Duloxetine 40mg gastro-resistant capsules

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Duloxetine hydrochloride

थमां उपलब्ध:

Consilient Health Ltd

ए.टी.सी कोड:

N06AX21

INN (इंटरनेशनल नाम):

Duloxetine hydrochloride

डोज़:

40mg

फार्मास्यूटिकल फॉर्म:

Gastro-resistant capsule

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 07040200

उत्पाद विशेषताएं

OBJECT 1
DULOXETINE 40 MG GASTRO-RESISTANT CAPSULES
Summary of Product Characteristics Updated 04-Nov-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Duloxetine 40 mg gastro-resistant capsules
2. Qualitative and quantitative composition
Each hard gastro-resistant capsule contains 40 mg duloxetine (as
duloxetine hydrochloride).
Excipient with known effect: sucrose.
Each 40 mg capsule contains 53.7 mg – 57.87 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard
White to almost white pellets in a hard gelatine capsule size 2. The
capsule body is light orange and the
cap light blue. The capsule body is imprinted with 40 in black.
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 i