VOLTAREN EMULGEL 120G 1%

VOLTAREN EMULGEL 1% GEL

active ingredients

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

Excellent

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

Therapeutic indications

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

-Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. -Patients in which asthma, angioedema, hives, or acute rhinitis after intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). -Third quarter of pregnancy. Children and teenagers: Use in children and adolescents under the age of 14 is contraindicated.

Population

For skin use. Adults over 18 years: Apply Voltaren Emulgel 1% gel 3 or 4 times a day on the area to be treated, frying slightly. The quantity to be applied depends on the size of the party concerned. For example 2-4 g Voltaren Emulgel 1% gel (quantitative of variable dimensions between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After the application clean your hands with paper towels and then wash them, unless they are the site to be treated. The absorbent paper must be thrown into household waste after use. Patients must wait for Voltaren Emulgel 1% to dry before taking a shower or bath. Caution: use only for short periods of treatment. Teenagers from 14 to 18 years old Apply Voltaren Emulgel 1% gel 3 or 4 times a day on the area to be treated, frying slightly. The quantity to be applied depends on the size of the party concerned. For example 2-4 g of Voltaren Emulgel 1% gel (quantitative of variable dimensions between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After the application clean your hands with paper towels and then wash them, unless they are the site to be treated. The absorbent paper must be thrown into household waste after use. Patients must wait for Voltaren Emulgel 1% to dry before taking a shower or bath. If this product is necessary for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years: Insufficient data are available on effectiveness 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. Seniors (over 65 years): The usual dosage for adults can be used.

Conservation

60 g pipe, 100 g, 120 g, 150 g gel and 120 g gel 1% with applicator cap: Store at a temperature below 30°C. Pressure container 50 gCaution: the container is under pressure: keep away from the direct sunlight, do not pierce, nor burn the container even after use.

Warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on extended skin areas and for a prolonged period (see the summary of the product characteristics of systemic forms of diclofenac). The topical diclofenac should be applied only on intact, unsick skin, and not on skin wounds or open injuries. It should not be let into contact with mucous membranes or eyes and should not be ingested. Stop the treatment if you develop skin rash after application of the product. The topical diclofenac can be used with non-occlusive bandages, but should not be used with an occlusive bandage that does not let air pass. 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 benzoate per dose (4 g) equivalent to 1 mg/g which can cause skin irritation. Voltaren Emulgel 1% gel contains Cream 45 perfume, an aroma in turn containing benzilic alcohol, citral, citronellol, cumarin, d-limonene, eugenol, foliage, geraaniol, linalol that can cause allergic reactions.

Interactions

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

Effects

Adverse reactions (Table 1) are listed by frequency, first the most frequent, using the following convention: very common (≥1/10), common (≥ 1/100, Table 1

Immune system disorders
Very rare	Hypersensitivity (including hives), angiourotic edema.
Infections and infestations
Very rare	Rash with pustula.
Respiratory, chest and mediastinic pathologies
Very rare	Asthma.
Pathologies of skin and subcutaneous tissue
Town	Rash, eczema, erythema, dermatitis (including contact dermatitis), itching.
Rare	Bold dermatitis.
Very rare	Reaction of photosensitivity, allergic reactions.
Notable	Feeling of burning in place of application, dry skin.

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The low systemic absorption of the topical diclofenac causes an overdose to be very unlikely. However side effects similar to those observed after overdosing diclofenac tablets, can be expected in case the topical diclofenac is ingested (1 60 g tube contains the equivalent of 600 mg of sodium diclofenac). In case of ingestion resulting from significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs must be taken. Additional methods of treatment, within a short time of ingestion, must take into account the clinical indications or recommendation of the anti-veleni center, where available.

Pregnancy The systemic concentration of diclofenac compared with oral formulations, is lower after topical administration. Referring to the experience with treatment with NSAIDs for systemic administration, we recommend the following: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, diclofenac should not be administered if not in strictly necessary cases. If diclofenac is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose must be kept as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Food Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of Voltaren Emulgel 1% gel there are no effects on the infant. Due to the lack of controlled studies in nursing women, the product should be used during breastfeeding only under the advice of a healthcare professional. In this circumstances, Voltaren Emulgel 1% gel should not be applied on the breasts of nursing mothers, or elsewhere on extended areas of skin or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati