Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: NOVARTIS SOUTH AFRICA (PTY) LTD, Magwa Crescent West, Waterfall City, Jukskei view, Johannesburg, 2090, +27113476600
Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthrosis and spondylarthritis.
Painful musculoskeletal conditions.
Non-articular rheumatism.
Acute attacks of gout.
Mild to moderately painful post-operative and post-traumatic inflammation and swelling, pain following dental surgery or orthopaedic surgery.
Symptomatic treatment of primary dysmenorrhoea.
Migraine attacks.
VOLTAREN 75 AMPOULES used for Intramuscular injection:
For initial therapy for inflammatory and degenerative rheumatic diseases, as well as for the treatment of mild to moderately painful conditions due to inflammation of non-rheumatic origin.
VOLTAREN 75 AMPOULES used for the preparation of Intravenous infusion:
Treatment or prevention of post-operative mild to moderate pain of inflammatory origin in the absence of any infection.
Because of their dosage strength, the following dosage strengths are not suitable for use in children and adolescents below 14 years of age; VOLTAREN 25 tablets could be used in these patients.
As a general recommendation, the dose should be individually adjusted, and the lowest effective dose given for the shortest possible duration.
VOLTAREN 25; VOLTAREN GT 50:
The tablets should be swallowed whole with a glass of water and must not be divided or chewed. For the relief of acute pain, the tablets should preferably be taken on an empty stomach.
The recommended initial daily dose is 100 to 150 mg. In milder cases, as well as for long-term therapy, 75 mg to 100 mg daily is usually sufficient.
The maximum daily dose of 150 mg should not be exceeded.
The total daily dose should generally be divided into 2 to 3 doses. To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by the administration of a suppository at bedtime (up to a total maximum daily dose of 150 mg).
In primary dysmenorrhoea, the daily dose should be individually adjusted and is generally 50 mg to 150 mg. A dose of 50 mg to 100 mg should be given initially and, if necessary, increased over the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started on appearance of the first symptoms and, depending on the symptomatology, continued for a few days.
No adjustment of the starting dose is generally required for elderly patients. However, caution is indicated on basic medical grounds, especially for frail elderly patients or patients with a low body weight. (see section 4.4)
VOLTAREN 75 TABLETS and VOLTAREN SIMPLE REGIMEN 100 TABLETS:
As a rule, the initial daily dosage is 100 mg to 150 mg administered as 1 tablet of VOLTAREN SIMPLE REGIMEN 100 as a single dose or as 2 tablets of VOLTAREN 75 TABLETS taken in two divided doses.
In milder cases, as well as for long-term therapy, 1 tablet of VOLTAREN 75 TABLETS daily is usually sufficient.
The VOLTAREN 75 TABLETS and VOLTAREN SIMPLE REGIMEN 100 tablets should neither be fragmented nor chewed and should preferably be taken at mealtimes. Where the symptoms are most pronounced during the night or in the morning.
VOLTAREN SIMPLE REGIMEN 100 tablets should preferably be taken in the evening.
VOLTAREN 75 AMPOULES should not be given for more than two days; if necessary, the treatment can be continued with VOLTAREN tablets or suppositories.
The following directions for intramuscular injection must be followed in order to avoid damage to a nerve or other tissue at the injection site.
Only for deep intragluteal injection into the upper outer quadrant.
After inserting the needle, the plunger should be pulled back to avoid inadvertent intra-arterial injection.
For adults the dose is generally one VOLTAREN 75 AMPOULE daily. VOLTAREN 75 AMPOULES should not be mixed with other injection solutions.
By way of exception, in severe cases, two injections of 75 mg, separated by an interval of a few hours, can be given per day (one into each buttock).
Alternatively, it is possible to combine one ampoule of 75 mg with either VOLTAREN 25 or VOLTAREN GT 50 tablets up to a maximum daily dosage of 150 mg.
VOLTAREN 75 AMPOULES used for the preparation of intravenous infusion.
