Duloxetin - 1 A Pharma 40mg hard Gastro-resistant capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DULOXETINE HYDROCHLORIDE

Available from:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

ATC code:

N06AX21

INN (International Name):

DULOXETINE HYDROCHLORIDE 40 mg

Pharmaceutical form:

GASTRO-RESISTANT HARD CAPSULE

Composition:

DULOXETINE HYDROCHLORIDE 40 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2018-02-06

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
[Duloxetin - 1 A Pharma 20 mg hard gastro-resistant capsules]
[Duloxetin - 1 A Pharma 40 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 [Duloxetin - 1 A Pharma] is and what it is used for
2. What you need to know before you take [Duloxetin - 1 A Pharma]
3. How to take [Duloxetin - 1 A Pharma]
4. Possible side effects
5. How to store [Duloxetin - 1 A Pharma]
6. Contents of the pack and other information
1. WHAT [DULOXETIN - 1 A PHARMA] IS AND WHAT IT IS USED FOR
[Duloxetin - 1 A Pharma] contains the active substance duloxetine.
[Duloxetin - 1 A Pharma]
increases the levels of serotonin and noradrenaline in the nervous
system.
[Duloxetin - 1 A Pharma] 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.
[Duloxetin - 1 A Pharma] 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 [Duloxetin - 1 A Pharma] is reinforced when combined
with a training program
called Pelvic Floor Muscle Training (PFMT).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [DULOXETIN - 1 A PHARMA]
Page 2 of 8
DO NOT TAKE [DULOXETIN - 1 A PHARMA] IF YOU:
- are allergic to duloxe

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
[Duloxetin - 1 A Pharma 20 mg hard gastro-resistant capsules]
[Duloxetin - 1 A Pharma 40 mg hard gastro-resistant capsules]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each capsule contains 34.37 mg sucrose.
For the full list of excipients, see section 6.1.
Each capsule contains 40 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each capsule contains 68.74mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Opaque blue body, imprinted with ‘163’ and an opaque blue cap,
imprinted with ‘A’.
Size “4” hard gastro-resistant capsules filled with white to off
white colored pellets
Hard gastro-resistant capsule.
Opaque orange body, imprinted with ‘162’ and an opaque blue cap,
imprinted with ‘A’.
Size “2” hard gastro-resistant capsules filled with white to off
white colored pellets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Duloxetin - 1 A Pharma ] is indicated for women for the treatment of
moderate to severe Stress
Urinary Incontinence (SUI).
[Duloxetin - 1 A Pharma ] is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of [Duloxetin - 1 A Pharma ] 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
Page 2 of 17
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.
[Duloxetin - 1 A Pharma 40 mg gastro-resistant capsule, hard]
A 20 mg capsule is also available.
However, limited data are available to support the efficacy of
Duloxetin - 1 A Pharma