Duloxetine 60mg gastro-resistant capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Duloxetine hydrochloride

Commercializzato da:

Aspire Pharma Ltd

Codice ATC:

N06AX21

INN (Nome Internazionale):

Duloxetine hydrochloride

Dosaggio:

60mg

Forma farmaceutica:

Gastro-resistant capsule

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04030400; GTIN: 5060209731308

Foglio illustrativo

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.
•
The full name of this medicine is Duloxetine 30mg and
60mg Gastro-resistant Capsules, hard, but within the
leaflet it will be referred to as Duloxetine capsules.
WHAT IS IN THIS LEAFLET
1. WHAT DULOXETINE CAPSULES ARE AND WHAT THEY ARE
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 CAPSULES ARE AND WHAT THEY ARE
USED FOR
Duloxetine capsules contain the active substance
duloxetine. Duloxetine capsules increase the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine capsules are 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 start 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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Duloxetine 60mg Gastro-resistant Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient with known effect: Each capsule contains 201.3 mg sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque grey body imprinted with ‘DLX 60’ and an opaque white cap,
imprinted with
‘DLX 60’.
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 anti-depressive 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 maintenance dose in most
patients.
In patients with co-morbid major depressive disorder, the starting and
maintenance
dose is 60 mg once daily (please see also dosing recommendation
above).
Doses up to 120