Duloxetine Milpharm 20mg gastro-resistant capsules, hard

Страна: Велика Британія

мова: англійська

Джерело: myHealthbox

Активний інгредієнт:

Duloxetine (as duloxetine hydrochloride)

Доступна з:

Milpharm Limited

Код атс:

N06AX21

ІПН (Міжнародна Ім'я):

Duloxetine (as duloxetine hydrochloride)

Дозування:

20mg

Фармацевтична форма:

Gastro-resistant capsule, hard

Адміністрація маршрут:

Oral use

Одиниць в упаковці:

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

Тип рецепту:

POM - Prescription Only Medicine

Виробник:

APL Swift Services (Malta) Limited

Терапевтична група:

Other antidepressants

Терапевтичні свідчення:

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

Статус Авторизація:

Authorised

Дата Авторизація:

2015-07-29

інформаційний буклет

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

Характеристики продукта

Duloxetine Milpharm 20 mg gastro­resistant capsules, hard
Summary of Product Characteristics Updated 10­Aug­2015 | Aurobindo Pharma ­ Milpharm Ltd.
1. Name of the medicinal product
Duloxetine Milpharm 20 mg gastro­resistant capsules, hard
2. Qualitative and quantitative composition
Each hard capsule contains 20 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect: Each capsule contains 47.84 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 interval