Duloxetine 40 mg gastro-resistant capsules
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
Duloxetine (as duloxetine hydrochloride)
Available from:
Consilient Health Limited
ATC code:
N06AX21
INN (International Name):
Duloxetine (as duloxetine hydrochloride)
Dosage:
40mg
Pharmaceutical form:
Gastro-resistant capsules
Administration route:
Oral use
Units in package:
7, 10, 14, 28, 30, 56, 60, 90 and 100 hard gastro-resistant capsules, in a box.
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
KRKA, d.d., TAD Pharma GmbH
Therapeutic group:
Psychoanaleptics, other antidepressants
Therapeutic indications:
It is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI)
Authorization status:
Authorised
Authorization date:
2015-05-20
Patient Information leaflet
1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR
This medicine 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”)
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
Read the complete document
Summary of Product characteristics
Duloxetine 40 mg gastroresistant capsules
Summary of Product Characteristics Updated 15Jun2015 | Consilient Health Ltd
1. Name of the medicinal product
Duloxetine 40 mg gastroresistant capsules
2. Qualitative and quantitative composition
Each hard gastroresistant capsule contains 40 mg duloxetine (as duloxetine hydrochloride).
Excipient with known effect: sucrose.
Each 40 mg capsule contains 53.7 mg – 57.87 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastroresistant capsule, hard
White to almost white pellets in a hard gelatine capsule size 2. The capsule body is light orange and the cap light blue.
The capsule body is imprinted with 40 in black.
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 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 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 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 intervals.
Combining Duloxetine with a pelvic floor mu
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