Yentreve 20mg gastro-resistant capsules

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Duloxetine hydrochloride

Disponibbli minn:

Eli Lilly and Company Ltd

Kodiċi ATC:

N06AX21

INN (Isem Internazzjonali):

Duloxetine hydrochloride

Dożaġġ:

20mg

Għamla farmaċewtika:

Gastro-resistant capsule

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 07040200; GTIN: 5014602301026

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
YENTREVE 40 MG HARD GASTRO-RESISTANT CAPSULES
YENTREVE 20 MG HARD GASTRO-RESISTANT CAPSULES
Duloxetine (as hydrochloride)
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 of the side effects talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What YENTREVE is and what it is used for
2.
What you need to know before you take YENTREVE
3.
How to take YENTREVE
4.
Possible side effects
5.
How to store YENTREVE
6.
Contents of the pack and other information
1.
WHAT YENTREVE IS AND WHAT IT IS USED FOR
YENTREVE contains the active substance duloxetine. YENTREVE increases
the levels of serotonin
and noradrenaline in the nervous system.
YENTREVE 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.
YENTREVE 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 YENTREVE is reinforced when combined with a training
program called Pelvic Floor
Muscle Training (PFMT).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE YENTREVE
DO NOT TAKE YENTREVE 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 ‘Oth

Karatteristiċi tal-prodott

OBJECT 1
YENTREVE 20MG HARD GASTRO-RESISTANT CAPSULES
Summary of Product Characteristics Updated 15-Jan-2016 | Eli Lilly and
Company Limited
1. Name of the medicinal product
YENTREVE* 20 mg and 40 mg hard gastro-resistant capsules.
2. Qualitative and quantitative composition
Each 20mg capsule contains 20 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect 20 mg:_ Each capsule may contain up to
37 mg sucrose.
Each 40mg capsule contains 40 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect 40 mg:_ Each capsule may contain up to
74 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard gastro-resistant capsule.
The 20 mg capsule has an opaque blue body, imprinted with '20mg', and
an opaque blue cap, imprinted
with '9544'.
The 40 mg capsule has an opaque orange body, imprinted with '40mg',
and an opaque blue cap, imprinted
with '9545'.
4. Clinical particulars
4.1 Therapeutic indications
YENTREVE is indicated for women for the treatment of moderate to
severe stress urinary incontinence
(SUI).
YENTREVE is indicated in adults.
For further information see section 5.1.
4.2 Posology and method of administration
Posology
The recommended dose of YENTREVE 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 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
YENTREVE 20 mg twice daily.
The efficacy of YENTREVE 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 YENTREVE with a pelvic floor muscle training (PFMT)
programme may be more effective
than e