PAROTIN 20

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PAROXETINE AS HYDROCHLORIDE

متاح من:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC رمز:

N06AB05

الشكل الصيدلاني:

COATED TABLETS

تركيب:

PAROXETINE AS HYDROCHLORIDE 20 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CTS CHEMICAL INDUSTRIES LTD

المجال العلاجي:

PAROXETINE

الخصائص العلاجية:

Treatment of (in adults):* Major Depressive Disorder* Obsessive Compulsive Disorder (OCD)* Panic Disorder with and without agoraphobia* Social Anxiety Disorders/Social phobia* Generalised Anxiety Disorder* Post-Traumatic Stress Disorder

تاريخ الترخيص:

2020-09-30

نشرة المعلومات

PATIENT LEAFLET IN
ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a
doctor’s prescription only
PAROTIN 20 MG FILM-COATED
TABLETS
Each film-coated tablet contains:
Paroxetine (as Hydrochloride) 20 mg
For a list of inactive ingredients and
allergens see section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY
BEFORE USING THE MEDICINE. This
leaflet contains concise information
about the medicine. If you have any
other questions, refer to the doctor or
the pharmacist.
This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them even if it seems to you that
their medical condition is similar.
Antidepressants and anti-anxiety
medicines increase the risk of
suicidal behavior and thoughts in
patients up to the age of 25.
When beginning treatment with the
medicine, patients of all ages and
their relatives should pay attention to
behavioral changes such as:
worsening of the depression, suicidal
thoughts, aggressiveness and the
like. If such changes occur, contact
the doctor immediately.
1. WHAT IS THE MEDICINE
INTENDED FOR?
PAROTIN IS INTENDED FOR THE TREATMENT
OF ADULTS WITH MAJOR/CLINICAL
DEPRESSIVE DISORDER AND/OR ANXIETY
DISORDERS. The anxiety disorders that
Parotin is used to treat are: obsessive
compulsive disorder, panic disorder,
social anxiety, post-traumatic stress
disorder and generalized anxiety
disorder.
THERAPEUTIC CLASS:_ Selective serotonin _
_reuptake inhibitors (SSRI)._
It is not fully understood how Parotin
and other selective serotonin reuptake
inhibitors work, but they may help by
increasing the level of serotonin in the
brain. Proper treatment of depression
or anxiety disorders is important to help
you feel better.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
YOU ARE SENSITIVE (ALLERGIC) to
paroxetine or to any of the other
ingredients this medicine contains
(for the list of inactive ingredients
see section 6).
•
YOU ARE TAKING MEDICINES CALLED
MONOAMINE OXIDASE INHIBITORS
(MAOIs,

خصائص المنتج

PRESCRIBING INFORMATION
PAROTIN 20, PAROTIN 30
1.
NAME OF THE MEDICINAL PRODUCT
Parotin 20 tablets
Parotin 30 tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
)
as Hydrochloride
(
mg of Paroxetine
20
each tablet contains
:
20
Parotin
)
as Hydrochloride
(
mg of Paroxetine
30
contains
each tablet
:
30
Parotin
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Parotin 20: White to off-white round, bisected, biconvex film coated
tablets.
Parotin 30: White to off-white round, biconvex film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS:
Depressive disorders
Obsessive compulsive disorder
Panic disorder with or without agoraphobia
Social phobia
Generalised Anxiety Disorder
Posttraumatic stress disorder
CHILDREN AND ADOLESCENTS (<18 YEARS)
Paroxetine is not indicated for use in children or adolescents aged
<18 years (see 4.4 Special warnings and
precautions for use).
Controlled clinical studies in children and adolescents with major
depressive disorder failed to demonstrate
efficacy and do not support the use of paroxetine in the treatment of
depression in this population. (See 4.4
Special warnings and precautions for use)
The safety and efficacy of paroxetine in children aged <7 years has
not been studied.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that Parotin is administered once daily in the
morning with food. The tablet should be
swallowed whole or crushed and swallowed immediately.
DEPRESSIVE DISORDER:
_ADULTS _
The recommended dose is 20 mg daily. Some patients not responding to a
20 mg dose may benefit from dose
increases in 10mg/day increments, up to a maximum dosage of 50mg/day
according to the patient's response.
As with all antidepressant drugs, dosage should be reviewed and
adjusted if necessary within 2 to 3 weeks of
initiation of therapy and thereafter as judged clinically appropriate.
Patients with depression should be treated for a sufficient period to
ensure that they are free from symptoms.
This period may be several months.
OBSESSIVE