Sertraline 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sertraline hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

N06AB06

INN (International Name):

Sertraline hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300

Patient Information leaflet

_ _
•
shortness of breath, nose bleed, breathing difficulty, possible
wheezing,
•
tarry stools, tooth disorder, inflammation of the oesophagus,
tongue problem, haemorrhoids, increased saliva, difficulty
swallowing, burping, tongue disorder,
•
eye swelling, hives, hair loss, itching, purple spots on skin, skin
problem with blisters, dry skin, face oedema, cold sweat,
•
osteoarthritis, muscle twitching, muscle cramps*, muscular
weakness,
•
increase in frequency of urination, problem urinating unable to
urinate, urinary incontinence, increase in urination, nighttime
urination,
•
sexual dysfunction, excessive vaginal bleeding, vaginal
haemorrhage, female sexual dysfunction,
•
swelling in legs, chills, difficulty walking, thirst,
•
increase in liver enzyme levels, weight decreased.
•
CASES OF SUICIDAL IDEATION AND SUICIDAL BEHAVIOURS HAVE
BEEN REPORTED DURING SERTRALINE THERAPY OR EARLY AFTER
TREATMENT DISCONTINUATION (SEE SECTION 2).
Rare (may affect up to 1 in 1,000 people):
•
diverticulitis, swollen lymph glands, decrease in clotting cells*,
decrease in white blood cells*,
•
severe allergic reaction,
•
endocrine problems*,
•
high cholesterol, problems controlling blood sugar levels
(diabetes), low blood sugar, increase in blood sugar levels*, low
blood salt*,
•
physical symptoms due to stress or emotions, terrifying
abnormal dreams*, drug dependence, sleep walking, premature
ejaculation
•
coma, abnormal movements, difficulty moving, increased
sensation, sudden severe headache (which may be a sign of a
serious condition known as Reversible Cerebral
Vasoconstriction Syndrome (RCVS))*, sensory disturbance,
•
spots in front of eyes, glaucoma, double vision, light hurts eye,
blood in the eye, unequal sized pupils*, vision abnormal*, tear
problem,
•
heart attack, light-headedness, fainting, or chest discomfort
which could be signs of changes in the electrical activity (seen
on electrocardiogram) or abnormal rhythm of the heart*, slow
heartbeat,
•
poor circulation of arms and legs,
•

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 50 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 50 mg of sertraline as sertraline
hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White film-coated caplet shaped tablet embossed with “50” on one
side and break-
line on the other side.
The tablet can be divided into equal doses.
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
Sertraline should be administered once daily, either in the morning or
evening.
Sertraline tablet can be administered with or without food.
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 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 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 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
level, with
subsequent ad