VOLTAREN EMULGEL 60G 2%

VOLTAREN EMULGEL 2% GEL

active ingredients

100 g of Voltaren Emulgel contain 2,32 g diethylene dichlofenac, equivalent to 2 g sodium dichlofenac. Excipients with known effects: propylene glycol (50 mg/g gel) butylhydroxytoluene (0.2 mg/g gel) pungent eucalyptus scent For full list of excipients, see paragraph 6.1.

Excellent

Butylhydroxytoluene, carbomers, captive cocoil, diethylamine, isopropyl alcohol, liquid paraffin, ether cetosterial macrogol, oleic alcohol, propylene glycol, , eucalyptus perfume punching, purified water.

Therapeutic indications

Local treatment of painful and phlogistic states of rheumatic or traumatic nature of joints (such as osteoarthritis and arthritis), muscles (such as contractures or lesions), tendons and ligaments (such as tendonitis).

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Asthma, angioedema, urticaria or acute rhinitis as a result of the intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). • During the third quarter of pregnancy. • Use in children and adolescents under the age of 14 is contraindicated.

Population

For skin use. Adults over 18 years: Voltaren Emulgel 2% gel gives relief from pain up to 12 hours: Apply Voltaren Emulgel 2% gel 2 times a day on the area to be treated (preferably in the morning and in the evening), frying slightly. The quantity to be applied depends on the size of the party concerned. For example 2-4 g of Voltaren Emulgel 2% gel (quantitative of variable dimensions between a cherry and a walnut) is 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 2% to dry before showering or bathing Attention: use only for short periods of treatment. The duration of the treatment depends on the indication of use and the clinical response. The gel should not be used for more than 14 days without the doctor's advice. Consult your doctor if symptoms persist or worsen after 7 days of treatment. Teenagers from 14 to 18 years: Apply Voltaren Emulgel 2% gel 2 times a day on the area to be treated (preferably morning and evening), frying slightly. The quantity to be applied depends on the size of the party concerned. For example 2-4 g of Voltaren Emulgel 2% gel (quantitative of variable dimensions between a cherry and a walnut) is 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 2% 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 4.3 Contraindications). Therefore, the use of Voltaren Emulgel 2% gel is contraindicated in children under 14 years of age. Seniors (over 65 years) The usual dosage for adults can be used.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The possibility of systematic adverse events with the application of Voltaren Emulgel 2% can not be excluded if the preparation is used on extended skin areas and for a prolonged period. Voltaren Emulgel 2% should be applied only on intact skin, not sick, 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. Voltaren Emulgel 2% can be used with non-oplusive bandages, but should not be used with an occlusive bandage that does not let air pass. Important information about some excipients Voltaren Emulgel 2% gel contains 200 mg of propylene glycol per dose (4 g) equivalent to 50 mg/g which can cause skin irritation. Voltaren Emulgel 2% gel contains butylhydroxytoluene that can cause reactions on the localized skin (e.g. contact dermatitis) or irritation to the eyes and mucosa. Voltaren Emulgel 2% gel contains pungent eucalyptus scent, an aroma in turn containing benzilic alcohol, citronellol, cumarin, d-limonene, eugenol, geraaniol, linalol that can cause allergic reactions.

Interactions

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

Effects

Side effects include mild and transient skin reactions to the application site. In many rare cases, allergic reactions can occur. The side effects (Table 1) are listed below by organ, apparatus/system and MedDRA frequency. The frequencies are defined as: very common (≥ 1/10) common (≥ 1/100 to Table 1

Infections and infestations
Very rare	Rash with pustula.
Immune system disorders
Very rare	Hypersensitivity (including hives), angioedema.
Respiratory, chest and mediastinic pathologies
Very rare	Asthma.
Pathologies of skin and subcutaneous tissue
Town	Dermatitis (including contact dermatitis), rash, erythema, eczema, 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

Low systemic absorption of 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 Voltaren Emulgel 2% be ingested (1 60 g tube contains the equivalent of 1.2 g sodium dichlofenac). In case of ingestion, which results in 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 increases from less than 1%, up to about 1.5%. It is believed 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-planning and embryo 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 trimester of pregnancy, diclofenac should not be administered unless 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. 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 2% 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 2% 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 Special warnings and precautions of employment).

Source: Farmadati