Paroxetine 30mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Paroxetine hydrochloride

Διαθέσιμο από:

Milpharm Ltd

Φαρμακολογική κατηγορία (ATC):

N06AB05

INN (Διεθνής Όνομα):

Paroxetine hydrochloride

Δοσολογία:

30mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04030300; GTIN: 8901175000166

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
PAROXETINE 20 MG FILM-COATED TABLETS
PAROXETINE 30 MG FILM-COATED TABLETS
Paroxetine
Pharmacode position may change as per Supplier’s m/c requirement &
additional
small pharma code may appear on the front / back panel
PAROXETINE
N10060
PAROXETINE
N10060
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 is and what it is used for
2.
What you need to know before you take Paroxetine
3.
How to take Paroxetine
4.
Possible side effects
5.
How to store Paroxetine
6.
Contents of the pack and other information
1.
WHAT PAROXETINE IS AND WHAT IT IS USED FOR
Paroxetine belongs to a group of medicines called Selective Serotonin
Reuptake Inhibitors
(SSRIs), which are antidepressants.
Paroxetine is used in the treatment of:
-
Depression (major depressive episodes).
-
Obsessive Compulsive Disorder (compulsive thoughts and compulsive
actions) (OCD).
-
Panic disorder with and without agoraphobia (e.g. fear of leaving the
house, entering
shops, or fear of public places).
-
Social phobia (overwhelming fear or avoidance of everyday social
situations).
-
Generalized anxiety disorder (more permanent present fear, in which
cronic nervous
worring is prominent).
-
Post-traumatic stress disorder(anxiety caused by a traumatic event).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PAROXETINE
Do not take Paroxetine
-
if you are allergic to paroxetine or any of the other ingredients of
this medicine (listed in
section 6)IF YOU ARE TAKING MEDICINES CALLED MONOAMINE OXIDASE
INHI

Αρχείο Π.Χ.Π.

OBJECT 1
Paroxetine 30mg Tablets
Summary of Product Characteristics Updated 30-Jun-2021 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Paroxetine 30 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 30mg paroxetine (as paroxetine
hydrochloride hemihydrate).
Excipient with known effect: anhydrous lactose 14.25mg /film-coated
tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Blue coloured film-coated capsule shaped, biconvex tablets debossed
with 'F' on one side and '12' on the
other side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of
- Major depressive episode.
- Obsessive Compulsive Disorder (OCD).
- 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
Method of administration
It