Duloxetine 60mg gastro-resistant capsules

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Duloxetine hydrochloride

Fáanlegur frá:

Milpharm Ltd

ATC númer:

N06AX21

INN (Alþjóðlegt nafn):

Duloxetine hydrochloride

Skammtar:

60mg

Lyfjaform:

Gastro-resistant capsule

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04030400

Upplýsingar fylgiseðill

_CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE_
Duloxetine should normally not be used for children
and adolescents under 18 years. Also, you should
know that patients under 18 have an increased risk
of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression,
oppositional behaviour and anger) when they take
this class of medicines. Despite this, your doctor
may prescribe Duloxetine for patients under 18
because he/she decides that this is in their best
interests. If your doctor has prescribed Duloxetine
for a patient under 18 and you want to discuss this,
please go back to your doctor. You should inform
your doctor if any of the symptoms listed above
develop or worsen when patients under 18 are
taking Duloxetine. Also, the long-term safety effects
concerning growth, maturation, and cognitive and
behavioural development of Duloxetine in this age
group have not yet been demonstrated.
OTHER MEDICINES AND DULOXETINE
Tell your doctor or pharmacist if you are taking
,have recently taken or might any other medicines,
including medicines obtained without a prescription.
The main ingredient of Duloxetine, duloxetine, is
used in other medicines for other conditions:
•
diabetic neuropathic pain, depression, anxiety
and urinary incontinence
Using more than one of these medicines at the
same time should be avoided. Check with your
doctor if you are already taking other medicines
containing duloxetine.
Your doctor should decide whether you can take
Duloxetine with other medicines. DO NOT START OR
STOP TAKING ANY MEDICINES, INCLUDING THOSE
BOUGHT WITHOUT A PRESCRIPTION AND HERBAL
REMEDIES, BEFORE CHECKING WITH YOUR DOCTOR.
You should also tell your doctor if you are taking
any of the following:
_MONOAMINE OXIDASE INHIBITORS (MAOIS):_ You
should not take Duloxetine if you are taking, or
have recently taken (within the last 14 days)
another antidepressant medicine called a
monoamine oxidase inhibitor (MAOI). Examples of
MAOIs include moclobemide (an antidepressant)
and linezolid (an anti

Vara einkenni

OBJECT 1
DULOXETINE MILPHARM 60MG GASTRO-RESISTANT
CAPSULES
Summary of Product Characteristics Updated 19-Sep-2016 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Duloxetine Milpharm 60 mg gastro-resistant capsules, hard
2. Qualitative and quantitative composition
Each hard capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect: Each capsule contains 143.52 mg
sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard
Blue opaque /green opaque, size "l" hard gelatin capsules filled with
white to off white pellets and
imprinted with "DLX" on blue opaque cap and "60" on green opaque body
with black 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 Milpharm 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