देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Duloxetine hydrochloride
Wockhardt UK Limited
N06AX
Duloxetine hydrochloride
30 milligram(s)
Gastro-resistant capsule
oral use
blister packs of 7, 28 and 56 capsules
Product subject to prescription which may not be renewed (A)
: Other antidepressants
Other antidepressants
Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder.
Not marketed
2015-10-02
go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Duloxetine Capsules. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of duloxetine in this age group have not yet been demonstrated. OTHER MEDICINES AND DULOXETINE CAPSULES Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. The main ingredient of Duloxetine Capsules, duloxetine, is used in other medicines for other conditions: • diabetic neuropathic pain, depression, anxiety and urinary incontinence Using more than one of these medicines at the same time should be avoided. Check with your doctor if you are already taking other medicines containing duloxetine. Your doctor should decide whether you can take Duloxetine Capsules with other medicines. DO NOT START OR STOP TAKING ANY MEDICINES, INCLUDING THOSE BOUGHT WITHOUT A PRESCRIPTION AND HERBAL REMEDIES, BEFORE CHECKING WITH YOUR DOCTOR. You should also tell your doctor if you are taking any of the following: _MONOAMINE OXIDASE INHIBITORS (MAOIS):_ You should not take Duloxetine Capsules if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking a MAOI together with many prescription medicines, including duloxetine, can cause serious or even life-threatening side effects. You must wait at least 14 days after you have stopped taking an MAOI before you can take Duloxetine Capsules. Also, you need to wait at least 5 days after you stop taking Duloxetine Capsules before you take a MAOI. _MEDICINES THAT CAUSE SLEEPINESS:_ These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines. _MEDICINES THAT IN पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 04 January 2021 CRN00C10Y Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duloxetine 30 mg Gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride). Excipient with known effect: Each 30 mg capsule contains 96.25 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Opaque blue cap and opaque white body size ‘3’ (15.80 ± 0.40 mm) hard gelatin capsules imprinted with ‘H’ on cap and ‘191’ on body, filled with white to off white colored pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Major depressive disorder_ The starting and recommended maintenance dose is 60 mg once daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials. However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations. Therapeutic response is usually seen after 2-4 weeks of treatment. After consolidation of the antidepressive response, it is recommended to continue treatment for several months, in order to avoid relapse. In patients responding to duloxetine, and with a history of repeated episodes of major depression, further long-term treatment at a dose of 60 to 120 mg/day could be considered. _Generalised anxiety disorder_ The recommended starting dose in patients with generalised anxiety disorder is 30 mg once daily with or without food. In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients. I पूरा दस्तावेज़ पढ़ें