Duloxetine 30mg gastro-resistant capsules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Duloxetine hydrochloride

Tilgængelig fra:

Dr Reddy's Laboratories (UK

ATC-kode:

N06AX21

INN (International Name):

Duloxetine hydrochloride

Dosering:

30mg

Lægemiddelform:

Gastro-resistant capsule

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04030400

Indlægsseddel

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 DULOXETINE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DULOXETINE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DULOXETINE IS AND WHAT IT IS USED
FOR
Duloxetine capsules contain 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)
•
have liver disease
•
have severe kidney disease
•
are taking or have taken within the last 14 days,
another medicine known as a monoamine oxidase
inhibitor (MAOI) (see ‘Other medicines and
Duloxetine’)
•
are taking fluvoxamine which is usually used to
treat depression, ciprofloxacin or enoxacin which
are used to treat some infections.
Talk to your doctor if you have high blood pressure or
heart disease. Your doctor will tell you if you should be
taking Duloxetine.
WARNINGS AND PRECAUTIONS
The following are reasons why Du

Produktets egenskaber

OBJECT 1
DULOXETINE DR. REDDYS 30 MG GASTRO-RESISTANT
CAPSULES, HARD
Summary of Product Characteristics Updated 05-Jan-2017 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Duloxetine Dr. Reddy's 30 mg Gastro-Resistant Capsules, Hard
2. Qualitative and quantitative composition
Each gastro-resistant capsule, hard contains 30 mg of duloxetine (as
hydrochloride).
_Excipient(s) with known effect:_ each gastro-resistant capsule, hard
contains 46.23 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard
White to off white spherical pellets filled in size '3' hard gelatin
capsules with opaque blue coloured cap
and opaque white coloured body, imprinted 'RDY609' on cap and '30mg'
on body with golden yellow ink.
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
disorder is 30 mg once daily with or without food. In p