Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Novartis Pharmaceuticals UK Limited, Trading as Geigy Pharmaceuticals, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
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).
For oral administration.
It is recommended that the tablets be taken with fluid, preferably with or after food.
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.
In migraine an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200 mg per day.
For children over 14 years of age, the recommended daily dose is 75-100 mg in two or three divided doses. Voltarol Rapid tablets are not recommended for children under 14 years of age.
The use of Voltarol Rapid (all forms) in migraine attacks has not been established in children.
Although the pharmacokinetics of Voltarol are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also precautions) and the patient should be monitored for GI bleeding during NSAID therapy.
Diclofenac is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (see section 4.3 Contraindications).
Patients with congestive heart failure (NYHA-I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration. Since cardiovascular risks with diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used and for the shortest duration possible (see section 4.4 Special warnings and precautions for use).
Voltarol Rapid is contraindicated in patients with renal failure (see section 4.3 Contraindications).
No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Voltarol Rapid to patients with mild to moderate renal impairment (see section 4.4 Special warnings and precautions for use).
Voltarol Rapid is contraindicated in patients with hepatic failure (see section 4.3 Contraindications).
No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Voltarol Rapid to patients with mild to moderate hepatic impairment (see section 4.4 Special warnings and precautions for use).
There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting or convulsions. In the case of significant poisoning acute renal failure and liver damage are possible.
Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.
Special measures such as forced diuresis, dialysis or haemo-perfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to high protein binding and extensive metabolism.
Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life threatening overdose.
Shelf life: 36 months.
Store in original packaging below 30°C and protect from moisture.
PVC/PE/PVdC blister strips containing 2, 3, 28 or 30 tablets.
(PVC 237.5-262.5 micron, PE 22.5-27.5 micron, PVdC 68.3-75.4 micron, aluminium foil 26-34 micron)
Medicines should be kept out of the reach of children.
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