Seroxat 20mg/10ml liquid

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Paroxetine hydrochloride

Commercializzato da:

GlaxoSmithKline UK Ltd

Codice ATC:

N06AB05

INN (Nome Internazionale):

Paroxetine hydrochloride

Dosaggio:

2mg/1ml

Forma farmaceutica:

Oral suspension

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04030300; GTIN: 5000483752507

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEROXAT

20 MG/10 ML ORAL SUSPENSION
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 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_).
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
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 OXI

Scheda tecnica

OBJECT 1
SEROXAT 10MG TABLETS
Summary of Product Characteristics Updated 26-Apr-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Seroxat® 10 mg film-coated tablets.
Seroxat® 20 mg film-coated tablets.
Seroxat® 30 mg film-coated tablets.
Seroxat® 20 mg/10 ml oral suspension.
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg/20 mg/30 mg paroxetine (as
paroxetine hydrochloride
hemihydrate).
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
- 6 mg propyl parahydroxybenzoate
- 0.9 mg sunset yellow FCF(E110)
- 4 g sorbitol (E420).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Oral suspension.
10 mg tablet
White to pinkish-white, film-coated, oval tablets, debossed FC1 and
break bar on one side and debossed
GS and break bar on the other side.
The 10 mg tablet can be divided into equal doses if required.
20 mg tablet
White, film-coated tablet, oval shaped biconvex tablets debossed with
“Seroxat 20” or“20” on one side
and a break bar on the other.
The 20 mg tablet can be divided into equal doses if required.
30 mg tablet
Blue, oval shaped biconvex tablets debossed with “Seroxat 30”or
“30” on one side and a break bar on the
other. The break bar is only to facilitate breaking for ease of
swallowing and not to divide into equal
doses.
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 st