Duloxetine 20mg gastro-resistant capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Duloxetine hydrochloride

Commercializzato da:

Actavis UK Ltd

Codice ATC:

N06AX21

INN (Nome Internazionale):

Duloxetine hydrochloride

Dosaggio:

20mg

Forma farmaceutica:

Gastro-resistant capsule

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 07040200; GTIN: 5012617025333

Foglio illustrativo

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.
•
The full name of this medicine is Duloxetine 20mg and 40mg
Gastro-resistant Capsules, hard but within the leaflet it will be
referred to as Duloxetine capsules.
WHAT IS IN THIS LEAFLET
1. What Duloxetine capsules are and what they are used for
2. What you need to know before you take Duloxetine capsules
3. How to take Duloxetine capsules
4. Possible side effects
5. How to store Duloxetine capsules
6. Contents of the pack and other information
1. WHAT DULOXETINE CAPSULES ARE AND WHAT THEY ARE USED FOR
Duloxetine capsules contain the active substance duloxetine.
Duloxetine capsules increases the levels of serotonin and
noradrenaline in the nervous system.
Duloxetine capsules 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 capsules 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 capsules is reinforced when combined with
a training program called Pelvic Floor Muscle Training (PFMT).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULOXETINE CAPSULES
DO NOT TAKE DULOXETINE CAPSULES IF YOU:
•
are allergic to duloxetine or any of the other ingredients of this
medicine (listed in section 6)
•
have liver diseas

Scheda tecnica

OBJECT 1
DULOXETINE 20MG GASTRO RESISTANT CAPSULES, HARD
Summary of Product Characteristics Updated 15-Dec-2017 | Accord-UK Ltd
1. Name of the medicinal product
Duloxetine 20mg Gastro-resistant Capsules, hard
2. Qualitative and quantitative composition
Each capsule contains 20 mg of duloxetine (as hydrochloride).
Excipient with known effect: Each capsule contains 67.1 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard.
Opaque blue body imprinted with 'DLX 20' and an opaque blue cap,
imprinted with 'DLX 20'.
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 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 20mg 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 placebo-controlled studies.
The benefit of treatment should be re-assessed at regular intervals.
Combining Duloxetine 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.
Special populations
_Paediatric population_
The safety and efficacy of Duloxetine for the treatment of stress
urinary incontinence has not been
studied. No data are available.
_Elderly_
Caution should be exercised when treating the eld