Paroxetine 20mg tablets

ประเทศ: สหราชอาณาจักร

ภาษา: อังกฤษ

แหล่งที่มา: MHRA (Medicines & Healthcare Products Regulatory Agency)

สารออกฤทธิ์:

Paroxetine hydrochloride

มีจำหน่ายจาก:

Genus Pharmaceuticals Ltd

รหัส ATC:

N06AB05

INN (ชื่อสากล):

Paroxetine hydrochloride

ปริมาณ:

20mg

แบบฟอร์มเภสัชกรรม:

Oral tablet

เส้นทางการบริหาร:

Oral

Class:

No Controlled Drug Status

ประเภทใบสั่งยา:

Valid as a prescribable product

สรุปสินค้า:

BNF: 04030300

แผ่นพับข้อมูลผู้ป่วย

approved for print/date
PROOF ROUND
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DATE SENT:
DATE RECEIVED:
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ORIGINATOR:
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DIMENSIONS:
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SUPPLIER:
NON PRINTING COLOURS
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[e-mail]
G. Worth
12/12/2019
18/02/2019
G. Worth
190 x 380
8 pt
Teva Zdravlje Serbia
13/12/2019
13/12/2019
PAROXETINE ALL STRENGTHS FILM-COATED TABLET PIL - UK
Black
Profile
BBBA7129
4
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
GTIN 13
(Belgium, Slovenia & Slovakia): n/a
Version 5
06.12.2019
German GTIN 14
(incorporating PZN): n/a
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PAROXETINE 20MG AND 30MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to
others. It may harm them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This
includes any possible side effects not listed in this leaflet. See
section 4.
IMPORTANT THINGS YOU NEED TO KNOW ABOUT PAROXETINE
IF YOU HAVE ANY CONCERNS ABOUT HOW YOU FEEL, OR ABOUT THIS
MEDICATION, IT IS IMPORTANT THAT YOU TALK TO YOUR DOCTOR - EVEN IF
YOU FEEL ANXIOUS OR WORRIED ABOUT DOING SO.
YOU MAY FIND IT HELPFUL TO TELL A FRIEND OR RELATIVE THAT YOU ARE
DEPRESSED OR SUFFERING FROM AN ANXIETY DISORDER, AND THAT YOU
HAVE BEEN PRESCRIBED THIS MEDICATION; IT MIGHT BE USEFUL TO SHOW
THEM THIS LEAFLET.
• PAROXETINE MAY NOT START TO WORK IMMEDIATELY. SOME PEOPLE
TAKING ANTIDEPRESSANTS MAY FEEL WORSE BEFORE FEELING BETTER.
YOUR DOCTOR MAY ASK TO SEE YOU AGAIN A COUPLE OF WEEKS AFTER
YOU START TREATMENT AND THEN REGULARLY U

สรุปลักษณะสินค้า

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paroxetine 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
20
mg
paroxetine
(as
paroxetine
hydrochloride
anhydrous).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Flat faced bevel edged off white round tablet, diameter 9.1mm,
inscribed 20
on one side with a score line. The tablet can be divided into equal
halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of:
•
Major Depressive Episode
•
Obsessive Compulsive Disorder
•
Panic Disorder with and without agoraphobia
•
Social Anxiety Disorders / Social phobia
•
Generalised Anxiety Disorder
•
Post – traumatic Stress Disorder
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
MAJOR DEPRESSIVE EPISODE
The recommended dose is 20 mg daily. In general, improvement in
patients
starts after one week but may only become evident from the second week
of
therapy.
As with all antidepressant medicinal products, dosage should be
reviewed and
adjusted if necessary within 3 to 4 weeks of initiation of therapy and
thereafter
as judged clinically appropriate. In some patients, with insufficient
response to
20 mg, the dose may be increased gradually up to a maximum of 50 mg a
day
in 10 mg steps according to the patient’s response.
Patients with depression should be treated for a sufficient period of
at least 6
months to ensure that they are free from symptoms.
OBSESSIVE COMPULSIVE DISORDER
The recommended dose is 40 mg daily. Patients should start on 20
mg/day and
the dose may be increased gradually in 10 mg increments to the
recommended
dose. If after some weeks on the recommended dose insufficient
response is
seen some patients may benefit from having their dose increased
gradually up
to a maximum of 60 mg / day.
Patients with OCD should be treated for a sufficient period to ensure
that they
are free from symptoms. This period may be several months or even
longer
(see section 5.1 Pharmacodynamic properties).
PANIC DISORDER
T