Voltaren Emulgel Gel 1% 60g

Voltaren Emulgel Gel pain reliever and anti-inflammatory For muscle and joint pain based on Diclofenac (1%). Voltaren Emulgel is a local treatment of painful and inflammatory conditions : of a rheumatic or traumatic nature of the joints, such as osteoarthritis and arthritis ; of the muscles, in case of contractures or injuries ; of tendons and ligaments, in the presence of tendonitis .

ACTIVE INGREDIENTS

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

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 Gel 1% 60g - What does Voltaren Emulgel Gel 1% 60g 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 Gel 1% 60g - Why is Voltaren Emulgel Gel 1% 60g used? What is it used 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 SIDE EFFECTS

Contraindications Voltaren Emulgel Gel 1% 60g - When should Voltaren Emulgel Gel 1% 60g 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 method of taking Voltaren Emulgel Gel 1% 60g - How is Voltaren Emulgel Gel 1% 60g 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 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 cm^2. 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 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 cm^2. 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. 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.

CONSERVATION

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

Tube of 60 g, 100 g, 120 g, 150 g gel and 120 g 1% gel with applicator cap: store below 30 degrees C. Pressurized container of 50 g: store below 30 degrees 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 Gel 1% 60g - On Voltaren Emulgel Gel 1% 60g 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 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 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 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 Gel 1% 60g - Which medicines or foods can modify the effect of Voltaren Emulgel Gel 1% 60g?'

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

SIDE EFFECTS

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

Adverse reactions 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). Immune system disorders: Very rare: hypersensitivity (including urticaria), angioneurotic oedema. Infections and infestations: Very rare: rash with pustules. Respiratory, thoracic and mediastinal disorders: 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 the 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.

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 Gel 1% 60g.

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 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 considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, 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 an 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).