Onelar 20mg hard Gastro-resistant capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DULOXETINE HYDROCHLORIDE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

N06AX21

INN (International Name):

DULOXETINE HYDROCHLORIDE 20 mg

Pharmaceutical form:

GASTRO-RESISTANT HARD CAPSULE

Composition:

DULOXETINE HYDROCHLORIDE 20 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2016-03-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ONELAR 20 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Onelar is and what it is used for
2.
What you need to know before you take Onelar
3.
How to take Onelar
4.
Possible side effects
5.
How to store Onelar
6.
Contents of the pack and other information
1.
WHAT ONELAR IS AND WHAT IT IS USED FOR
Onelar contains the active substance duloxetine. Onelar increases the
levels of serotonin and
noradrenaline in the nervous system.
Onelar 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.
Onelar 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 Onelar is reinforced when combined with a training
program called Pelvic Floor
Muscle Training (PFMT).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONELAR
DO NOT TAKE ONELAR 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 Onelar’)
-
are taking fluvoxamine whi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Onelar 20 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 51mg of sucrose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Hard gelatine capsules, about 14.3mm in length, size “4” with
white body and turquoise cap
containing off white pellets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Onelar is indicated for women for the treatment of moderate to severe
Stress Urinary Incontinence
(SUI).
Onelar is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Onelar 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.
However, limited data are available to support the efficacy of Onelar
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 _
_Hepatic impairment_
Onelar must not be used in women with liver disease resulting in
hepatic impairment (see sections 4.3
and 5.2).
_Renal impairment_
No dosage adjustment is necessary for patients with mild or moderate
renal dysfunction (creatinine
clearance 30 to 80 ml/min). Onelar must not be used in patients with
seve