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, tendinitis 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.

INDICATIONS

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).

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Voltaren Emulgel 1% Gel 60 g?

Composition

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.

Excipients

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

DOSAGE

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 is contraindicated in children under six 14 years of age. Elderly (over 65 years): The usual dosage for adults can be used.

CONTRAINDICATIONS AND SIDE EFFECTS

When should Voltaren Emulgel 1% Gel 60 g not be used and what side effects can it cause?

Contraindications

- Hypersensitivity to the active substance or to any of the excipients (see the section "What is the composition of Voltaren Emulgel 1% Gel 60 g?"). - 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.

Side effects

Adverse reactions (Table 1) are listed by frequency, most frequent first, using the following convention: very common (≥1/10), common (≥1/100, less than 1/10); uncommon (≥ 1/1,000, less than 1/100); rare (≥1/10,000, less than 1/1,000); very rare (less than 1/10,000); not known (frequency 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 disorders Very rare Asthma. Pathologies of the skin and subcutaneous tissue 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 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.

INTERACTIONS

Which medicines or foods can change 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.

PREGNANCY AND BREASTFEEDING

Can Voltaren Emulgel 1% Gel 60 g be used during 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 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 should not be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time ((see the section "What are the warnings of Voltaren Emulgel 1% Gel 60 g?")).

WARNINGS

What are the warnings of Voltaren Emulgel 1% Gel 60 g?

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 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.

Overdose

The low systemic absorption of topical diclofenac makes overdose very unlikely. However, side effects similar to those seen 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 diclofenac sodium). 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.

Driving vehicles and using machinery

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

CONSERVATION

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.

FORMAT

What is the format of Voltaren Emulgel 1% Gel 60 g?

60 g

DRUG LEGAL TEXT

Content responsibility

This sheet contains information that is not intended to replace a doctor's diagnosis or advice, as only the doctor can draw up any prescription and give therapeutic indications. All contents must be understood and are of an exclusively informative nature and aimed exclusively at bringing to the attention of customers or potential customers in the pre-purchase phase of the products sold through this site. In case of pathologies, disorders or allergies it is always best to consult your doctor first.

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