Duloxetine 40 mg gastro-resistant capsules

国家: 英国

语言: 英文

来源: myHealthbox

有效成分:

Duloxetine (as duloxetine hydrochloride)

可用日期:

Consilient Health Limited

ATC代码:

N06AX21

INN（国际名称）:

Duloxetine (as duloxetine hydrochloride)

剂量:

40mg

药物剂型:

Gastro-resistant capsules

给药途径:

Oral use

每包单位数:

7, 10, 14, 28, 30, 56, 60, 90 and 100 hard gastro-resistant capsules, in a box.

处方类型:

POM - Prescription Only Medicine

厂商:

KRKA, d.d., TAD Pharma GmbH

治疗组:

Psychoanaleptics, other antidepressants

疗效迹象:

It is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI)

授权状态:

Authorised

授权日期:

2015-05-20

资料单张

1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR
This medicine contains the active substance duloxetine. Duloxetine 
increases the levels of serotonin and noradrenaline in the nervous 
system.
Duloxetine is a medicine to be taken by mouth to treat Stress 
Urinary Incontinence (SUI) in women.

Stress urinary incontinence is a medical condition in which patients 
have accidental loss or leakage of urine during physical exertion or 
activities such as laughing, coughing, sneezing, lifting, or
exercise.

Duloxetine is believed to work by increasing the strength of the 
muscle that holds back urine when you laugh, sneeze, or perform 
physical activities.

The efficacy of Duloxetine is reinforced when combined with a 
training program called Pelvic Floor Muscle Training (PFMT).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
DULOXETINE
Do not take Duloxetine if you:
•  
are

allergic to Duloxetine or any of the other ingredients of this 
medicine (listed in section 6).
•  
have liver disease 
•  
have severe kidney disease 
•  
are taking or have taken within the last 14 days, another 
medicine known as a monoamine oxidase inhibitor (MAOI) (see 
“Other medicines and Duloxetine”)
Read all of this leaflet carefully before you start taking this 
medicine because it contains important information for you.
•  
Keep this leaflet. You may need to read it again.
•  
If you have any further questions, ask your doctor or pharmacist.
•  
This medicine has been prescribed for you only. Do not pass it on 
to others. It may harm them, even if their signs of illness are
the 
same as yours.
•  
If you get any side effects, talk to your doctor or
pharmacist. This 
includes any possible side effects not listed in this leaflet. See 
section 4.
What is in this leaflet
1. What Duloxetine is and what it is used for
2. What you need to know before you take Duloxetine
3. How to take Duloxetine
4. Possible side effects
5. How to store Duloxetine
6. Contents of the

产品特点

Duloxetine 40 mg gastro­resistant capsules
Summary of Product Characteristics Updated 15­Jun­2015 | Consilient Health Ltd
1. Name of the medicinal product
Duloxetine 40 mg gastro­resistant capsules
2. Qualitative and quantitative composition
Each hard gastro­resistant 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
Gastro­resistant 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 2­4 weeks of treatment,
patients should be re­assessed 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 placebo­controlled studies. The benefit of
treatment should be re­assessed at regular intervals.
Combining Duloxetine with a pelvic floor mu