SERRAPRESS 20 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharma Dynamics (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS PAROXETINE HYDROCHLORIDE EQUIVALENT TO PAROXETINE 20,0 mg

Authorization status:

Registered

Authorization date:

2006-11-09

Patient Information leaflet

SERRAPRESS 20
_Each film coated tablet contains paroxetine _
_Pharma Dynamics (Pty) Ltd_
_ _
_hydrochloride equivalent to 20 mg paroxetine _
_ _
APPROVED PATIENT INFORMATION LEAFLET
_ _
Page 1 of 19
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S5
SERRAPRESS 20, Film coated tablets
Paroxetine
SERRAPRESS 20 contains sugar (Mannitol 133,6 mg)
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SERRAPRESS
20
•
Keep this leaflet. You may need to read it again._ _
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
healthcare provider._ _
•
SERRAPRESS 20 has been prescribed for you personally and you should
not share
your medicine with other people. It may harm them, even if their
symptoms are the
same as yours._ _
_ _
WHAT IS IN THIS LEAFLET
1.
What SERRAPRESS 20 is and what it is used for_ _
2.
What you need to know before you take/use SERRAPRESS 20
3.
How to take/use SERRAPRESS 20_ _
4.
Possible side effects_ _
5.
How to store SERRAPRESS 20_ _
6.
Contents of the pack and other information_ _
SERRAPRESS 20
_Each film coated tablet contains paroxetine _
_Pharma Dynamics (Pty) Ltd_
_ _
_hydrochloride equivalent to 20 mg paroxetine _
_ _
APPROVED PATIENT INFORMATION LEAFLET
_ _
Page 2 of 19
_ _
1.
WHAT SERRAPRESS 20 IS AND WHAT IT IS USED FOR_ _
Paroxetine (the active ingredient in SERRAPRESS 20) belongs to a group
of medicines called
SSRIs (selective serotonin reuptake inhibitors).
Everyone has a substance called serotonin in their brain. People who
are depressed or
anxious have lower levels of serotonin than others. It is not fully
understood how paroxetine
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.
SERRAPRESS 20 is used to treat a variety of emotional problems.
•
DEPRESSION
Continuing depression that interferes with your ability to function.
•
OBSESSIVE COMPULSIVE DISORDER (OCD)
A condition identified by unwanted, but stubbornly pe

Summary of Product characteristics

SERRAPRESS 20
_Each film coated tablet contains paroxetine _
_ Pharma Dynamics (Pty) Ltd _
_ _
_ _
_hydrochloride equivalent to 20 mg paroxetine _
APPROVED PROFESSIONAL INFORMATION
_ _
Page 1 of 26
SCHEDULING STATUS
S5
1. NAME OF THE MEDICINE
SERRAPRESS 20, Film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SERRAPRESS 20: Each film coated tablet contains paroxetine
hydrochloride equivalent to
paroxetine 20 mg.
SERRAPRESS 20 film coated tablets contains sugar (Mannitol 133,6 mg).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film coated tablet.
SERRAPRESS 20: White to off-white, round, coated, bi-convex film
coated tablets,
diameter 10 mm, scored on both walls and sides. Marked “P” on one
wall and “20” on the
other wall.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SERRAPRESS 20 is indicated for the treatment of:
•
depression
•
Obsessive Compulsive Disorder (OCD)
SERRAPRESS 20
_Each film coated tablet contains paroxetine _
_ Pharma Dynamics (Pty) Ltd _
_ _
_ _
_hydrochloride equivalent to 20 mg paroxetine _
APPROVED PROFESSIONAL INFORMATION
_ _
Page 2 of 26
•
social phobia
•
panic disorder
•
Generalised Anxiety Disorder (GAD).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DEPRESSION: 20 mg daily. This dose can be increased gradually, if
needed, by 10 mg
increments to a maximum of 50 mg daily, according to the patient’s
response.
PANIC DISORDER: The recommended dose is 40 mg daily. The initial
starting dose is 10
mg daily, which may be increased by 10 mg increments. The maximum dose
is 60 mg
daily.
The low initial starting dose is recommended to minimise the potential
worsening of panic
symptoms when initiating treatment with SERRAPRESS 20.
OBSESSIVE COMPULSIVE DISORDER: The recommended dose is 40 mg daily.
The initial
starting dose is 20 mg daily, which may be increased by 10 mg
increments to a maximum
of 60 mg daily.
SOCIAL PHOBIA: The recommended daily dose is 20 mg. This dose may be
increased
gradually, if needed, by 10 mg increments to a maximum of