Duloxetine 60mg gastro-resistant capsules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Duloxetine hydrochloride

Dostupné z:

Zentiva

ATC kód:

N06AX21

INN (Medzinárodný Name):

Duloxetine hydrochloride

Dávkovanie:

60mg

Forma lieku:

Gastro-resistant capsule

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04030400; GTIN: 5000283657439

Príbalový leták

Package leaflet: Information for the user
Duloxetine Zentiva 30 mg gastro-resistant hard capsules
Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Duloxetine
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 Zentiva is and what it is used for
2. What you need to know before you take Duloxetine
Zentiva
3. How to take Duloxetine Zentiva
4. Possible side effects
5. How to store Duloxetine Zentiva
6. Contents of the pack and other information
1. What Duloxetine Zentiva is and what it is used for
Duloxetine Zentiva contains the active substance
duloxetine. Duloxetine Zentiva increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetine Zentiva 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 Zentiva 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 Zentiva 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 bette

Súhrn charakteristických

OBJECT 1
DULOXETINE ZENTIVA 30MG AND 60MG GASTRO-
RESISTANT HARD CAPSULES
Summary of Product Characteristics Updated 26-Jun-2017 | Zentiva
1. Name of the medicinal product
Duloxetine Zentiva 30 mg gastro-resistant hard capsules
Duloxetine Zentiva 60 mg gastro-resistant hard capsules
2. Qualitative and quantitative composition
Duloxetine Zentiva 30 mg gastro-resistant hard capsules
Each capsule contains duloxetine hydrochloride equivalent to 30 mg
duloxetine.
Excipient(s) with known effect: each capsule contains 42.26 – 46.57
mg of sucrose.
Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Each capsule contains duloxetine hydrochloride equivalent to 60 mg
duloxetine.
Excipient(s) with known effect: each capsule contains 84.51 - 93.14 mg
of sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant hard capsule
Duloxetine Zentiva 30 mg gastro-resistant hard capsules
Hard opaque gelatin capsules of length approx. 15.9 mm with white
opaque body and light-blue opaque
cap which contain off-white to light-brown-yellow spherical pellets.
Duloxetine Zentiva 60 mg gastro-resistant hard capsules
Hard opaque gelatin capsules of length approx. 19.4 mm with ivory
opaque body and light-blue opaque
cap which contain off-white to light-brown-yellow spherical pellets.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine Zentiva 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.
Therapeu