Depalta 60mg gastro-resistant capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Duloxetine hydrochloride

Inapatikana kutoka:

Disposable Medical Equipment Ltd

ATC kanuni:

N06AX21

INN (Jina la Kimataifa):

Duloxetine hydrochloride

Kipimo:

60mg

Dawa fomu:

Gastro-resistant capsule

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04030400; GTIN: 5060342241894

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEPALTA 30MG GASTRO-RESISTANT CAPSULES, HARD
DEPALTA 60MG GASTRO-RESISTANT CAPSULES, HARD
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 Depalta Gastro-resistant Capsules are and what they are used
for
2. What you need to know before you take Depalta Gastro-resistant
Capsules
3. How to take Depalta Gastro-resistant Capsules
4. Possible side effects
5. How to store Depalta Gastro-resistant Capsules
6. Contents of the pack and other information
1. WHAT DEPALTA GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED
FOR
Depalta Gastro-resistant Capsules contain the active substance
duloxetine. Duloxetine
increases the level of serotonin and noradrenaline in the nervous
system.
Depalta is used to treat the following conditions in adults:
• depression
• 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)
• generalised anxiety disorder (chronic feeling of anxiety or
nervousness)
Depalta Gastro-resistant Capsule 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 Depalta Gastro-resistant Capsule when you are
feeling better
to prevent your depression or anxie

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Depalta 60mg gastro-resistant capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60 mg of duloxetine (as hydrochloride).
Excipients with known effect:
Each capsule contains 167 mg sucrose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
White to off white spherical to oval pellets filled in hard gelatin
capsule shells of
size"1" with “
” imprinted in grey ink on opaque blue coloured cap and "086”
imprinted in black ink on clear transparent body.
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 start