Escitalopram 5mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Escitalopram oxalate

Dostopno od:

Zentiva Pharma UK Ltd

Koda artikla:

N06AB10

INN (mednarodno ime):

Escitalopram oxalate

Odmerek:

5mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04030300; GTIN: 5000283657187

Navodilo za uporabo

2020 04 UK MAH address change 5 mg ZN2952
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESCITALOPRAM 5 MG FILM-COATED TABLETS
Eight important things you need to know about Escitalopram
Please read all of the leaflet. It includes a lot of additional
important information about this medicine.
•
ESCITALOPRAM TREATS DEPRESSION.
Like all medicines it can have unwanted effects.
It is therefore important that you and your doctor weigh up the
benefits of treatment against the
possible unwanted effects, before starting treatment.
•
ESCITALOPRAM IS NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER 18.
See section 2, Use in c
_hildren _
_and adolescents under 18 years of age, _
inside this leaflet.
•
ESCITALOPRAM WON’T WORK STRAIGHT AWAY.
Some people taking antidepressants feel worse before
feeling better. Your doctor should ask to see you again a couple of
weeks after you first start
treatment. Tell your doctor if you haven’t started feeling better.
See section 3,
_How to take _
_escitalopram, _
inside this leaflet.
•
SOME PEOPLE WHO ARE DEPRESSED THINK OF HARMING OR KILLING THEMSELVES.
If you start
to feel worse, or think of harming or killing yourself,
SEE YOUR DOCTOR OR GO TO A HOSPITAL STRAIGHT
AWAY.
See section 2
_Thoughts of suicide and worsening of your depression, _
inside this leaflet.
•
DON’T STOP TAKING ESCITALOPRAM WITHOUT TALKING TO YOUR DOCTOR.
If you stop taking escitalopram
suddenly or miss a dose, you may get withdrawal effects. See section
4, S
_topping escitalopram, _
inside
this leaflet.
•
IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL,
TELL YOUR DOCTOR.
Increasing the dose
of escitalopram may make these feelings worse. See section 5,
_Possible side effects, _
inside this leaflet.
•
TAKING SOME OTHER MEDICINES WITH ESCITALOPRAM CAN CAUSE PROBLEMS.
You may need to talk to
your doctor. See section 2
_Other medicines and escitalopram, _
inside this leaflet.
•
IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT,
talk to your doctor. See section 2
_Pregnancy, _
_breastfeeding and

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Escitalopram 5 mg film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg escitalopram (as escitalopram
oxalate)
Excipients with known effect
Each Escitalopram 5 mg film-coated tablet contains maximum of 0.42 mg
sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white, round, biconvex film-coated tablets.
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 pat