DICLANGEL*GEL 50G 1%

DICLANGEL*GEL 50G 1%

Therapeutic indications

For short-term treatments. Local symptomatic relief of acute pain from strains, sprains or bruises following superficial trauma.

Dosage and method of use

Depending on the size of the area of skin to be treated, apply 2-4 g of DICLANGEL (quantity of variable size between a cherry and a walnut) 3-4 times a day on the affected parts and let it penetrate by massaging lightly. In order to facilitate the absorption of the active principle, DICLANGEL can be applied with iontophoresis and must be associated with the cathode (the negatively charged pole). Adolescents over 14 years of age: In adolescents aged 14 years and over, if this product is needed for more than 7 days to relieve pain or if symptoms worsen, the patient and / or parents should consult their physician. Children and adolescents below 14 years: There are insufficient data on safety and efficacy in children and adolescents below 14 years of age (see also section 4.3 “Contraindications”).

Contraindications

Hypersensitivity to the active substance or to any of the excipients. DICLANGEL is also contraindicated in patients who have experienced asthma attacks, urticaria or acute rhinitis following the intake of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs). Children and adolescents: Use in children and adolescents under the age of 14 is contraindicated. Third trimester of pregnancy.

Side effects

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

Occasionally, redness, skin burning, rashes such as bullous or papular rash, skin blisters, peeling, tingling, involuntary muscle contractions may occur. If DICLANGEL is applied on relatively large skin areas and for a prolonged period of time, the possibility of systemic side effects such as nausea, dyspepsia, heartburn, excitation, taste alterations, conjunctivitis cannot be completely excluded. The use of the product in combination with other drugs containing diclofenac can give rise to phenomena of hypersensitivity to light, rash with blistering, eczema, erythema and skin reactions with severe evolution (Stevens-Johnson syndrome, Lyell's syndrome).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 at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

DICLANGEL should not be applied to open sores or wounds, but only to intact skin. Avoid contact with eyes or mucous membranes. Do not ingest. The possibility of systemic adverse events with the application of DICLANGEL cannot be excluded if the product is used on large areas of skin and for a prolonged period (see the Summary of Product Characteristics in systemic forms of diclofenac). Patients with asthma, chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to antirheumatic treatment with NSAIDs more often than other patients. 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.

Pregnancy and breastfeeding

Pregnancy: The systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Referring to experience with NSAID treatment 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 use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% 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 increased 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 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 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.Feeding time:Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of DICLANGEL no effects on the suckling child are anticipated. 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, DICLANGEL 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

This medicine does not require any special storage conditions.

Interactions with other drugs

Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely. Theoretically, competition between absorbed diclofenac and other drugs with high plasma protein binding is possible.

Overdose

The low systemic absorption of topical diclofenac makes an overdose very unlikely, however in such an event it is recommended to wash the affected skin area with water. Undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 tube of 60 g contains the equivalent of 600 mg of diclofenac sodium).In case of overdose from accidental ingestion: disorders of the gastrointestinal tract (nausea, vomiting, gastrointestinal bleeding) and of the central nervous system (headache, irritability and, in children, convulsions) may appear. In the event of accidental ingestion resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Gastric decontamination and the use of activated charcoal must be considered, especially within a short time of ingestion.

Active principles

1 g of gel contains 10 mg of diclofenac sodium. For the full list of excipients, see section 6.1.

Excipients

Alpha-tocopherol, carbomers, decyl oleate, octyldodecanol, lecithin / isopropyl alcohol, 10% ammonia solution, sodium edetate, “oil vert de creme” perfume, isopropyl alcohol, purified water.