Prosentio 100 mg tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Modafinil

Saatavilla:

Clonmel Healthcare Ltd

ATC-koodi:

N06BA; N06BA07

INN (Kansainvälinen yleisnimi):

Modafinil

Annos:

100 milligram(s)

Lääkemuoto:

Tablet

Prescription tyyppi:

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

Terapeuttinen alue:

Centrally acting sympathomimetics; modafinil

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2012-07-06

Pakkausseloste

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROSENTIO 100MG TABLETS
PROSENTIO 200MG TABLETS
MODAFINIL
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Prosentio is and what it is used for
2.
What you need to know before you take Prosentio
3.
How to take Prosentio
4.
Possible side effects
5.
How to store Prosentio
6.
Contents of the pack and orther information
1.
WHAT PROSENTIO IS AND WHAT IT IS USED FOR
The active ingredient in the tablets is modafinil.
Modafinil can be taken by adults who suffer from narcolepsy to help
them to stay awake. Narcolepsy
is a condition that causes excessive daytime sleepiness and a tendency
to fall asleep suddenly in
inappropriate situations (sleep attacks). Modafinil may improve your
narcolepsy and reduce the
likelihood that you will have sleep attacks but there may still be
other ways that you can improve your
condition and your doctor will advise you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROSENTIO
DO NOT TAKE PROSENTIO

if you are ALLERGIC to modafinil or any of the other ingredients of
this medicine (listed in section
6).

if you have an IRREGULAR HEARTBEAT.

if you have UNCONTROLLED, MODERATE TO SEVERE HIGH BLOOD PRESSURE
(hypertension).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Prosentio

if you have any HEART PROBLEMS or HIGH BLOOD PRESSURE. Your doctor
will need to check these
regularly while you are taking Prosentio.

if you have ever had DEPRESSION, LOW MOOD, ANXIETY, PSYCHOSIS (loss of
cont

Valmisteyhteenveto

Health Products Regulatory Authority
20 July 2022
CRN00CZZM
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prosentio 100 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg modafinil.
Excipient(s) with known effect:
Each tablet contains 53.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White to off white coloured, capsule-shaped tablet debossed with
‘M’on one side and ‘100 MG’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prosentio is indicated in adults for the treatment of excessive
sleepiness associated with narcolepsy with or without cataplexy
Excessive sleepiness is defined as difficulty maintaining wakefulness
and an increased likelihood of falling asleep in
inappropriate situations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by or under the supervision of a
physician with appropriate knowledge of indicated disorders
(see section 4.1).
A diagnosis of narcolepsy should be made according to the
International Classification of Sleep Disorders (ICSD2) guideline.
Patient monitoring and clinical assessment of the need for treatment
should be performed on a periodic basis.
Posology
The recommended starting daily dose is 200 mg. The total daily dose
may be taken as a single dose in the morning or as two
doses in the morning and at noon, according to physician assessment of
the patient and the patient's response.
Doses of up to 400mg in one or two divided doses can be used in
patients with insufficient response to the initial 200mg
modafinil dose.
Health Products Regulatory Authority
20 July 2022
CRN00CZZM
Page 2 of 10
Long-term use
Physicians prescribing modafinil for an extended time should
periodically re-evaluate the long-term use for the individual
patients as the long-term efficacy of modafinil has not been evaluated
(> 9 weeks).
Patients with renal impairment
There is inadequate information to determine safety and efficacy of
d