Seroxat 20mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Paroxetine hydrochloride

Disponibil de la:

GlaxoSmithKline UK Ltd

Codul ATC:

N06AB05

INN (nume internaţional):

Paroxetine hydrochloride

Dozare:

20mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04030300; GTIN: 5000483553401

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEROXAT 10 MG, 20 MG AND 30 MG FILM-COATED TABLETS
PAROXETINE
SEROXAT
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_). 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 methylthioninium chloride (methylene blue)) or have
taken them at any

Caracteristicilor produsului

OBJECT 1
SEROXAT 20MG TABLETS
Summary of Product Characteristics Updated 19-Feb-2021 |
GlaxoSmithKline UK
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Seroxat 20 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 20 mg paroxetine (as paroxetine
hydrochloride hemihydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated 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.
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 recomm