ACTION AND MECHANISM - Topical anti-inflammatory and analgesic. Diclofenac is a non-steroidal anti-inflammatory drug derived from phenylacetic acid, which acts by preventing the synthesis of prostaglandins and other prostanoids, through the inhibition of cyclooxygenase involved in inflammatory processes. PATIENT ADVICE - You should consult your doctor and/or pharmacist if you have had previous allergic reactions to other anti-inflammatory drugs, including acetylsalicylic acid. - Do not cover the area with occlusive bandages. - Do not apply to areas of skin with burns, open wounds, dermatitis or infections. - Do not expose treated areas to sunlight or UVA light sources until at least one day after the last application. - Consult your doctor and/or pharmacist if symptoms continue or worsen after the number of days specified in the package leaflet for the corresponding presentation. CONTRAINDICATIONS - Hypersensitivity to diclofenac or any other component of the medication. There are reports of cross-reactions between different NSAIDs, as well as with salicylates, therefore diclofenac is also not recommended in cases of [NSAID ALLERGY] or [SALICYLATE ALLERGY]. - In patients who have previously suffered attacks of [ASTHMA], [URTICARIA] or [RHINITIS] caused by acetylsalicylic acid or another non-steroidal anti-inflammatory drug (NSAID). - Do not apply to wounds, eczematous lesions, mucous membranes, or burns. - In children and adolescents under 14 years of age. - In the third trimester of pregnancy. - Do not administer concomitantly with other products containing diclofenac ADVANCED AGE The same dose as for adults can be used. There is no recommendation for use in elderly patients. PREGNANCY Animal safety: prenatal, perinatal and postnatal development of offspring was not affected. Safety in humans: Approximately 10% of the topical dose is absorbed systemically, with considerably lower bioavailability via the topical route than via the oral route. Adequate and well-controlled studies in humans with topical diclofenac are not available, but systemic diclofenac has resulted in fetal toxicity in late pregnancy. Although cutaneous absorption is minimal, the possibility of systemic effects cannot be ruled out. Topical use of diclofenac during the first two trimesters of pregnancy is only acceptable if, in the absence of other safer therapeutic alternatives, the benefits outweigh the possible risks. The use of diclofenac during the third trimester of pregnancy is contraindicated, as diclofenac has been associated with delayed labor and adverse cardiopulmonary effects in the fetus, such as premature closure of the ductus arteriosus and pulmonary hypertension, and renal effects, such as acute renal failure and oligohydramnios. It may also increase bleeding time in the mother. Effects on fertility: There is no evidence that diclofenac has teratogenic potential in mice, rats, or rabbits. In humans, preclinical data from acute and repeated-dose toxicity studies, as well as genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac, have revealed no specific risk at the intended therapeutic doses. PHARMACOKINETICS - Absorption: INDICATIONS - Symptomatic treatment of processes involving [INFLAMMATION] and/or [ACUTE PAIN], such as: * [CONTUSION] or [SPRAIN] caused by twisting. INTERACTIONS No interactions have been described at the recommended doses. However, in case of significant systemic absorption, the same interactions as with systemic diclofenac could occur. Furthermore, as with any topical treatment, it is not advisable to apply two topical medications at the same time to the same area. LACTATION Animal safety: no data available. Safety in humans: Diclofenac is excreted in breast milk, although it is not believed to have adverse effects on the infant. Because there are insufficient data, a decision must be made whether to discontinue breastfeeding or to discontinue/stop treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother. CHILDREN See the dosage section which specifies from what age it can be used in children. GUIDELINES FOR PROPER ADMINISTRATION It should be applied to healthy, intact skin, free of lesions or open wounds. Covering the area with occlusive dressings is not recommended. Application near the eyes and mucous membranes should be avoided. After application, hands should be washed unless they are the treatment site. POSOLOGY OLFEN FORTE, VOLTADOL FORTE - Adults and adolescents over 14 years of age: apply a thin layer every 12 hours (preferably morning and night) (2-4 g of gel, equivalent to the size of a cherry or walnut, respectively). Duration of treatment: If symptoms continue or worsen after 5 days of use, it is recommended to consult a doctor and/or pharmacist. PRECAUTIONS [PHOTOSENSITIVITY REACTIONS]. Diclofenac has caused photosensitivity reactions. It is recommended to avoid exposing treated areas to sunlight or UV light for at least one day. - Systemic reactions. The risk of systemic reactions from topical diclofenac is minimal, although it cannot be ruled out if significant systemic absorption occurs, as may happen if it is applied to damaged skin (dermatitis, burns, wounds) or with an occlusive dressing. It is recommended to adhere to the dosage recommendations in patients with asthma, a history of peptic ulcer, renal or cardiac insufficiency, as well as hypertension. ADVERSE REACTIONS - Dermatological: Frequent (1-10%) local reactions in the application area, such as [PRURITUS], [SKIN IRRITATION], [ERYTHEMA], [SKIN ERUPTIONS], with the appearance of pustules or papules on occasion. - Allergic: Infrequent (0.1-1.0%) [HYPERSENSITIVITY REACTIONS], [CONTACT DERMATITIS]; isolated cases of [ANAPHYLAXIS], [ANGIOEDEMA] and [PHOTOSENSITIVITY REACTIONS]. In case of significant absorption, systemic adverse reactions of diclofenac may occur. ADVERSE REACTIONS RELATED TO EXCIPIENTS - Because it contains butylhydroxytoluene as an excipient, it may produce local skin reactions such as [CONTACT DERMATITIS], [EYE IRRITATION] or [SKIN IRRITATION] on mucous membranes. OVERDOSE Symptoms: Due to its route of administration, symptoms are not very likely to appear in case of overdose, although accidental ingestion or improper application could produce the typical systemic adverse effects. Treatment: In case of accidental ingestion, gastric lavage and symptomatic treatment will be performed.