VOLTAREN 75 AMPOULES must not be given as an intravenous bolus injection and must not be mixed with other injection solutions. Infusion solutions of sodium chloride 0,9% or glucose 5% without sodium bicarbonate as an additive present a risk of supersaturation, possibly leading to formation of crystals or precipitates. Only clear solutions should be used. If crystals or precipitates are observed, the infusion solution should not be used.
Do not use infusion solutions other than those recommended.
To prepare an intravenous infusion, one VOLTAREN 75 AMPOULE should be diluted with 100 mL – 500 mL of either sodium chloride solution (0,9%) or glucose solution (5%). Both solutions should first be buffered with bicarbonate solution (0,5 mL 8,4% or 1 mL 4,2%). Only clear infusion solutions should be used. VOLTAREN infusions should be freshly made up and used immediately. Once prepared, the infusion should not be stored. VOLTAREN should not be administered as an intravenous bolus injection.
Two alternative dosage regimens of VOLTAREN IV Infusion are recommended
VOLTAREN infusion should not be given for more than 2 days; if necessary, treatment to be continued with tablets or suppositories.
VOLTAREN 25 SUPPOSITORIES:
Children aged 2 years or over and adolescents should be given 0.5 to 2 mg/kg body weight daily in 2 to 3 divided doses, depending on the severity of the disorder. For treatment of juvenile rheumatoid arthritis, the daily dose can be raised up to a maximum of 3 mg/kg daily, given in divided doses.
VOLTAREN 100 SUPPOSITORIES:
The average adult dose is one VOLTAREN 100 SUPPOSITORIES daily.
To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by the administration of one VOLTAREN 100 SUPPOSITORIES at bedtime, up to a maximum dosage of 150 mg daily.
Note:
Not to be taken by mouth, as per rectal use only. The suppositories should be inserted well into the rectum. It is recommended to take the suppositories after passing stools.
Suppositories should never be divided for administration as incorrect storage conditions could have led to an uneven distribution of active substance in the suppository.
Do not use suppositories deformed by exposure to temperatures above 30°C.
There is no typical clinical picture resulting from VOLTAREN overdosage. Overdosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal haemorrhage, diarrhoea, dizziness, disorientation, excitation, tinnitus or convulsions and coma. In the event of significant poisoning, acute renal failure and liver damage are possible.
Management of acute poisoning with VOLTAREN 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 haemoperfusion are probably of no help in eliminating VOLTAREN due to the high protein binding and extensive metabolism.
Activated charcoal may be considered within one hour after ingestion of a potentially toxic overdose.
Voltaren 25 mg and Voltaren GT 50: 24 months.
Voltaren 75 mg and Voltaren SIMPLE REGIMEN 100 mg: 36 months.
Voltaren 75 mg ampoules: 24 months.
Voltaren 25 suppositories and Voltaren 100 mg Suppositories: 36 months.
VOLTAREN 25; VOLTAREN GT 50:
Store below 30°C.
Protect from moisture.
VOLTAREN 75 TABLETS:
Store below 30°C.
Protect from moisture.
VOLTAREN SIMPLE REGIMEN 100:
Store below 30°C.
Protect from moisture.
VOLTAREN 75 AMPOULES:
Store below 30°C.
Store in the original package in order to protect from light.
VOLTAREN 25 SUPPOSITORIES and VOLTAREN 100 SUPPOSITORIES:
Store below 30°C at all times.
VOLTAREN 25 is supplied as enteric-coated tablets of 25 mg in packs of 30 and 50.
VOLTAREN GT 50 is supplied as enteric-coated tablets of 50 mg in blister packs of 15 and 20.
VOLTAREN 75 TABLETS are supplied in packs of 10 and 30.
VOLTAREN SIMPLE REGIMEN 100 tablets are supplied in blister packs of 28 and 30.
VOLTAREN 75 AMPOULES: 75 mg/3 mL in packs of 5, 50 and 200.
VOLTAREN 25 SUPPOSITORIES and VOLTAREN 100 SUPPOSITORIES are supplied in packs of 5.
No special requirements.
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