Sertraline 100mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Sertraline hydrochloride

Предлага се от:

Accord-UK Ltd

АТС код:

N06AB06

INN (Международно Name):

Sertraline hydrochloride

дозиране:

100mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04030300; GTIN: 5060149311998 5055565757147

Листовка

Depression is a clinical illness with symptoms like
feeling sad, unable to sleep properly or to enjoy life
as you used to.
• Social anxiety disorder (in adults).
Medicines are not always suitable for everyone. Tell
your doctor before you take Sertraline, if you suffer
from or have suffered in the past from any of the
following conditions:
• If you have or have previously had thoughts of
harming or killing yourself (see below-Thoughts of
suicide and worsening of your depression or
anxiety disorder).
Medicines like Sertraline (so called SSRIs/SNRIs)
may cause symptoms of sexual dysfunction (see
section 4). In some cases, these symptoms have
continued after stopping treatment.
• Obsessive compulsive disorder (OCD) (in adults and
children and adolescents aged 6-17 years old).
• If you have suffered from bleeding disorders or
have been taking medicines which thin the blood
(e.g. acetylsalicyclic acid (aspirin) or warfarin) or
may increase the risk of bleeding.
• If you are having electro-convulsive therapy
(ECT).
• If you have epilepsy (fit) or a history of seizures. If
you have a fit (seizure), contact your doctor
immediately.
Sertraline contains the active substance sertraline.
• Depression and prevention of recurrence of
depression (in adults).
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).
SERTRALINE CAN BE USED TO TREAT:
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).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SERTRALINE
• Panic diso

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 100 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg sertraline (as hydrochloride).
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
12 × 6 mm, caplet shaped, white coloured film-coated tablets having
debossed
“SR 100” on one side and plain on other side.
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
For oral administration.
Sertraline should be given as a single daily dose either in the
morning or evening.
Sertraline tablets can be administered with or without food.
_Initial treatment_
_ _
_ _
_Depression and OCD _
Sertraline treatment should be started at a dose of 50mg/day.
_Panic Disorder, PTSD, and Social Anxiety Disorder_
_ _
Therapy should be initiated at 25mg/day. After one week, the dose
should be
increased to 50mg once daily. This dosage regimen has been shown to
reduce the
frequency of early treatment emergent side effects characteristic of
panic disorder.
_Titration _
_Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD _
Patients not responding to a 50mg dose may benefit from dose
increases. Dose
changes should be made in steps of 50mg at intervals of at least one
week, up to a
maximum of 200mg/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_
_ _
Dosage during long-term therapy should be kept at the lowest effective
lev