Duloxetine Milpharm 40mg gastro-resistant capsules, hard

국가: 영국

언어: 영어

출처: myHealthbox

유효 성분:

Duloxetine (as duloxetine hydrochloride)

제공처:

Milpharm Limited

ATC 코드:

N06AX21

INN (국제 이름):

Duloxetine (as duloxetine hydrochloride)

복용량:

40mg

약제 형태:

Gastro-resistant capsule, hard

관리 경로:

Oral use

패키지 단위:

Blister packs: 14, 28, 56 and 98 capsules; bottle pack: 30, 98, 250 and 1000 capsules

처방전 유형:

POM - Prescription Only Medicine

Manufactured by:

APL Swift Services (Malta) Limited

치료 그룹:

Other antidepressants

치료 징후:

It is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).

승인 상태:

Authorised

승인 날짜:

2015-07-29

환자 정보 전단

DULOXETINE 20 MG GASTRO-RESISTANT CAPSULES, HARD
DULOXETINE 40 MG GASTRO-RESISTANT CAPSULES, HARD
Duloxetine (as hydrochloride)
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 pack and other information  
Duloxetine 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). 
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

제품 특성 요약

Duloxetine Milpharm 40mg gastro­resistant capsules
Summary of Product Characteristics Updated 10­Aug­2015 | Aurobindo Pharma ­ Milpharm Ltd.
1. Name of the medicinal product
Duloxetine Milpharm 40 mg gastro­resistant capsules, hard
2. Qualitative and quantitative composition
Each hard capsule contains 40 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect: Each capsule contains 95.68 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro­resistant capsule, hard
Green opaque /green opaque, size “4” hard gelatin capsule filled with white to off white pellets and imprinted with “X” on
green opaque cap and "01" on green opaque body with black ink.
4. Clinical particulars
4.1 Therapeutic indications
Duloxetine Milpharm is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).
Duloxetine Milpharm is indicated in adults.
For further information see section 5.1.
4.2 Posology and method of administration
Posology
The recommended dose of Duloxetine Milpharm is 40mg 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 20mg twice daily for two weeks before increasing to the recommended
dose of 40mg 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 Milpharm 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.
Combin