Seroxat 20 mg/10 ml oral suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paroxetine

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

N06AB; N06AB05

INN (International Name):

Paroxetine

Dosage:

20 milligram/ 10 millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Selective serotonin reuptake inhibitors; paroxetine

Authorization status:

Not marketed

Authorization date:

1998-05-06

Patient Information leaflet

Package leaflet : Information for the patient
SEROXAT 10 mg film‑coated tablets
SEROXAT
20 mg film‑coated tablets
SEROXAT 30 mg film‑coated tablets
paroxetine (as the hydrochloride hemihydrate)
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 SEROXAT is and what it is used for
2.
What you need to know before you take SEROXAT
3.
How to take SEROXAT
4.
Possible side effects
5.
How to store SEROXAT
6.
Contents of the pack and other information
1.
What Seroxat is and what it is used for
SEROXAT is a treatment for adults with depression and/or anxiety
disorders. The anxiety disorders that SEROXAT 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); and generalised
anxiety disorder (generally feeling very anxious or nervous).
SEROXAT is one of a group of medicines called SSRIs (selective
serotonin reuptake inhibitors). It is not fully understood how SEROXAT
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 Seroxat
Do not take SEROXAT
-
If you are taking medicines called monoamine oxidase inhibitors
(MAOIs, including moclobemide and me

Summary of Product characteristics

Health Products Regulatory Authority
03 February 2023
CRN00CW77
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seroxat 20 mg/10 ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of oral suspension contains 20 mg paroxetine (as paroxetine
hydrochloride hemihydrate).
Excipients with known effect
Each 10 ml of oral suspension contains:

20 mg methyl parahydroxybenzoate (E218)

6 mg propyl parahydroxybenzoate (E216)

0.9 mg sunset yellow FCF (E110)

(maximum) 2.7 g sorbitol (E420)

(typically) 283 mg maltitol (E965)

500 mg propylene glycol (E1520)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
A bright orange fairly viscous suspension having an odour of oranges,
free from foreign matter.
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
reco