DOLAUT*GEL SPRAY FL 25G 4%
Local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.
Dosage and method of use
Adults over 18 years: Apply DOLAUT 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 3-5 sprays of DOLAUT are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel. Attention use only for short periods of treatment. Teenagers aged 14 to 18: Apply DOLAUT 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 3-5 sprays of DOLAUT 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 your doctor. Children under the age of 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 DOLAUT is contraindicated in children under 14 years of age. Senior citizens: The usual adult dosage can be used.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children and adolescents: Use in children and adolescents under the age of 14 is contraindicated. Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). Third trimester of pregnancy.
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 edema.|
|Infections and infestations|
|Very rare||Rush 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|
|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 at 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 large skin areas and for a prolonged period (see the summary of product characteristics of the systemic forms of diclofenac). Therefore, particularly in patients with previous gastrointestinal diseases, the occurrence of systemic side effects such as nausea, dyspepsia, heartburn, excitation, taste alteration, conjunctivitis cannot be excluded for DOLAUT. 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. DOLAUT contains propylene glycol which may cause mild localized skin irritation in some people. 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. External use. KEEP OUT OF REACH OF CHILDREN.
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 can 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 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. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered 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 DOLAUT 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, DOLAUT 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).
Expiry and retention
Keep away from heat sources and naked flames
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, undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 bottle of 25 g contains the equivalent of 1000 mg diclofenac sodium). 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.
Each 100 g of gel contains: Active ingredient: Diclofenac sodium 4 g Excipient with known effect: propylene glycol For the full list of excipients, see section 6.1.
Propylene glycol, Isopropyl alcohol, Ethyl alcohol, Soy lecithin, Sodium phosphate dihydrate, Disodium phosphate dodecahydrate, Disodium edetate, Ascorbyl palmitate, Mint essence, Purified water.