Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Duloxetine hydrochloride
Wockhardt UK Limited
N06AX
Duloxetine hydrochloride
20 milligram(s)
Gastro-resistant capsule
oral use
packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100 and 500 capsules.
Product subject to prescription which may not be renewed (A)
Other antidepressants
Other antidepressants
Duloxetine is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI)
Not marketed
2015-10-02
are taking, have recently taken or might take any other medicines. 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) an 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 sedative antihistamines. _MEDICINES THAT INCREASE THE LEVEL OF _ _SEROTONIN:_ Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John’s Wort and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with duloxetine, you should see your doctor. _ORAL ANTICOAGULAN Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 04 January 2021 CRN00C10Y Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duloxetine 20 mg Gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of duloxetine (as hydrochloride). Excipient with known effect: Each 20 mg capsule contains 64.16 mg sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard. Opaque green cap and opaque green body size ‘4’ (14.40 ± 0.40 mm) hard gelatin capsules, imprinted with ‘H’ on cap and ‘190’ on body, filled with white to off white colored pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Duloxetine is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). Duloxetine is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Duloxetine is 40 mg twice daily without regard to meals. After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy. Some patients may benefit from starting treatment at a dose of 20 mg twice daily for two weeks before increasing to the recommended dose of 40 mg twice daily. Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness. A 20 mg capsule is also available. However, limited data are available to support the efficacy of Duloxetine 20 mg twice daily. The efficacy of Duloxetine has not been evaluated for longer than 3 months in placebo-controlled studies. The benefit of treatment should be re-assessed at regular intervals. Combining Duloxetine with a pelvic floor muscle training (PFMT) programme may be more effective than either treatment alone. It is recommended that consideration be given to concomitant PFMT. _Hepatic impairment _ Duloxetine must not be used in women with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2). _Ren Olvassa el a teljes dokumentumot