The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended: The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. There are no data available on the use of topical formulations of diclofenac and its effects on fertility in humans. Washing clothing and bedding may reduce product build-up but not totally remove it. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Instruct patients not to smoke or go near naked flames - risk of severe burns. Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases. Voltarol Emulgel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing. Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
#VOLTAREN CREAM SKIN#
It should not be allowed to come into contact with the eyes or mucous membranes, and should not be ingested.ĭiscontinue the treatment if a skin rash develops after applying the product. Voltarol Emulgel should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of, bronchial asthma. Voltarol Emulgel contains propylene glycol and benzyl benzoate, which may cause mild, localised skin irritation in some people. oral or injection for systemic adverse reactions).Ĭoncomitant use of systemic NSAIDs should be cautioned since the possibility of an increase in incidence of untoward effects, particularly systemic side effects, cannot be ruled out. The possibility of experiencing systemic adverse events (those associated with the use of systemic forms of diclofenac) from application of Voltarol Emulgel cannot be excluded if the preparation is used at higher dosage/large amounts over large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac e.g. If large areas of the body are covered with gel, systemic absorption will be greater and the risk of side-effects increased, especially if the therapy is used frequently. Voltarol Emulgel is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor. Use in the elderly: The usual adult dosage may be used.Ĭhildren and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications section 4.3). Īfter application, the hands should be washed unless they are the site being treated. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) of gel should be applied 3 - 4 times a day. Date of first authorisation/renewal of the authorisationĪdults and children 14 years and over: Voltarol Emulgel should be rubbed gently into the skin. 6.6 Special precautions for disposal and other handling.4.7 Effects on ability to drive and use machines.4.5 Interaction with other medicinal products and other forms of interaction.4.4 Special warnings and precautions for use.4.2 Posology and method of administration.
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