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

Product Information

Skin rash with blisters; hives. (These side effects are likely to affect 1 to 10 people in every 10,000).

Diclofenac diethylammonium contains the active substance diclofenac which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It is specially formulated for rubbing into the skin. The Voltarol gel range contains a non-steroidal anti-inflammatory (NSAID) called diclofenac. Diclofenac works to inhibit prostaglandins, substances in the body that cause pain and inflammation helping to relieve pain and reduce inflammation. There are different types of Voltarol gel and products formulated to help relieve pain and inflammation. How does Voltarol 12-Hour Joint Pain Relief Gel Work? As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged treatment with Diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure. Close medical surveillance and caution should be exercised in patients with ulcerative colitis, or with Crohn's disease as these conditions may be exacerbated (see section 4.8 Undesirable effects).The concomitant use of Voltarol with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects (see section 4.5 Interactions with other medicaments and other forms of interaction).

If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel. Bursitis is a condition that affects the small, synovial fluid-filled sacs – called bursae – that cushion the bones and tendons near your joints. Bursitis most often occurs in joints that are used in frequent, repetitive motions. The most common locations of burstitis are the shoulder, elbow, and hip. However, it can also occur in the knee, heel, or at the base of your big toe. GoutThe effective daily dose after ocular application of Voltarol Ophtha (approximately 0.25 - 0.5 mg diclofenac sodium) corresponds to less than 1% of the daily dose recommended for Voltarol in rheumatic indications. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration and GI and cardiovascular risks below). Gastrointestinal bleeding (haematemesis, melaena) ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be withdrawn. Your medicine is known as Diclofenac diethylammonium 2.32% w/w Gel but will be referred to as Diclofenac diethylammonium throughout the following leaflet.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding). Apply 1 drop 2 times in the hour prior to surgery, one drop 2 times five minutes apart immediately after PRK surgery and then post-operatively 1 drop every 2-5 hours while awake for up to 24 hours.

Patient leaflet - VOLTAROL MAX STRENGTH PAIN RELIEF 2.32% GEL, DICLOFENAC DIETHYLAMMONIUM 2.32% W/W GEL

The recommended daily dose is 100-150mg in two or three divided doses. For milder cases, 75-100 mg daily in two or three divided doses is usually sufficient. Due to an increased possibility of side effects, take care if you are using any other medicine containing diclofenac or painkillers known as NSAIDs, such as aspirin or ibuprofen. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). Caution should be exercised when topical NSAIDs such as diclofenac are used concomitantly with topical steroids (see section 4.5 Interaction with other medicinal products and other forms of interaction). Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high doses (150mg daily) and in long term treatment (see sections 4.3 and 4.4 for Contraindications and Special warnings and special precautions for use) .

Children 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). 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.Voltarol Ophtha contains diclofenac sodium, a non-steroidal compound with pronounced anti-inflammatory and analgesic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is regarded as having an important bearing on its mechanism of action. Prostaglandins play a major role in the causation of inflammation and pain. Paediatric use: Voltarol Ophtha and Voltarol Ophtha SDU are not indicated for use in children. Paediatric experience is limited to a few published clinical studies in strabismus surgery.