Loxentia 40mg hard gastro-resistant capsule
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
21-01-2022
Summary of Product characteristics
(SPC)
09-06-2022
Active ingredient:
Duloxetine
Available from:
KRKA, d.d., Novo mesto
ATC code:
N06AX; N06AX21
INN (International Name):
Duloxetine
Dosage:
40 milligram(s)
Pharmaceutical form:
Gastro-resistant capsule, hard
Administration route:
Oral use
Units in package:
Blisters of 7, 10, 14, 28, 30, 56, 60, 90 and 100 capsule
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
KRKA, d.d, TAD Pharma GmbH
Therapeutic group:
Psychoanaleptics, other antidepressants
Therapeutic area:
Other antidepressants; duloxetine
Therapeutic indications:
It is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
Authorization status:
Marketed
Authorization date:
2015-05-15
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOXENTIA 20 MG HARD GASTRO-RESISTANT CAPSULES
LOXENTIA 40 MG HARD GASTRO-RESISTANT CAPSULES
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 Loxentia is and what it is used for
2.
What you need to know before you take Loxentia
3.
How to take Loxentia
4.
Possible side effects
5.
How to store Loxentia
6.
Contents of the pack and other information
1.
WHAT LOXENTIA IS AND WHAT IT IS USED FOR
Loxentia contains the active substance duloxetine. Loxentia increases
the levels of serotonin and
noradrenaline in the nervous system.
Loxentia 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.
Loxentia 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 Loxentia is reinforced when combined with a training
program called Pelvic Floor
Muscle Training (PFMT).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOXENTIA
DO NOT TAKE LOXENTIA 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 medicine
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
08 June 2022
CRN00CS12
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Loxentia 40mg hard gastro-resistant capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gastro-resistant capsule contains 40 mg duloxetine (as
duloxetine hydrochloride).
Excipient with known effect: sucrose.
Each 40 mg hard gastro-resistant capsule contains up to 58 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard gastro-resistant capsule
White to almost white pellets in a hard gelatine capsule size 2
(average length: 17.9 mm). 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
Loxentia is indicated for women for the treatment of moderate to
severe Stress Urinary Incontinence (SUI).
Loxentia is indicated in adults.
For further information see section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Loxentia 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 Loxentia 20 mg twice daily.
The efficacy of Loxentia 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 Loxentia 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 _
Loxentia must not be used in women with liver disease resulting in
hepatic
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