Modafinil 100 mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-09-2019
Summary of Product characteristics
(SPC)
25-09-2019
Active ingredient:
Modafinil
Available from:
Chanelle Medical
ATC code:
N06BA; N06BA07
INN (International Name):
Modafinil
Dosage:
100 milligram(s)
Pharmaceutical form:
Tablet
Administration route:
Oral use
Units in package:
Packs containing 30, 50, 60, 90 or 100 tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
Chanelle Medical
Therapeutic group:
Psychoanaleptics, centrally acting sympathomimetics
Therapeutic area:
Centrally acting sympathomimetics; modafinil
Therapeutic indications:
It is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy.
Authorization status:
Not marketed
Authorization date:
2015-06-12
Patient Information leaflet
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
MODAFINIL 100 MG TABLETS
MODAFINIL 200 MG 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 Modafinil is and what it is used for
2.
What you need to know before you take Modafinil
3.
How to take Modafinil
4.
Possible side effects
5.
How to store Modafinil
6.
Contents of the pack and other information
1.
WHAT MODAFINIL 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 MODAFINIL
DO NOT TAKE MODAFINIL
If you are ALLERGIC to modafinil, or to 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 Modafinil if you
Have any HEART PROBLEMS or HIGH BLOOD PRESSURE. Your doctor will need
to check
these regularly while you are taking Modafinil.
Have ever had DEPRESSION, LOW MOOD, ANXIETY, PSYCHOSIS (loss
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Summary of Product characteristics
Health Products Regulatory Authority
24 September 2019
CRN0095VR
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Modafinil 100 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of modafinil.
Excipients with known effect:
Each tablet contains 104 mg lactose.
Each tablet contains 2.5 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
The tablets are white to off-white, 12.65 mm x 5.55 mm capsule shaped
tablet embossed with ‘100’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Modafinil 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, one in the morning and one 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.
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).
_Renal impairment _
There is inadequate information to determine safety and efficacy of
dosing in patients with renal impairment (see section 5.2).
_Hepati
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