Escitalopram 20mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Escitalopram oxalate

可用日期:

Brown & Burk UK Ltd

ATC代码:

N06AB10

INN（国际名称）:

Escitalopram oxalate

剂量:

20mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04030300; GTIN: 5060124640389

资料单张

Product:
Escitalopram 5mg, 10mg,
and 20mg Film-coated Tablets
Item Code:
P1340T
Size:
210 x 544mm
Min. Point size:
7pt
O. Artwork
06/02/20
Proof No.
2
Amendment Date
19/03/20
Process Black
Keyline - does not print
Colours Used
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM 5mg, 10mg and 20mg
FILM-COATED TABLETS
Escitalopram
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. THIS INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
WHAT IS IN THIS LEAFLET:
1.
What Escitalopram Tablets are and what they are used for
2.
What you need to know before you take Escitalopram Tablets
4.
Possible side effects
5.
How to store Escitalopram Tablets
6.
Contents of the pack and other information
3.
How to take Escitalopram Tablets
1. WHAT ESCITALOPRAM TABLETS ARE AND WHAT THEY ARE USED FOR
The full name of your medicine is Escitalopram 5mg, 10mg, or
20mg film-coated tablets but within the leaflet it will be referred
to as Escitalopram Tablets. This medicine contains the active
substance escitalopram and belongs to a group of
antidepressants called selective serotonin reuptake inhibitors
(SSRIs). These medicines act on the serotonin-system in the
brain by increasing the serotonin level. Disturbances in the
serotonin-system are considered an important factor in the
development of depression and related diseases.
Escitalopram Tablets are used to treat depression (major
depressive episodes) and anxiety disorders (such as panic
disorder with or without agoraphobia, social anxiety disorder,
generalised anxiety disorder and obsessive-compulsive disorder).
It may take a couple of weeks before you start to feel better.
Cont

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Escitalopram 20 mg film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20mg escitalopram (as escitalopram
oxalate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white, oval shaped, film-coated tablets with break line
on one side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
Safety of daily doses above 20 mg has not been demonstrated.
Escitalopram is administered as a single daily dose and may be taken
with or without
food.
_Major depressive episodes _
Usual dosage is 10 mg once daily. Depending on individual patient
response, the dose
may be increased to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response.
After
the symptoms resolve, treatment for at least 6 months is required for
consolidation
of the response.
Elderly patients (> 65 years of age)
Initial dosage is 5 mg once daily. Depending on individual patient
response the dose
may be increased to 10 mg daily (see section 5.2).
Children and adolescents (< 18 years)
Escitalopram should not be used in the treatment of children and
adolescents under
the age of 18 years (see section 4.4).
Reduced renal function
Dosage adjustment is not necessary in patients with mild or moderate
renal
impairment. Caution is advised in patients with severely reduced renal
function
(CL
CR
less than 30 ml/min) (see section 5.2).
Reduced hepatic function
An initial dose of 5 mg daily for the first two weeks of treatment is
recommended
in patients with mild or moderate hepatic impairment. Depending on
individual
patient response, the dose may be increased to 10 mg daily. Caution
and extra careful
dose titration is advised in patients with severely reduced hepatic
function
(see section 5.2).
Poor metabolisers of CYP2C19
For patients who are known to be poor metab