Duloxetine 20mg gastro-resistant capsules

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Duloxetine hydrochloride

Dostupné s:

Zentiva

ATC kód:

N06AX21

INN (Mezinárodní Name):

Duloxetine hydrochloride

Dávkování:

20mg

Léková forma:

Gastro-resistant capsule

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 07040200; GTIN: 5000283658115

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE 20 MG GASTRO-RESISTANT HARD CAPSULES
DULOXETINE 40 MG GASTRO-RESISTANT HARD 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 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
1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR
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).
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 kno

Charakteristika produktu

OBJECT 1
DULOXETINE ZENTIVA 20 MG GASTRO-RESISTANT HARD
CAPSULES
Summary of Product Characteristics Updated 11-May-2016 | Zentiva
1. Name of the medicinal product
Duloxetine Zentiva 20 mg gastro-resistant hard capsules
2. Qualitative and quantitative composition
Each capsule contains 20 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect: each capsule contains 28.17 – 31.05
mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant hard capsule
Hard opaque gelatin capsules of length approx. 14.3 mm with light-blue
opaque body and light-blue
opaque cap which contain off-white to light-brown-yellow spherical
pellets.
4. Clinical particulars
4.1 Therapeutic indications
Duloxetine Zentiva is indicated for women for the treatment of
moderate to severe Stress Urinary
Incontinence (SUI).
Duloxetine Zentiva is indicated in adults.
For further information see section 5.1.
4.2 Posology and method of administration
Posology
The recommended dose of Duloxetine Zentiva 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 Zentiva 20 mg twice daily.
The efficacy of Duloxetine Zentiva 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 Zentiva 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 Zentiva must not be used in women with liver d