VOLTAREN EMULGEL * GEL150G 1%
Local treatment of painful and inflammatory conditions 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 tendinitis).
DOSAGE AND METHOD OF USE
For cutaneous use. Adults over 18 years: To apply Voltaren Emulgel 1% gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel 1% gel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel. Warning: use only for short periods of treatment. Teenagers aged 14 to 18 Apply Voltaren Emulgel 1% gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2-4 g of Voltaren Emulgel 1% gel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel. If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14: Insufficient data are available on efficacy and safety in children and adolescents below 14 years (see also section 4.3 Contraindications). Therefore, the use of Voltaren Emulgel 1% gel it is contraindicated in children under six to 14 years of age. Elderly (over 65): The usual adult dosage can 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 non-steroidal anti-inflammatory drugs (NSAIDs). – Third trimester of pregnancy. Children and adolescents: Use in children and adolescents under the age of 14 is contraindicated.
Adverse reactions (Table 1) are listed by frequency, most frequent first, using the following convention: very common (≥1 / 10), common (≥ 1/100, Table 1
|Disorders of the immune system|
|Very rare||Hypersensitivity (including urticaria), angioneurotic oedema.|
|Infections and infestations|
|Very rare||Rash with pustules.|
|Respiratory, thoracic and mediastinal disorders|
|Skin and subcutaneous tissue disorders|
|Common||Rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus.|
|Very rare||Photosensitivity reaction, allergic reactions.|
|Not known||Burning sensation on application, dry skin.|
Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on extensive skin areas and for a prolonged period (see 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 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. 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 can cause skin irritation.
PREGNANCY AND BREASTFEEDING
Pregnancy: The systemic concentration of diclofenac compared with 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 adversely affect pregnancy and / or embryo / fetal 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 early pregnancy. The absolute risk of cardiac malformations increased by less than 1%, up to about 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 increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, 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 administered except in strictly necessary cases. 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 prostaglandin synthesis inhibitors can expose the fetus to: – cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); – renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: – possible prolongation of the bleeding time, and antiplatelet 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. Feeding time: 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 expected. Due to the lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding under the advice of a healthcare professional. In this circumstance, Voltaren Emulgel 1% gel it should not be applied to the breasts of nursing mothers, or elsewhere on large areas of skin or for an extended period of time (see section 4.4).
EXPIRATION AND RETENTION
60g, 100g, 120g, 150g gel and 120g gel tube 1% with applicator cap: Store below 30 ° C. 50g pressurized container: store below 30 ° C. Warning: the container is under pressure: store away from direct sunlight, do not pierce or burn the container even after use.
INTERACTIONS WITH OTHER DRUGS
Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely.
The low systemic absorption of topical diclofenac makes an overdose very unlikely. However, side effects similar to those seen after an overdose of diclofenac tablets, may be expected in the event that topical diclofenac is ingested (1 tube of 60 g contains the equivalent of 600 mg of diclofenac sodium). In the event of ingestion resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Additional treatment modalities, within the short term of ingestion, should take into account clinical indications or the recommendation of the poison control center, where available.
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 gel) benzyl benzoate (1 mg / g gel) For a full list of excipients, see section 6.1.
Diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, Cream 45 perfume (contains benzyl benzoate), propylene glycol, purified water.