Voltaren Emulgel 1% Gel 60 g

Voltaren Emulgel 1% Gel 60 g it's a anti-inflammatory and painkiller for topical use based on diclofenac diethylammonium, belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs). It is indicated for local treatment of painful and inflammatory states of a rheumatic or traumatic nature involving joints, muscles, tendons and ligaments.

Thanks to its targeted action, Voltaren Emulgel 1% is particularly useful in case of muscle and joint pain, contractures, sprains, muscle strains, tendonitis and sports injuries. Local application allows you to act directly on the affected area, helping to relieve pain and reduce inflammation.

The gel formulation allows a rapid absorption without greasing the skin, facilitating application and making the product suitable for daily use. The active ingredient acts locally by counteracting inflammatory processes and promoting the recovery of normal musculoskeletal function.

Voltaren Emulgel 1% represents a practical solution for the local treatment of pain of traumatic or rheumatic origin, ideal for those who want a targeted intervention without resorting to systemic treatments. The practical tube from 60 g allows convenient use both at home and away from home.

ACTIVE INGREDIENTS

Active ingredients contained in Voltaren Emulgel 1% Gel 60 g - What is the active ingredient in Voltaren Emulgel 1% Gel 60 g?

100 g of Voltaren Emulgel 1% gel contain 1.16 g of diclofenac diethylammonium, equivalent to 1 g of diclofenac sodium. Excipients with known effects: propylene glycol (50 mg/g gel); benzyl benzoate (1 mg/g gel); Cream 45 perfume. For the complete list of excipients, see paragraph 6.1.

EXCIPIENTS

Composition of Voltaren Emulgel 1% Gel 60 g - What does Voltaren contain Voltaren Emulgel 1% Gel 60 g?

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

INDICATIONS

Therapeutic indications Voltaren Emulgel 1% Gel 60 g - Why is Voltaren Emulgel 1% Gel 60 g used? What is it for?

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 AND SIDE EFFECTS

Contraindications Voltaren Emulgel 1% Gel 60 g - When should Voltaren Emulgel 1% Gel 60 g not be used?

- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. - Patients in whom asthma, angioedema, urticaria or acute rhinitis have occurred after taking acetylsalicylic acid or other non-steroidal 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 method of taking Voltaren Emulgel 1% Gel 60 g - How is Voltaren Emulgel 1% Gel 60 g taken?

For cutaneous use.

Adults over 18 years: Apply Voltaren Emulgel 1% gel 3 or 4 times a day on the area to be treated, rubbing lightly. The quantity to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel 1% gel (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 1% to dry before showering or bathing. Warning: use only for short treatment periods. Adolescents aged 14 to 18 Apply Voltaren Emulgel 1% gel 3 or 4 times a day on the area to be treated, rubbing lightly. The quantity to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel 1% gel (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 1% to dry before showering or bathing. If this product is needed for more than 7 days for pain relief 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 (see also section 4.3 Contraindications). Therefore, the use of Voltaren Emulgel 1% gel It is contraindicated in children under six 14 years of age. Elderly (over 65 years): The usual dosage for adults can be used.

CONSERVATION

Storage Voltaren Emulgel 1% Gel 60 g - How is Voltaren Emulgel 1% Gel 60 g stored?

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

WARNINGS

Warnings Voltaren Emulgel 1% Gel 60 g - On Voltaren Emulgel 1% Gel 60 g 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 skin areas and for a prolonged period (see the summary of product characteristics of 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 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 excipients Voltaren Emulgel 1% gel contains 200 mg of propylene glycol per dose (4 g) equivalent to 50 mg/g and 4 mg of benzyl benzoate per dose (4 g) equivalent to 1 mg/g which may cause skin irritation. Voltaren Emulgel 1% gel contains Cream 45 perfume, an aroma which in turn contains benzyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farinasol, geraniol, linalool which may cause allergic reactions.

INTERACTIONS

Interactions Voltaren Emulgel 1% Gel 60 g - Which medicines or foods can modify the effect of Voltaren Emulgel 1% Gel 60 g?

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

SIDE EFFECTS

Like all medicines, Voltaren Emulgel 1% Gel 60 g can cause side effects - What are the side effects of Voltaren Emulgel 1% Gel 60 g?

Adverse reactions (Table 1) are listed by frequency, 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 (frequency cannot be estimated from the available data). Table 1

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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% Gel 60 g - What are the risks of Voltaren Emulgel 1% Gel 60 g gel in case of 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 if topical diclofenac is ingested (1 60 g tube contains the equivalent of 600 mg of sodium diclofenac). In case of ingestion resulting in 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

If you are pregnant, think you may be pregnant or are planning to become pregnant, or are breast-feeding, ask your doctor for advice before taking Voltaren Emulgel 1% Gel 60 g

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 increased from less than 1% to approximately 1.5%. The risk was thought 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-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were 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. Consequently, 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 1% gel 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 1% gel 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).

DRIVING AND USING MACHINERY

Taking Voltaren Emulgel 1% Gel 60 g before driving or using machinery - Does Voltaren Emulgel 1% Gel 60 g affect driving and using machinery?

Cutaneous application of topical diclofenac does not alter the ability to drive or use machinery.