Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: Medililink Pharmaceuticals Ltd, 30 Armenias Street, 2003 Strovolos, Nicosia, Cyprus, Tel.: +357 22319282, Fax: +357 22319290
Symptomatic treatment of pain and inflammation in:
Because the release of active substance from Difene Dual Release 100mg is delayed, this preparation is not suitable for starting treatment in conditions where rapid onset of action is needed.
The dose of diclofenac depends on the severity of the condition. The recommended dose range for adults lies between 50 and 100 mg diclofenac sodium per day.
| Age | Single dose: Number of Difene Dual Release 100mg modified‑release capsules, hard | Total daily dose: Number of Difene Dual Release 100mg modified‑release capsules, hard |
| Adults | 1 (equivalent to 100 mg diclofenac sodium) | 1 (equivalent to 100 mg diclofenac sodium) |
Difene Dual Release 100mg is taken without chewing and with plenty of fluid. Those with sensitive stomachs are recommended to take Difene Dual Release 100mg during meals.
The patient’s doctor decides the length of administration. For rheumatic diseases, it can be necessary to take Difene Dual Release 100mg for a long time.
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).
No specific dose adjustment is required. Because of the potential undesirable effect profile, elderly patients should be monitored with particular care.
For patients with mildly to moderately impaired renal function no dose reduction is required (for patients with severe renal impairment see section 4.3).
For patients with mild to moderate hepatic dysfunction no dose reduction is required (for patients with severe hepatic dysfunction see section 4.3).
For use in children and adolescents see also section 4.3.
Symptoms of overdose can be central nervous system disorders, such as headache, dizziness, drowsiness and loss of consciousness (in children, also myoclonic seizures), and abdominal pain, nausea and vomiting. Gastrointestinal bleeding and liver and kidney dysfunction are also possible. Hypotension, respiratory depression and cyanosis may occur.
No specific antidote exists.
he shelf life is 4 years.
This medicinal product should not be used after the expiry date.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Blister packs of PVC/PVDC foil and aluminium foil.
Original pack of 10, 20, 50, 100 modified‑release capsules, hard.
Hospital pack of 500 (10 × 50) modified‑release capsules, hard.
No special requirements.
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