Duloxetine Zentiva
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
16-08-2022
Valmisteyhteenveto
(SPC)
16-08-2022
Julkisesta arviointikertomuksesta
(PAR)
27-08-2015
Aktiivinen ainesosa:
duloxetine
Saatavilla:
Zentiva, k.s.
ATC-koodi:
N06AX21
INN (Kansainvälinen yleisnimi):
duloxetine
Terapeuttinen ryhmä:
Other antidepressants
Terapeuttinen alue:
Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Käyttöaiheet:
Treatment depressive disorder, diabetic neuropathic pain, anxiety disorder. Duloxetine Zentiva is indicated in adults.,
Tuoteyhteenveto:
Revision: 11
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2015-08-20
Pakkausseloste
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE ZENTIVA 30 MG GASTRO-RESISTANT HARD CAPSULES
DULOXETINE ZENTIVA 60 MG GASTRO-RESISTANT HARD 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 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 Duloxetine Zentiva is and what it is used for
2.
What you need to know before you take Duloxetine Zentiva
3.
How to take Duloxetine Zentiva
4.
Possible side effects
5.
How to store Duloxetine Zentiva
6.
Contents of the pack and other information
1.
WHAT DULOXETINE ZENTIVA IS AND WHAT IT IS USED FOR
Duloxetine Zentiva contains the active substance duloxetine.
Duloxetine Zentiva increases the levels
of serotonin and noradrenaline in the nervous system.
Duloxetine Zentiva 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).
Duloxetine Zentiva 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
Duloxetine Zentiva when you are
feeling better to prevent your depression or anxiety from returning.
In people with diabetic neuropathic pain it can take
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Duloxetine Zentiva 30 mg gastro-resistant hard capsules
Duloxetine Zentiva 60 mg gastro-resistant hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Duloxetine Zentiva 30 mg gastro-resistant hard capsules
Each capsule contains duloxetine hydrochloride equivalent to 30 mg
duloxetine.
Excipient(s) with known effect
Each capsule contains 42.26 – 46.57 mg of sucrose.
Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Each capsule contains duloxetine hydrochloride equivalent to 60 mg
duloxetine.
Excipient(s) with known effect
Each capsule contains 84.51 - 93.14 mg of sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard capsule
Duloxetine Zentiva 30 mg gastro-resistant hard capsules
Hard opaque gelatin capsules of length approx. 15.9 mm with white
opaque body and light-blue
opaque cap which contain off-white to light-brown-yellow spherical
pellets.
Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Hard opaque gelatin capsules of length approx. 19.4 mm with ivory
opaque body and light-blue
opaque cap which contain off-white to light-brown-yellow spherical
pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Zentiva is indicated in adults.
For further information see section 5.1.
3
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 anti
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