Voltarol Pain Relief Gel, 12 Hour Joint Pain Relief 2.32% Gel (packaging may vary), 50 g (Pack of 1)

Product Information

Do not apply to skin with conditions such as cuts, open wounds, or on skin that has a rash or eczema. Discontinue the treatment if a skin rash develops after applying the product. In 15 clinical studies involving the use of rectal diclofenac in the treatment of postoperative pain in children with an overall mean age of 8 years, the use of rescue analgesia (particularly opiates) was reduced. (12.5mg and 25mg suppositories only) possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; This medicine is only for use on your skin. Do not use it in the mouth. Do not swallow it. Wash your hands after use unless they are the area to be treated. Be careful not to get Diclofenac diethylammonium in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity. Voltarol may reversibly inhibit platelet aggregation (see anticoagulants in section 4.5 Interaction with other medicaments and other forms of interactions). Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored. Quinolone antibacterials: Convulsions may occur due to an interaction between quinolones and NSAIDs. This may occur in patients with or without a previous history of epilepsy or convulsions. Therefore, caution should be exercised when considering the use of a quinolone in patients who are already receiving an NSAID.

The use of Voltarol may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Voltarol should be considered (see section 4.6 Pregnancy and Lactation).

v. reduce ocular inflammation and discomfort more effectively than topical steroids after strabismus surgery whilst avoiding steroidal adverse effects such as delayed conjunctival wound healing and raised intraocular pressure Drugs known to cause hyperkalemia: Concomitant treatment with potassium-sparing diuretics, ciclosporin, tacrolimus or trimethoprim may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4 Special warnings and precautions for use).Diclofenac was detected in a low concentration (100 ng/mL) in breast milk in one nursing mother. The estimated amount ingested by an infant consuming breast milk is equivalent to a 0.03 mg/kg/day dose (see section 4.6 Pregnancy and lactation).

In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during organogenetic period. From the 20th week of pregnancy onward, Voltarol use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arterious constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, Voltarol should not be given unless clearly necessary. If Voltarol is used by a woman attempting to conceive, or during the first or second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to diclofenac for several days from gestational week 20 onward. Voltarol should be discontinued if oligohydramnios or ductus arteriosus constriction is found. Appropriate monitoring and advice are required for patients with a history of hypertension and congestive heart failure (NYHA-I) as fluid retention and oedema have been reported in association with NSAID therapy, including diclofenac.

3. Who can and cannot take diclofenac

possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.