haematuria, proteinuria), interstitial Occasional: Elevation of serum aminotransferase enzymes (ALT, AST).Rare: Liver function disorders including hepatitis (in isolated cases fulminant) with or without jaundice.In isolated cases: Thrombocytopenia, leucopenia, agranulocytosis, haemolytic anaemia, aplastic anaemia.Hypersensitivity reactions have been reported following treatment with NSAIDs. General Sales List medicines can be sold without prescription from general retail outlets. - To assess the phototoxic potential of diclofenac DEA 2.32% gel and vehicle gel after a single application to the skin of healthy subjects with ultraviolet (UV) exposure. Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration and the duration of treatment. Because of the age of the studies, there are a number of gaps that might be expected in a more up-to-date package. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. The use of activated charcoal should be considered, especially within a short time (within one hour) of ingestion of a toxic dose. If the evaluations were at variance, a final score was mutually agreed upon. It allows continued monitoring of the benefit/risk balance of the medicinal product. A summary of the studies completed are provided below. Subjects were randomised to one of four treatment sequences; treatments being given over 7 days in A=Test product 2g DDEA 2.32% gel applied twice daily B=Test product 2g DDEA 2.32% gel applied twice daily C=Reference product 2g DDEA 1.16% gel applied four times in 24 D=Reference 50mg oral diclofenac sodium three times daily Subjects were instructed to apply the test product to a 400 cm² area covering the anterior, posterior, lateral and medial surfaces of the right ankle. Read more about diclofenac sodium gel onine at PatientDiclofenac eye drops are used to relieve pain and swelling. 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. It allows continued monitoring of the benefit/risk balance of the medicinal product. There are no data available on the use of topical formulations of diclofenac and its effects on fertility in humans. due to sprains, strains and bruisesAfter application, the hands should be washed unless they are the site being treated.If symptoms persist after 7 days or get worse at any time, medical advice should be sought.Not to be used for more than 7 days unless recommended by a doctor.Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. oral or injection for systemic adverse reactions).Concomitant 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 mean values of FI(2) and FI(1) were higher with diclofenac DEA 2.32% gel than with vehicle gel, and higher with vehicle gel than with blank patch (Table 21). By Day 8, the difference in tenderness between ankles had decreased from 2.9 – 3.0 N/cm2 on Day 1 to in the two groups given active treatment, but only to 1.7 N/cmbetween the Figure-of-eight measurements of the injured and contralateral ankles decreased rapidly after the start of treatment, from 1.6 – 1.8 cm on Day 1 to 1.1 cm on Day 3, 0.6 cm on Day 5 and 0.3 cm on Day 8. The medicines are specially formulated for Voltarol Emulgel P Gel is Pharmacy (P) medicine, available in pharmacies under the supervision of a Voltarol Emulgel Gel (GSL) is a General Sale List (GSL) medicine, which can be obtained without a prescription, at pharmacies, supermarkets and other retail outlets.

The pharmacodynamic, pharmacokinetic and toxicological properties of diclofenac are well-known. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. However, at therapeutic doses of Voltarol 12 Hour Emulgel 2.32% Gel no effects on the suckling child are anticipated.

This is just the first eMC Summary of Product Characteristics from your search. The amount needed will vary dependingupon the size of the painful or swollen area; an amountranging in size from a 1 penny to a 2 pence piece willusually be sufficient (2-4g). Continue typing to refine. It explains how Voltarol Emulgel P Gel and Voltarol Emulgel Gel (GSL) were assessed and their authorisation recommended, as well as their conditions of use.

To complete the induction phase, a subject had to have nine consecutive induction phase applications and at least eight subsequent consecutive induction phase readings as well as no patch re-located for any reason other than a reaction of grade 3 or above. As stated above, nine subjects had fewer than nine patch applications during the induction phase. The overall incidence of adverse events (AEs) ranged between 7.7% and 17.9% after topical DDEA treatment and was greater, 25.6%, after oral treatment (Table 18).