What is Ariclaim?
Ariclaim is a medicine that contains the active substance duloxetine. It is available as gastroresistant capsules (white and blue: 30 mg; green and blue: 60 mg). "Gastroresistant" means that the contents of the capsules cross the stomach and remain intact until it reaches the intestine; in this way the active principle is prevented from being destroyed by the acid present in the stomach.
What is Ariclaim used for?
Ariclaim is indicated for the treatment of pain due to diabetic peripheral neuropathy (damage to the nerves of the extremities, which can occur in patients with diabetes).
The medicine can only be obtained with a prescription.
How is Ariclaim used?
The recommended dose of Ariclaim is 60 mg once a day, but some patients may need a higher dose of 120 mg a day. Response to treatment should be evaluated two months after the start of treatment. If the treatment is effective, it must be evaluated at least every three months. Ariclaim can be taken with or without food. The dose should be reduced gradually when treatment is stopped.
How does Ariclaim work?
The active substance in Ariclaim, duloxetine, is a serotonin and noradrenaline re-uptake inhibitor. It works by preventing the neurotransmitters 5-hydroxytrypamine (also called serotonin) and Noradrenaline from being taken back up into nerve cells in the brain and spinal cord. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. By preventing their re-uptake, duloxetine increases the number of neurotransmitters in the spaces between nerve cells, increasing the level of communication between cells.
As these neurotransmitters also intervene in reducing the sensation of pain, preventing their re-uptake into nerve cells also helps alleviate the symptoms of neuropathic pain.
How has Ariclaim been studied?
Ariclaim has been studied in two 12-week studies in 809 adults with diabetes who had experienced pain every day for at least six months.
Three different doses of Ariclaim were compared with that of placebo. The main measure of effectiveness was the change in pain severity every week, as reported by patients, on an 11-point scale, in a daily diary.
What benefit has Ariclaim shown during the studies?
Ariclaim at a dose of 60 mg once or twice a day was more effective than placebo in reducing pain. In both studies, pain relief was observed from the first week of treatment up to a maximum period of 12 weeks and patients treated with Ariclaim reported a lower pain score of 1.17 to 1.45 points than that of patients treated with placebo.
What is the risk associated with Ariclaim?
The most common side effects with Amiclaim (seen in more than 1 patient in 10) are headache, drowsiness, dizziness, nausea and a dry mouth. Many of them were mild or moderate and soon manifested in the treatment becoming more moderate while the treatment continued. For the full list of all side effects reported with Ariclaim, see the Package Leaflet.
Ariclaim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other ingredients. Ariclaim should not be given to patients with certain types of liver diseases or to patients with severe kidney disease. It must not be used together with monoamine oxidase inhibitors (a group of antidepressants), fluvoxamine (another antidepressant) or ciprofloxacin or enoxacine (types of antibiotics). Treatment should not be initiated in patients with uncontrolled high blood pressure due to the risk of hypertensive crisis (sudden and sometimes dangerous increase in blood pressure).
Why has Ariclaim been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ariclaim's benefits are greater than its risks for the treatment of diabetic peripheral neuropathic pain in adults. The committee recommended the granting of a marketing authorization for Ariclaim.
Ariclaim was originally also authorized at doses of 20 mg and 40 mg for the treatment of stress urinary incontinence (SUI) in the moderate to severe dose, but the company withdrew these dosages when the marketing authorization is it was renewed in August 2009. Stress urinary incontinence means the accidental loss of urine during physical exertion or following coughing, laughter, sneezing, lifting or physical exercise.
More information on Ariclaim:
On 11 August 2004, the European Commission issued a marketing authorization for Ariclaim, valid throughout the European Union. The marketing authorization holder is Eli Lilly Nederland BV The marketing authorization was renewed on 11 August 2009.
Last update of this summary: 08-2009
