Duloxetine 20mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Duloxetine hydrochloride

Available from:

Milpharm Ltd

ATC code:

N06AX21

INN (International Name):

Duloxetine hydrochloride

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040200

Patient Information leaflet

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
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 known as a monoamine
oxidase inhibitor (MAOI) (see ‘Other medicines
and Duloxetine’)
-
are taking fluvoxamine which is usually used
to treat depression, ciprofloxacin or enoxacin
which a

Summary of Product characteristics

OBJECT 1
DULOXETINE MILPHARM 20 MG GASTRO-RESISTANT
CAPSULES, HARD
Summary of Product Characteristics Updated 19-Sep-2016 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Duloxetine Milpharm 20 mg gastro-resistant 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
Gastro-resistant capsule, hard
Green opaque /green opaque, size “4“ hard gelatin capsules filled
with white to off white pellets and
imprinted with “DLX“ on green opaque cap and "20" 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 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 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 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.
_Hepatic impairment_
Duloxetine Milpharm must not b