Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Wisdom Pharmaceutical Technology Co Limited, Wilton Park House, Wilton Place, Dublin 2, Ireland
Short-term treatment of all grades of pain and inflammation in the following acute conditions:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
The contents of the sachet should be dissolved with stirring in a glass of natural (non-carbonated) water. The solution may remain slightly opalescent, but this should not influence the efficacy of the preparation. The solution should be swallowed preferably before meals.
The recommended initial daily dosage is 100-150mg. In milder cases, 50-100mg daily are usually sufficient. The daily dosage should generally be divided up to 3 doses.
In primary dysmenorrhoea the daily dosage should be individually adjusted and is generally 50-150mg. Initially a dose of 50-100mg should be given and, if necessary, raised in the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started upon appearance of the first symptoms and, depending on the symptomatology, continued for a few days.
In migraine an initial dose of 50mg should be taken at the first signs of an impending attack. In cases where pain relief within 2 hours after the first dose is not sufficient, a further dose of 50mg may be taken. If needed, further doses of 50mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200mg per day.
Voltfast 50mg powder for oral solution is not recommended for use in children and adolescents below 14 years of age. For treatment in children and adolescents below 14 years of age, oral drops and suppositories of diclofenac 12.5mg are available.
For adolescents aged 14 years and over, 50 to 100mg daily are usually sufficient, given as 1 to 2 divided doses.
The maximum daily dose of 150mg should not be exceeded.
The use of Voltfast 50mg powder for oral solution in migraine attacks has not been established in children and adolescents.
Although the pharmacokinetics of Votlfast are not impaired to any clinically relevant extent in elderly patients, non-steroidal anti-inflammatory drugs should be used with particular caution in frail elderly patients or those with a low body weight. In particular, it is recommended that the lowest effective dosage be used in these patients (see Section 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or if intolerance occurs.
Diclofenac is contraindicated in patients with severe renal impairment (see section 4.3).
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 diclofenac to patients with mild to moderate renal impairment (see section 4.3 and 4.4).
Diclofenac is contraindicated in patients with severe hepatic impairment (see section 4.3).
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 diclofenac to patients with mild to moderate hepatic impairment (see section 4.3 and 4.4).
There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
Management of acute poisoning with NSAIDs including diclofenac consists essentially 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 haemoperfusion are probably unlikely to be helpful in accelerating the elimination of NSAIDs including diclofenac because of their high protein binding rate 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.
3 years.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Sachet consisting of coupled paper/aluminium/polyethylene, hermetically sealed in four directions. Three sachets are packaged in one carton.
No special requirements.
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