Sertraline 100mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Sertraline hydrochloride

Доступна з:

Sandoz Ltd

Код атс:

N06AB06

ІПН (Міжнародна Ім'я):

Sertraline hydrochloride

Дозування:

100mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04030300

інформаційний буклет

Sertraline contains the active substance sertraline.
Sertraline is one of a group of medicines called Selective
Serotonin Re-uptake Inhibitors (SSRIs); these medicines
are used to treat depression and or anxiety disorders.
SERTRALINE CAN BE USED TO TREAT:
• Depression and prevention of recurrence of
depression (in adults).
• Social anxiety disorder (in adults).
• Post traumatic stress disorder (PTSD) (in adults).
• Panic disorder (in adults).
• Obsessive compulsive disorder (OCD) (in adults and
children and adolescents aged 6-17 years old).
Depression is a clinical illness with symptoms like feeling
sad, unable to sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety
with symptoms like being constantly troubled by persistent
ideas (obsessions) that make you carry out repetitive
rituals (compulsions).
PTSD is a condition that can occur after a very emotionally
traumatic experience, and has some symptoms that
are similar to depression and anxiety. Social anxiety
disorder (social phobia) is an illness linked to anxiety.
It is characterised by feelings of intense anxiety or distress
in social situations (for example: talking to strangers,
speaking in front of groups of people, eating or drinking
in front of others or worrying that you might behave in
an embarrassing manner).
Your doctor has decided that this medicine is suitable
for treating your illness.
You should ask your doctor if you are unsure why you
have been given sertraline.
DO NOT TAKE SERTRALINE:
• If you are allergic to sertraline or any of the other
ingredients of this medicine (listed in section 6).
• If you are taking or have taken medicines called
monoamine oxidase inhibitors (MAOIs such as
selegiline, moclobemide) or MAOI like medicines
(such as linezolid). If you stop treatment with sertraline,
you must wait until at least one week before you start
treatment with a MAOI. After stopping treatment with
a MAOI, you must wait at least 2 weeks before you
can start treatment with sertraline.

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of sertraline (as
hydrochloride).
Excipient(s) with known effect:
Each film-coated tablet contains 87.42 mg lactose (as monohydrate) and
1.34
mg (0.058 mmol) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, capsule shaped tablet scored on one side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sertraline is indicated for the treatment of:
Major depressive episodes. Prevention of recurrence of major
depressive episodes.
Panic disorder, with or without agoraphobia.
Obsessive compulsive disorder (OCD) in adults and paediatric patients
aged 6-17
years.
Social anxiety disorder.
Post traumatic stress disorder (PTSD)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Initial treatment _
_Depression and OCD _
Sertraline treatment should be started at a dose of 50 mg/day.
_Panic Disorder, PTSD, and Social Anxiety Disorder _
Therapy should be initiated at 25 mg/day. After one week, the dose
should be
increased to 50 mg once daily. This dose regimen has been shown to
reduce
the frequency of early treatment emergent adverse reactions
characteristic of
panic disorder.
_Titration _
_Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD _
Patients not responding to a 50 mg dose may benefit from dose
increases.
Dose changes should be made in steps of 50 mg at intervals of at least
one
week, up to a maximum of 200 mg/day. Changes in dose should not be
made
more frequently than once per week given the 24-hour elimination half
life of
sertraline.
The onset of therapeutic effect may be seen within 7 days. However,
longer
periods are usually necessary to demonstrate therapeutic response,
especially
in OCD.
_Maintenance _
Dose during long-term therapy should be kept at the lowest effective
level,
with subsequent
adjustment depending