Duloxetine 60mg gastro-resistant capsules

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Duloxetine hydrochloride

Доступна з:

HBS Healthcare Ltd

Код атс:

N06AX21

ІПН (Міжнародна Ім'я):

Duloxetine hydrochloride

Дозування:

60mg

Фармацевтична форма:

Gastro-resistant capsule

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04030400

інформаційний буклет

Leaflet sizs: 160mm x 500mm
Print area: 140mm x 480mm
Portrait, two columns, double sided
Body Text: Titillium 8pt
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 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 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 DUL

Характеристики продукта

OBJECT 1
DULOXETINE 60MG GASTRO-RESISTANT CAPSULES,HARD
Summary of Product Characteristics Updated 14-Oct-2016 | HBS
Healthcare Ltd
1. Name of the medicinal product
Duloxetine 60 mg gastro-resistant capsules, hard
2. Qualitative and quantitative composition
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Excipient(s) with known effect:
Each capsule contains 140,6 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard.
White body, imprinted with '60 mg' and an opaque blue cap.
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 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 (pl