Emulgel 1 % 120 g gel?

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

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: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Voltaren Emulgel 1 % 120 g gel - What are the risks of Voltaren Emulgel 1 % 120 g gel in case of overdose?

The low systemic absorption of topical diclofenac makes overdose very unlikely. However, similar adverse effects to those observed after an overdose of diclofenac tablets may be expected if topical diclofenac is ingested (1 tube of 60 g contains the equivalent of 600 mg of diclofenac sodium). In the event of ingestion resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with nonsteroidal anti-inflammatory drugs should be undertaken. Further treatment, within the short term of ingestion, should take into account clinical indications or the recommendation of the poison control centre, where available.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Voltaren Emulgel 1% 120 g gel.

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).

DRIVING AND USE OF MACHINERY

Taking Voltaren Emulgel 1 % 120 g gel before driving or using machines - Does Voltaren Emulgel 1 % 120 g gel affect driving or using machines?

The cutaneous application of topical diclofenac does not alter the ability to drive vehicles or use machines.