SERTRALINE-DP 50 sertraline (as hydrochloride) 50 mg tablet blister

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

sertraline hydrochloride, Quantity: 55.9 mg

זמין מ:

Medis Pharma Pty Ltd

INN (שם בינלאומי):

Sertraline hydrochloride

טופס פרצבטיות:

Tablet, film coated

הרכב:

Excipient Ingredients: microcrystalline cellulose; methylcellulose; magnesium stearate; hypromellose; hyprolose; titanium dioxide; indigo carmine; colloidal anhydrous silica; macrogol 8000

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Sertraline is indicated in adults for the treatment of 1) major depression; 2) premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria.

leaflet_short:

Visual Identification: Blueish purple oval scored film-coated tablet, marked 'APO' on one side, 'SE' over '50' on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

2005-07-15

עלון מידע

_SERTRALINE-DP™ 50 AND SERTRALINE-DP™ 100_
_ _
_ _
Sertraline hydrochloride 50mg & 100mg tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
Sertraline-DP 50 and Sertraline-DP 100. It does not
contain all the available information.
It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has
weighed the risks of you taking sertraline against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT _SERTRALINE-DP 50 AND _
_SERTRALINE-DP 100_ ARE USED FOR
Sertraline-DP is used to treat depression and
conditions such as premenstrual dysphoric disorder
(PMDD). PMDD affects some women in the days
before their period. PMDD is different from
premenstrual syndrome (PMS). The mood symptoms
(anger, sadness, tension, etc) in PMDD are more
severe than in PMS and affect the woman’s daily
activities and relationships with others.
This medicine belongs to a group of medicines called
selective serotonin reuptake inhibitors (SSRIs). SSRIs
work by correcting certain chemical imbalances in the
brain which can cause depression and other
conditions.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this medicine for
another purpose.
There is no evidence that this medicine is addictive.
This medicine is available only with a doctor's
prescription.
BEFORE YOU TAKE _SERTRALINE-DP 50 _
_AND SERTRALINE-DP 100_
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE _SERTRALINE-DP 50 AND SERTRALINE-DP 100_
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing sertraline
•
any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may
include shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other
parts of the body; rash,

מאפייני מוצר

Product Information
110523 Sertraline-DP PI v5
Page 1 of 14
SERTRALINE-DP 50 AND SERTRALINE-DP 100 TABLETS
NAME OF THE MEDICINE
Sertraline hydrochloride
DESCRIPTION
Sertraline hydrochloride is a antidepressant for oral administration.
It is chemically unrelated to tricyclic,
tetracyclic or other antidepressants agents. Sertraline hydrochloride
has the following chemical name (1S,4S)-
4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine
hydrochloride.
Sertraline hydrochloride is a white to off-white crystalline powder
that is slightly soluble in water and isopropyl
alcohol and sparingly soluble in ethanol.
Chemical structure:
Empirical formula: C
17
H
17
Cl
2
N•HCl
Molecular weight: 342.7
CAS Registry Number: 79559-97-0
Each
sertraline
hydrochloride
tablet
intended
for
oral
administration
contains
sertraline
hydrochloride
equivalent to 50 mg or 100 mg of sertraline. In addition, each tablet
contains the following inactive ingredients:
silica – colloidal anhydrous, indigo carmine CI73015 (in 50 mg
tablets), iron oxide yellow CI77492 (in 100 mg
tablets), titanium dioxide, cellulose – microcrystalline,
methylcellulose, magnesium stearate, hypromellose,
hydroxypropylcellulose, and macrogol 8000.
PHARMACOLOGY
PHARMACODYNAMICS
The mechanism of action of sertraline is presumed to be linked to its
inhibition of CNS neuronal uptake of
serotonin (5HT). Studies at clinically relevant doses in humans have
demonstrated that sertraline blocks the
uptake of serotonin into human platelets. _In vitro_ studies in
animals also suggest that sertraline is a potent and
selective inhibitor of neuronal serotonin reuptake and has only very
weak effects on noradrenaline and
dopamine neuronal reuptake. _ In vitro_ studies have shown that
sertraline has no significant affinity to
adrenergic (alpha
1
, alpha
2
, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic
(5HT
1A
,
5HT
1B
, 5HT
2
) or benzodiazepine receptors; antagonism of such receptors has been
hypothesised to be
associated with various anticho