Cymbalta Capsule 60mg

Country: Малезија

Језик: Енглески

Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активни састојак:

DULOXETINE HYDROCHLORIDE

Доступно од:

ZUELLIG PHARMA SDN BHD

INN (Међународно име):

DULOXETINE HYDROCHLORIDE

Јединице у пакету:

14Capsule Capsules; 28Capsule Capsules

Произведен од:

LILLY DEL CARIBE INC

Информативни летак

CYMBALTA
® CAPSULES
Duloxetine (30mg, 60mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Cymbalta is used for
2.
How Cymbalta works
3.
Before you use Cymbalta
4.
How to use Cymbalta
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Cymbalta
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CYMBALTA
IS USED FOR
Cymbalta is used in adults to treat:

depression

generalised anxiety disorder

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)
HOW CYMBALTA WORKS
Cymbalta contains the active ingredient
duloxetine. Cymbalta increases the
levels of serotonin and noradrenaline in
the nervous system. Cymbalta 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 Cymbalta when you are feeling
better to prevent your depression or
anxiety from returning. 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.
BEFORE YOU USE CYMBALTA
-
_When you must not use it _
DO NOT take Cymbalta if you:

are allergic to duloxetine or any of the
other ingredients of this medicine
(listed in section
PRODUCT
DESCRIPTION
)

have liver disease

have severe kidney disease

have uncontrolled high blood
pressure
Talk to your doctor if you have high
blood pressure or heart disease. Your
doctor will tell you if you should be
taking Cymbalta.
_ _
-
_Before you start to use it _
The following are reasons why
Cymbalta may not be suitable for you.
Talk to your doctor before you take
Cymbalta if you:

have kidney disease

have had seizures (fits)


Карактеристике производа

Cymbalta 30mg_60mg PI EUSPC 25 Jul 2019_27 Jul 2020
1
1.
NAME OF THE MEDICINAL PRODUCT
CYMBALTA 30 mg hard gastro-resistant capsules.
CYMBALTA 60 mg hard gastro-resistant capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cymbalta 30 mg
Each capsule contains 30 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect: _
Each capsule may contain up to 56 mg sucrose.
Cymbalta 60 mg
Each capsule contains 60 mg of duloxetine (as hydrochloride).
_Excipient(s) with known effect: _
Each capsule may contain up to 111 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
Cymbalta 30 mg
Opaque white body, imprinted with ‘30 mg’ and an opaque blue cap,
imprinted with ‘9543’.
Cymbalta 60 mg
Opaque green body, imprinted with ‘60 mg’ and an opaque blue cap,
imprinted with ‘9542’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Management of neuropathic pain associated with diabetic peripheral
neuropathy in adults.
Treatment of generalised anxiety disorder.
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 repeated
episodes of major depression, further long-term treatment at a dose of
60 to 120 mg/day could be
considered.
Cymbalta 30mg_60mg PI EUSPC 25 Jul 2019_27 Jul 2020
2
_Diabetic peripheral neuropathic pain _
The starting and recomme