Duloxetine 30mg gastro-resistant capsules

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Duloxetine hydrochloride

Disponible des:

Accord Healthcare Ltd

Codi ATC:

N06AX21

Designació comuna internacional (DCI):

Duloxetine hydrochloride

Dosis:

30mg

formulario farmacéutico:

Gastro-resistant capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04030400; GTIN: 5055565722206

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
DULOXETINE 30 MG HARD GASTRO-RESISTANT CAPSULES
DULOXETINE 60 MG HARD GASTRO-RESISTANT 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 capsule is and what it is used for
2.
What you need to know before you take Duloxetine capsules
3.
How to take Duloxetine capsules
4.
Possible side effects
5.
How to store Duloxetine capsules
6.
Contents of the pack and other information
1.
WHAT DULOXETINE CAPSULE
IS AND WHAT IT IS USED FOR
Duloxetine capsule contains the active substance duloxetine.
Duloxetine capsule increases the
levels of serotonin and noradrenaline in the nervous system.
Duloxetine capsule 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 capsules 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 capsules
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

Fitxa tècnica

OBJECT 1
DULOXETINE 30 MG HARD GASTRO-RESISTANT CAPSULES
Summary of Product Characteristics Updated 16-Oct-2015 | Accord
Healthcare Limited
1. Name of the medicinal product
Duloxetine 30 mg hard gastro-resistant capsules
2. Qualitative and quantitative composition
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Excipient with known effect:
Each 30 mg capsule contains 96.25 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard gastro-resistant capsules.
Opaque blue cap and opaque white body size '3' (15.80 ± 0.40 mm) hard
gelatin capsules imprinted with
'H' on cap and '191' on body, filled with white to off white colored
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 capsule 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 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 maintena