Paroxetine 40 mg, tabletten

Страна: Нідерланди

мова: голландська

Джерело: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активний інгредієнт:

PAROXETINEHYDROCHLORIDE 0-WATER SAMENSTELLING overeenkomend met ; ; PAROXETINE 40 mg/stuk

Доступна з:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

Код атс:

N06AB05

ІПН (Міжнародна Ім'я):

PAROXETINEHYDROCHLORIDE 0-WATER SAMENSTELLING overeenkomend met ; ; PAROXETINE 40 mg/stuk

Фармацевтична форма:

Tablet

Склад:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551)

Адміністрація маршрут:

Oraal gebruik

Терапевтична области:

Paroxetine

Дата Авторизація:

2005-12-20

інформаційний буклет

Paroxetine, NL/H/0453/001, 08.11.23
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rvg 33151 EU PIL IB/023 met NL info-tracked
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PAROXETINE 40 MG, TABLETTEN
paroxetine
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.
WHAT IS IN THIS LEAFLET
1.
What _Paroxetine 40 mg_ is and what it is used for
2.
What you need to know before you take _Paroxetine 40 mg_
3.
How to take _Paroxetine 40 mg_
4.
Possible side effects
5.
How to store _Paroxetine 40 mg_
6.
Contents of the pack and other information
1.
WHAT _PAROXETINE 40 MG_ IS AND WHAT IT IS USED FOR
_PAROXETINE 40 MG_ IS A TREATMENT FOR ADULTS WITH DEPRESSION AND/OR
ANXIETY DISORDERS.
The anxiety disorders that _Paroxetine 40 mg_ is used to treat are:
-
obsessive compulsive disorder (repetitive, obsessive thoughts with
uncontrollable behaviour),
-
panic disorder (panic attacks, including those caused by agoraphobia,
which is a fear of open spaces),
-
social anxiety disorder (fear or avoidance of social situations),
-
post-traumatic stress disorder (anxiety caused by a traumatic event),
-
generalised anxiety disorder (generally feeling very anxious or
nervous).
_Paroxetine 40 mg_ is one of a group of medicines called SSRIs
(selective serotonin re-uptake inhibitors). It is
not fully understood how _Paroxetine 40 mg_ and other SSRIs work but
they may help by increasing the level
of serotonin in the brain. Treating depression or anxiety disorders
properly is important to help you get
better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _PAROXETINE 40 MG _
DO NOT TAKE PAROXETINE 40 MG
-
IF YOU A

Характеристики продукта

Paroxetine, NL/H/0453/001, 08.11.23
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rvg 33151 EU SPC IB/023 met NL info-tracked
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Paroxetine 40 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg paroxetine (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Capsule shaped off white tablet with a score line.
The tablet can be divided into equal doses.
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 (OCD)
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
Paroxetine, NL/H/0453/001, 08.11.23
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rvg 33151 EU SPC IB/023 met NL info-tracked
sufficient period to ensure that they are free from symptoms. This
period may be severa