Plotis 30 mg film-coated tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

DAPOXETINE

Saadav alates:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC kood:

G04BX14

INN (Rahvusvaheline Nimetus):

DAPOXETINE 30 mg

Ravimvorm:

FILM-COATED TABLET

Koostis:

DAPOXETINE 30 mg

Retsepti tüüp:

POM

Terapeutiline ala:

UROLOGICALS

Toote kokkuvõte:

Licence number in the source country: NOT APPLICAPABLE

Volitamisolek:

Authorised

Loa andmise kuupäev:

2020-05-15

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PLOTIS 30 MG FILM-COATED TABLETS
PLOTIS 60 MG FILM-COATED TABLETS
Dapoxetine
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 Plotis is and what it is used for
2.
What you need to know before you take Plotis
3.
How to take Plotis
4.
Possible side effects
5.
How to store Plotis
6.
Contents of the pack and other information
1.
WHAT PLOTIS IS AND WHAT IT IS USED FOR
Plotis contains an active substance called ‘dapoxetine’. This
belongs to a group of medicines called
‘selective serotonin reuptake inhibitors’ (SSRIs). Dapoxetine may
also be known as a ‘urological’
medicine.
Dapoxetine increases the time it takes to ejaculate and can improve
the control over the ejaculation.
This may reduce the frustration or worry about fast ejaculation.
Plotis is used to treat premature ejaculation in adult men aged 18 to
64 years.
Premature ejaculation is when a man ejaculates with little sexual
stimulation and before the man
wants. This can cause problems for the man and may cause problems in
sexual relationships.
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PLOTIS
DO NOT TAKE PLOTIS:
-
If you are allergic to dapoxetine or any of the other ingredients of
this medicine (listed in section
6).
-
If you have heart problems, such as heart failure or problems with the
heart rhythm.
-
If you have a history of fainting.
-
If you have ever had mania (symptoms include feeling over-excited,
irritable or not being able to
think clearly) or severe depression.
-
If you are tak

Toote omadused

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PLOTIS 30 mg film-coated tablets
PLOTIS 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains dapoxetine hydrochloride equivalent
to 30 mg or 60 mg dapoxetine.
Excipient with known effect: lactose monohydrate.
Each 30 mg tablet contains 46.75 mg of lactose monohydrate.
Each 60 mg tablet contains 93.501 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
PLOTIS 30 mg
Buff, round, biconvex, film-coated tablets, embossed ‘MC’ on one
side with diameter of nucleus
6.5 mm.
PLOTIS 60 mg
Grey, round, biconvex, film-coated tablets, plain on both sides with
diameter of nucleus 8.0 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Plotis is indicated for the treatment of premature ejaculation (PE) in
adult men aged 18 to 64 years.
Plotis should only be prescribed to patients who meet all the
following criteria:
-
An intravaginal ejaculatory latency time (IELT) of less than two
minutes; and
-
Persistent or recurrent ejaculation with minimal sexual stimulation
before, on, or shortly after
penetration and before the patient wishes; and
-
Marked personal distress or interpersonal difficulty as a consequence
of PE; and
-
Poor control over ejaculation; and
Page 2 of 24
-
A history of premature ejaculation in the majority of intercourse
attempts over the prior 6 months.
Plotis should be administered only as on-demand treatment before
anticipated sexual activity. Plotis
should not be prescribed to delay ejaculation in men who have not been
diagnosed with PE.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men (aged 18 to 64 years) _
The recommended starting dose for all patients is 30 mg, taken as
needed approximately 1 to 3 hours
prior to sexual activity. Treatment with dapoxetine should not be
initiated with the 60 mg dose.
Dapoxetine is not intended for continuous daily use. Dapoxetine should
be taken only when sex