Duloxetine 60mg gastro-resistant capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: myHealthbox

Aktívna zložka:

Duloxetine

Dostupné z:

Consilient Health Limited

ATC kód:

N06AX21

INN (Medzinárodný Name):

Duloxetine

Dávkovanie:

60mg

Forma lieku:

Gastro-resistant capsule, hard

Spôsob podávania:

Oral use

Počet v balení:

7, 10, 14, 28, 30, 56, 60, 90 and 100 hard gastro-resistant capsules, in a box.

Typ predpisu:

POM - Prescription Only Medicine

Výrobca:

KRKA, d.d.

Terapeutické skupiny:

Antidepressants, Other antidepressants

Terapeutické indikácie:

Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder.

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2015-03-26

Príbalový leták

1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR
This medicine contains the active substance duloxetine. Duloxetine 
increases the levels of serotonin and noradrenaline in the nervous 
system.
Duloxetine 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 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 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 
DULOXETINE
Do not take Duloxetine if you:
•  
are allergic to Duloxetine or any of the other ingredients of this 
medicine (listed in section 6).
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 Duloxetine is and what it is used for
2. What you need to know before you take Duloxetine
3. How to take Duloxe

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Duloxetine 60 mg gastro-resistant capsules 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each hard gastro-resistant capsule contains 60 mg duloxetine (as
duloxetine 
hydrochloride). 

Excipient with known effect: sucrose. 
Each 30 mg capsule contains 80.2 mg – 86.8 mg sucrose. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Gastro-resistant capsule, hard 

White to almost white pellets in
a hard gelatine capsule size 1. The capsule 
body is yellowish green and the cap dark blue. The capsule
body is imprinted 
with 60 in black. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Treatment of major depressive disorder. 
Treatment of diabetic peripheral neuropathic pain. 
Treatment of generalised anxiety disorder. 

Duloxetine 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 disord