Duloxetin Distriquimica 60 mg Enterokapsel, hård

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

duloxetinhydroklorid

Tillgänglig från:

Ebb Medical AB

ATC-kod:

N06AX21

INN (International namn):

duloxetine hydrochloride

Dos:

60 mg

Läkemedelsform:

Enterokapsel, hård

Sammansättning:

natriumlaurilsulfat Hjälpämne; sackaros Hjälpämne; sockersfärer Hjälpämne; duloxetinhydroklorid 67,356 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Burk, 112 (4 x 28) kapslar; Burk, 28 kapslar

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2019-07-31

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DULMIS 30 MG GASTRO-RESISTANT CAPSULES, HARD
DULMIS 60 MG GASTRO-RESISTANT CAPSULES, HARD
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 Dulmis is and what it is used for
2.
What you need to know before you take Dulmis
3.
How to take Dulmis
4.
Possible side effects
5.
How to store Dulmis
6.
Contents of the pack and other information
1.
WHAT DULMIS IS AND WHAT IT IS USED FOR
Dulmis contains the active substance duloxetine. Dulmisincreases the
levels of serotonin and
noradrenaline in the nervous system.
Dulmis 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)
Dulmis 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 Dulmis
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULMIS
DO NOT TAKE DU

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dulmis 30 mg gastro-resistant capsules, hard
Dulmis 60 mg gastro-resistant capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dulmis 30 mg
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each capsule contains approximately 63.7 mg sucrose.
Dulmis 60 mg
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each capsule contains approximately 127.4 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Dulmis 30 mg
Opaque blue cap and opaque white body capsules printed (cap E/body
127) of 15 mm approximately.
Dulmis 60 mg
Opaque blue cap and opaque green body capsules printed (cap E/body
129) of 19 mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Dulmis 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.
2
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.
_Generalised anxiety disorder _
The recommended starting dose in patients with generalised anxiety
diso