Duloxetine 60mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Duloxetine hydrochloride

Available from:

Actavis UK Ltd

ATC code:

N06AX21

INN (International Name):

Duloxetine hydrochloride

Dosage:

60mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400; GTIN: 5012617025364

Patient Information leaflet

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
increases the levels of serotonin and noradrenaline in the nervous
system.
Duloxetine capsules 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

Summary of Product characteristics

OBJECT 1
DULOXETINE 60MG GASTRO-RESISTANT CAPSULES, HARD
Summary of Product Characteristics Updated 01-Mar-2018 | Accord-UK Ltd
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