PLEASE NOTE: MEDICINE IS NO LONGER AUTHORIZED
What is Duloxetine Boehringer Ingelheim?
Duloxetine Boehringer Ingelheim is a medicine that contains the active substance duloxetine. It is available as gastroresistant capsules (blue: 20 mg; white and blue: 30 mg; orange: 40 mg; green and blue: 60 mg). "Gastroresistant" means that the contents of the capsules pass through the stomach and remain intact until it reaches the intestine. This prevents the active ingredient from being destroyed by the acid present in the stomach.
This medicine is similar to Ariclaim, which is already authorized in the European Union (EU). The company that makes Ariclaim has agreed that its scientific data will be used for Duloxetine Boehringer Ingelheim.
What is Duloxetine Boehringer Ingelheim used for?
Duloxetine Boehringer Ingelheim is indicated for the treatment:
- of moderate to severe stress urinary incontinence in women (involuntary leakage of urine during physical exertion or following coughing, laughter, sneezing, lifting or physical exercise);
- of pain due to diabetic peripheral neuropathy (damage to nerves in the limbs that can develop in patients with diabetes).
The medicine can only be obtained with a prescription.
How is Duloxetine Boehringer Ingelheim used?
For stress urinary incontinence, the recommended dose of Duloxetine Boehringer Ingelheim is 40 mg twice a day. Some patients may benefit from an initial treatment with a dose of 20 mg twice a day for two weeks before increasing to 40 mg twice a day, in order to reduce the appearance of nausea and dizziness. The combination of Duloxetine Boehringer Ingelheim with a program of exercise of the pelvic floor musculature can give further benefit.
For diabetic neuropathic pain, the recommended dose is 60 mg once a day, but some patients may need a higher dose (120 mg a day). Response to therapy should be evaluated two months after the start of treatment.
Duloxetine Boehringer Ingelheim can be taken with or without food. The benefit of the treatment must be re-evaluated at regular time intervals. Duloxetine Boehringer Ingelheim should be used with caution in elderly patients and should not be given to patients who have
certain liver problems or severe kidney problems. When treatment is stopped, the dose should be reduced gradually.
How does it work?
The active substance in Duloxetine Boehringer Ingelheim, duloxetine, is a serotonin and noradrenaline reuptake inhibitor. It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and Noradrenaline from being recaptured in 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.
The action of duloxetine in stress urinary incontinence is not clear, but it is believed that by increasing the concentrations of 5-hydroxytryptamine and Norepinephrine in correspondence with the nerves that control the musculature of the urethra (the channel that connects the bladder to the outside) ), duloxetine causes stronger urethral closure during urine filling. By closing the urethra more vigorously, Duloxetine Boehringer Ingelheim prevents the involuntary loss of urine during a physical effort such as a cough or a laugh.
Since these neurotransmitters are also involved in reducing the sensation of pain, preventing their re-uptake into nerve cells can also improve the symptoms of neuropathic pain.
How has Duloxetine Boehringer Ingelheim been studied?
For the treatment of stress urinary incontinence, Duloxetine Boehringer Ingelheim has been studied in a total of 2 850 women. The four main studies were conducted on 1 913 women and lasted 12 weeks comparing Duloxetine Boehringer Ingelheim (mostly at a dose of 40 mg twice a day) with placebo (a sham treatment). The main measures of effectiveness were the frequency of incontinence episodes (the number of incontinence episodes per week) reported in a patient diary and the score reported by patients based on a incontinence specific quality of life questionnaire (I -QOL).
For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim was tested in two 12-week studies in 809 diabetic adults who had pain every day for at least six months. The efficacy of three different doses of Duloxetine Boehringer Ingelheim was compared with that of placebo. The main measure of effectiveness was the change in the severity of pain every week reported by patients, on a scale of 1 to 11, in a daily diary.
What benefit has Duloxetine Boehringer Ingelheim shown during the studies?
In all four studies on stress urinary incontinence, patients treated with Duloxetine Boehringer Ingelheim had fewer episodes of incontinence after 12 weeks, about four or five fewer episodes per week than the frequency recorded before the study began. The frequency of incontinence episodes decreased by 52% in the Duloxetine Boehringer Ingelheim group compared to a 33% decrease in the placebo group. The I-QOL questionnaire scores also improved in the Duloxetine Boehringer Ingelheim group compared to the placebo group. Duloxetine Boehringer Ingelheim was more effective than placebo only in patients who had more than 14 episodes of incontinence per week (moderate to severe stress urinary incontinence) at the start of the study.
For the treatment of diabetic neuropathic pain, Duloxetine Boehringer Ingelheim at a dose of 60 mg once or twice a day was more effective than placebo in reducing pain. In both studies, pain reduction was seen from the first week of treatment up to a maximum of 12 weeks and patients taking Duloxetine Boehringer Ingelheim reported a lower pain score of 1.17 to 1.45 points compared to that of patients taking placebo.
What is the risk associated with Duloxetine Boehringer Ingelheim?
The most common side effects with Duloxetine Boehringer Ingelheim in the treatment of stress urinary incontinence (seen in more than 1 patient in 10) are nausea, dry mouth, constipation and fatigue (tiredness). In most cases, these are mild or moderate effects, which occur at the beginning of the treatment and decrease as treatment continues. The most common side effects in the treatment of diabetic neuropathic pain (seen in more than 1 patient in 10) are headache, drowsiness, dizziness, nausea and dry mouth. For the full list of all side effects reported with Duloxetine Boehringer Ingelheim, see the Package Leaflet.
Duloxetine Boehringer Ingelheim should not be used in people who may be hypersensitive (allergic) to duloxetine or any of the other substances. Duloxetine Boehringer Ingelheim should not be given to patients with certain types of liver disease or severe kidney disease. Duloxetine Boehringer Ingelheim should not be used together with monoamine oxidase inhibitors (a group of antidepressants), with fluvoxamine (another antidepressant) or with 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 dangerous increase in blood pressure).
Why has Duloxetine Boehringer Ingelheim been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Duloxetine Boehringer Ingelheim outweigh its risks for the treatment of moderate to severe stress urinary incontinence and diabetic peripheral neuropathic pain in adults. The committee recommended the granting of the marketing authorization for Duloxetine Boehringer Ingelheim.
More information on Duloxetine Boehringer Ingelheim:
On 8 October 2008, the European Commission granted Boehringer Ingelheim International GmbH a marketing authorization for Duloxetine Boehringer Ingelheim, valid throughout the European Union.
The full EPAR for Duloxetine Boehringer Ingelheim can be found here.
Last update of this summary: 03-2009.
