Onelar 30mg hard Gastro-resistant capsules

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

DULOXETINE HYDROCHLORIDE

可用日期:

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

ATC代码:

N06AX21

INN（国际名称）:

DULOXETINE HYDROCHLORIDE 30 mg

药物剂型:

GASTRO-RESISTANT HARD CAPSULE

组成:

DULOXETINE HYDROCHLORIDE 30 mg

处方类型:

POM

治疗领域:

PSYCHOANALEPTICS

授权状态:

Authorised

授权日期:

2016-03-15

资料单张

pildulocaps30mg1.6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ONELAR 30 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 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 used in adults to treat:
-
depression
-
generalised anxiety disorder (chronic feeling of anxiety or
nervousness)
-
diabetic neuropathic pain (often described as burning, stabbing,
stinging, shooting or aching or
like an electric shock. There may be loss of feeling in the affected
area, or sensations such as
touch, heat, cold or pressure may cause pain)
Onelar starts to work in most people with depression or anxiety within
two weeks of starting
treatment, but it may take 2-4 weeks before you feel better. Tell your
doctor if you do not start to feel
better after this time. Your doctor may continue to give you Onelar
when you are feeling better to
prevent your depression or anxiety from returning.
pildulocaps30mg1.6
In people with diabetic neuropathic pain it can take some weeks before
you feel better. Talk to your
doctor if you do not feel better after 2 months.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONELAR
DO NOT TAKE ONELAR IF YOU:
-
are

产品特点

spcdulocaps30mg1.6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Onelar 30 mg hard gastro-resistant capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Excipients with known effect: each capsules contains 76.5mg sucrose
and 0.0009mg carmoisine
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Hard gelatine capsules, size “3”, about 15.9mm in length, with
white body and blue cap containing off
white pellet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Onelar is indicated in adults.
For further information see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Major depressive disorder_
The starting and recommended maintenance dose is 60 mg once daily with
or without food. Dosages
above 60 mg once daily, up to a maximum dose of 120 mg per day have
been evaluated from a
safety perspective in clinical trials. However, there is no clinical
evidence suggesting that patients
not responding to the initial recommended dose may benefit from dose
up-titrations.
Therapeutic response is usually seen after 2-4 weeks of treatment.
After consolidation of the antidepressive response, it is recommended
to continue treatment for
several months, in order to avoid relapse. In patients responding to
duloxetine, and with a history of
spcdulocaps30mg1.6
repeated episodes of major depression, further long-term treatment at
a dose of 60 to 120 mg/day
could be considered.
_Generalised anxiety disorder_
The recommended starting dose in patients with generalised anxiety
disorder is 30 mg once daily
with or without food. In patients with insufficient response the dose
should be increased to 60 mg,
which is the usual maintenance dose in most patients.
In patients with co-morbid major depressive disorder, the starting and
maintenance dose is 60 mg
once